The agency published an overview of marketing authorizations made in 2016.

Luke Miels will replace Abbas Mussain as president of GSK’s Global Pharmaceutical division later this year.

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

With this new line, Bischof + Klein will double its extrusion capacities for its CleanFlex clean room films.

Evotec and MaRS launched Fibrocor Therapeutics, a company dedicated to developing novel therapeutics for fibrosis.

The company opened a facility in Spain dedicated to the production of meglumine.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

High Street Capital acquired Avomeen, a full-service chemical testing laboratory, in late December 2016

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

New website allows access to research quantities of commercial-grade ligands and catalysts.

FDA published a flurry of guidance documents in late 2016.

Industry experts identify the future focus of the biopharma industry in a new survey.

The agency plans on publishing more than 100 new or revised guidance documents in 2017.

The locations will feature end-to-end bioprocessing centers and will be in Shanghai, China and Boston, MA.

The membrane-based Protein A purification tool was unveiled at the 2017 PepTalk Conference in San Diego, California.

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

The company announced that it has terminated an agreement made with UMN Pharma for the co-development of influenza vaccine programs in Japan.

The company made a new strain of the influenza virus available for use as a challenge agent in clinical trials.

The companies will combine expertise on T-cell therapies with two or more binding domains to create novel oncology medications.

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

GEA’s ConsiGma continuous tableting line combined with Siemens’ automation and Sipat data management systems enables continuous manufacturing.

UK-based Orchard Therapeutics and PharmaCell ally to support clinical trials and commercialization of Orchard’s ex-vivo gene therapies.

Catalent announces a development agreement with JOT to evaluate softgel options for a resveratrol drug candidate.

Takeda will acquire ARIAD Pharmaceuticals for approximately $5.2 billion.

The company was cited by FDA for violations of sterile processing GMPs.

The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.