Merck KGaA boosts lab-supplies business with $17B Sigma-Aldrich buy | BIO among groups urging CMS to provide context for Open Payments data | Tekmira's experimental Ebola drug approved for emergency use by U.S., Canada
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September 23, 2014
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Merck KGaA boosts lab-supplies business with $17B Sigma-Aldrich buy
German firm Merck KGaA agreed to pay $17 billion in cash to acquire Sigma-Aldrich, a U.S.-based supplier of laboratory substances, biochemicals and organic chemicals for major drugmakers and research laboratories. Merck said the deal, the largest takeover in its history, would strengthen its laboratory-supplies business. "With this acquisition we have the opportunity to turn one of our most reliable businesses into a core earnings contributor," Merck Chief Financial Officer Marcus Kuhnert said. Reuters (9/22)
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Health Care & Policy
BIO among groups urging CMS to provide context for Open Payments data
BIO, AdvaMed and the Pharmaceutical Research and Manufacturers of America have sent a letter to the CMS encouraging the agency to provide clear context and background information for Open Payments data, which will be made available publicly on Sept. 30 through the Sunshine Act system. "Providing context for reported payments and other transfers of value is critical to ensuring patients do not form mistaken impressions that all payments to physicians are suspect," the letter states. Bloomberg BNA (free content)/Health Care Blog (9/22), The Hill (9/22)
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Tekmira's experimental Ebola drug approved for emergency use by U.S., Canada
Tekmira Pharmaceuticals was granted approval by the FDA and Health Canada under an expanded-access program to provide its experimental Ebola drug TKM-Ebola to patients with confirmed or suspected Ebola virus infections. The drug, an RNAi therapeutic, is being developed under a contract with the U.S. Defense Department. "Our TKM-Ebola drug supplies are limited, but we will continue to help where we can," Tekmira CEO Mark Murray said. Reuters (9/22), The Wall Street Journal (tiered subscription model) (9/22)
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Amgen submits leukemia drug for FDA review
Amgen has submitted a biologic license application to the FDA for approval to market its bispecific T-cell engager antibody blinatumomab as a treatment for Philadelphia-negative relapsed/refractory B-precursor forms of acute lymphoblastic leukemia. The application was based on data from a midstage trial that showed the drug resulted in a complete response rate of 43%. PharmaTimes (U.K.) (9/22)
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Company & Financial News
Avalon, GSK create 2 startups focused on iron disorders, Graves' orbitopathy
Avalon Ventures and GlaxoSmithKline have launched biotech startups, Silarus Therapeutics and Thyritope Biosciences, as part of their $495 million alliance announced last year. Both companies will get $10 million in Series A funding and will be located at COI Pharmaceuticals. Silarus will focus on developing a drug for anemia and iron overload disorders, while Thyritope will specialize on Graves' orbitopathy treatments. (9/22)
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BioCryst receives more NIH funding to develop Ebola drug
The National Institute of Allergy and Infectious Diseases has given an additional $2 million to BioCryst to support the development of the experimental drug BCX4430 for the treatment of viral hemorrhagic diseases. More than 20 ribonucleic acid viruses in nine families may respond to the drug. American City Business Journals/Raleigh/Durham, N.C. (9/18), Pharmaceutical Business Review Online (9/19)
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Global Developments
Diabetes drug combo from Novo Nordisk gets EU approval
The European Commission has approved Novo Nordisk's once-daily injectable treatment Xultophy, a combination of Tresiba, or insulin degludec, and Victoza, or liraglutide, as a treatment for type 2 diabetes. The drug was cleared for use along with glucose-lowering drugs when those drugs alone or in combination with basal insulin fail to provide sufficient glycemic control. Novo plans to commercialize Xultophy in some European countries in the first half of next year. PharmaTimes (U.K.) (9/19)
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European Commission approves Gilead's leukemia drug idelalisib
The European Commission has granted approval for Gilead Sciences to market idelalisib, or Zydelig, as a treatment for chronic lymphocytic leukemia and follicular lymphoma. The phosphoinositide 3-kinase delta inhibitor was approved for similar indications in July in the U.S. Medscape (free registration) (9/19)
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Food & Agriculture
Gatekeeper gene discovery could lead to improved wheat varieties
Researcher Kulvinder Gill of Washington State University said he has identified the key gene that functions as a gatekeeper for wheat's genetic composition. Gill said that temporarily silencing this gene would permit researchers to move desired traits from wild grass relatives, such as disease and pest resistance, into wheat varieties. The research was published in the journal Proceedings of the National Academy of Sciences. Capital Press Agriculture (Salem, Ore.) (9/19)
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Industrial & Environmental
2014 is turning out to be a boom year for ethanol business
U.S. ethanol producers are experiencing one of their most profitable years, thanks to low corn prices and high demand for the biofuel, industry insiders said. Big companies such as Valero Energy and Green Plains, as well as small producers such as Advanced BioEnergy and Gevo, all recently reported strong earnings from ethanol operations. "If you are a farmer invested in an ethanol plant, the potential is high that it will cushion a downfall in the farm economy. If you think back, this is why farmers developed ethanol plants," said Highwater Ethanol CEO Brian Kletscher. Star Tribune (Minneapolis-St. Paul, Minn.) (9/20)
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News From BIO
New BIO Survey Tool: FDA/Sponsor Interactions During Drug Development
BIO is conducting a first-of-its-kind survey on FDA/Sponsor Interactions During Drug Development. BIO's new survey tool gives participants 24/7 access to provide input on their experiences with FDA regarding current drug development programs. This valuable feedback will enable BIO to provide real-time information to FDA and will inform BIO's policy priorities in the upcoming user fee negotiations that will begin in 2015. Companies are encouraged to share their insights by signing up. All data collected will be blinded and aggregated, and participants will receive exclusive access to reports and analysis throughout the survey process. If you have any questions, please contact Charles Crain.
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