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Pharmaceutical Processing is the leading source of pharmaceutical and biopharmaceutical manufacturing news. (To read some of Meg’s work, click here or scroll through the summaries of her stories below.)


Filling the Gap

Published September 2017

There is an unmet need in the CDMO marketplace, says Avista Pharma Solutions: stand-alone process chemical development support.

With 200,000 square feet of laboratory and manufacturing space, contract testing, development, and manufacturing organization Avista Pharma Solutions provides services from early drug development and drug product manufacturing to stand-alone analytical and microbiology testing support for the pharmaceutical, animal health, and medical device industries.

This cover story was published on Pharmaceutical Processing’s website and in the September/October 2017 print magazine.

(Photo courtesy of Avista Pharma Solutions)


Editor’s Note: Serialization – The Hurry Up and Wait Game

Published September 2017

In June, the U.S. FDA extended the Product Identifier Requirements under the Drug Supply Chain Security Act (DSCSA)—resulting in some of the biggest changes in 2017 for manufacturers. The previous implementation timeline dictated that all manufacturers must have serialized products after November 2017. Now, however, manufacturers have a ‘hard’ deadline of November 2018. Until then, the FDA does not plan to take action against unprepared companies.

This editor’s note was published on Pharmaceutical Processing’s website and in the September/October 2017 print magazine.


AstraZeneca Sells Remaining Anesthetics Portfolio to Aspen in $766M Deal

Published September 2017

Aspen Global Incorporated (AGI) is set to purchase the remaining rights to AstraZeneca’s portfolio of anesthetics for approximately $766 million.

In June 2016, AstraZeneca sold exclusive commercialization rights to its global anesthetics portfolio outside of the U.S. in a $770-million deal to Aspen.


Experts Comment on FDA’s DSCSA Serialization Extension: Manufacturers Now Have Until 2018

Published August 2017

As of June 30, 2017, the U.S. FDA extended the Product Identifier Requirements under the Drug Supply Chain Security Act (DSCSA).

The previous implementation timeline dictated that all manufacturers must have serialized products after November 2017.

According to the new Guidance document, titled Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry:

“FDA does not intend to take action against manufacturers who do not, prior to November 27, 2018, affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction into commerce as required by section 582(b)(2)(A) of the FD&C Act.”


Defining ‘Clean’: Cleanroom Operation Market Trends

Published July 2017

AES Clean Technology participates in an exclusive Q&A with Pharmaceutical Processing on cleanroom operations.

The pharmaceutical and biotechnology industries, according to Solid State Technology, occupy the second largest slot for cleanroom usage. These rooms, which maintain the concentration of airborne particles, control environmental factors such as air flow patterns, temperature, humidity, cleanliness, and pressurization—among others.

Founded in 1986, AES Clean Technology, Inc., based in Montgomeryville, Pennsylvania, designs, builds, and manufactures modular cleanrooms and custom cleanroom equipment for a variety of manufacturing facilities—including pharmaceutical, biotechnology, life sciences, and technology industries. The company complies with regulatory standards such as ISO, FDA, cGMP, and EU guidelines.

This feature story was published on Pharmaceutical Processing’s website and in the July/August 2017 print magazine.

(Photo courtesy of AES Clean Technology)


Continuous Manufacturing: A Practical Industry Solution?

Published July 2017

Over the last 50 years, continuous manufacturing technologies have been slow to advance, remaining relatively unchanged. However, there has been an uptick in recent years in the dialogue surrounding continuous manufacturing and its potential applicability in the pharmaceutical and biopharmaceutical industries.

At the forefront, the U.S. Food and Drug Administration (FDA) now encourages companies to incorporate continuous manufacturing into their processes, stating it has a strong impact on drug quality.

“We know that the FDA, which has been encouraging industry adoption of new manufacturing technologies as a means to improve and ensure quality, is a strong advocate of continuous manufacturing,” said Eric Jayjock, Director of Continuous Manufacturing at Patheon, a contract development and manufacturing organization (CDMO).

This feature story was published on Pharmaceutical Processing’s website and in the July/August 2017 print magazine.


Meeting Niche Market Needs: How a Small CDMO Excels Through Customization

Published July 2017

Spanish CDMO IDIFARMA finds home in niche generics and innovative drugs market—excelling in small batch sizes and packaging customization.

Founded in 2001, the Spanish contract development and manufacturing organization (CDMO) IDIFARMA was formed to serve the niche generics and innovative drugs market. Targeting the pharmaceutical and biotechnology markets, the company has worked with more than 500 active pharmaceutical ingredients (APIs) and in more than 100 complete drug development projects since its founding.

The company’s founders, three entrepreneurs, “anticipated the growth of outsourcing in the pharmaceutical industry as a means to optimize resources, investment, and client process costs,” said Manuel Leal Sánchez, Business Development Director at IDIFARMA. “Our growth as a company comes as a direct result of a clear business model that fits the needs of the market.”

This cover story was published on Pharmaceutical Processing’s website and in the July/August 2017 print magazine.

(Photo courtesy of IDIFARMA)


Microneedle Technology Makes a Splash in Drug Delivery Space

Published July 2017

Every year, companies are coming out with new, innovative drug delivery technologies, improving ease of access and design by modifying the devices for easy administration and the best possible drug absorption.

3M Drug Delivery Systems, a part of the Health Care Business Group of 3M, researches and develops new ways to deliver drugs to patients and (ultimately) manufactures those devices. The company offers a wide array of drug delivery technologies—inhalation, nasal, oral, topical, transdermal, and more.

“Our process begins with identifying the needs of both patients and drug manufacturers,” said Ethan Trepp, Global Marketing Manager, 3M Drug Delivery Systems Division. “Because we know each illness and drug treatment is unique, we partner with drug manufacturers to develop the best approach to address those unique challenges.”


INTERPHEX Live: Streamlining Operations Using AR/VR

Published July 2017

During this INTERPHEX Live video conference Meg LaTorre-Snyder, Editor of Pharmaceutical Processing, interviews Angelo Stracquatanio, Co-Founder, Apprentice Field Suite, about augmented and virtual reality technologies and their potential application in the pharmaceutical industry.


Editor’s Note: A Continued Push for Customization

Published July 2017

Another exciting year at INTERPHEX has revealed the hot topics on the tip of everyone’s tongue. Is it any surprise that ‘continuous manufacturing’ is one of them? During the INTERPHEX Live panel titled Continuous Manufacturing Opportunities Keep Expanding in Pharma, which will be available for viewing in late August, several industry experts—including Eric Jayjock, PhD, Director of Continuous Manufacturing, Patheon—spoke with moderator Russ Somma on the potential applications of continuous manufacturing.

This editor’s note was published on Pharmaceutical Processing’s website and in the July/August 2017 print magazine.


Q&A: Bayer Comments on Recent FDA Approval of Stivarga

Published June 2017

In April, it was announced that Stivarga® (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib) was approved by the FDA.

Mark Rutstein, Vice President of Oncology Clinical Development at Bayer, participated in an exclusive Q&A with Pharmaceutical Processing on the company’s latest FDA approval and other products coming down the pipeline.


Breast Milk: The Next Cancer Treatment?

Published May 2017

The benefits of breast milk have been studied for years, from things such as lowered asthma and allergy risk to fewer ear infections, respiratory illnesses, and diarrhea. Researchers now believe there is the potential to use a compound found in breast milk to treat cancer.

In 1995, a research group led by Professor Catharina Svanborg discovered that the compound nicknamed “HAMLET” found in human breast milk contains a substance that kills tumor cells without harming mature, healthy cells. This biological substance is formed by two molecules naturally present in breast milk, the protein alpha-lactalbumin and the lipid oleic acid.

Today, the small pharmaceutical company, HAMLET Pharma, continues its research, particularly on molecules that are naturally present in humans, called GRAS (Generally Regarded As Safe).


Drug Compounding: Too Dangerous to Address Rising Drug Prices?

Published May 2017

The Pew Charitable Trusts voices concerns that drug compounding could endanger the patients it seeks to help.

With the pharmaceutical industry working toward a means to bring down the price of drugs on the market, some eyes have been drawn to the potential of compounding pharmacies as one possible remedy.

“Compounding is a long-standing practice—as old as pharmacy itself—although it has evolved over time,” said Elizabeth Jungman, Director of Public Health Programs at The Pew Charitable Trusts, an independent, non-partisan research and policy organization with a long history of engagement in issues affecting public health, including drug safety and drug quality. “Compounded products are customized for patients whose clinical needs cannot be met by an approved or commercially available drug.”


Using Real-World Evidence to Propel Personalized Treatments, Improve Clinical Trial Outcomes

Published May 2017

Compared to 2006 when approximately 13 personalized treatment options were available, in 2014 that number increased to 113 personalized medicine drugs, treatments, and diagnostic products, according to the Personalized Medicine Coalition. Personalized medicine is becoming more prominent in the pharmaceutical and biopharmaceutical industries, with new technologies and research coming out constantly to make this vision a more tangible reality.

Deloitte Consulting, a company that provides audit, consulting, financial advisory, risk advisory, tax, and related services to public and private clients spanning multiple industries, released their first ever real world evidence (RWE) benchmark survey.


Amazon Considering Retail Pharmacy, Hires Team to Investigate Options

Published May 2017

CNBC reported on Tuesday that Amazon is considering breaking into the pharmacy market, hiring a general business manager to explore potential opportunities.

According to the article:

“For the last few years, Amazon has held at least one annual meeting at its Seattle headquarters to discuss whether it should enter the pharmacy business, says two people familiar with the company’s plans.

“But this year, with the rise of high-deductible plans and the trend toward consumers paying for health care, it is ready to get more serious.”

(Photo credit: Robert Scoble.)


Scottish Specialty CMO Thrives as ‘One-Stop-Shop’ Becomes the Trend

Published May 2017

CMO Symbiosis Pharmaceutical Services, a small-scale, niche sterile manufacturer, finds market sweet spot in the development and manufacturing of biologics, highly potent APIs, and small molecules.

“Although Scotland has a very vibrant life science community—covering biotech and traditional pharmaceutical—location is less of a factor than ever before,” said Colin MacKay, CEO, Symbiosis Pharmaceutical Services, a contract manufacturing organization (CMO) located in Stirling, Scotland. “With clinical trials conducted all over the world, the drug development sector is a truly global sector.”

Symbiosis Pharmaceutical Services was established in 2011 in order to address specific gaps in the sterile drug product manufacturing marketplace. The Scotland facility was designed with biologic and small molecule sterile production capabilities in mind to support biotech and specialty pharmaceutical companies worldwide that require small-scale injectable products made to comply with regulatory standards.

This cover story was published on Pharmaceutical Processing’s website and in the April/May 2017 print magazine.

(Photo courtesy of Symbiosis Pharmaceutical Services)


Q1 2017 Pharma Recall Trends

Published May 2017

Every quarter, Stericycle Expert Solutions publishes a Recall Index, which breaks down recalls in various industries: consumer products, automotive, pharmaceuticals, medical device, and food and beverage.

Information is gathered for this report using “cumulative data from the four primary federal agencies that oversee recalls in the United States,” which are:

  1. The Consumer Product Safety Commission (CPSC)
  2. The Food and Drug Administration (FDA)
  3. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA)
  4. The National Highway Traffic Safety Administration (NHTSA)

Michael Good, Vice President of Marketing and Sales Operations at Stericycle Expert Solutions, participated in an exclusive Q&A with Pharmaceutical Processing to go over some of the findings.


Drug Delivery, Development, & Supply: Catalent’s Journey as a Global CDMO

Published May 2017

Navigating the global pharmaceutical landscape with facilities across five continents.

By 2021, the drug delivery market is forecasted to reach approximately $1,700 billion—rising from $1,200 billion in 2016—one report by Markets and Markets projects. An increase in demand for biologics, drug delivery technology, and the prominence of chronic diseases are expected to drive this movement forward in the coming years.

With such a fertile ground for opportunity, many contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) have immersed themselves in drug delivery technologies along with traditional drug and biologic development and manufacturing. Headquartered in Somerset, New Jersey, CDMO Catalent Pharma Solutions is no exception.

This feature story was published on Pharmaceutical Processing’s website and in the March 22 edition of the 2017 INTERPHEX Show Daily.


Marchesini Group USA Celebrates 25 Years in Business

Published May 2017

An exclusive Q&A with the automatic packaging machinery manufacturer about the anniversary as well as pharmaceutical packaging trends.

Marchesini Group USA, a manufacturer of primary and secondary automatic packaging machinery, is celebrating their 25th anniversary this year. Originally founded in 1992, the company’s USA headquarters are located in West Caldwell, New Jersey and support North America as well as parts of the Caribbean.

Backed by a worldwide staff of 1,200 employees, the Marchesini Group USA has a full range of equipment, including cartoners, blister and deep draw thermoformers, form/fill/seal machines, labelers, vial, ampoule filling-stoppering closing units and sterilization/depyrogenation tunnels, and solutions for track and trace/serialization.

Roger Toll, executive vice president, Marchesini Group USA, participated in an exclusive Q&A with Pharmaceutical Processing on the milestones leading to this year’s anniversary as well as industry trends in pharmaceutical packaging.

This feature story was published on Pharmaceutical Processing’s website and in the March 21 edition of the 2017 INTERPHEX Show Daily.


DSCSA Implementation: A Wholesaler’s Perspective

Published March 2017

Signed into law on November 27, 2013, the Drug Supply Chain Security Act (DSCSA) doesn’t just affect U.S. pharmaceutical manufacturers. It also will have an impact on wholesale distributors and third-party logistics providers. In particular, it will require the establishment of licensure standards and annual reporting of information to the FDA. By November 2019, distributors will be required to have implemented traceability at their operations.

In the first phase of the DSCSA, wholesale distributors were tasked to trade only with authorized partners; to send and receive transaction information, transaction history, and transaction statements; to quarantine and investigate suspect drugs; to notify the FDA and other stakeholders of any illegitimate drugs; and to meet the FDA licensing requirement.

AmerisourceBergen, one of the big three pharmaceutical wholesale distributors, has helped to shape the implementation of the DSCSA in the pharmaceutical supply chain.

This feature story was published on Pharmaceutical Processing’s website and in the March 2017 print magazine.


CMO Roundtable: What’s Next for the Contract Manufacturing Industry

Published March 2017

An exclusive roundtable with Cambrex and West Pharmaceutical Services, Inc. on contract manufacturing as a whole, how the space has changed, upcoming trends, as well as what the industry will look like in the coming years.

2016 saw a continued increase in outsourcing manufacturing operations to contract manufacturers in order for pharmaceutical companies to cut back on in-house costs and capacity while maintaining quality and improving time to market. With increased pressures for companies to reduce cost while still expanding core competencies (such as R&D) and marketing, outsourcing continues to make a name for itself in the industry.

A number of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) have expanded their offerings to meet market demands, becoming even more versatile as the demand for a greater availability of drugs and swifter drug approvals increases (with more regulations in place).

This cover story was published on Pharmaceutical Processing’s website and in the March 2017 print magazine.

(Photo courtesy of West Pharmaceutical Services, Inc.)


A CDMO with Forensic Insight

Published February 2017

Juniper Pharma Services’ story—from formulation experts to specialist CDMO.

“Juniper Pharma Services was initially born as Molecular Profiles back in the late 90s,” said Claire Madden-Smith, BSc PhD, Senior Vice President, Juniper Pharma Services. “It was founded to take some higher-end analytical tools to understand how and why formulations were working and how and why formulations were failing.”

A subsidiary of Juniper Pharmaceuticals, Juniper Pharma Services is a contract development and manufacturing organization (CDMO) based in Nottingham, UK that produces oral and topical drug products for clinical trials, supporting pharmaceutical and biotechnology companies worldwide.

“We were able to look at the properties of formulations in a way that wasn’t at that point in time standard in the pharmaceutical industry,” she continued.

This cover story was featured on Pharmaceutical Processing’s website and in the January/February 2017 print magazine.

(Photo courtesy of Juniper Pharma Services.)


Lyophilization: The Basics

Published February 2017

Lyophilization, defined as a freeze-drying process that removes water from a product after it is frozen and placed under a vacuum, is often messy, but filled with possibilities for potential applications.

Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredient (chemical or biologics found in nature), protein, collagen, peptide, oligonucleotide, chemical API, enzymes, and mAbs.

This feature story was featured on Pharmaceutical Processing’s website and in the January/February 2017 print magazine.


Compounding Pharmacies to Compete with Pharma Manufacturers?

Published February 2017

As the media pressures the pharmaceutical industry to offer the same high-quality drugs at lower prices, industry experts actively seek ways to meet this growing demand. And the answer isn’t always from where you might expect.

With companies such as Mylan making headlines for its price hike of the EpiPen—from $100 in 2007 to more than $600 in 2016—many companies are turning to their internal operations and assessing where money can be saved and the ultimate cost of the drug cut (while not impacting overall revenue). However, the answer may not be within pharmaceutical companies alone.

Big pharmacies, such as Walgreens, have increased their pharmaceutical compounding operations, preparing personalized medications for patients at a lower price and without the need for a drug supply from pharmaceutical companies (on select medications).

This feature story was featured on Pharmaceutical Processing’s website and in the January/February 2017 print magazine.


