Celgene-Sutro expanded antibody drug pact could be worth over $1B | Pharma companies to collaborate on Ebola vaccine | Relypsa submits hyperkalemia drug candidate for FDA review
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October 24, 2014
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Celgene-Sutro expanded antibody drug pact could be worth over $1B
Celgene and Sutro Biopharma agreed to collaborate in the development of antibody drug candidates against certain immuno-oncology targets using the latter's cell-free biologics development technologies, as part of an expanded deal between the firms. Celgene also secured an exclusive option to buy Sutro and all its programs. The deal gives Sutro $95 million upfront and up to $90 million in payments during the initial research period. Sutro is also eligible to receive more than $1 billion in milestone fees and sales royalties on all products arising from the collaboration. Genetic Engineering & Biotechnology News (10/23), American City Business Journals/San Francisco/BiotechSF blog (10/23)
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Health Care & Policy
Pharma companies to collaborate on Ebola vaccine
Johnson & Johnson of the U.S. and the U.K.'s GlaxoSmithKline plan to collaborate on the development and large-scale production of an Ebola vaccine. GSK's vaccine is undergoing clinical tests, and J&J will hold human trials of its vaccine in January. Experts are meeting in Geneva to discuss how all companies can work together to avoid bottlenecks in the process, says Andrew Witty, GSK's chief executive. Reuters (10/22)
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Relypsa submits hyperkalemia drug candidate for FDA review
Relypsa has submitted its experimental drug Patiromer for FDA review for the treatment of hyperkalemia, which affects patients with chronic kidney disease. Relypsa CEO John Orwin said the drug could be approved next year. American City Business Journals/San Francisco/BiotechSF blog (10/22)
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Janssen seeks approval for ibrutinib as Waldenstrom's macroglobulinemia therapy
Janssen Research & Development has filed a supplemental new drug application for ibrutinib's use as treatment for patients with Waldenstrom's macroglobulinemia. If approved, it would be the first treatment cleared by the FDA for the rare type of B-cell lymphoma, according to the International Waldenstrom's Macroglobulinemia Foundation. OncLive (10/22)
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FDA delays decision on NPS Pharma's hypoparathyroidism drug
The FDA postponed by three months its decision on NPS Pharmaceuticals' marketing application for Natpara as a treatment for hypoparathyroidism, saying it needs more time to evaluate additional material. The agency also asked the firm to submit a plan explaining the drug's risks and how to mitigate them. A decision is now expected by Jan. 24. Yahoo/The Associated Press (10/23)
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Portola signs production agreement with Lonza for andexanet alfa
Portola Pharmaceuticals has entered into a supply agreement with Lonza for the commercial manufacture of andexanet alfa, a Factor Xa inhibitor antidote. Large-scale production is projected to begin 18 to 24 months after the drug's expected 2016 introduction to the U.S. market. Outsourced Pharma (10/22)
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Company & Financial News
Enigma moves to bring molecular Dx platform to China
Enigma Diagnostics has entered into a joint venture with Beijing Leadman Biochemistry to offer the Enigma Mini Laboratory platform on the Chinese market. The fully automated molecular diagnostic system is used to assess various RNA and DNA disease targets at the point of care. Separately, Enigma has secured a subscription deal with Shanghai Debay Capital worth $50 million, which it aims to use to market the Mini Laboratory system worldwide. GenomeWeb Daily News (free registration) (10/22)
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Investors pump $13M into Calif. molecular Dx company
California-based InSilixa has obtained $13 million in financing from Morningside and PointGuard Ventures. The company will use the money to develop molecular diagnostic systems that build on complementary metal-oxide semiconductor, or CMOS, processes. GenomeWeb Daily News (free registration) (10/22)
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Food & Agriculture
Colo. biotech food labeling proposal would be expensive, confusing
Colorado's biotech food labeling proposal would not only be expensive to implement, it would also raise food costs and put a heavy burden on farmers and ranchers, according to an editorial in Steamboat Pilot & Today. Proposition 105, which would create a separate food labeling system, could also confuse the public and lead to the assumption that there's something wrong with biotech foods, the editorial says. The Steamboat Pilot & Today (Steamboat Springs, Colo.) (10/18)
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Industrial & Environmental
Feds offer $14M funding for cellulosic feedstock research projects
The Department of Energy is offering up to $14 million for projects that use landscape design principles to integrate sustainable production of cellulosic feedstocks into existing farms or forests. The agency expects to select up to three projects. The funding opportunity is aimed at feedstocks that are available in the U.S. and are capable of producing at least 50 million dry metric tons of lignocellulosic biomass annually. EthanolProducer.com (10/22)
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News From BIO
Summer 2014 BIO Therapeutic Newsletters
The BIO Emerging Companies Section Policy Team has compiled the latest news to keep you informed on the action in Washington with respect to the disease category on which your company is focused. Topics covered comprise: Allergy/Infectious Disease/Antiviral; Cardiology/Pulmonology/Blood; Nephrology/Endocrinology/Metabolism/Gastroenterology; Neurology/CNS; Oncology; and Rheumatology/Anesthesia/Inflammation/Pain. BIO has attempted to include updates from biotech stakeholders around Washington, including Congress, FDA, NIH, and patient organizations. Access our Summer 2014 Therapeutic Newsletters. Should you have any comments or questions, please contact Matt Stross.
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