Biopharma News

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

Physician-administered biosimilars under Medicare Part B will be reimbursed at a rate based on innovator drug prices and new changes will make costly innovator Part D drugs easier to exclude from formularies.

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

Novartis announced that it entered into a multiyear alliance with Aduro Biotech to develop cancer immunotherapies, offering up to $250 million in upfront payments and equity investments.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

The company’s new corporate name will be simply Biogen.

Biogen Idec says its investigational candidate is the first drug to both reduce amyloid plaque in the brain and slow cognitive decline.

As a result of the decision, Sandoz will be able to immediately launch Zarxio, the first biosimilar in the United States.

Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.

The company will build an R&D team to find promising drug targets with genetic information submitted by customers in its database.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

Baxter announced that its new biopharmaceutical arm, scheduled to become independent from Baxter in 2015, will be located in Bannockburn, Illinois.

Leased facilities in California will expand Kite Pharma's capacity for T-cell therapies.

The agency cites Apotex’s Bangalore facility with quality system failures.

Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

Juno's new manufacturing facility in Washington state will support clinical trials for immunotherapies.

The companies partnered to create more effective biopharmaceuticals through the exploitation of PASylation.

Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders.

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.