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.

A study of 53 cancer drugs found that new treatments extended patient life an average of 3.43 months when compared with treatments available in 2003.

A judge ruled that Regeneron’s mAb be removed from the market after Amgen alleged that the marketing of Praluent hurt its reputation as innovator of this class of drugs.

In an attempt to battle low production volumes of hard-to-manufacture biopharmaceuticals, GE Healthcare announced on January 4, 2017 that it will partner with Synpromics on the development of synthetic promotors. The goal of the collaboration is to identify promoters that will work most effectively with GE’s existing expression system for optimal transcription.

IPEC-Americas published a position paper in response to misconceptions regarding DMFs.

The combined company’s turnover is estimated to reach €8 million ($8.35M) in 2017.

Sun Pharma said a fire that left two dead at the company’s Ahmednagar, India factory did not affect production.

FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.

J&J’s Innovation Global announced the company has entered into 15 new collaborations.

According to a Deloitte report, the industry’s return on its research investment has been steadily slipping for the past six years. The conclusion? Fundamental change may no longer be a given, but a necessity for the industry

Prokarium in the UK and Probiomed in Mexico hope to demonstrate large-scale production of oral vaccines that will reduce cost compared to injections and improve availability.

Top C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?

Translating campaign promises to predictions for bio/pharma is difficult, but optimism prevails.

As Europe’s bio/pharma market learns that breaking up is hard to do, it also must address productivity, regulatory, and drug pricing challenges.

The agency has published its refuse-to-receive standards guidance for abbreviated new drug applications.

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Pharma Tech introduced a new high-speed bottling line to its facility in Union, MO.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Novasep’s three facilities located in France and Germany are free of Form 483.

The company has manufactured double-digit number of batches on the new filling line, for use in early-stage clinical trials.

The companies entered into a manufacturing agreement for voclosporin active pharmaceutical ingredient.

The two companies have entered into an agreement to provide Suzeken with access to AmerisourceBergen’s Cubixx inventory solution.

The $2-billion facility will be located in Clayton, North Carolina.

The contract service provider entered into a contract agreement with the US Army to provide services in the development of treatments of malaria.

Portola signed a $50-million loan agreement with BMS and Pfizer to provide additional funding for the development of andexanet alfa.

Baxter will acquire Claris Injectables Limited, adding additional generic injectable capabilities to the company’s porfolio.

The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.