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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FDA expands use of Promacta

Wednesday, August 26, 2015

The FDA has approved an expanded use for Novartis’ Promacta (eltrombopag) to include children age 1 and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 and older and in 2008 for use in adult patients with the same condition.

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