News

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

The organization launched its GOBOLDLY campaign to highlight the work of US biopharmaceutical companies.

WuXi AppTech acquired HD Biosciences, a preclinical drug-discovery-focused CRO.

The company released the Biopharma Compass 2.0 software, which automates workflows for high-resolution mass spectrometry.

A new report says that failure to account for rebates, discounts, and price concessions leads to an “overstatement of payments realized by manufacturers” in most annual industry drug spend reports.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

The company will begin trials with its CBD chewing gum, CanChew Plus, for the treatment of irritable bowel syndrome.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

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.

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FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

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

The company agreed to pay Forward Pharma $1.25 billion to settle a patent dispute over the formulation of Tecfidera, the company’s leading multiple sclerosis treatment.

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

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