News

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

Takeda will acquire ARIAD Pharmaceuticals for approximately $5.2 billion.

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

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.

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

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.

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

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

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

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

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.

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

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

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

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

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.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

FDA’s Center for Drug Evaluation and Research makes plans for implementation of the 21st Century Cures Act that include patient-focused drug development.

GlaxoSmithKline opened a new vaccines R&D center in Rockville, MD creating up to 200 new jobs.

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

DuPont received a grant from the Bill & Melinda Gates Foundation to produce pharmaceutical proteins.