INTERPHEX: What’s in Store for 2017

Published January 2017

It’s hard to believe that INTERPHEX 2017 is nearly here. Set to take place on March 21-23, INTERPHEX will be housed at the Javits Center in New York City.

Pharmaceutical Processing will once again be partnering with INTERPHEX to put on INTERPHEX Live, a live Q&A panel hosted by a moderator who guides the speakers through tough industry questions.

INTERPHEX Live will take place at the Crystal Palace inside the Javits Center, which is located behind the registration area. The videos will be broadcast throughout the show floor during the three show days and shared on Pharmaceutical Processing and INTERPHEX’s respective social media pages after the show.

(To view the 2016 panels, click here.)

Check out our intro video on INTERPHEX Live and what’s in store for 2017!


Trump Moves to Repeal & Replace Obamacare in a Matter of Weeks

Published January 2017

On Tuesday, President-elect Donald Trump announced his intention to repeal the Affordable Care Act (ACA), saying that he hopes to see Congress repeal it as soon as possible and pass a replacement health law.

Trump moves to repeal Obamacare swiftly—within days—and have a replacement very shortly thereafter. “Long to me would be weeks,” Trump said, aiming to replace a health law that took approximately two years to pass in a matter of weeks.

“We have to get to business,” Trump told The New York Times. “Obamacare has been a catastrophic event.”


Takeda to Acquire Ariad in a $5.2B Deal, Expanding Oncology Portfolio

Published January 2017

Takeda Pharmaceutical Company Limited announced on Monday, 1/9, its intentions to acquire Ariad Pharmaceuticals in a deal with a $5.2 billion price tag, with each Ariad share amounting to $24 cash. The deal, unanimously approved by the board of directors, is expected to close in February.

“The acquisition of ARIAD is a unique opportunity that will enable us to positively impact the lives of more patients worldwide, advance our strategic priorities and generate attractive returns for our shareholders,” said Christophe Weber, President and Chief Executive Officer of Takeda. The company will broaden its hematology portfolio and add two target therapies for the treatment of solid tumors.


Dedusting & Polishing in Capsule Manufacturing

Published January 2017

Each year, capsules become increasingly more sophisticated. With various types of capsules available—such as hard and soft gelatin capsules, enteric coated capsules, sustained release capsules, and rectal capsules—pharmaceutical manufacturers must not only select which type of capsule ensures the most advantageous delivery of their drug product, but they must also navigate (and be attentive to) the operational best practices for this method of delivery.

Nic Michel, General Manager, North America, for Pharma Technology Inc.—a company that designs and manufactures specialty dedusters, metal detecting devices, and loading systems for tablet- and capsule-producing machinery—participated in an exclusive Q&A with Pharmaceutical Processing. His edited responses are below.


New Synthetic Pathway Discovered to Manufacture Cannabinoid API

Published December 2016

On December 1, Nemus Bioscience announced that the company found a synthetic pathway to manufacture tetrahydrocannabinol-valine-hemisuccinate (THCVHS), including the ability to scale-up production. The research was done in conjunction with Albany Molecular Research Inc., Nemus’ API contract developer and manufacturer. Furthermore, the API exceeded the FDA’s purity requirements.

Catalent Pharma Solutions is set to begin formulation work for the candidate product, NB2111, which is indicated for managing chemotherapy-induced nausea and vomiting (CINV). The company’s other candidate product, NB1111, is also a cannabinoid compound but is intended for the treatment of glaucoma.

Dr. Brian Murphy, CEO of Nemus Bioscience, participated in an exclusive Q&A with Pharmaceutical Processing on the company’s recent breakthrough.


The Benefits of Continuous Manufacturing

Published December 2016

An exclusive Q&A with CONTINUUS Pharmaceuticals on continuous manufacturing operational best practices and trends for 2017.

Continuous manufacturing is a trend in the pharmaceutical market that seems to always be at the forefront of the news. With the FDA giving the thumbs up to companies transitioning from batch to continuous manufacturing, such as Johnson & Johnson, one thing has become apparent: this is one trend that isn’t going away any time soon.

Bayan Takizawa, MD, MBA, Co-Founder & Chief Business Officer of CONTINUUS Pharmaceuticals—a spin-out of the Novartis-MIT Center for Continuous Manufacturing—participated in a Q&A with Pharmaceutical Processing on continuous manufacturing operational best practices as well as trends for 2017. His edited responses are below.


Print Inspection Best Practices

Published December 2016

Exclusive Q&A with GlobalVision on print inspection best practices in the pharmaceutical industry.

Operations in the pharmaceutical industry are complex—and rightly so. Pharmaceutical packaging is no exception. Vast amounts of information are required to be present on any given pharmaceutical product. But with so much information squeezed into that tiny space, there is always the risk that the packaging could potentially harbor a number of errors that can render the product defective and mandate its removal from the market.

Mike Malz, Marketing & Creative Director of GlobalVision, participated in an exclusive Q&A with Pharmaceutical Processing on best practices for print inspection in the pharmaceutical industry. His edited responses are below.


Capsugel Comments on Lonza Acquisition

Published December 2016

On Thursday, December 15, Lonza Group AG and Capsugel announced that the two companies have entered into a definitive agreement, under which Lonza will acquire Capsugel from KKR for $5.5 billion in cash (including refinancing an existing Capsugel debt of approximately $2 billion).

A Capsugel spokesperson participated in a brief Q&A with Pharmaceutical Processing on this new development.

(Photo courtesy of Capsugel.)


Understanding Serialization Challenges

Published December 2016

TraceLink reveals webinar survey findings about how companies have adapted to lot-level requirements and DSCSA serialization deadlines.

The Drug Supply Chain Security Act (or the DSCSA) is a name that seems to be on everyone’s lips these days. With 2016 teetering to a close—and the looming November 2017 deadline coming ever nearer—many companies are making fast and furious plans to finalize their serialization implementation efforts.

On Tuesday, December 13, TraceLink and Actionable Research hosted a webinar titled “Global Drug Supply, Safety and Traceability Report: Using 2015 Lot-Level Learnings to Understand Future Serialization Challenges.” The companies surveyed 331 professionals in the pharmaceutical industry, including pharmaceutical manufacturers, wholesale distributors, hospitals, and pharmacies in an attempt to understand lot-level compliance challenges.


Biosimilar Waiting Game Continues as Supreme Court Ducks Review

Published December 2016

On December 12, the U.S. Supreme Court declined to hear Apotex’s case about whether biosimilar companies must wait six months following federal approval before bringing a biosimilar to market, an article in Reuters reports.

According to the article: “The justices opted not to take up Apotex Inc’s appeal of a July federal appeals court ruling that could delay the Canadian generic drug maker’s launch of so-called biosimilar versions of California-based Amgen Inc’s Neulasta, used to fight infection in cancer patients.”


Global Pharma Market Roundtable: China vs. Ireland

Published December 2016

Two of today’s emerging markets in the pharmaceutical space, China and Ireland, continue to make a mark on the global market as a whole, while operating independently and excelling in diverse areas.

Although certain markets tend to dominate the news sphere, the pharmaceutical industry is truly a global one—with many countries contributing research, resources, and (ultimately) new drugs. However, countries continue to fight for dominance in the pharmaceutical space.

According to both the Association of the British Pharmaceutical Industry (ABPI) and World Atlas, the top three global pharmaceutical markets are presently the U.S., Japan, and China. ABPI reports that, as of 2013, the U.S. was worth approximately 340 million, with Japan coming to 94 million, and China close on its heels at 87 million. CPhI projects China, in particular, to reach $150 billion worldwide in 2016. The country currently covers 40 percent of global API production and is the world’s largest producer of pharmaceutical ingredients. By 2020, some experts predict that China will become the leading player in Asia.


AstraZeneca to Cut 700 U.S. Positions

Published December 2016

AstraZeneca revealed plans to eliminate 700 positions, including 120 positions from the company’s headquarters in Fairfax, Delaware.

The company announced the layoffs just a few weeks before the holidays on Thursday, December 8:

“We will reduce US Commercial Business expenses, which includes the elimination of approximately 700 positions (roughly 80 of those will come from existing vacancies) and a reduction in discretionary spend. The impacted positions are across the US organization, including the company’s North America Commercial headquarters, and some field-based sales and field-based non-sales roles. This reduction will contribute to the planned decline in Core SG&A costs in FY 2016 and FY 2017, as previously announced in February of this year.”


Ireland Vies for the EMA’s Relocation to Dublin

Published December 2016

Oliver O’Connor, CEO of Irish Pharmaceutical Healthcare Association (IPHA), discusses what the Brexit means for the pharmaceutical industry and what could be coming next for the EMA.

On June 23, 2016, the citizens of the UK voted to break away from the European Union (EU)—leading to what has been termed as the ‘Brexit’ (or British exit). One of the potential impacts of the Brexit is the relocation of the European Medicines Agency (EMA), which is currently headquartered in London.

Unable to be located in a non-EU member state, the EMA—should the UK formally notify the EU of its intention to separate—will be forced to relocate from London to another location. And many industry professional in Ireland are vying for that relocation to be to Dublin.

(Image editorial credit: Gordon Bell/Shutterstock.com)


Trump Announces Intention to Bring Down Drug Prices in Person of the Year Interview

Published December 2016

Time magazine has named President-elect Donald Trump the person of the year. In his interview, Trump addressed the rise in biotechnology stocks after the announcement of his election, saying that (contrary to popular belief) he intends to “bring down drug prices.” Despite what many investors and experts in the pharmaceutical industry believed, Hillary Clinton wasn’t the only presidential candidate with intentions to change the way the pharmaceutical industry operates.


Sanofi Considers a Counterbid for Actelion, Challenging J&J for Biotech Company

Published December 2016

According to Bloomberg, a counterbid for Actelion Ltd. might be in the cards for Sanofi, which would rival an offer made by Johnson & Johnson (J&J) last week.

J&J’s original bid on November 24 was kept under wraps—with neither company commenting on the offer.

Actelion is currently valued at $17 billion. The biotech company has a portfolio of pulmonary arterial hypertension (PAH) treatments, including oral, inhaled, and intravenous.


INTERPHEX 2017 Exhibitor List Continues to Grow

Published December 2016

With approximately 15 weeks until INTERPHEX 2017, a number of companies have committed to exhibiting at the upcoming trade show, which will take place on March 21-23 at the Javits Center in New York City.

The 2017 exhibitors, a list of which can be found on INTERPHEX’s website, include companies such as:

  • MG America
  • Pall Life Sciences
  • MilliporeSigma
  • NJM Packaging
  • GE Healthcare
  • Thermo Fisher Scientific
  • And many more

There are, however, a number of new exhibitors set to attend INTERPHEX 2017, including companies such as Boron Molecular Inc. and CapsCanada.


Cold Chain Solution: Additives that Stabilize Vaccines at Room Temperature for Weeks

Published December 2016

One of the main contributing factors to low immunization coverage in remote areas and developing countries is due to having to store vaccines at 2-8°C, according to Doctors Without Borders. Shipping these vaccines in a temperature-controlled supply chain is both a logistical and a financial challenge, and one that often prevents patients from receiving these much-needed vaccines.

In order to avoid this obstacle, EPFL’s Supramolecular Nanomaterials and Interfaces Laboratory (SUNMIL) researchers have come up with three vaccine additives, the findings of which were published in Nature Communications, which stabilized vaccines at room temperature for several weeks or, in some cases, months.


Boehringer Ingleheim Eliminates 244 Jobs, Closes Small-Molecule Discovery Operations

Published December 2016

Boehringer Ingelheim has confirmed that the company will cut an additional 244 jobs in the U.S.

The confirmation follows a 720-job cut in the U.S. last summer, with most of the recent job eliminations (three-quarters) coming from the company’s U.S. headquarters in Ridgefield, CT.


Teva to Cease Operations at Manufacturing Facility, Slashing 200+ Jobs

Published November 2016

Before the end of 2017, Teva Pharmaceutical Industries will be laying off more than 200 workers.

Currently employing 540 workers at its Bulebel plant and 180 workers in Hal Far, the company will be laying off approximately 210 workers between the two plants, respectively, as a result of its “European restructuring,” according to an article in Malta Today.


West Deepens Roots in Ireland with Multiple Facility Expansions

Published November 2016

Big changes are on the horizon for the contract manufacturing sector of West Pharmaceutical Services.

On Tuesday, November 29, West Pharmaceutical Services announced a 60,000-square-foot expansion of its contract manufacturing facility in Dublin, Ireland. In addition, the contract manufacturing branch of West, known as The Tech Group, will now be using the West branding.


Waiting Out the Different Phases of the DSCSA

Published November 2016

The industry continues to hold its breath in preparation for the implementation of the latter phases of the Drug Supply Chain Security Act (DSCSA).

November 2017 marks the second phase of the DSCSA (where manufacturers have to serialize their products), and many companies are only now getting preparations underway for the first phase.

“We’re seeing what we call the ‘long tail,’” said Peter Sturtevant, Sr. Director, Industry Engagement, Pharmaceuticals, GS1 US. “Smaller manufacturers who are just starting down the journey of serialization understand the requirements of the legislation, but some are waiting to understand implementation best practices in the next phase of DSCSA before they roll it out.”


Pfizer Announces $200M Facility Plans in St. Louis, Adding 80 Jobs

Published November 2016

Pfizer announced plans to retain more than 450 employees as well as create an additional 80 jobs in St. Louis County, Missouri at a new R&D site, estimated at $200 million.

Planned for a 2020 completion, the new R&D site will be a state-of-the-art facility located in St. Louis County for Pfizer’s R&D and process development operations.

Operating in St. Louis County for more than 13 years, Pfizer currently possesses R&D labs, manufacturing operations, and office space at two different locations in the county for its biotherapeutics and vaccine development.


AbbVie Ends Development Program with Halozyme After Phase 1 Study Failure of Humira Formulation

Published November 2016

AbbVie has discontinued a development program with biotechnology company Halozyme Therapeutics after a phase 1 study did not achieve its target results.

Halozyme announced AbbVie’s discontinuation of the development program using Halozyme’s ENHANZE™ platform technology and the tumor necrosis factor alpha (TNF-alpha) target on Monday, November 21. The company said in a statement: “Halozyme and AbbVie will continue to work collaboratively to identify additional targets for co-development under their 2015 Global Collaboration and Licensing agreement. TNF-alpha was the first nominated target of nine included as part of the agreement.”


Clinical Trial Innovations

Published November 2016

An exclusive Q&A with label vendor, Schreiner MediPharm, on the supply of drugs for clinical trials, important aspects of investigational product appearance, drug labeling, clinical trial innovations, and more.

Clinical trials are a standardized (and important) element of the drug development process—their phases, design, and duration are all things that are well-monitored and well-understood. There are constantly innovations and changes implemented into the process with the hopes of improving the various aspects of clinical trials, such as patient medication adherence.

Schreiner MediPharm, a company that develops and produces specialty labels and self-adhesive marking solutions, has a hand in the pharmaceutical clinical trials, as many of their products are utilized therein.

(Photo courtesy of Schreiner MediPharm.)


Former Private Investigators Sue GSK after ‘Misleading’ Information Lands Them in Chinese Prison

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Published November 2016

GlaxoSmithKline is being sued by two former private investigators, claiming that GSK misled them to investigate an innocent person, which ended in the investigators’ imprisonment.

In 2013, the two private investigators were detained. An article in The New York Times reveals that the private investigators, Peter Humphrey (British) and his wife Yu Yingzeng (American)—who were investigating potential fraud and bribery on behalf of GSK—were in their home in Shanghai when two dozen officers stormed in, confiscated all of their files, and they were then brought to detention house (undergoing a harsh interrogation).


Implementing Serialization

Published November 2016

An exclusive Q&A with American Health Packaging on implementing serialization, understanding the DSCSA regulations, and challenges for companies up and down the pharmaceutical supply chain.

“Serialization” is a word that is on everyone’s lips in the pharmaceutical industry. As of November 2017, manufacturers will be required to have serialized their products, with more deadlines coming in quick succession thereafter.

Many companies have expressed their concerns regarding the implementation of the Drug Supply Chain Security Act (DSCSA) regulations, as well as voiced a number of questions—many of which are as yet unanswered.


Is an FDA Reform in the Cards with a Trump Presidency?

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Published November 2016

In the 2016 U.S. presidential election, it seemed as though healthcare and pharmaceuticals took a (surprising) backseat position.

Democratic nominee Hillary Clinton took a more decisive role in that she expressed intentions to address drug pricing, while Republican nominee Donald Trump—although he agreed drug pricing was an issue—focused primarily on repealing the Affordable Care Act (ACA) and replacing it with another policy. Though, what that substitute would be, no one knows.

Some pharmaceutical industry experts say, however, that Trump’s election is a “positive for the (pharmaceuticals) sector,” since much of the aggressive legislation is off the table. Though, other experts predict that the pharmaceutical industry will still undergo some semblance of a drug pricing reform.


INTERPHEX 2017 Preparations Underway

Published November 2016

Even as the fall gives way to the chilly winds of winter, preparations for the International Pharmaceutical Expo (INTERPHEX) are underway.

