News

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.

PF-06410293 met primary endpoints during clinical trials and demonstrated similar efficacy to its reference product.

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.

A pilot project, beginning in 2017, will support the development of biosimilars.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

Emergent signed a follow-up contract to provide 29.4 million doses of BioThrax to the Strategic National Stockpile.

The agency announces that 81 medicines overall were recommended in 2016.

Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.

Lonza adds CDMO, capsule, and consumer healthcare and nutrition capabilities with $5.5-billion acquisition of Capsugel.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

PDA is conducting a survey of industry members challenged by the complexity of making post-approval changes.