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.

Camfil Air Pollution Control has expanded its testing laboratory and added a dust collection test rig for the ANSI dust collection standard.

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

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

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

The presentation details the addition of triethylamine to the guideline on toxic solvents.

EAG Laboratories offers dermal absorption studies using OECD methods.

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FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

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.

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?