INTERPHEX, the trade show focused on pharmaceutical, biopharmaceutical, biotechnology, and medical device industries, will take place on March 21-23, 2017 at the Javits Center in New York City.

2016 saw an increase in attendance—18 percent for pharmaceutical engineers, specifically, and 4.5 percent for total attendance—with attendees and exhibitors from 48 states and 52 countries. The exhibit hall featured more than 600 suppliers, and the technical education programs were also a huge success, including Pharmaceutical Processing and INTERPHEX’s INTERPHEX Live—a series of live video panels.


Cannabinoid-Based Therapies Find a Home in the Pharma Industry

Published November 2016

Despite legal restrictions that have limited research into the potential medical applications of cannabis across the world, the synthetic cannabinoid market is on the rise.

The majority of clinicians are in favor of using medical marijuana to treat certain disease states, according to a survey conducted by NEJM. In this same survey, 76 percent of participants world-wide voted in favor of using marijuana for medicinal purposes even though the use of marijuana is still illegal in most of these countries. In North America, specifically, 78 percent voted in favor of medical marijuana use.

GBI Research’s latest white paper reports that—despite legal restrictions that have limited research into the potential medical applications of cannabis across the world—the synthetic cannabinoid market is on the rise.


Trump’s Election Impacts the Pharma Market: But for Good or Ill?

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Published November 2016

After the world held its breath on Tuesday, November 8—awaiting the outcome of the U.S. presidential election—the resulting rippling effect has impacted a number of markets, the pharmaceutical industry included.

According to FirstWord Pharma, shares of the following European and Indian pharmaceutical companies rose with the announcement of the election of Donald Trump:

  • Novo Nordisk: 6.5 percent increase
  • Roche: 5 percent increase
  • Sanofi: 3 percent increase
  • Shire: 5 percent increase
  • Bayer: 3 percent increase
  • Hikma Pharmaceuticals: 7 percent increase

PACK/Pharma Expo Q&A: Processing, Tableting, & Packaging Equipment

Published November 2016

Pharmaceutical Processing created a questionnaire to learn more about Romaco North America Inc., their technologies, and some of the upcoming trends they are seeing in the industry. Romaco is an exhibitor at PACK/Pharma Expo 2016. Charles Ravalli, Managing Director of Romaco North America Inc., answers our questions.


PACK/Pharma Expo Q&A: Pharmaceutical Packaging on a Global Scale

Published November 2016

Pharmaceutical Processing created a questionnaire to learn more about Maruho Hatsujyo Innovations (MHI), their technologies, and some of the upcoming trends they are seeing in the industry. MHI is an exhibitor at PACK/Pharma Expo 2016. Greg Zaic, President and Chief Executive Officer for MHI, answers our questions.


Pharmaceutical Recall Trends in 2016

Published November 2016

In 2016, pharmaceutical recalls went up in Q2—though, it was down compared to historical trends in 2004, according to Stericycle ExpertSOLUTIONS’ quarterly Recall Index.

“The Recall Index is a quarterly analysis of the ‘what’ and ‘why’ behind recall activity in the U.S.,” said Michael Good, Vice President, Stericycle ExpertSOLUTIONS. Focusing on five industries—pharmaceuticals, automotive, consumer products, medical devices, and food and beverage—the Recall Index compiles data from all of the major U.S. government agencies that order product recalls.

Good participated in a Q&A with Pharmaceutical Processing to discuss the findings of the Recall Index as well as trends in pharmaceutical recalls. His edited responses are below.


The Building Blocks of Pharmaceutical Traceability

Published November 2016

Like any other great movement in history, sometimes looking back is the best way to help us look forward.

The Drug Supply Chain Security Act (DSCSA) was enacted in November 2013 by Congress, which has set off a series of changes for companies all along the pharmaceutical supply chain.

“What the pharmaceutical industry is focusing on now is the next major U.S. milestone, which is November of 2017, where the manufacturers are having to put a serial number with the GS1 DataMatrix sometimes referred as a 2D barcode,” said Peter Sturtevant, GS1 US Senior Director, Pharmaceuticals.

This feature story was featured on Pharmaceutical Processing‘s website and in the November/December 2016 print magazine.

(Photo courtesy of Oncobiologics.)


Finding Your Niche as a CDMO

Published November 2016

CDMO Tapemark possesses not only a broad range of capabilities in transdermal patches and oral thin films, but also a Midwestern commitment to personalized service.

All contract development and manufacturing organizations (CDMOs) as well as contract manufacturing organizations (CMOs) have a niche—a special place in the market where their expertise and offerings are entirely unique to their company and surpass that of their competition. For some companies this could be expertise in handling potent drugs, for others this could be their all-inclusive offerings, while yet for others it could be their R&D and preclinical research capabilities.

For CDMO Tapemark, it is their knowledge in transdermal patches and oral transmucosal thin films for the pharmaceutical and medical device markets, along with their Midwestern commitment to personalized service.

This cover story was featured on Pharmaceutical Processing‘s website and in the November/December 2016 print magazine.

(Photo courtesy of Tapemark.)


Understanding Biosimilars

Published November 2016

Despite how far we have come, there is still ample room to grow.

Biosimilars have come a long way since their initial entry in the U.S. on March 6, 2015. However, with a number of unanswered questions (such as pricing, availability, and interchangeability) and a lack of understanding in the marketplace, biosimilars still have so much opportunity to grow in prominence in the U.S.

This feature story was featured on Pharmaceutical Processing‘s website and in the November/December 2016 print magazine.

(Photo courtesy of Oncobiologics.)


Valeant in Advanced Discussions with Takeda to Sell Salix for $10B

Published November 2016

Valeant Pharmaceuticals is in advanced discussions with Takeda Pharmaceutical to sell its Salix Pharmaceuticals subsidiary for $10 billion, according to The Wall Street Journal.

The purchase price of Salix, Valeant’s stomach-drug business, would include approximately $8.5 billion in cash as well as future royalty payments to Valeant.

Valeant purchased Salix in 2015 for approximately $11 billion. Salix makes treatments for stomach-related disorders, including irritable bowel syndrome and diarrhea.

However, there is no guarantee the two companies will reach an agreement.


Diabetes Drug Adherence: Injectables vs. Oral Medication

Published October 2016

In adults, types 2 diabetes accounts for 90-95 percent of diagnosed cases of diabetes. In the U.S., 29.1 million people are estimated to have diabetes, with an approximate 8.1 million people who aren’t aware of their condition.

To manage their diabetes, the CDC reports that 50.3 percent of patients take pills only, 17.8 take insulin only, and 13 percent take both pills and insulin. But how many of those patients, regardless of the medication they are prescribed, are actually adhering to their prescribed dosages?


Generic Drug Prices on the Rise?

Published October 2016

Generic drugs prices are on the rise, and the possible reasons why are stirring up heated discussions.

Accounting for approximately 80 percent of all prescriptions, generic drugs that have been around for years have recently seen a spike in price.

CBS News cites an analysis by Pembroke Consulting, which “found nearly 10 percent of generics more than doubled in price in the past year.” In an article by Forbes, researchers found that 222 drug groups increased in price by 100 percent or more between November 2013 and November 2014 in a research sample of 4,421 (generic) drug groups. “There are also some extreme cases (17 drug groups) where price increases of more than 1000% were seen,” the author adds.


NEXUS Day 1: A Deeper Look into the DSCSA & Traceability

Published October 2016

Boasting a broad range of attending companies such as Eli Lilly, Patheon, Pfizer, Amgen, Sanofi, and others, NEXUS 2016 kicked off with an extensive coverage of the supply chain, the Drug Supply Chain Security Act (DSCSA), serialization, and mastering global traceability.

Serialization is “one step in a much longer journey ahead of us,” said Shabbir Dahod, President and CEO, TraceLink. Transforming the supply chain is going to take “not just a lot of individual work, but a lot of collaboration as well.”


Mylan to Pay $465M Over Medicaid EpiPen Rebate Dispute

Published October 2016

To settle allegations that it overbilled Medicaid for the EpiPen, which has been incorrectly classified as a generic product under the Medicaid health program for the poor and disabled since late 1997, Mylan has agreed to pay a $465 million.

It has been questioned whether Mylan underpaid U.S. government healthcare programs by “misclassifying its EpiPen emergency allergy treatment, which has come under intense scrutiny after a series of drastic price increases,” said Reuters.


Novartis Cuts More Jobs, Closes Swiss & Chinese Locations, Relocates Tropical Disease Institute

Published October 2016

In an effort to centralize control over its drug discovery programs and contain costs, Novartis is cutting 175 jobs and closing some of its research operations in Switzerland and China. The company will also be relocating its Institute for Tropical Diseases in Singapore to California, enabling scientists to work on infectious diseases from one location.

“The move is part of a broader, global strategic plan,” Novartis said.


Lawmakers Misled: EpiPen Profits Are 60% Higher Than What Mylan Disclosed to Congress

Published September 2016

Less than a week past, Mylan CEO Heather Bresch spoke before the House Oversight Committee on Capitol Hill in Washington, where she defended the cost for EpiPens—infuriating unconvinced lawmakers for the company’s reason behind the more than 500 percent price increase since 2007.

According to AP: “[i]n almost four hours of questioning, the soft-spoken CEO at times seemed unsure, or declined to answer directly, when asked questions about the company’s finances and profits, angering lawmakers.”


FDA Approves Amgen’s Biosimilar of Humira

Published September 2016

On Friday, 9/23, the FDA approved the first biosimilar version of AbbVie’s Humira.

Developed by Amgen, Amjevita™ (adalimumab-atto) has been approved to treat the following inflammatory diseases:

  • Moderate-to-severe rheumatoid arthritis
  • Moderate-to-severe polyarticular juvenile idiopathic arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Moderate-to-severe chronic plaque psoriasis
  • Adult moderate-to-severe Crohn’s disease
  • Moderate-to-severe ulcerative colitis

Risk Mitigation & Management in the Pharmaceutical Industry

Published September 2016

“As we operate in a highly regulated environment, being on top of all possible high-risk areas is essential,” said Robert Nass, Head of Quality & Regulatory Management, MilliporeSigma.

Critical aspects to risk mitigation/management in the pharmaceutical industry, according to Nass, are having:

  • Global systems and oversight in place
  • Local assessments by multidisciplinary teams and subject matter experts
  • Regular evaluation

“The key is to get a sound understanding of the processes,” Nass explained.


Allergan to Acquire Tobira, Securing NASH Drugs for $1.7B

Published September 2016

Allergan has entered into an agreement to acquire Tobira Therapeutics in a deal worth approximately $1.695 billion.

Tobira is a clinical-stage biopharmaceutical company that develops therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases. NASH is commonly associated with obesity and type 2 diabetes.


Capsugel Expands Micronization Capabilities Through Quakertown Facility Expansion

Published September 2016

Capsugel announced in early September that the company will be expanding the capacity and capabilities of its Quakertown, PA facility to increase its micronization services output for clinical and commercial manufacturing—the very same facility that Capsugel acquired in January of this year.

Capsugel acquired Xcelience and Powdersize in January 2016, the latter of which its Quakertown facility originated from. Providing particle-size reduction and particle-size control/classification technologies, the acquisition of Powdersize expanded Capsugel’s suite of bioavailability enhancement tools.

But with the expansion close on the heels of the acquisition, not only will the company have additional capacity for manufacturing operations, but product lead times are expected to improve by up to 75 percent.

(Photo courtesy of Capsugel.)


Allergan to Acquire Vitae for $639M

Published September 2016

Allergan has entered into a definitive agreement to acquire Vitae Pharmaceuticals Inc. for $639 million, which was unanimously approved by the Boards of Directors of both companies.

Vitae, a development-stage biotechnology company, is based in Fort Washington Pennsylvania and does not currently have a product on the market.

This acquisition will add a number of dermatology products to Allergan’s dermatology product pipeline.


Fette Compacting America Celebrates 25 Years of Operation

Published September 2016

On Thursday, 9/8, Fette Compacting America Inc. celebrated 25 years of operation.

Fette Compacting America Inc., a subsidiary of the German-based manufacturer, Fette Compacting GmbH, was founded in 1991 and is a leader in precision tablet press technology. Headquartered in Rockaway, NJ, the company’s serves clients in the United States, Canada, and Puerto Rico.


How One CDMO Stays on Top by Expanding Expertise Through Acquisitions

Published September 2016

Patheon’s journey as an industry leader in the CDMO/CMO space—how they continue to expand their development and manufacturing services each year, while increasing the quantity of drugs they manufacture.

“The CDMO market, overall, is currently around a $40 billion-dollar industry. It’s growing at a seven percent rate,” said Rebecca Holland New, Corporate Office and EVP, Enterprise Operations, Patheon. “Today, Patheon can address 75 percent of that business.”

Headquartered in Durham, North Carolina, Patheon Inc. is an international contract development and manufacturing organization (CDMO) with a broad range of services and capabilities from preclinical and clinical, to development, to scale-up, to commercial supply. There are approximately 8,000 employees worldwide.

This cover story was featured on Pharmaceutical Processing‘s website and in the September/October 2016 print magazine.

(Photo courtesy of Patheon.)


Growth Strategies Open New Risks in Biopharma

Published September 2016

With so many saturated markets, many pharmaceutical/biopharmaceutical companies look to expand their operations to other drug products or entirely different regions, in general. However, manufacturers face countless challenges as they enter into new and unfamiliar geographies, replenish pipelines, and broaden their offerings into novel areas such as gene and cell therapies (which require more complex development and production).


U.S. Government Promises Takeda Up to $312M to Develop Zika Vaccine

Published September 2016

In the ongoing fight against Zika, the Biomedical Advanced Research and Development Authority (BARDA) has chosen to support Takeda Pharmaceutical Company’s Zika vaccine development, promising as much as $312 million in potential funding.


Continued Corporate Makeover: Novartis Disbands Cell & Gene Therapy Unit

Published September 2016

Novartis announced on Wednesday that it is shutting down its Cell and Gene Therapy unit and “reintegrating activities” from these units into the wider organization, which will eliminate approximately 120 jobs.

However, according to Novartis, most of these employees will be reassigned to other areas.

Despite this move, Novartis assures the public that it remains committed to its cancer-fighting CAR-T cell program.


Shkreli Comments on EpiPen Price Hike, Mylan CEO Has 671% Salary Increase

Published August 2016

As the media is stirring up over the price hike of Mylan’s EpiPen—from $100 for a two-pen set in 2007 to more than $600 in 2016—a number of voices are speaking out on the issue, Martin Shkreli being one of them.

Most well-known for his endorsed price hike of Turing’s antiparasitic drug Daraprim (used to treat toxoplasmosis and prevent infections such as malaria and HIV) from $13.50 to $750 per tablet, Shkreli is making his opinions about EpiPen’s price tag known—even as Congress demands a response from Mylan as to why the price for the EpiPen has skyrocketed.

(Photo courtesy of Intropin.)


Congress Gets Involved, Demands Answers from Mylan for EpiPen Price Hike

Published August 2016

As school season is about to begin, members of Congress express concern over the soaring prices of Mylan’s EpiPen, voicing the complaints of anxious parents.

According to an article in the New York TimesSenator Charles E. Grassley, spoke out on Monday (8/22), sending a letter to Mylan, which produces EpiPens, demanding an explanation for the 400 percent price increase.


Pfizer Acquires Medivation in $14B Deal

Published August 2016

Pfizer announced a definitive merger agreement to acquire the cancer drug company Medivation in a deal with a $14 billion-dollar price tag—adding Medivation’s oncology portfolio to Pfizer’s offerings.

Paying $81.50 per Medivation share (a 21 percent premium to Friday’s closing stock price), Pfizer’s purchase comes at the end of months of bidding for Medivation. According to reports, Pfizer wasn’t the only company interested in acquiring Medivation—Sanofi, Merck, Celgene, and Gilead Sciences also expressed interest. Three months ago, Medivation rejected a “$9.3 billion takeover bid from the French drugmaker Sanofi, saying that offer, worth $52.50 per share, undervalued the company,” AP said.


U.S. Court Ruling: Pfizer’s Biosimilar Doesn’t Infringe J&J Remicade Patent

Published August 2016

The District of Massachusetts Federal Court has determined that the patent for Johnson & Johnson’s Remicade (infliximab) is invalid—ruling in favor of Celltrion and Pfizer’s Hospira, who are seeking to bring a cheaper version of the drug onto the market.

With $6.6 billion in sales last year ($4.5 billion of which was in the U.S.)—and arguably Johnson & Johnson’s biggest product—the patent for Remicade will end in September of 2018, leaving the door wide open for competitors. Remicade is indicated for the treatment of numerous autoimmune disorders, including Crohn’s disease, ulcerative colitis, and rheumatoid arthritis.


The Origin of Single-Use Technologies: Part 2

Published August 2016

Significant headway has been made in standardizing offerings and processes of single-use technologies—particularly since the early days of bioprocessing companies utilizing large-scale, food bag manufacturing lines in their pharmaceutical facilities.

The term ‘savings’ has also become inextricably linked with ‘single-use,’ leaving many companies with the notion that this technology has the lowest price tag in all circumstances. But that isn’t always the case.


