Bio/Pharma News

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

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

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.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

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.

On Sept. 19, 2016, FDA announced that it has granted accelerated approval to Exondys 51 (eteplirsen), an injection for the treatment of Duchenne muscular dystrophy (DMD). The drug is marketed by Sarepta Therapeutics in the United States and is currently the only approved treatment for DMD. In light of the approval, Sarepta shares catapulted 76%, Seeking Alpha reported.

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

The autoinjector is based on core technology licensed from Bespak.

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

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

Allergan will acquire Vitae pharmaceuticals for $639 million.

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

Horizon Pharma will acquire Raptor Pharmaceuticals with the transaction expected to close in the fourth quarter of 2016.

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

Results show the drug was effective at reducing the risk of uveitic flare or visual impairment.

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

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

Results from a small Phase Ib trial with Biogen’s aducanumab showed the drugs potential as an investigational treatment for patients with Alzheimer’s disease (AD). Researchers from the University of Zurich evaluated the efficacy of aducanumab in 165 patients with early-stage AD. At the conclusion of 54 weeks, the researchers reported seeing a dose-dependent reduction of amyloid-beta in patient’s brains compared to a placebo. Exploratory results indicate the drug may also slow clinical decline.

Sandoz won FDA approval for its biosimilar version of Enbrel.

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

The company will launch a generic version of EpiPen at the price of $300 for a two-pack.

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

Ranking members of the Senate Judiciary Committee called on Mylan to explain its decision to raise the price of EpiPens nearly 400%.

The portfolio in this agreement include approved antibiotics Merrem, Zinforo, and Zavicefta, as well as candidates in clinical development, ATM-AVI and CXL.

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.

The company received breakthrough therapy designation for esketamine, a treatment for major depressive disorder with imminent risk for suicide.

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