Biopharma News

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

Mucodel reported that the study met its objectives, and effectively delivered a dose of naloxone using an oromucosal route.

The companies will collaborate on mRNA-based cancer vaccine development.

CRT and SV Life Sciences launched Artios Pharma, a new company formed to develop drugs targeting the DNA damage response to cancer.

The company said it has plans to address global health challenges including vaccines, antimicrobial resistance, and preparation for future pandemics.

Walmsley will succeed Andrew Witty as CEO of the British drug maker.

Adaptimmune entered into a manufacturing agreement with PCT for the manufacture of its SPEAR T-cell therapies.

The agency granted accelerated approval to Sarepta’s controversial DMD treatment, under the condition the company conduct additional studies to demonstrate efficacy.

The agency has recommended marketing authorization for Ibrance in the European Union.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

Bayer will acquire the agricultural company for $66 billion in an all cash transaction.

Allergan will acquire Vitae pharmaceuticals for $639 million.

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.

The company voluntarily recalled the product due to detached needles on the syringe in the kit.

The companies launched Onduo, a joint venture focused on developing solutions to assist patients with Type 2 diabetes.

Results of Phase III trials involving AbbVie’s blockbuster drug Humira (adalimumab) for the treatment of noninfectious uveitis were released on Sept 7, 2016. FDA approved the drug for noninfectious intermediate, posterior, and panuveitis in June 2016, bringing Humira’s list of approved US indications to 10.

Allergan acquired clinical-stage gene-therapy company, RetroSense Therapeutics, for $60 million.

The company established a dedicated research center in Bangalore, India for Amgen.

In Phase Ib trials, Biogen’s aducanumab reduced amyloid-beta in the brains of patients with Alzheimer’s disease.

Sandoz won FDA approval for its biosimilar version of Enbrel.

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The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.

Pfizer will acquire Medivation for approximately $14 billion.

The joint venture, created through a collaboration with Bayer and CRISPR Therapeutics, will be based in Cambridge, MA.

Mallinckrodt announced a planned merger agreement with Stratatech Corporation, a regenerative medicine company.

The EDA offered Allergan tax credits in order to encourage the company to remain in the state.

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.