Study Finds Sanofi’s Drug Causes Birth Defects, French Government Denies Hiding Results

Published August 2016

A study on Sanofi’s epilepsy drug, which was found to cause birth defects, appears to have been concealed by French health authorities.

According to the Associated Press, the French health authorities deny having concealed a study on a drug used to treat epilepsy—the findings of which showed that the drug caused birth defects. Other sources claimthat authorities delayed the publication of the study.


Despite Mounting Financial Losses in Q2, Valeant Says Turnaround Will Happen

Published August 2016

Despite a $302 million net loss for its second quarter and being approximately $30 billion in debt, Valeant Pharmaceuticals’ executives assure the public that things will “get better.”

According to Valeant’s second quarter 2016 financial results, the financial state of the company has certainly looked better:

  • Since its highest close in August of 2015 (at $262.52), Valeant’s stock has continued to fall—itscurrent rate being $22.45
  • In Q2 of 2016, Valeant reported a $302 million net loss, which is almost six times more than Q2 of 2015
  • Falling from $2.73 billion to $2.42 billion, the company’s revenue has decreased 11 percent in Q2 of 2016

Bristol-Myers’ Blockbuster Drug Fails to Meet Endpoint in Lung Cancer Study, Shares Drop

Published August 2016

Bristol-Myers Squibb’s stock market value dropped $20 billion on Friday (approximately 16 percent) after the company’s blockbuster cancer drug failed to extend its usage for lung cancer patients in a key study.

Opdivo, Bristol’s cancer drug, is already approved to treat melanoma and lung cancer—though, only after chemotherapy. It is intended to “bolster the immune system so that patients can better fight cancer.” Costing approximately $12,900 each month (per patient), the treatment was originally approved in 2014 to treat melanoma, but U.S. regulators have expanded its use to include “patients whose lung cancer worsened after trying chemotherapy, as well as patients with kidney cancer and a type of lymphoma,” an article in The Wall Street Journal reports.


CVS Health Shortens Formulary List, Excluding 35 More Drugs

Published August 2016

CVS Health intends to remove 35 drug products used to treat patients with cancer, diabetes and hepatitis C from its standard 2017 formulary in order to address the financial impact of costly medications.

According to CNBC, this announcement came on the heels of Express Scripts’ release of the list of drugs that will be excluded next year from their formulary. CVS’ removal, however, now includes a total of 155 medications, whereas Express Scripts’ list excludes a total of 85 products.


New Treatment Tackles Functional Dyspepsia: Medical Food

Published August 2016

New treatments are emerging daily for countless conditions and diseases—pills and injectables being the foremost of these. But there is also another category of treatments that has been causing a stir in the healthcare market: medical food.

According to the FDA, medical food is “intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Other definitions of medical food explain that this specially formulated treatment is intended “for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone.”

(Photo courtesy of IM HealthScience.)


The Origin of Single-Use Technologies: Part 1

Published August 2016

Single-use technologies have made headlines across the pharma/biopharma manufacturing space—with countless education sessions devoted to this very topic at trade shows across the world.

With this household name commonly darting across digital screens or cropping up in workplace discussions, the origin of single-use technologies may fade from memory as new innovations are introduced to the market.


Keryx Halts Supply of Kidney Drug Due to Production-Related Issue at Contract Manufacturer

Published August 2016

There will be an interruption in the supply of Keryx Biopharmaceuticals’ Auryxia® (ferric citrate) tablets, the company’s kidney drug, on account of a production-related issue converting active pharmaceutical ingredient (API) to finished drug product at its contract manufacturer.

As a result of this interruption of supply, the company has exhausted its reserve of finished drug product and the current inventories of Auryxia aren’t enough “to ensure uninterrupted patient access to this medicine.”


Big Changes on Horizon for GSK: CEO to Retire, Investments in UK, & New HIV Drugs on the Way

Published July 2016

There’s a lot of big changes on the horizon for the pharmaceutical giant GlaxoSmithKline (GSK) in the coming year.

The company announced yesterday that it plans to invest approximately $360 million into three plants in Britain—which comes as a surprise on the heels of the announcement of the Brexit and the resulting concerns companies have expressed with the pharmaceutical climate in the UK going forward.


Medical Marijuana: A Potential Treatment for Alzheimer’s?

Published July 2016

According to a study published in npj Aging and Mechanisms of Disease, tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis, assists in the removal of toxic plaque in the brain, which is a common symptom of the disease.

“Cannabinoids such as tetrahydrocannabinol [THC] stimulate the removal of intraneuronal Aβ [beta amyloid], block the inflammatory response, and are protective,” researchers reported. By blocking inflammation, THC helps to prevent damages to the neurons in the brain.


Gilead’s Q2 Profit Plummets After Launch of Generics & Alleged Hep. C Drug Scandal

Published July 2016

Gilead’s profits have dropped approximately $1 billion, according to the company’s Q2 announcement Monday. Going from $4.5 billion in profits in 2015 to $3.5 billion in 2016, the second quarter earnings aren’t looking as bright as the company may have hoped.

It may come as no surprise to some after recent events, such as AHF’s ad campaign: “Gilead Scandal: Gay Men, We Don’t Care About Your Kidneys and Bones.” The ad campaign was to draw attention to the Gilead’s patent manipulation of its best-selling HIV drug, according to revelations in an LA Times article.


The Events Leading to the Brexit & What It Means for Pharma’s Future

Published July 2016

Since the world-changing vote on June 23rd, where UK citizens opted to break away from the European Union (EU), countless questions have arisen as to the referendum’s impact on the UK going forward—as well as what this means for the pharmaceutical and biopharmaceutical industries.

The ‘Brexit’ (or British exit) was a result of a referendum, where 30 million people voted—52 percent in favor of leaving the EU.


DSCSA Implementation: Steps & Challenges

Published July 2016

The Drug Supply Chain Security Act (DSCSA) was signed into law in November of 2013—enacted with the ultimate goal of better visibility across the U.S. pharmaceutical supply chain. Despite a government-mandated, multi-year timeline for implementation, many industry experts are left questioning how to achieve and sustain unit-level traceability.

Don Eberts, Senior Manager for Clarkston Consulting, participated in an exclusive interview with Pharmaceutical Processing on the DSCSA implementation steps and its inherent challenges. His edited responses are below.

This article was featured on Pharmaceutical Processing‘s website and in the July 2016 print issue.


A CMO with a Hand in Parenteral Drugs

Published July 2016

BioPharma Solutions, as the contract manufacturing business unit of Baxter, has the advantage of Baxter’s more than 80 years of parenteral expertise and a manufacturing network of more than 50 facilities across six continents. Founded in 1931, Baxter was the first manufacturer of commercially-prepared intravenous (IV) solutions and has since had a hand in parental delivery systems, sterile contract manufacturing solutions, and various drug categories, such as small molecules, biologics, and vaccines.

This cover story was featured on Pharmaceutical Processing‘s website and in the July 2016 print issue.

(Photo courtesy of Baxter Biopharma Solutions.)


What’s Driving Personalized Medicine

Published July 2016

According to the PMC (Personalized Medicine Coalition), approximately 75 percent of cancer drugs are ineffective in patients. In addition, 70 percent of Alzheimer’s drugs, 50 percent of arthritis drugs, and 43 percent of diabetes are, on average, insufficient to treat these conditions, as they too are ineffective for patients.

Genentech Inc., a biotechnology company and subsidiary of Roche as of 2009, is a leader in biologics manufacturing and has a hand in personalized medicines. Josina Reddy, M.D., Ph.D., Senior Group Medical Director for Genentech, participated in an exclusive Q&A with Pharmaceutical Processing to discuss some of the driving factors of personalized medicine.

This article was featured on Pharmaceutical Processing‘s website and in the July 2016 print issue.

(Photo courtesy of Genentech.)


New Complexities in the Pharmaceutical Supply Chain: Cellular Therapies, the DSCSA, & More

Published July 2016

As time goes on and researchers search for new treatments, one thing has become abundantly clear—a one-size-fits-all approach to treating patients doesn’t always work. Such a revelation leads to innovations, like personalized medicines.

This blog was featured on Pharmaceutical Processing‘s website and in the July 2016 print issue.


EpiPen Price Skyrockets, Lack of Competition

Published June 2016

For people who suffer from allergies and anaphylaxis, it appears the price of EpiPens are on the rise—with many people attributing the increased cost to lack of competition.

For more than 25 years, the EpiPen auto-injector has been the most prescribed epinephrine auto-injector in the U.S.

“EpiPen is like Kleenex. Doctors write [prescribe] EpiPen,” said Don Bukstein, an Allergist at Allergy, Asthma and Sinus Center. “There was some competition in the field and then one of the devices went off the market.”

(Photo courtesy of Intropin.)


Chemotherapy: Making Treatment More Tolerable

Published June 2016

The Wall Street Journal published a video, titled Making Chemo More Tolerable, where news anchor Tanya Rivero interviews reporter Jeanne Whalen on Lunch Break about chemotherapy.

“Chemotherapy actually just means chemical therapy. Technically, that could mean any sort of drug made by chemicals,” explained Whalen. “But usually doctors use it to refer to older cancer medicines that are designed to work by killing fast-growing cells in the body.”


New Route of Administration for Opioid Overdose Antidote

Published June 2016

In 2014, 28,000 people died from an opioid overdose (including both prescription opioids and heroin), according to the CDC. The “opioid epidemic” as it has come to be termed is a household topic and a worldwide problem that experts in the pharmaceutical industry are endeavoring to address. The CDC has detailed several methods to prevent abuse of opioids, such as prescription drug monitoring programs and patient education safely storing and disposing prescription opioids.

According to a study published in Annals of Internal Medicine, when patients were prescribed an overdose antidote with painkillers, there were fewer painkiller-related visits to the emergency room. The study investigates the use of an opiate antidote, naloxone, which is used to block the effects of opioids and reverse an overdose. Naloxone is (usually) a prescription medicine and can treat emergency overdoses on drugs, such as heroin and prescription painkillers (morphine, codeine, oxycodone, methadone, and Vicodin).

(Photo courtesy of Adapt Pharma)


FDA Unearths Counterfeit Scam: Drugs with Bogus FDA Labels

Published June 2016

The owner of a small company in Cranston, R.I. was recently charged and convicted of falsely labeling preretail medical products, money laundering, and immigration fraud in federal court. Arif Diwan, 60, owner of Cranston, Lifescreen LLC, pled guilty to the scam, which was carried out between 2012 and 2015.

What’s interesting about this whole situation wasn’t that Diwan held illegal operations to sell foreign-made drugs, but that he bought drugs manufactured in India, faked these drugs being FDA-approved and made in the U.S., and then proceeded to sell them in other countries (rather than the U.S.).


The U.K. Votes to Leave the EU, Impacts Pharma

Published June 2016

The U.K. citizens have voted and the results are in—the U.K. will be leaving the European Union (EU).

The U.K. Prime Minister David Cameron announced his resignation after the ‘Brexit’ (British exit) and addresses the British voters on leaving the EU.

Before the party conference in October, Britain will have a new Prim Minister, Cameron said.

According to the voting results on The Guardian, 48 percent of the U.K. citizens voted to remain (16,141,241 votes), while 52 percent voted to leave (17,410,742 votes).


How Will Pharma Be Impacted by the EU Referendum Vote?

Published June 2016

On Thursday, June 23, U.K. voters will head to the poles for the European Union (EU) referendum, deciding whether Britain should leave or remain in the EU.

The referendum is being held after Prime Minister David Cameron promised to hold one should he win the 2015 general election, which was “in response to growing calls from his own Conservative MPs and the UK Independence Party (UKIP), who argued that Britain had not had a say since 1975, when it voted to stay in the EU in a referendum,” according to an article in BBC News.


Study: Industry-Sponsored Meals Increase Physician Prescribing Patterns of Brand Name Drugs

Published June 2016

Doctors receiving an industry-sponsored meal prescribe brand-name drugs at significantly higher rates to Medicare patients.

Not only is the way to our hearts through our stomach, but it is also the key to getting physicians to prescribe a brand-name drug to their Medicare patients, according to a study published in JAMA Internal Medicine.

Every pharmaceutical company—once their drug has made it through clinical trials and is available commercially—is eager to get their drugs into the hands of patients who could benefit from these medications. And what stands between these drugs and the patients? Their physicians.


The State of the Biosimilars Industry

Published June 2016

Biosimilars continue to gain momentum in the U.S. To date, two biosimilars have been approved in the U.S., with many more in production and going through clinical trials.

“Two biosimilars have been approved, both with full extrapolation across all indications of the reference product (for which there was not existing exclusivity), demonstrating the U.S. Food and Drug Administration (FDA) is experienced and comfortable with the 351 (k) approval pathway,” said Bertrand Liang, M.D., Ph.D., M.B.A., Founding Chief Executive Officer (CEO) of Pfenex and Chair of the Generic Pharmaceutical Association Biosimilars Council.

But, as we know, biosimilars are not new to the pharmaceutical industry—only to the U.S. pharmaceutical market as of 2015. With this youthful emergence, many industry experts and consumers yet remain in the dark as to what biosimilars truly are. According to a survey by PricewaterhouseCoopers (PwC), 67 percent of consumers do not know what a biosimilar is.


Opinion Leaders Still Skeptical About Biosimilars

Published June 2016

Biosimilars have the potential to change the way the biopharmaceutical market operates. But the real question is—why haven’t they?

A 2015 survey conducted by APCO Insight has discovered that the answer lies in opinion leaders and health care providers—and what they don’t know about biosimilars. When asked how similar or different is a biosimilar to the original biologic medicine, 29 percent of opinion leaders and 36 percent of health care providers answered “in-between” in 2015.

Furthermore, there was an evident lack of understanding about various properties of biosimilars—particularly relating to ingredients and production method. According to APCO Insight, “[l]ess than one third [of respondents] confirm the difference between biosimilars and biologics completely matches their understanding of biosimilars, and even fewer indicate their understanding that biologics made by different manufacturers are different from each other.”


Judge Vetos Merck’s $200M Hep C Patent Win Over Gilead Due to ‘Fabricated’ Testimony

Published June 2016

A federal judge has reversed a jury’s verdict, which had Gilead Sciences paying $200 million to Merck & Co. for patent infringement over a drug compound that cures hepatitis C. According to sources, the judge concluded that Merck was involved in misconduct while trying to obtain patents for hepatitis C drugs.

In March, the jury had originally awarded Merck $200 million after hearing R&D evidence of Pharmasset—a company Gilead bought in 2011. However, U.S. District Judge Beth Labson Freeman reopened the case last month when Gilead offered additional evidence of Merck’s misconduct.


New Smartphone App for Clinical Trial Enrollment

Published June 2016

It has been estimated that a mere five to ten percent of eligible adults enroll in clinical trials, while only five percent of those who do participate complete the trial. In addition, two-thirds of trials are either never fully recruited or are late in their recruitment—six months behind, on average.

To address this issue, a University at Buffalo researcher has developed a smartphone app designed to boost recruitment.


Why Novartis Invested in an R&D Facility in Shanghai, Despite Challenges

Published June 2016

Novartis’ Shanghai R&D facility, a $1 billion research center that has been in the works since 2009, officially opened its doors this week. Novartis also has two other R&D centers, which are located in Cambridge, Mass., and Basel, Switzerland.

Ten years ago, many companies were drawn to China on account of lower salaries among their scientists. Today, however, companies are tasked with a challenge in the Chinese pharmaceutical market: government pressure on drug prices.


Syncing Science and Manufacturing

Published June 2016

MilliporeSigma announced an expansion of its Carlsbad, California facility, which is scheduled to be completed in 2016. In order to meet the demand for viral and gene therapy products, the Carlsbad campus will increase from 44,000 square feet to 65,000 square feet, with 16 modular viral bulk manufacturing cleanroom suites, two fill/finish suites, and twice the warehouse capacity.

Martha S. Rook, Ph.D.—Head of Novel Therapies at MilliporeSigma—participated in an exclusive Q&A regarding their new facility as well as what needs to happen in order to bring science and manufacturing in sync.

(Photo courtesy of MilliporeSigma)


Large Price Cuts on Three Top-Selling Drugs in China

Published Pay 2016

On Friday, May 27, Chinese health authorities announced price cuts on three top-selling patented drugs of more than 50 percent, which is part of the Chinese government’s effort to make medicines more affordable.

According to an article in Reuters: “[i]n exchange for the negotiated price reductions, drug companies can expect to sell much bigger volumes in the cost-conscious Chinese healthcare system.” The price cut is an effort by the government to make healthcare more affordable for patients.


Best Practices for Pharmaceutical Waste

Published May 2016

As more and more pharmaceutical companies launch into new projects, an even greater amount of pharmaceuticals are secreted into the environment. “Sustainability” has become commonplace in operational discussions; however, companies are still working toward that end.

According to statistics reported by WHO, 15 percent of waste generated by health-care activities is considered to be hazardous: infectious, toxic, or radioactive.

With the EPA’s proposed regulation scheduled to take effect at some point in 2016, pharmaceutical waste disposal processes at facilities are going to change.

(Photo courtesy of Mass Innovation Labs)


MilliporeSigma Wins Efficiency Champion Award at INTERPHEX 2016

Published May 2016

On April 26, 2016, the first day of INTERPHEX, six winners were announced for the competitive INTERPHEX Exhibitor Awards.

