Thursday, August 1, 2013

FibroGen licenses anemia drug to AstraZeneca in potential $815M deal

Nearly 450 drugs for neurological disorders are in the pipeline | FDA advisers support OTC use of Sanofi's nasal spray | Don't ignore irresponsible denials of advances in drugs, patient care
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August 1, 2013
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FibroGen licenses anemia drug to AstraZeneca in potential $815M deal
AstraZeneca secured the rights to develop and market FibroGen's late-stage anemia drug candidate FG-4592 in the U.S., China and certain other markets. The small molecule hypoxia-inducible factor inhibitor is the first of a new class of treatment designed to increase red blood cell production by triggering the body's response to high altitude conditions. FibroGen is eligible to receive $350 million upfront and as much as $465 million in milestone fees plus sales royalties, with more payments possible if approved indications go beyond anemia related to kidney disease. Reuters (7/31), PharmaTimes (U.K.) (7/31)
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Commerce in Motion and JDA, surveyed 130 quality control, supply chain and operations professionals. The goal was to understand their ability to effectively track, trace, and recall products. Per the study financial cost is the greatest risk associated with the inability to trace items. Download the free report now to see where the Life Sciences industry stands on traceability.

Health Care & Policy
Nearly 450 drugs for neurological disorders are in the pipeline
Pharmaceutical Research and Manufacturers of America reported Wednesday that 444 drugs intended to treat neurological disorders are in clinical development or being reviewed by the FDA. "Despite the incredible complexity of neurological disorders, biopharmaceutical scientists have delivered significant advances for patients in recent years, including new medicines for multiple sclerosis and Huntington's diseases," said John J. Castellani, PhRMA's president and CEO. Drug Store News (7/31)
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FDA advisers support OTC use of Sanofi's nasal spray
An FDA advisory panel voted 10-6 in favor of allowing Sanofi's Nasacort AQ nasal spray to be sold without a prescription. If approved, the respiratory allergy drug would be the first over-the-counter intranasal corticosteroid available in the U.S. Reuters (7/31), Pharmaceutical Business Review Online (8/1)
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Don't ignore irresponsible denials of advances in drugs, patient care
The "foolish" statements made by Donald W. Light of the University of Medicine & Dentistry of New Jersey against the FDA and the pharmaceutical industry can't be ignored, John LaMattina writes. Light, who said that around 90% of all new approved treatments in the past 30 years are less or no more effective than existing treatments, ignores great advances in the care and treatment of patients with HIV, cancer and cardiovascular disease, LaMattina writes. Forbes (7/30)
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Stem cells produce blood vessels using novel vasculogenic method
Researchers at Massachusetts General Hospital and Harvard University were able to produce endothelial cells and multipotent stromal cells from human induced pluripotent stem cells and use them to generate blood vessels in vivo. "To our knowledge, this is the first report demonstrating the use of triple selection markers CD34, NP1 and KDR for the isolation of vasculogenic precursor cells from human induced pluripotent stem cells that are, most importantly, highly potent in an in vivo setting," according to one of the researchers. MedicalXpress.com (7/30)
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Company & Financial News
Sage wins up to $10M grant to develop drug for fragile X syndrome
The NIH awarded Sage Therapeutics a grant worth up to $10 million to develop a treatment for fragile X syndrome. The Cambridge, Mass.-based company plans to develop a positive allosteric modulator that targets GABAA, a key central nervous system neurotransmitter that affects neuron excitability. Sage will work with 15 NIH institutes and centers. American City Business Journals/Boston/bioflash blog/Mass High Tech (7/31)
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Maker of gene therapy will set up new plant in Mass.
UniQure plans to construct a 55,000-square-foot manufacturing facility for commercial-grade adeno associated virus-based gene therapy products in Lexington, Mass. The firm will use part of the $10 million it raised in a venture debt round to support the project. The plant is expected to start up by early 2015. Pharmaceutical Business Review Online (7/30)
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The Latest From BIO ...
Join us Nov. 11-13 at the BIO Convention in China in Beijing!
The BIO Convention in China brings together executives to meet and explore business opportunities with China's emerging biotech sector. Register today.
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Industry Deals
Swiss biotech announces plan to buy Ceptaris for $250M
Actelion Pharmaceuticals said it plans to purchase U.S. specialty drug firm Ceptaris, which is developing a topical gel called Valchlor for treatment of an early-stage lymphoma that causes lesions. The deal hinges on the FDA's approval of Valchlor. Actelion has paid Ceptaris $25 million and will pay an additional $225 million when the acquisition is finalized. Reuters (7/31), The Wall Street Journal (tiered subscription model)/Dow Jones Newswires (7/31)
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Food & Agriculture
Biotechnology can help foods fight devastating plant diseases
Biotech success stories include oranges that hold promise for fighting citrus greening bacteria and a ringspot virus-resistant papaya. Development of a blight-resistant potato has been slowed by opposition and regulatory hurdles in Europe. International Business Times (7/31)
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Industrial & Environmental
Ineos Bio reports commercial-scale cellulosic ethanol production in Fla.
Ineos Bio has started production at its $130 million commercial-scale cellulosic ethanol plant in Vero Beach, Fla., and intends to start shipping ethanol from the facility this month in a move hailed as a milestone by the Department of Energy. The Indian River BioEnergy Center uses wood and plant waste and is allowed to use municipal solid waste, which the company intends to do starting next year. The New York Times (tiered subscription model) (7/31), DomesticFuel.com (7/31), Bloomberg (7/31), EthanolProducer.com (7/31)
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News from BIO
Register today for the BIO Investor Forum, Oct. 8-9, in San Francisco
The BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables and therapeutic workshops, company presentations, and One-on-One partnering meetings. BIO is renowned for its successful business development, partnering and investor meetings in North America, Europe and Asia. Partnering at this conference will be powered by BIO One-on-One Partnering, an interactive environment to intelligently search, contact and schedule private meetings with potential partners and investors. Register today.
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SmartQuote
We choose our joys and sorrows long before we experience them."
-- Khalil Gibran,
Lebanese-American artist, poet and writer
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