Celgene invests $100M, gains option to buy Acetylon Celgene agreed to invest $100 million in Acetylon Pharmaceuticals in exchange for an exclusive option to purchase the Boston drugmaker at a price from $500 million to $1.1 billion contingent on certain milestones. Acetylon will use some of the funding to further develop ACY-1215, its lead drug candidate for myeloma. Celgene took a $15 million equity stake in Acetylon last year. The Boston Globe (tiered subscription model) (7/29)  | Getting Ready for the Physician Payment 'Sunshine' Rule
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 | FDA to review AstraZeneca-Bristol's diabetes drug again The FDA has accepted AstraZeneca and Bristol-Myers Squibb's resubmission of a marketing application for dapagliflozin for treatment of type 2 diabetes. A decision is expected by Jan. 11. The sodium-glucose co-transporter 2 inhibitor has been approved for sale in Europe and is being sold in Brazil and Australia, among other nations. Medscape (free registration) (7/26) EU panel supports approval of Novartis' COPD drug The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of Novartis' Ultibro Breezhaler, or QVA149, as a treatment for chronic obstructive pulmonary disease. The once-daily drug is a combination of long-acting beta2-adrenergic agonist indacaterol and long-acting muscarinic antagonist glycopyrronium. Reuters (7/26) Israeli pharma seeks U.S. approval for hep B vaccine SciVac has filed an application with the FDA for approval to distribute its hepatitis B vaccine Sci-B-Vac to dialysis and HIV-positive patients. The Israeli firm plans to conduct a clinical trial in the U.S. and submit a similar application in Europe if it gets the FDA's nod. The vaccine "looks the same as the virus itself. The immune system cannot ignore it, so it gives full protection," CEO Michal Ben-Attar said. Reuters (7/25) 2 melanoma drugs from GSK win Canadian OK Health Canada approved GlaxoSmithKline's BRAF-inhibitor Tafinlar, or dabrafenib mesylate, and first-in-class MEK-inhibitor Mekinist, or trametinib, to treat melanoma patients with BRAF V600 mutation. The drugs are indicated as oral monotherapy for metastatic melanoma or unresectable melanoma. Tafinlar will be available in 75 mg and 50 mg capsules, and Mekinist in 2.0 mg and 0.5 mg tablets. Pharmaceutical Business Review Online (7/25) GSK, Biogen gain rights to Adimab's antibody technology Adimab granted GlaxoSmithKline nonexclusive rights to use its antibody technology for discovery and optimization of all antibody formats including bispecific antibodies. The deal includes upfront, licensing and milestone fees plus sales royalties on products arising from the collaboration. In another deal, Biogen Idec secured the rights to use Adimab's antibody platform in the discovery of potential drugs for neurodegenerative and autoimmune diseases. Genetic Engineering & Biotechnology News (7/26) | Gene therapy startup gets $30M funding boost Audentes Therapeutics, a California-based startup specializing in gene treatments for very rare diseases, secured $30 million in a Series A funding round from 5AM Ventures, OrbiMed Advisors and Versant Ventures. The firm plans to use the proceeds to support development of treatments for rare diseases such as X-linked myotubular myopathy and Pompe disease. Xconomy/San Francisco (7/26) | Biotech crop-makers launch website to show transparency Six agricultural biotechnology firms will launch today a website that seeks to promote biotech crop transparency. The site will publish safety data about biotech products and will allow consumers to ask any questions regarding biotech crops. It will be run by the Council for Biotechnology Information, whose members include Monsanto, Dow Chemical, Syngenta, DuPont, BASF and Bayer CropScience. "We have not done a very good job communicating ... . We want to get into the conversation," said Cathleen Enright, the council's executive director and BIO's executive vice president for food and agriculture. The New York Times (tiered subscription model) (7/28) | | Industrial & Environmental | Tampering with the RFS may stunt growth of next-generation biofuels Congress should leave the Renewable Fuel Standard alone because without it, investors would have second thoughts about funding next-generation biofuels, write NexSteppe CEO Anna Rath and Novozymes North America Regional President Adam Monroe. The key to growth in the sector is "continued investment and support from companies, including traditional ethanol producers, and the market confidence derived from a strong, stable federal policy: the RFS," Rath and Monroe write. The Hill/Congress Blog (7/26)
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