Janice Lloyd Simler, Global Product Manager for Single-Use Upstream Systems at MilliporeSigma, participated in an exclusive Q&A with Pharmaceutical Processing to talk about the company’s INTERPHEX Exhibitor Award, the Efficiency Champion award.


Videojet Wins Best Technological Innovation Award at INTERPHEX 2016

Published May 2016

On April 26, 2016, the first day of INTERPHEX, six winners were announced for the competitive INTERPHEX Exhibitor Awards.

Sascha Ammesdoerfer, Laser Business Manager Videojet Technologies Inc. participated in an exclusive Q&A with Pharmaceutical Processing to talk about the company’s INTERPHEX Exhibitor Award, the Best Technological Innovation award.

(Photo courtesy of Videojet)


The Evolving Biosimilars Market: 2016 Expected to Be a Pivotal Year

Published May 2016

The biosimilar industry, as many of you well know, has undergone an instrumental change in the U.S. over the past year.

According to PwC’s (PricewaterhouseCoopers’) industry report: “[f]inally entering the US market, biosimilar drugs have the potential to be as disruptive as generic drugs following the Hatch-Waxman Act of 1984.”

Michael Wyand, DVM, PhD, Chief Technical Officer of EPIRUS Biopharmaceuticals—a biopharmaceutical company that specializes in the global development and commercialization of biosimilar monoclonal antibodies (mAbs)—participated in an exclusive Q&A with Pharmaceutical Processing about the biosimilar landscape in 2016.


Novartis Splits Drug Division in Two

Published May 2016

On May 17, Novartis announced it was splitting its Pharmaceutical Division into two business units: Novartis Pharmaceutical and Novartis Oncology. This reorganization accounts for approximately two-thirds of the company’s $49 billion annual sales.

Some reports claim that the restructure is partly in response to Novartis’ $20 billion asset swap with GlaxoSmithKline last year. During the swap, Novartis acquired several cancer drugs, including Tafinlar (dabrafenib) and Mekinist (trametinib).


Nemera Wins Best New Product/Service Award at INTERPHEX 2016

Published May 2016

On April 26, 2016, the first day of INTERPHEX, six winners were announced for the competitive INTERPHEX Exhibitor Awards.

Two representatives from Nemera— Fanny Sellier, Global Category Manager for the Ophthalmic range, and Juan Sarmiento, North America Sales Director—participated in an exclusive Q&A with Pharmaceutical Processing to talk about their INTERPHEX Exhibitor Award, the Best New Product/Service Award.


Bausch + Stroebel Wins Biotech Innovation Award at INTERPHEX 2016

Published May 2016

On April 26, 2016, the first day of INTERPHEX, six winners were announced for the competitive INTERPHEX Exhibitor Awards.

Two representatives from Bausch + Stroebel—Katrin Schuler, Business Development, and Jim Nadlonek, Pharmaceutical Operations Specialist—participated in an exclusive Q&A with Pharmaceutical Processing to talk about their INTERPHEX Exhibitor Award, the Biotech Innovation Award.


FDA Alert: BiCNU Counterfeit Discovered in Foreign Countries

BiCNU (carmustine for injection) 100 mg counterfeit potentials_5

The FDA is alerting professionals of a counterfeit of the drug BiCNU (carmustine for injection) 100 mg, which has been detected in some foreign countries.

At this time, the FDA said that there is no indication that the “counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU.”

(Photo courtesy of the FDA)


Sanofi Recalls Painkiller in India

Published May 2016

On Thursday, May 12, Sanofi recalled four batches of its painkiller, Combiflam (a combination of paracetamol and ibuprofen), in India after the country’s drug regulatory body (CDSCO) found the lots were substandard.

The Central Drugs Standard Control Organization (CDSCO), India’s regulatory body, said on its website in February and April that some of the Combiflam batches weren’t of “standard quality,” having failed disintegration tests. Used to test the time it takes for tablets and capsules to break down inside the body, these disintegration tests are a quality-assurance measure in pharmaceuticals, according to the FDA.


FDA Issues 3D Printing Guidance

Published May 2016

The FDA has issued guidance for the creation of medical devices using 3D printing, as well as the Center for Devices and Radiological Health’s role in regulating 3D printed medical devices.

Orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics, are a few of the medical devices the FDA listed. To date, the FDA has approved more than 85 medical devices created by 3D printing.


CFD Simulation: A Game Changer for API Continuous Manufacturing?

Published May 2016

“Adoption of Computational Fluid Dynamics (CFD) simulation is emerging as a game changer for continuous manufacturing applied to Active Pharmaceutical Ingredients (APIs),” says CD-adapco, a supplier of CFD and computer-aided engineering software.

CFD simulation software helps to predict the impact of fluid flows on a given product throughout design and manufacturing as well as during end use.


Patient Dies from DRESS After Taking Antipsychotic

Published May 2016

Since 1996 when the first product containing olanzapine was approved, 23 cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported worldwide, according to a search of the FDA Adverse Event Reporting System (FAERS) database. One of those 23 cases was fatal.

The Journal of Clinical and Aesthetic Dermatology defines DRESS as a reaction to a drug “characterized by a prolonged latency period,” which is followed by various clinical manifestations, including fever, rash, lymphadenopathy, eosinophilia, and a wide range of mild-to-severe systemic presentations.


Study: Malaria Vaccine Protects Adults for One Year

Published May 2016

For people with no prior malaria infection, Sanaria Inc. may have found a malaria vaccine that works for up to one year after immunization.

According to results from a Phase 1 trial published in Nature Medicine, the experimental malaria vaccine, PfSPZ (Plasmodium falciparum sporozoite) Vaccine, was found to protect a small number of healthy, malaria-naïve adults in the United States from infection for more than one year after immunization. The vaccine was developed and produced by Sanaria with “support from several Small Business Innovation Research (SBIR) awards from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health,” according to one press release.


INTERPHEX Live 2016: Day 3 Show Wrap Up

Published May 2016

The third day of INTERPHEX 2016 featured discussions on tech transfer and softgel capsule manufacturing during its final two INTERPHEX Live panels.

Russ Somma, PhD, President of SommaTech LLC, an affiliated consulting company of IPS, moderated the INTERPHEX Live panels, which took place throughout the three days of INTERPHEX (4/26-4/28) and was sponsored by Pharmaceutical Processing.


INTERPHEX Live 2016: Day 2 Show Wrap Up

Published May 2016

The second day of INTERPHEX 2016 consisted of another great set of INTERPHEX Live panels—including CMOs and the manufacturing of controlled substances, drug shortages, biosimilars, single-use technologies, and more.

Moderated by Russ Somma, PhD, President of SommaTech LLC, an affiliated consulting company of IPS, INTERPHEX Live panels ran throughout the three days of INTERPHEX (4/26-4/28) and featured a variety of experts immersed in the industry. INTERPHEX Live was sponsored by Pharmaceutical Processing.


INTERPHEX Live 2016: Day 1 Show Wrap Up

Published May 2016

It was another great year for the International Pharmaceutical Expo (INTERPHEX), a trade show dedicated to pharmaceutical and biotechnology innovation, technology, and knowledge from development through commercialization, which took place at the Javits Center in New York City on April 26-28.

Back by popular demand, INTERPHEX Live hosted a number of hot-topic discussions, such as continuous processing and managing FDA audits, and featured industry experts from companies such as Johnson & Johnson, GE Healthcare Life Sciences, Patheon, and many more. INTERPHEX Live was moderated by Russ Somma, PhD, President of SommaTech LLC, an affiliated consulting company of IPS.


Ireland Emerges as New Hub for Biotech Investments

Grange Castle Aerial
Published May 2016

According to IPHA (Irish Pharmaceutical Healthcare Association), “Ireland is one of the leading locations for the pharmaceutical industry in Europe.” With a population of 4.5 million people, Ireland boasts approximately 120 plants from overseas companies, including nine of the 10 big pharma companies—most of whom have operated in Ireland since the 1960s. IPHA also reports that “Ireland is now the largest net exporter of pharmaceuticals in the EU,” accounting for over 50 percent of all exports from the country.

Ireland’s inward investment promotion agency, the IDA, is a non-commercial, semi-state body that promotes Foreign Direct Investment into Ireland. Barry Heavey, Head of Life Sciences at IDA Ireland, participated in an exclusive Q&A with Pharmaceutical Processing.

(Photo credit: IDA Ireland)


INTERPHEX 2016: From the Ground Up – Facing Pharma/Biopharma Facility Challenges Head-On

Fixing pharmaceutical machine1

Building a new pharmaceutical facility, or restructuring/expanding one, is incredibly expensive. With the creation of new drugs costing approximately $5 billion, the construction of the buildings in which these drugs are made is certainly not going to be friendly on the wallet nor simple to design.3 One company estimated that projects typically fall in the range of $500,000 to $60 million.

As new innovations and industry trends, such as single-use technologies, process automation, and cGMP facility designs become the new normal, the once complicated process of designing a new facility or updating a currently-existing facility becomes even more involved—with that many more choices for a company to make prior to launching into construction.

This article was featured on Pharmaceutical Processing‘s website and in the INTERPHEX 2016 Show Daily: Wednesday, April 27. 


INTERPHEX Q&A: CMOs – Manufacturing Controlled Substances & Tech Transfer Strategies

Published April 2016

Wellspring Pharma Services, a provider of formulation, development, and clinical supply to commercial and clinical manufacturing, participated in two presentations at INTERPHEX 2016:

1. “What You Need to Know: CMOs and the Manufacture of Controlled Substances”

  • Presented by: David Mayers, President of Wellspring Pharma Services

2. “The Importance of Effective Tech Transfer and Validation Strategies with CMOs”

  • Presented by: Norm Fong, Technical Transfer Manager, Business Development of Wellspring Pharma Services

Mayers and Fong participated in an exclusive Q&A with Pharmaceutical Processing about manufacturing controlled substances and tech transfer strategies.


INTERPHEX Q&A: Processing & Packaging Machinery

Published April 2016

Pharmaceutical Processing created a questionnaire to learn more about MG America, their technologies, and some of the upcoming trends they are seeing in the industry. MG America is an exhibitor at INTERPHEX 2016. Randy Fraatz, Business Development Manager for MG America, answers our questions.

 


INTERPHEX Q&A: Biopharma Pump Technology

Published April 2016

Pharmaceutical Processing created a questionnaire to learn more about PSG®, their technologies, and some of the upcoming trends they are seeing in the industry. Quattroflow, part of PSG, a Dover Company, is an exhibitor at INTERPHEX 2016. Wallace Wittkoff, Global Sales Director, Biopharma, PSG®, answers our questions.


Fette Unveils New Capsule Filling Machine at INTERPHEX 2016

FEC40_Fette Compacting_INTERPHEX 2016
Published April 2016

On Tuesday, April 26, Fette Compacting unveiled its first capsule filling machine at INTERPHEX, which doubles the previously set output record at 400,000 capsules per hour.

The FEC40, available in two configurations, utilizes some of the technologies from Fette’s tablet presses and is the world’s first capsule filling machine that follows the Duplex Concept. It is also the first capsule filling machine that is driven fully by servo and torque motors.


INTERPHEX 2016: Utilizing Augmented Reality in Biopharma

Published April 2016

One company’s journey to develop and implement augmented reality technology for smart glasses in the biopharmaceutical manufacturing space.

VR is a computer-generated simulation or recreation of a real life environment or situation, which is achieved by wearing a headset. Users feel like they are experiencing the simulated reality firsthand. AR, on the other hand, is a technology that layers computer-generated enhancements atop an existing reality and is typically developed into apps.

Recap: INTERPHEX 2015 Exhibitor Awards

During last year’s INTERPHEX Exhibitor Awards, Apprentice Field Suite took home the ‘Best New Product/Service’ award for its three smart glasses apps: Tandem, Manuals, and Gauge. These apps leverage AR through smart glasses—empowering operators and engineers in machine maintenance, functionality, and repairs in the biopharmaceutical manufacturing space.

This article was featured on Pharmaceutical Processing‘s website and in the INTERPHEX 2016 Show Daily: Tuesday, April 26. 

(Photo credit: Apprentice Field Suite)


INTERPHEX Q&A: Machinery for Tablet & Capsule Production

Published April 2016

Pharmaceutical Processing created a questionnaire to learn more about Pharma Technology Inc. (PTI), their technologies, and some of the upcoming trends they are seeing in the industry. PTI is an exhibitor at INTERPHEX 2016. Nic Michel, General Manager of North America at PTI, answers our questions.

 


INTERPHEX 2016: Once-Tabooed Botanicals Gain International Acceptance

Published April 2016

With approximately 58 percent of Americans now supporting cannabis legalization and the market currently valued at $3 billion, many pharmaceutical companies are beginning to seriously consider the potential economic and medicinal benefits of this once-banned botanical.1 According to Medical Marijuana Inc., 23 states in the U.S. have already legalized medical marijuana, with many more pending legislation.

“It’s a completely different world today than it was even six months or a year ago,” said Leslie Bocskor, Managing Partner and Founder of Electrum Partners, an advisory firm to start-up companies in the nascent cannabis industry in the United States.

This article was featured on Pharmaceutical Processing‘s website and in the INTERPHEX 2016 Show Daily: Tuesday, April 26


INTERPHEX 2016 Exhibitor Awards Selected

Published April 2016

INTERPHEX announced the winners for the INTERPHEX Exhibitor Awards for 2016. The awards—sponsored by Pharmaceutical Processing—were broken into six categories: best in show, best new product/service, editor’s choice, best technological innovation, efficiency champion, and biotech innovation award.

The Exhibitor Awards program was launched in November of 2014, and the latter two awards, efficiency champion and biotech innovation award, were added this year.

The judges on this year’s Exhibitor Awards panel were Meg LaTorre-Snyder, Editor of Pharmaceutical Processing, David Hall, Vice President of Sales for Parenteral Drug Association (PDA), Christa Myers, Process Chemical Engineer for CRB, Patrick Poisson, SVP Manufacturing and Chief Manufacturing Officer for the United Therapeutics Corp., and Gil Roth, Founder and President of the Pharma & Biopharma Outsourcing Association (PBOA).

On behalf of INTERPHEX, the judges are pleased to present this year’s winners.


INTERPHEX Q&A: Track-and-Trace/Serialization Solutions

Published April 2016

Pharmaceutical Processing created a questionnaire to learn more about Adents, their technologies, and some of the upcoming trends they are seeing in the industry. Adents is an exhibitor at INTERPHEX 2016. Jim Cummings, Vice President, Americas, for Adents, answers our questions.

 


INTERPHEX Q&A: Advanced Delivery Technologies

Published April 2016

Pharmaceutical Processing created a questionnaire to learn more about Catalent Pharma Solutions, their technologies, and some of the upcoming trends they are seeing in the industry. Catalent is an exhibitor at INTERPHEX 2016. Elliott Berger, VP Global Marketing & Strategy at Catalent, answers our questions.

 


INTERPHEX Q&A: Serialization & Track-and-Trace Technologies

Published April 2016

Pharmaceutical Processing created a questionnaire to learn more about Videojet Technologies Inc., their technologies, and some of the upcoming trends they are seeing in the industry. Videojet is an exhibitor at INTERPHEX 2016. Torben Vogt, Global Pharma Director for Videojet, answers our questions.

 


INTERPHEX Q&A: Quality Management Systems for Life Science

Published April 2016

Pharmaceutical Processing created a questionnaire to learn more about MasterControl, their technologies, and some of the upcoming trends they are seeing in the industry. MasterControl participated in some of the technical education sessions at INTERPHEX 2016. Walt Murray, President and CEO of ARC Experts and essential part of the MasterControl QCC services team, answers our questions.

 


Pennsylvania Legalizes Medical Marijuana

Published April 2016

On Sunday, April 17, Governor Tom Wolf signed the bill into law, which makes Pennsylvanian the 24th state in the U.S. to legalize medical marijuana. This new law permits the sale and consumption of cannabis to treat specific disease and symptoms.

“Marijuana is medicine and it’s coming to Pennsylvania,” said Democratic Sen. Daylin Leach, the bill’s co-sponsor.

On Wednesday, 4/13, the Pennsylvania House of Representatives passed Senate Bill 3, “with a vote of 149-46 after the Senate passed it Tuesday with a 42-7 vote,” according to a report by WNEP News.


Cover Story

A CMO with a Hand in Both the Contract and Commercial Business

(Photo credit: PCI Synthesis)
Published April 2016

Operating two sites in the Greater Boston area, PCI Synthesis’ pharmaceutical development contract manufacturing organization (CMO) business has grown in recent years—aiding the company in its emergence as the largest small molecule drug substance manufacturer in the New England area. PCI Synthesis is a custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products.

This article was featured on Pharmaceutical Processing‘s website and in the April 2016 print issue.

(Photo credit: PCI Synthesis)


A Changing Industry: What’s on the Horizon

Published April 2016

Leading up to INTERPHEX—a trade show covering the pharmaceutical, biotechnology, and medical device spaces that takes place in New York City each year in April—I have had the privilege to talk with countless experts on new inventions, exciting developments, and goals for the future. As I’ve been delving into the three Show Daily’s and videos for INTERPHEX as well as our April issue, I can’t help but to reflect on how far we’ve come as an industry, in addition to all of the changes lingering on the horizon.


