Array, Pierre Fabre collaborate on oncology

Monday, November 16, 2015

Array BioPharma and Pierre Fabre are collaborating to globally develop and commercialize Array’s late-stage novel oncology products binimetinib and encorafenib. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, currently are advancing in three global phase III trials for melanoma and ovarian cancer. Top-line results from NEMO, a phase III study of binimetinib in patients with NRAS-mutant melanoma, are anticipated before the end of 2015.

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FDA accepts Sandoz submission for proposed biosimilar

Monday, October 5, 2015

The FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Enbrel (etanercept)—a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, a Novartis company, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affectingabout 1.3 million and 7.5 million people (respectively) in the U.S.

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Exelixis adds top personnel

Monday, September 28, 2015

Exelixis has announced three high-level appointments as the company prepares for the potential commercialization of its lead compound, cabozantinib, for the treatment of advanced renal cell carcinoma (RCC) following positive results from the METEOR pivotal phase III trial. William Berg, M.D., has joined the company as senior vice president of medical affairs, Jonathan Berndt as vice president of sales, and Gregg Bernier as vice president of marketing.

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Novartis launches affordable medicines portfolio

Thursday, September 24, 2015

Novartis has launched Novartis Access, a portfolio of 15 medicines to treat chronic diseases in low- and low-middle-income countries. The portfolio addresses cardiovascular diseases, diabetes, respiratory illnesses and breast cancer and will be offered to governments, non-governmental organizations (NGOs) and other public-sector healthcare providers for $1 per treatment, per month.

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PeptiDream, Sanofi collaborate

Monday, September 14, 2015

PeptiDream, a public Tokyo-based biopharmaceutical company, has announced a multi-target discovery and optimization collaboration with Sanofi. PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to generate macrocyclic/constrained peptides against multiple targets of interest selected by Sanofi. Sanofi will have the right to develop and commercialize all therapeutic peptides resulting from the collaboration.

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