Biopharma News

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.

Alexion will construct a biologics facility in Ireland that is its first outside the US.

Emergent gives ProMetic long-term access to its Winnipeg facility.

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.

Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.

FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.

Juno Therapeutics announces that it will expand its cellular therapies pipeline with the acquisition of Stage Cell Therapeutics for €52.5 million.

With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.

Johnson & Johnson announces partnership with NYU School of Medicine to launch a compassionate care committee for individual patient requests of investigational drugs.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.

The company voluntarily recalls select lots of Adrucil due to particulate matter.

Alexion announces it will expand its rare disease pipeline with a definitive agreement to acquire Synageva.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

In a seething letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Innate Pharma announces a co-development and commercialization agreement with AstraZeneca to accelerate the development of Innate’s anti-NKG2A antibody.

The agency has recommended granting marketing authorization for Opdivo.

The combination of two mAb drugs eradicated a large tumor, but also sparked new toxicity concerns associated with immunotherapies.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

FDA approved the first generic version of Copaxone (glatiramer acetate), a widely prescribed drug to treat multiple sclerosis. The generic version of the medication, called Glatopa, will be marketed by Sandoz and Momenta. Glatopa is the first generic indicated for the treatment of patients with relapsing-remitting forms of multiple sclerosis (RRMS).

The company announced that a pharmacokinetic study comparing ONS-1045 to US- and EU-sourced Avastin will conclude shortly.

Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.

Hydra Biosciences enters into an agreement with Boehringer Ingelheim to research and develop small-molecule TRP inhibitors for renal diseases and disorders.

The grants will be offered to investigators conducting research in the field of PCSK9 biology.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

Mylan announces that it would offer Perrigo $29 billion in cash and stock to buy the Irish company.

Novartis will make payments to Juno to settle a patent dispute covering chimeric antigen receptor T-cell (CAR-T) therapies.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.