NJ Considers Medical Cannabis for Menstrual Cramps

Published April 2016

Thanks to a new legislation introduced by New Jersey lawmakers, medical marijuana may very well be approved for use in patients with menstrual cramps in the state of New Jersey.

On Thursday, April 7, NJ Assembly members Tim Eustace, L. Grace Spencer, and Angelica Jimenez introduced the potential law—close on the heels of Whoopi Goldberg’s announcement to collaborate with a maker of organic marijuana edibles to provide cannabis-based products for women.

Should the bill be passed, dysmenorrhea (abdominal cramping due to uterine contractions) would be added to the list of conditions for which a doctor may authorize medical marijuana use, should conventional therapies be insufficient.


U.S. Biosimilar Market in 2016

Published April 2016

Changing the landscape of biologics, biosimilars entered the market in the U.S. in 2015 after an FDA advisory panel decided unanimously that Sandoz’s replacement biosimilar of Amgen Inc.’s Neupogen (filgrastim) should be accepted.

For the past decade, the EU has been evaluating and approving biosimilars, while the U.S. until very recently has avoided biosimilar applications—with Sandoz’s Zarxio being accepted in 2014 and later approved in early 2015.

Unlike generic drugs, biosimilars are inexact copies and are therefore required to undergo more testing prior to approval.


5 Steps to Choosing a Conveyor

Published April 2016

One of those important parts of being a pharmaceutical manufacturer is selecting a conveying system for your facility—whether it is for compressing pills, blister packaging, high-speed bottle filling, or anything in between. Not only do batches need to make it swiftly out the door, but cross contamination between has to carefully be considered while shuffling products and projects.

(Infographic courtesy of Dorner Mfg. Corp.)


The Changing Regulatory Landscape: 2016

Published April 2016

With the spotlight on pharmaceutical pricing and the upcoming presidential election in the U.S., there is ample opportunity for a bit of a shakeup in the regulatory landscape.

In July of 2015, the 21st Century Cures Act was passed by the House of Representatives (344-77). The stated goal of this 360-page bill was to speed up/stimulate the development of new cures for a range of diseases. (Think: precision medicines.) For good or ill, this bill could potentially affect how researchers go about testing medicines—namely speeding a drug to market primarily through testing less patients.


INTERPHEX Live: QbD Leveraged as a Business Strategy

Published April 2016

INTERPHEX Live, a live technical talk show that takes place at the Javits Center in NYC during INTERPHEX, features experts who share their expertise and offer solutions on key industry issues.

Russ Somma, PhD, President of SommaTech LLC, an affiliated consulting company of IPS, joined us for an INTERPHEX Live video conference on quality by design (QbD) leveraged as a business strategy.


New Oral Agent for Treating IBS with Diarrhea

Published March 2016

After two phase 3 trials, researchers believe they have found an effective and safe treatment for irritable bowel syndrome (IBS) with diarrhea.

Treatment with eluxadoline, a new oral agent with mixed opioid effects (μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist), was found to decrease symptoms in patients with IBS with diarrhea in two phase 3 trials, the findings of which were published in The New England Journal of Medicine (NEJM).


Experts Call for Global Drug Policy Reform

Published March 2016

The Johns Hopkins-Lancet Commission calls for new policies that would transform our approach to drug use, addiction, and control worldwide, including the decriminalization of minor and non-violent drug offenses.

Drug policies aimed at restricting and criminalizing drug use and minor possession have had detrimental effects on the health, wellbeing, and human rights of drug users and the wider public in the past 50 years, according to a new report by The Lancet and Johns Hopkins University in the U.S.


More Than the Product: Negative Provider Experiences Affect Oncology Manufacturers

Published March 2016

Ever wonder how physicians would rate your oncology pharmaceutical company? One survey endeavored to find out.

The oncology industry severely lags behind other industries in the customer experience that manufacturers deliver, a recent survey of doctors, nurses, and administrators found. Eighty percent of the oncology manufacturers studied earned negative “net promoter scores” from physicians.


Heroin Overdose Antidote: A Crutch for Inmates?

Published March 2016

Health officials train soon-to-be-released inmates to use the overdose-reversal drug naloxone, which can undo the effects of an opiate overdose almost instantly.

Naloxone, also known by the brand name Narcan, has become a key tool in curbing overdoes resulting from the nation’s opioid abuse epidemic. According to the CDC, the class of drug that includes prescription painkillers and heroin was involved in a record 28,648 deaths in 2014, and opioid overdoses have more than quadrupled since 2000.


The First FDA-Approved Drug Manufactured Using 3D Printing

Published March 2016

The first prescription drug manufactured using 3D printing technology has been approved by the FDA.

Aprecia Pharmaceuticals’ SPRITAM® (levetiracetam) tablets for oral suspension are now available as an adjunctive therapy for the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. With a sip of liquid, SPRITAM disintegrates in the mouth.

(Photo courtesy of Aprecia Pharmaceuticals)


INTERPHEX: What’s in Store for 2016

Published March 2016

Pharmaceutical Processing‘s Editor, Meg Snyder, and Andrew Berg, Editorial Director of Advantage Business Media’s manufacturing group, introduce INTERPHEX, which will take place on April 26-28 at the Javits Center in NYC.

Back by popular demand, Interphex Live will feature a number of the best and brightest leaders in the industry.These subject-matter experts will be discussing the latest trends and technologies on topics such as:

  • Biosimilars
  • Continuous processing
  • Preparing for FDA audits
  • Medicine authenticity
  • Capsule dosing
  • Overcoming facility upgrade challenges
  • As well as many more topics

To view the video, click here.


The Industry Reacts to the CDC’s Opioid Guidelines

Published March 2016

On March 15, the CDC released updated opioid guidelines for chronic pain, which has caused quite the stir among healthcare experts and the pharma industry.

In the guidelines, three principles of the 12 recommendations were considered essential for patient care:

  • For chronic pain outside of active cancer, palliative, and end-of-life care, nonopioid therapy is preferred.
  • To reduce risks of opioid use disorder and overdose, the lowest possible effective dosage should be prescribed when opioids are used.
  • Providers should always exercise caution when prescribing opioids and monitor all patients closely.

Experimental Vaccine Prevents Dengue Infection

Published March 2016

A clinical trial was launched in Brazil to test an experimental dengue vaccine on volunteers who were infected with the dengue virus.

Developed by scientists in the laboratory of Stephen Whitehead, Ph.D., at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), the vaccine (TV003) has been in the works since 2008 and will ideally protect against all four dengue strains.


Malaria Combination Therapy for Pregnant Women

Published March 2016

According to the findings of a study, a two-drug preventative treatment was found to reduce the severity of malaria during pregnancy. 

Malaria, a cause of prematurity, low birth weight, and death in infants in Africa, could be prevented in pregnant women using a common artemisinin combination therapy for adults: dihydroartemisinin-piperaquine (DP).

The study, published in NEJM and funded by the NIH, is among the first to show that artemisinin combination therapies like DP can be used to prevent malaria in pregnancy.


Cover Story

An International CDMO Presence

Published March 2016

Offering manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material, and pharmaceutical product development, Recipharm AB has emerged in recent years as a leading contract development and manufacturing organization (CDMO) based in Sweden. Consisting of 2,200 employees, the company currently manufactures more than 200 different products for both Big Pharma and smaller R&D companies.

Recipharm was established in 1995, but did not have a presence in the contract manufacturing business until a number of years later. In 2001, the company established the brand name Recipharm, and between 2001 and 2007, six facilities were acquired, which impacted both their capacity and their business. It wasn’t until 2007 that Recipharm decided to dedicate its resources fully to its CDMO business.

This article was featured on Pharmaceutical Processing‘s website and in the March 2016 print issue.

(Photo credit: Recipharm AB)


Advantages and Challenges of Pre-filled Syringes

Published March 2016

Pre-filled syringes have emerged as one of the fastest-growing choices for unit dose medication as the pharmaceutical industry seeks new and more convenient drug delivery methods. Pharmaceutical companies are able to minimize drug waste and increase product life span, while patients are able to self-administer injectable drugs at their home instead of the hospital.

The market has expanded and is exploring all options outside of the traditional process. In the past, glass syringes dominated the market, but there has been a movement toward plastic and disposable syringes. Pre-filled syringes have also been utilized across a wide range of therapeutic sectors, such as vaccines, blood stimulants, and therapeutic proteins.


A Tide of Innovations: New Advances in the Pharma Industry

Cleanroom 2
Published March 2016

New technologies in the pharmaceutical market never cease to amaze me—from new advances in continuous manufacturing, to safety equipment for cleanrooms and laboratories, to flexible packaging solutions, to everything in between.

As pharmaceutical manufacturers pursue efficiency and excellence, the surrounding players have driven forward to offer new innovations, which in turn affects the expectations for processes going forward.


The Opioid Epidemic Across the Supply Chain

doctor prescribing 1
Published February 2016

In 2012, enough opioids were prescribed for every American adult to have a bottle of pills, according to statistics by the CDC. As many as two million Americans over the age of 12 were reported to either be dependent upon opioids or abused them in 2013. As a result, many consumers and physicians are calling for the creation of new drugs—alternatives to opioids, specifically for non-cancer pain.

According to one report, approximately 80 percent of the world’s pain pills are consumed in the United States. Accidental overdose of prescription opioids, as a result, is now the leading cause of acute preventable death for Americans (exceeding car fatalities).


Jimi Hendrix-Themed Cannabis Supplements

Jimi Hendrix-Themed Cannabis Supplements - Copy
Published February 2016

Cannabis Science and Purple Haze Properties LLC have partnered to create Jimi Hendrix-themed cannabis supplements.

Powered by Cannabis Science, “Jimi’s Meds” has a number of varieties and dosages, and was recently made available in the State of California.

 

 


New Child-Resistant Flexible Packaging Technology

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Published February 2016

With greater market and regulatory demands, pharmaceutical packaging continues to evolve—with new technologies and innovations emerging every day. Pharmaceutical packaging companies must oversee authentication, stay abreast of track-and-trace technologies and methods, while also being attentive to shelf life, contamination control, and child-resistant packaging.

One company attempts to redefine how the industry approaches packaging—specifically child-resistant packaging.


The World’s First 24-Hour Aspirin

DURLAZA
Published February 2016

In January, New Haven Pharmaceuticals, Inc. (NHP) announced that the FDA approved DURLAZA, the first and only 24-hour, extended-release aspirin capsules (162.5 mg) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack) in high-risk cardiovascular patients.

Maximizing the benefit of aspirin by providing consistent platelet inhibition, DURLAZA utilizes extended-release, microcapsule technology to prolong aspirin release.

DURLAZA received FDA approval in September 2015, and is now commercially available by prescription.

(Photo credit: New Haven Pharmaceuticals, Inc.)


FDA Medication Guides: Updated Drugs

Published February 2016

The FDA sent an update to its medication guides page, which address issues that are specific to particular drugs and drug classes.

Information related to adverse effects, product side-effects, and directions for the use of a product are often included in medication guides.

Ten drugs were updated.


In Development: HSDD Treatment for Women

Published February 2016

S1 Biopharma’s approach to the treatment of hypoactive sexual desire disorder (HSDD), and an overview of what’s coming down the pipeline. 

Approximately one in 10 women suffer from HSDD—defined as a woman’s chronic or ongoing lack of interest in sex—according to Even the Score, a women’s sexual health campaign supported by Sprout Pharmaceuticals.

However, HSDD is a condition that both men and women face, though a greater number of women tend to have HSDD.

S1 Biopharma, Inc., a clinical-stage biopharmaceutical company focused on the treatment of sexual dysfunction in both women and men, and CKD Pharmaceuticals are investigating Lorexys™, S1 Biopharma’s investigational therapy currently positioned to advance to a Phase 2b clinical trial for treatment of HSDD in women.


Five Things to Know About the Zika Virus

Published February 2016

On February 8, CMAJ, the Canadian Medical Association Journal, published an article called “Five Things to Know About… Zika Virus Infection.”

Concern for the mosquito-borne Zika virus’ possible connection to microcephaly, a neurological birth defect, has stirred international awareness of the virus as the outbreak spreads through parts of the Americas.

In response, two doctors compiled a list of five things that people should know about the virus—which is spread through mosquitos in the Aedes group (carried primarily by the species Aedes aegypti).

(Photo credit: Emil August Goeldi) 


The Changing Face of Pharmaceutical Distribution Traceability

Published February 2016

International Business Systems’ approach to ERP systems in light of the DSCSA requirements.

Effective in January of 2015, pharmaceutical distributors were required to report the chain of custody of the products they sell: who they acquired the drug from and who they sold the drug to. In 2017, the track-and-trace requirements become much more complex for the pharmaceutical distributors, as they must report this same chain of custody at the serial number level of the individual drug.

As a result, many companies are now seeking out pharmaceutical-specific enterprise resource planning (ERP) solutions to support their operations. The same traceability infrastructure has to be in place for a company with 5 employees and 5 thousand employees.


EMD Millipore: The Development and Manufacturing of Biosimilars

Published February 2016

Simon Boa from EMD Millipore participates in a Q&A about the benefits and challenges of (as well as the demand for) biosimilars.

As biosimilars form roots in the U.S., many companies are eager to launch into this new industry and form partnerships. On October 22, EMD Millipore joined the ranks, announcing that the company entered into an alliance with Turgut Ilaç, a leading biosimilars company based in Turkey. In the first phase of their agreement, monoclonal antibody biosimilars for non-small cell lung carcinoma and rheumatoid arthritis will be their focus.


Cover Story

A Focus on Core Competencies

Published February 2016

How Ash Stevens’ approach to their business—focusing on their API manufacturing expertise—has helped the company grow in prominence as a CMO.

Founded in 1962 by chemists Arthur Ash, Ph.D., and Calvin Stevens, Ph.D., and headquartered in Riverview, Michigan, Ash Stevens Inc. is a privately-held, full service contract manufacturing organization (CMO) with over five decades of experience manufacturing active pharmaceutical ingredients (APIs).

Ash Stevens’ services, spanning from early-stage development through registration and commercial manufacturing, specialize in high-quality drug substance development and API manufacturing services for Life Science companies that are developing innovator small-molecule therapeutics.

This article was featured on Pharmaceutical Processing‘s website and in the January/February 2016 print issue.

(Photo credit: Ash Stevens)


The Conundrum of the Pharma Industry: Inexpensive and Effective Drugs

Published February 2016

As you may be aware, there has been quite a fuss in the news lately about a number of scandals—Martin Shkreli’s arrest for securities fraud, numerous recalls, and the high pricing of drugs (not the least of these). Many people are calling for a change in the pharmaceutical industry, and that change is simply (and primarily): drugs should cost less.

With the amount of research (and therefore money) that is required to determine a drug’s safety and efficacy, many industry professionals wonder if a significant change on price tags is entirely plausible in the immediate future. Though, complex problems often involve creative opportunities, such as the instrumental change that has recently occurred in the U.S.—the first biosimilar approval in 2015.


Retrophin Agrees to Pay $3M to Resolve Lawsuit Involving Shkreli

Published February 2016

To resolve a lawsuit that accuses Retrophin Inc. of failing to disclose Martin Shkreli’s transactions (founder and former CEO of Retrophin), the company has agreed to pay $3 million, according to an article published this morning in Reuters.

The lawsuit was filed in 2014, the same year that Shkreli was fired from Retrophin. The proposed class action settlement would resolve claims against Shkreli, who continues to plead not guilty to the criminal charges. Prosecutors accuse Shkreli of having been involved in a Ponzi-like scheme, “defrauding investors in his MSMB Capital Management hedge fund and misappropriating $11 million in assets from Retrophin to repay them.”


Sanofi Searches for Zika Vaccine as the WHO Declares Global Emergency

Gleyse Kelly da Silva holds her daughter Maria Giovanna as she sleeps in their house in Recife, Pernambuco state, Brazil, Wednesday, Jan. 27, 2016. Brazilian officials still say they believe there's a sharp increase in cases of microcephaly and strongly suspect the Zika virus, which first appeared in the country last year, is to blame. The concern is strong enough that the U.S. Centers for Disease Control and Prevention this month warned pregnant women to reconsider visits to areas where Zika is present. (AP Photo/Felipe Dana)
Published February 2016

The World Health Organization (WHO) declared a global emergency on Monday, February 1, on account of the Zika virus’ suspected link to birth defects.

In Brazil, there was an outbreak of the Zika virus in May. Since that time, the virus has spread into more than20 countries in Latin America, including two additional countries announced on Monday: Costa Rica and Jamaica.

WHO Director-General Margaret Chan told reporters that “coordinated international action was needed to improve detection and expedite work on a vaccine and better diagnostics for the disease, but said curbs on travel or trade were not necessary.”

(Photo credit: The Associated Press.)


Keeping Counterfeit Medicines Out of the Supply Chain

TruTag--edible code
Published January 2016

Counterfeit products have a wide scope: managing to slip through the cracks in every industry and every market. Unlike counterfeited retail products, such as clothes, handbags, and shoes, counterfeit medicines—which can be contaminated, contain the wrong (or no) active ingredient, or have the right active ingredient but at the wrong dose—have a significant impact, in that the use of these can (and often does) result in patient deaths. As such, many companies have emerged to address this profound issue.

TruTag Technologies, Inc., a developer of authentication technology platforms, has gained repute for its microtags that serve as covert “edible bar codes.” These microtags can be utilized by pharmaceutical companies to track their drug product on a batch basis. When the microtags are mixed with the outer coating of a pill or tablet, it enables companies to determine the identification and supply chain history of an individual pill.

(Photo credit: TruTag Technologies)


Sanders is Third Senator to Block Obama’s Nomination for FDA

Bernie Sanders_Photo credit - Gage Skidmore
Published January 2016

Bernie Sanders, a Democratic presidential candidate and senator from Vermont, is now the third senatorto block President Barack Obama’s nominee, Dr. Robert Califf, to head the FDA.

President Obama nominated Califf in November, upon which time he was met with skepticism from members of a Senate committee about the his ties to the pharmaceutical industry. Having been a consultant to drug companies and run a research institute that received a majority of its funding from the industry, many people believe Califf is too close to the industry that President Obama wants him to regulate.

(Photo credit: Gage Skidmore)


The Effects of the TPP on Pharmaceutical Innovation

TPP_Photo credit - Julianita Qué Tal
Published January 2016

The Trans-Pacific Partnership (TPP), a multi-national trade agreement that is being considered by 12 countries, stirs up controversy in its effect on pharmaceutical innovation.

In an article published in the Research in Social & Administrative Pharmacy (RSAP), Robert A. Freeman, PhD, of the Department of Pharmacy Practice and Administration at The University of Maryland Eastern Shore, Princess Anne, Maryland, USA details three primary areas of controversy.

Click here to read more.

(Photo credit: Julianita Qué Tal)


Opioid-Dependence Implant: A New Treatment for Opioid Addiction

Probuphine_Photo credit - Braebum Pharmaceuticals
Published January 2016

A new treatment for opioid addiction is on the horizon—and one that goes beneath the skin.

Probuphine is a small rod that contains the medication buprenorphine, which was approved by the FDA for opioid addiction in 2002. Developed by Titan Pharmaceuticals and Braeburn Pharmaceuticals, the rod is placed under the skin (usually in the upper arm) by a doctor in an office procedure. One implant provides patients with 6 months of continuous buprenorphine dosing.

(Photo credit: Braebum Pharmaceuticals)


Video Pills Improve Detection of Throat and Gut Cancers

Published January 2016

At the University of Glasgow, researchers have made swallowable cameras, or “video pills,” to detect throat and gut cancers.

In recent years, small, sensing cameras swallowed by patients have been used to capture images of the throat and gut, as compared to more intrusive techniques such as use of endoscopes. These cameras, created by researchers from the University’s School of Engineering, utilize fluorescence imaging to identify the rich blood supplies that support cancers and help them to grow. The team used an advanced semiconductor single-pixel imaging technique to create this pill, which enabled them to utilize the fluorescence imaging technique that is known to be expensive and bulky (and therefore often limited to laboratory settings).


New Smart Pills Could Offer Clues for the Development of Gut Disorder Treatments

Smart gas sensing pills developed at RMIT University
Published January 2016

Researchers at RMIT University in Australia have conducted the very first smart pill trials—measuring intestinal gases inside the body, and how fiber affects the gut.

In the past, gas and bloating have been found to be late symptoms of colon cancer. According to About Health, “[a]n obstruction caused by a tumor could lead to bloating and the trapping of gas within the colon.” A press release from RMIT University adds that: “[i]ntestinal gases have been linked to colon cancer, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD), but their role in health is poorly understood and there is currently no easy and reliable tool for detecting them inside the gut.”

Designed at Melbourne’s RMIT University, this new smart pill could help us learn more about the body’s production of gases—potentially even assisting us in customizing what we eat to minimize gas production in our bodies.


Prescription Drug Prices Climb Over 10 Percent in 2015

Published January 2016

This past year has been one filled with many new adventures and challenges for pharma.

The first big change that comes to mind for many of us is the approval of the first biosimilar in the U.S. InSeptember, Novartis AG launched Zarxio, a biosimilar version of Amgen Inc.’s Neupogen—which boosts white blood cell production to prevent infections in certain cancer and other patients.

The year of 2015 was also inundated with single-use technologies—both new discoveries, as well as some discussions as to their disadvantages—and new technologies for various serialization efforts: such as advances in labeling.

3-D technology has also reared its head, with new advances, like the potential for patient-specific medical devices. There have also been a number of cannabis-derived products that have emerged as potential treatments, Kalytera Therapeutics’ cannabidiol (CBD)-like molecule being one of these.


Rhythm Receives FDA BTD & Orphan Drug Designation

Published January 2016

Rhythm, a biopharmaceutical company that develops peptide therapeutics for rare genetic deficiencies treatments, has been given two thumbs up by the FDA for its treatment.

Setmelanotide, the company’s novel melanocortin-4 receptor (MC4R) agonist for the treatment of pro-opiomelanocortin (POMC) deficiency obesity, was granted Breakthrough Therapy designation today by the FDA. Setmelanotide is presently in Phase 2 clinical trials for the treatment of rare genetic disorders of obesity caused by MC4 pathway deficiencies.


Valeant’s CEO Takes Medical Leave & Ex-CFO is Named Interim

Published January 2016

Chief Executive Officer, Michael Pearson, of Valeant Pharmaceuticals International Inc. has taken a medical leave of absence. In his stead, the company has named former Chief Financial Officer, Howard Schiller, as the interim CEO, while Bob Ingram will take the place of interim chairman.

Pearson has been hospitalized with severe pneumonia, and when he will return remains uncertain. The company officially disclosed Pearson’s hospitalization on Christmas Day.

From December 2011 through June 2015, Schiller served as the company’s CFO and is on its board of directors. But in June of 2015, he stepped down, saying he wished to “pursue new opportunities most likely in areas outside of a publicly-traded company.”


Capsugel Expands Portfolio through Acquisitions

Published January 2016

Capsugel, a company well known for its manufacturing of drug capsules, continues to expand its ever-growing portfolio and capabilities.

On December 14, Capsugel, Xcelience, and Powdersize announcedthat the three companies entered into an agreement wherein Capsugel would acquire Xcelience and Powdersize. Today, Capsugel has announced that it completed its acquisitions of Xcelience and Powdersize.


KaloBios Seeks Bankruptcy Protection & Class Action Lawsuit is Filed

Published January 2016

Less than two weeks after Martin Shkreli’s arrest for securities fraud, KaloBios Pharmaceuticals (formerly led by Shkreli) seeks bankruptcy protection.

KaloBios is the second pharmaceutical company—Turing Pharmaceuticals Inc. being the first—with ties to Shkreli that is in financial turmoil following his indictment.

Under Shkreli’s guidance, Turing acquired the rights to a treatment for a rare parasitic infection. After which time, the company raised the price from $13.50 to $750 per pill—resulting in an uproar from both lawmakers and the public about soaring drug prices.

At KaloBios, there had been similar discussions of raising the prices of the parasitic infection drug, benznidazole, as well. The company said it intended to charge around $1,000 per pill (more than $80,000 for a course of treatment)—akin to the pricing of some HCV treatments. At present, benznidazole has not been approved in the U.S. for the treatment of Chagas disease, as the disease is not common in the U.S.


The Hatch-Waxman Act: A Patent Infringement Liability Loophole

Published December 2015

In November, a ruling was made with the potential to significantly impact patent infringement liabilities going forward.

According to a ruling in Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals, Inc.: under the Hatch-Waxman Act, quality-control testing of drugs is not considered to be the actual “making” of a product. Quality assurance is no longer ensured, as the infringement for importation of products made by a patented process does not extend to the testing of a finished product.

Some see this decision as providing added “incentive for pharmaceutical companies to outsource manufacturing and avoid infringement liability.”

As a result of this recent U.S. Court of Appeals for the Federal Circuit ruling, drug manufacturers who outsource quality control measures abroad may have been given a loophole to avoid patent infringement liability.


Opioids Prescribed After Overdose, Study Finds

Published December 2015

Most patients who have chronic pain and are hospitalized after a nonfatal opioid overdose continue to receive prescription opioids, according to a new study. These patients are also at a high risk of having another overdose.

The study, led by Boston Medical Center (BMC) and published in Annals of Internal Medicine, consisted of almost 3,000 patients (18-64 years of age) who had an overdose during long-term opioid therapy for noncancer pain (chronic pain). Taking place over twelve years, this study’s primary outcome was a daily morphine-equivalent dosage of opioids dispensed between 60 days post-overdose and 730 days post-overdose.

The findings of this large study—how many opioids were dispensed after the first overdose and how many patients overdosed a second time—will surprise you.


New Weight-Loss Program Combines Lifestyle Changes with Prescription Drugs

Published December 2015

As the holiday binges lurch to their unfortunate and inevitable end, many people will find themselves philosophically debating the merit in getting on the diet bandwagon and stop eating so many cookies, cake, turkey, ham, potatoes, eggnog, fried eggs, caramel lattes, and the other various marvels that have soared down their gullet with unnatural ease these past few weeks. Many people may even create their own personal New Year’s resolution to stay their hand in hopes of trimming off those extra holiday pounds.

A new national online survey has found that that over-the-counter (OTC) products and plans are a big part of the reason that weight loss plans do not yield success among obese or overweight American adults, and that it is very difficult for people to change their lifestyles.


Former Turing CEO Calls Federal Charges Against Him Baseless

Published December 2015

Martin Shkreli, former CEO of Turing Pharmaceuticals and the centerpiece of the recent drug industry’s price-gouging scandal, has been indicted on seven counts of securities and wire fraud for alleged conduct at several of his previous companies.

According to the U.S. Attorney’s Office for the Eastern District of New York, Shkreli was arrested earlier this month and faces up to 20 years in prison if convicted on all counts.

Federal investigators believe Shkreli defrauded Retrophin of $3.4 million in cash and stock.


Single-Use Technologies in Biopharmaceutical Manufacturing

Published December 2015

In biopharmaceutical manufacturing, the implementation of single-use technology (SUT) is growing rapidly. Offering improved flexibility and reduced contamination risk, SUTs have more appeal than their expenditure alone. Some other advantages include rapid product development, adaptability, decreased manufacturing footprint, no cleaning validation, as well as decreased process times.

Bulk drug substance (BDS) have also found a home among SUTs—utilizing fluoropolymer (PFA and FEP) bottles for the storage and transportation of BDSs (particularly for their low particulate content and wide temperature range). In addition, biopharmaceutical labs are beginning to invest in ICP-MS instrumentation and supplies with regulations on elemental impurities close to being implemented.

Needless to say, biopharmaceutical facilities don’t want to be left behind with all the SUT hype among pharmaceutical manufacturers.


 “Holiday Recall Readiness

Drug Recall_3
Published December 2015

In the 2015 calendar year, there was an influx of the number of drugs that were recalled—many of which were amidst the holiday season. These recalls can be disastrous throughout the year, but can be even more so around the holidays.

According to one source, “[m]anufacturing defects account for the majority of recalls.” These defects can occur when something goes wrong during the manufacturing process, “such as when a batch of drugs produced at a facility deviates from their proper design specifications, or the drugs are adulterated or contaminated with other substances.”

Stericycle ExpertSOLUTIONS, a firm that handles product recalls, participated in a Q&A about what manufacturers can do to prepare for the busiest time of the year and protect themselves from a recall crisis taking place during the holiday season.


In Development: Patient-Specific Medical Devices Using 3-D Printing

Assistant Professor Randall Erb & Joshua Martin_Photo credit - Northeastern University
Published December 2015

The end of 2015 has brought about a number of new technologies and the promise of change—particularly for the potential implementation of 3-D printing technology in patients.

A team of researchers at Northeastern University have developed a new 3-D printing technology. This technology, which uses magnetic fields to shape composite materials (mixes of plastics and ceramics), has the potential to be applicable for patient-specific products.

“There is a lot in store for the future in fiber-reinforced polymer composites,” says Randall Erb Assistant Professor at Northeastern University. “Composites are strong and light weight, and the 3-D printing enables the patient-specific process.”

However, there is still a considerable amount of research ahead of the team.


The Dangerous Realities of Counterfeited Products in Pharma

pharmaceutical anti-counterfeiting
Published December 2015

Mark Davison, Principal Consultant & CEO at Blue Sphere Health and author of Pharmaceutical Anti-Counterfeiting, is well-versed in pharmaceutical anti-counterfeiting. Davison is the founder of Blue Sphere Health, and he advises a variety of entities on how to keep patients safe from the dangers of falsified medicines—drug companies, non-governmental organizations (NGOs), and government bodies.

At Systech’s Uniquity 2015 Conference, Davison’s presentation, titled “When Bad Things Happen: Anti-counterfeiting,” covered a variety of aspects involving counterfeited products and their respective dangers. His first point was a blunt (but important) one: counterfeiters can kill people. Period. This is especially applicable in counterfeited pharmaceuticals and medical devices.

Davison participated in a Q&A, divulging more of his knowledge on the dangers with counterfeits and precautionary steps pharmaceutical manufacturers can take.


A New Approach to Self-Injection Medication Adherence

Published December 2015

Self-injection medicines are prescribed to millions of people worldwide to help manage various conditions. However, medication adherence is not always a top priority for patients.

According to one study, “non-adherence is a complicated and common problem,” with nearly three out of four Americans reporting that they “do not always take their medicine as directed.”

Consequently, Ypsomed and Thinfilm are striving to change this. They will incorporate smart labels and connectivity to injectable medication—notifying patients of usage guidelines, reminding them of injections, as well as providing refill instructions on their phones.

Researchers may spend years creating and perfecting any one medication, but that has little impact if the patients are not taking medications that they need.


Regenerative Medicine: Orgenesis’s Therapeutic Technology For Type 1 Diabetes

Diabetes
Published December 2015

Vered Caplan, CEO of Orgenesis, participated in a Q&A about their therapeutic technology, which converts the liver cells of patients with type 1 diabetes into functioning insulin-producing cells.

The Orgenesis approach differs from others in the field because it is focuses on providing a potential cure and enabling the patient to have their own insulin-production and regulation capabilities so they do not have to depend on external insulin injections. Orgenesis has developed a novel therapeutic technology intended to convert a patient’s own liver cells into functioning insulin-producing cells.

This technology may provide people with insulin-dependent type 1 diabetes a new means of producing adequate levels of insulin, thereby mitigating or eliminating the need for external insulin injections.


New Pharma Manufacturing Portal in the UK

Typing_computer
Published December 2015

A new web portal, providing a platform that outlines the United Kingdom’s pharmaceutical manufacturing strengths and capabilities, has been launched—an announcement made by the Knowledge Transfer Network (KTN) on November 26. This portal was developed by the KTN on behalf of the Medicines Manufacturing Industry Partnership (MMIP).

According to the announcement, the “MMIP had previously discovered there was confusion about UK activity in this sector in terms of the current industry base, academic research, and support for innovation in medicines manufacturing.


Proposal: Free Wi-Fi For Everyone Using the NHS

Martha Lane Fox_Photo credit - OFFICIAL LEWEB PHOTOS
Published December 2015

Patients, healthcare workers, and visitors alike should have access to free Wi-Fi while using the National Health Service (NHS)—or, so said Martha Lane Fox at Tuesday’s National Information Board (NIB) in the UK.

According to one report on FirstWord Pharma, Fox—in response to the Health Secretary, Jeremy Hunt’s, question regarding practice proposals to the NIB on “how to ensure increased use of new health digital innovations”—said the following: “Turning on free Wi-Fi access across the NHS estate could significantly increase take up of online health tools . . . it would allow patients staying in hospital to self-monitor their conditions using apps and maintain contact with social networks that can support recovery and promote well-being.”


The World’s First Ibuprofen Patch

Professor David Haddleton (left) of The university of Warwick and Nigel Davis, CEO of Medherant, look at medicated skin patch test. Photograph by Martin Neeves Photography - www.martinneeves.com - Tel: +44 (0)7973 638591 - E-mail: martinneeves@googlemail.com
Published December 2015

Researchers at the University of Warwick produced and patented the world’s first ibuprofen patch, which delivers the drug directly through skin at a consistent dose rate to exactly where it is needed. The researchers worked with Coventry-based Medherant, a Warwick spinout company.

This transparent adhesive patch delivers a prolonged high dose of the painkiller ibuprofen directly through the skin. It is developed by Bostik and exclusively licensed for transdermal use to Medherant.

Some of the features of Medherant’s ibuprofen patch include:

  • Incorporation of polymer technology
  • Contains significant amounts of the drug (up to 30 percent weight) in the polymer matrix
  • Delivers at a steady rate over up to 12 hours
  • Has 5 to 10 times the drug load than that found in some currently used medical patches and gels
  • Has a cosmetically-pleasing transparent design with stronger adhesion than other commercial products

Image Source: University of Warwick


Aeterna Zentaris Regains Compliance with NASDAQ

Published December 2015

On December 7, 2015, NASDAQ notified Aeterna Zentaris Inc. that the company regained compliance with Rule 5450(a)(1). This rule requires a minimum bid price of $1.00 for continued listing on the NASDAQ Capital Market.

But, compliance with this rule has been an ongoing challenge for Aeterna Zentaris Inc.

This late-stage drug development company, which specializes in oncology and endocrinology, originally received a letter from the Listing Qualifications Department of the NASDAQ Stock Market on January 21, 2010. This letter indicated that the minimum closing bid price of its common shares had fallen below $1.00 for 30 consecutive trading days. As a result, the company was not in compliance with NASDAQ Listing Rule 5450(a)(1). The company was provided a grace period of 180 calendar days, or until July 20, 2010, to regain compliance with this requirement.

Today, Aeterna Zentaris Inc. once again announces that it has regained compliance with Rule 5450(a)(1).


Recap: The Top 4 Encapsulation Mistakes

Capsule_2
Published December 2015

On Thursday, December 3rd, Pharmaceutical Processing facilitated the webinar “The Top 4 Most Expensive Encapsulation Mistakes and How to Avoid Them,” which was sponsored by Capsugel. And, yours truly, had the amazing opportunity to be the host.

The four most expensive encapsulation mistakes that we discussed are as follows:

  1. Not considering the dosing style or machine type during formulation
  2. Choosing the wrong capsule size
  3. Lack of standardized methods
  4. Not recognizing and controlling levers of cost in manufacturing

This story is a brief recap of some of the key points that were discussed at the webinar.


The ANA Responds to the AMA’s Ban on DTC Pharmaceutical Advertising

Dan Jaffe, Group EVP, Government Relations from the ANA
Published November 2015

On November 17th, the American Medical Association (AMA) adopted a new policy with the intention of making prescription drugs more affordable. Every year, according to a press release on the matter, billions of dollars are spent advertising and promoting prescription products. As a result, the AMA has called for a ban on direct-to-consumer (DTC) pharmaceutical advertising in the United States.

For more information, see our previous story: “AMA Calls for Ban on Prescription Drug Ads.”

The Association of National Advertisers (ANA) has called this ban “wrong and misguided,” in response to the vote last Tuesday.

Dan Jaffe, Group EVP, Government Relations from the ANA, voices his thoughts on the matter.


IBgard: The Medical Food that Combats IBS

IBgard
Published November 2015

Dr. Michael Epstein explains the discovery and makings of IBgard, as well as the patient-response thus far to the medical food.

According to the International Foundation for Functional Gastrointestinal Disorders (IFFGD), approximately 10 to 15 percent of the population is affected irritable bowel syndrome (IBS) in the U.S. This disorder, according to the same report, is characterized by “abdominal pain or discomfort, and altered bowel habit (chronic or recurrent diarrhea, constipation, or both—either mixed or in alternation).”

Consequently, IBgard® has emerged.


Pharmaceutical & Biopharmaceutical Labeling: Simplified

Videojet
Published November 2015

Tim Kearns, Pharmaceutical & Medical Devices Manager for Videojet Technologies, explains some of the processes behind varying printing methods, as well as the impact of serialization on labeling.

Kearns participated in a Q&A about the company’s printing technologies. Specifically, he delves into standard printing methods for drug and vaccine packaging, what makes Videojet standout, as well as recommendations for serialization.


RM2 Introduces New Pallet

Published November 2015

The BLOCKPal pallet’s new design changes the outlook of transferring materials—particularly with regards to sustainability, longevity, and versatility.

David Kalan, VP of Marketing and Business Development for RM2, participated in a Q&A about their new product, the BLOCKPal pallet.


Drug Safety Labeling Changes: October 2015

Pill bottle_Photo credit - Kevin Dufendach
Published November 2015

In the month of October, there have been 26 drugs with safety labeling changes. These changes were made to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.

Click here for a list of drugs that had modifications to the CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections.

 


Data Integrity at the Corporate Level

ISPE_Data Integrity_Karen Takahashi_0
Published November 2015

At the Annual ISPE Meeting, I also attended the presentation titled “Data Integrity Trends: Regulatory and Compliance Perspective.”

Karen Takahashi, Senior Policy Advisor, FDA/CDER/OPPQ/DRGS/Co., laid down the foundation for this discussion with her talk on the controls and expectations of data integrity. Following Takahashi, David Churchward, Expert GMP Inspector, MHRA, dove into data integrity trends and perspectives.


Drug Shortages: Planning for Prevention

ISPE
Published November 2015

At this year’s 2015 Annual ISPE Meeting, one particular presentation focused on drug shortages and prevention. Titled “Business Continuity Planning for Prevention of Drug Shortages: Introducing the ISPE Drug Shortages Assessment and Prevention Tool,” this presentation gathered a panel of experts from a variety of different backgrounds to explore what companies can do to help establish a reliable supply chain.

According to the FDA, 37 percent of drug shortages in the U.S. are due to manufacturing issues. In addition, 27 percent of drug shortages are on account of raw materials, and another 27 percent is due to delays/capacity. A mere five percent of drug shortages result from an increased demand. That means, according to the FDA’s data, that more than one third of drug shortages could potentially be prevented.


The Downside to Single-Use Technologies

ISPE 2015
Published November 2015

For those in the pharmaceutical and biopharmaceutical manufacturing field, single-use technologies are a hot topic. Their convenience, improved utilization, and adaptability often make them preferable to using conventional, large steel machinery that need to be cleaned after each use/batch of drugs. However, have you ever considered the potential disadvantages to these disposables?

At this year’s 2015 Annual ISPE Meeting, one presentation, titled “Lessons Learned from Implementing Single-use Technology in Biomanufacturing from Clinical to Commercial Scale,” dove into just that topic.


In Development: Cannabidiol Treatments

Cannabis
Published November 2015

Over the past months, there has been a considerable amount of discussion regarding the legalization of cannabis. A number of states in the U.S. have legalized the use of medical marijuana, while yet others have resisted this tide of change. Around the world, the vast majority of countries have remained steadfast on their ruling of marijuana—only a select few countries, such as Spain and Peru, permit cannabis (and those that do under a number of restrictions).

Despite this ongoing debate, there are those that seek to pursue other medicinal applications of this complex plant.

Kalytera Therapeutics is currently in the process of developing non-psychoactive cannabinoid and cannabinoid-modulating medicines. Their intention is to address unmet needs in the market.


Hazardous Waste Management & Regulation

Hazardous Waste
Published November 2015

On August 31st, the Environmental Protection Agency (EPA) issued two proposed hazardous waste regulations:

  1. Management Standards for Hazardous Waste Pharmaceuticals
  2. Hazardous Waste Generator Improvements

Elise Paeffgen (a senior associate in the Environment, Land Use, & Natural Resources Group) and Jonathan Wells (a partner in the Alston & Bird’s Environment, Land Use, & Natural Resources and Toxic Tort Groups) participate in this exclusive Q&A, discussing the future and implications of these proposed regulation changes on the industry.


Electronic Data Capture: Changing the Landscape of Clinical Data

Clinical Trials
Published November 2015

Clinical trials, a necessary but often elongated process in the creation/approval of a drug, can take years—sometimes over a decade. During this time, countless information is recorded about the patients, the drug, and the interaction of the two. This information is critical not simply for pharmacologists conducting trials, but for manufacturers as they use that clinical data to establish the right manufacturing processes.

In the past, paper-based systems have been utilized to record this essential information. Today, electronic data capture (EDC) systems have emerged and can be used to capture and manage data during clinical trials—after which point it can then be presented to the FDA for approval. EDCs collect clinical trial data electronically, which is one potential solution for streamlining data processing.


The Building Blocks of Operational Excellence

Operational Excellence
Published November 2015

Regardless of how a company defines “operational excellence” and its specific application in a given company or field of work, there are key facets that act as the foundation.

Patricia Santos-Serrao, RAC, Senior Product Manager, describes MasterControl’s approach to these building blocks of operational excellence:

  • Documenting: Recording the processes that need to be put in place.
  • Processes Management: Identifying who should execute specific tasks (and when) in order to get the desired end results.
  • Training: Ascertaining people know documents and SOPs.
  • Auditing: Checking to make sure all things are done correctly.
  • Risk Mitigation and Management: The sooner you can identify the possible areas of risk that might go wrong, the sooner it can be adjusted and fixed.

The Steps & Challenges of Getting a Drug to Market

FDA approved
Published November 2015

The process of getting a drug to market involves a number of steps—including preclinical, clinical, and approval. The FDA breaks these down even further: toxicology, INDA, phase I, II, and III trials, an NDA, and then a postmarket surveillance (phase IV).

With many new drugs to try to bring to market, companies often need to be proactive in the various phases of planning as they go through the necessary steps. Sometimes, having an extra pair (or pairs) of eyes may be of great assistance to companies in the process of trying to bring a new drug to market.


A Shifting in the Wind

Copyright
Published November 2015

As I hunkered down and took the reins on the November/December 2015 issue of Pharmaceutical Processing, I found myself reflecting quite a lot on the emergence of new technologies.

To learn more about the behind the scenes of the makings of the November/December issue of this journal, check out my blog post—consisting largely of ruminations, reflections, and a touch of sarcasm.

 


The Proactive Pessimist: Surveying the Landscape for the Next Pandemic

Healthcare
Published October 2015

The summer of 2014 brought with it the like we haven’t seen in years: the outbreak of a deadly virus. It was the first urban Ebola epidemic in history, during which the virus spread across three nations of West Africa.

Since that time, experts have immersed themselves in the creation of a vaccine for Ebola and outbreak preparation.

 


Clinical Trials Update: GlycoMimetics, Arena Pharmaceuticals, Seattle Genetics, & Charleston Laboratories

Research_Scientist
Published October 2015

The 29th of October ushers in drugs entering into varying clinical trials, as well as drugs meeting primary endpoints.

  • GlycoMimetics, Inc. announced that the first healthy participant has been dosed with a subcutaneous (SC) formulation of rivipansel in a Phase 1, single ascending-dose clinical study to evaluate its safety, tolerability and pharmacokinetics.
  • Arena Pharmaceuticals, Inc. announced the initiation of patient dosing in a Phase 1b multiple-ascending dose clinical trial of APD371, a selective and potent agonist of the cannabinoid 2 (CB2) receptor.
  • Seattle Genetics, Inc. announced the initiation of a randomized phase 2 clinical trial of denintuzumab mafodotin (SGN-CD19A) in combination with the second-line salvage regimen of rituximab (Rituxan), ifosfamide, carboplatin and etoposide (RICE), for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
  • Charleston Laboratories, Inc., and Daiichi Sankyo, Inc., announced that a third Phase 3 clinical trial of CL-108, an opioid-containing formulation, met its primary endpoints.

Sterilization of Injectable Components

Syringe
Published October 2015

Injectable drugs have been around for several hundred years, and very likely originated from the use of weapons—such as blowpipes and poison-tipped darts—that brought various substances into the human body by piercing the skin. As early as the 17th century, various persons were given credit for having invented the syringe.

Today, however, injectable drugs have grown and expanded in its use. These drugs are favored in many medical settings for its increased (and rapid) effects—as it goes straight into the blood—and its efficiency (since smaller amounts of a drug are needed). Despite these advantages, there are also disadvantages to this method—the foremost of these being the increased risk of infection.


Pharmaceutical Distribution: Cloud Platform for Supply Chain Analytics

Business Intelligence
Published October 2015

Business intelligence in the pharmaceutical supply chain has grown in the past years. With companies having to retain and keep track of copious amounts of data, the need for a new way to approach business intelligence and data management has manifested itself. With the lurking prospect of serialization and the data that will soon need to be readily available to companies and those that work with them, information technology is key.

H. D. Smith, a wholesale distributor and pharmaceutical brand support company for manufacturers and healthcare providers, has joined forces with FusionOps to supply information. FusionOps is a cloud application with built-in supply chain analytics that transforms data into information that can be acted upon.


Pipeline Update: The Emergence of Biosimilars and Botanical Alternatives

Botanisol
Published October 2015

Today’s pharmaceutical market is growing exponentially in potential. Not only has there been new brand-name and generic drugs produced for a myriad of medical conditions, but also botanicals with historical value emerging with the potential to act as alternative treatments, as well as the arrival of biosimilars in the United States. All of these changes only serve to engender a competitive environment, thriving on quantitative and qualitative productivity and rapidity, among manufacturers.

This article is featured on Pharmaceutical Processing‘s website in its entirety, as well as in the October 2015 digital edition. The story was also separated into an online feature on biosimilars and another on botanicals.


Full Steam Ahead

(The Editor’s Note of Pharmaceutical Processing‘s October 2015 Digital Edition)

Copyright
Published October 2015

In the October 2015 edition of Pharmaceutical Processing, one of the things we talk about is biosimilars (as well as generics, botanical medicines, and a number of other topics). Although we have heard much on the subject of biosimilars in recent years, the first was approved in the United States only this year. Given the emergence of this new form of medication (particularly on my home turf), I am eager to learn more about this new development and see where it takes us as an industry.

 


Uniquity 2015, Day 2: Global Counterfeiting & Company/Consumer Safety

Uniquity 2015
Published October 2015 (Photo credit: Ryan Burke)

The second and final day of Systech’s 2015 Uniquity Global Conference began with a cautionary tale, narrated by Mark Davison, author of Pharmaceutical Anti-Counterfeiting. As the title of his book might suggest, he engaged his readers with discussions on global counterfeiting and best practices.

For more information about this year’s Uniquity conference, go to: SystechOne.com/Uniquity-2015.


Uniquity 2015, Day 1: Delving Into the Future & Implementation of Serialization

Uniquity 2015
Published October 2015 (Photo credit: Ryan Burke)

On the eve of the inauguration of Systech’s Uniquity 2015 Global Conference, there is much to ponder after a day steeped in hearty discussions on the future and implementation of serialization across country borders, and its implication in the ongoing battle against counterfeiting.

For more information on Systech’s Uniquity conference, click here or read the full article.


Ethypharm & Spherix Global Insights Announce Acquisitions

Shaking Hands
Published October 2015

The companies Ethypharm and Spherix Global Insights announce recent acquisitions to their respective companies. Ethypharm announces the total acquisition of the share capital of DBA Group (DBA), while Spherix Global Insights has acquired Rare Insights LLC.


The CHMP of the EMA Adopts Positive Opinion for UCDs and Parkinson’s Disease Treatment

Published September 2015

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for UCDs and Parkinson’s disease treatments.

 


EMA’s CHMP Adopts Positive Opinion for AML, Metastatic Melanoma, & Hemophilia A Treatments

Published September 2015

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AML, metastatic melanoma, and hemophilia A treatments.

 


Nexvet Develops Treatment for Pain in Cats and Dogs

Nexvet
Published September 2015

Nexvet, a biotechnology company headquartered in Dublin, is developing species-specific monoclonal antibody (mAb) therapies to treat pain—particularly degenerative joint disease—in cats and dogs. Founded in 2010, the company utilizes their technology platform, PETization™, to transform mAbs between any two species.

Two of Nexvet’s therapies—which are currently in development—are NV-01 and NV-02. For the treatment of osteoarthritis in dogs, NV-01 was created. This treatment inhibits the activity of canine nerve growth factor (NGF). NV-02, an anti-NGF mAb, treats feline pain associated with degenerative joint disease.


Pharmaceutical Processing Welcomes New Editor, Meg Snyder

Copyright
Published September 2015

Through my experiences as a medical writer and journalist, I have become intimately acquainted with the unique signatures of different genres of writing, as well as the prominence of creativity interwoven throughout as both readers and writers seek knowledge and understanding. I believe that the pursuit of excellence is a universal standard amongst all genres of readership—particularly so amongst professionals in the pharmaceutical and manufacturing industries.


 

 

MD-IQ LogoMD-IQ, a program that publishes online quizzes on topics in different medical specialties, is featured on numerous online medical journal websites. Below are some of the quizzes I have composed in varying medical publications.


Cardiology News Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

Clinical Endocrinology News Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

2014

Clinical Neurology News Quizzes:

2015

2014

Clinical Psychiatry News Quizzes:

2014

Clinician Reviews Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

Current Psychiatry Quizzes:

2015

2014

Emergency Medicine Quizzes:

2015

Family Practice News Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

January 2015

2014

Federal Practitioner Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

GI & Hepatology News Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

Hospitalist News Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

January 2015

2014

Internal Medicine News Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

January 2015

2014

The Journal of Family Practice Quizzes:

September 2015

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

Neurology Reviews Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

January 2015

2014

Ob. Gyn. News Quizzes:

2015

2014

OBG Management Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

January 2015

2014

Oncology Practice Quizzes:

2015

2014

Pediatric News Quizzes:

2015

Rheumatology News Quizzes:

August 2015

July 2015

June 2015

May 2015

April 2015

March 2015

February 2015

2014

Skin & Allergy News Quiz:

2014

*Please note that quizzes are only live for one year after they are posted.

Specialty Quizzes

Anticoagulation Hub Quizzes:

2015

Multiple Sclerosis Hub Quizzes:

2015

Neurology Reviews‘ Epilepsy Resource Center Quizzes:

2015

Pneumonia Hub Quizzes:

2015

*Please note that some of the specialty quizzes are only up for a short duration due to program specificities.
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