Tuesday, July 23, 2013

Novo, Amgen lead ranking of biotech firms based on market cap

FDA clears kidney transplant rejection drug from Astellas | FDA, EU agree to review Biogen's MS drug Plegridy | Azure gains development rights to Ligand's lasofoxifene
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July 23, 2013
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Novo, Amgen lead ranking of biotech firms based on market cap
Novo Nordisk again topped the Genetic Engineering & Biotechnology News ranking of biotechnology companies based on market capitalization. Amgen and Gilead Sciences took the second and third spots, respectively. Rounding out the top 10 were Celgene, Biogen Idec, Teva Pharmaceutical Industries, Merck KGaA, CSL, Regeneron Pharmaceuticals and Alexion. Genetic Engineering & Biotechnology News (7/22)
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Global Oncology Trial Management Strategies
This complimentary white paper from Novella Clinical will help small- to mid-size pharma and biotech companies develop effective operational study plans, create robust and realistic feasibility studies and navigate regulatory submissions across multiple countries. Download: Global Oncology Trials - Planning for Success.
 
Health Care & Policy
FDA clears kidney transplant rejection drug from Astellas
Astellas Pharma obtained the FDA's approval to market Astragraf XL, an extended-release version of the firm's Prograf, or tacrolimus, for prevention of kidney transplant rejection. The approval makes Astragraf XL the first once-daily tacrolimus formulation available to kidney transplant patients in the U.S. The approval was based on data from two late-stage trials involving 1,093 patients. PharmaTimes (U.K.) (7/22), MedPage Today (free registration) (7/22)
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FDA, EU agree to review Biogen's MS drug Plegridy
The FDA and the European Medicines Agency have accepted Biogen Idec's marketing applications for Plegridy, or peginterferon beta-1a, a subcutaneous injectable formulation for the treatment of relapsing forms of multiple sclerosis. The applications included data from the late-stage ADVANCE trial. Pharmaceutical Business Review Online (7/22), PMLive.com (U.K.) (7/23)
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Azure gains development rights to Ligand's lasofoxifene
Ligand Pharmaceuticals granted Azure Biotech the rights to develop a novel formulation of lasofoxifene focusing on a women's health market. The drug, a selective estrogen receptor modulator, is used as a treatment for osteoporosis and other diseases. Ligand is eligible to receive $2.7 million in milestone fees plus sales royalties. Genetic Engineering & Biotechnology News (7/22)
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Stem cell discovery shows promise in tissue regeneration
BMI1, a protein essential in the self-renewing cell divisions of adult stem cells, can be prevented from spawning potentially defective or misplaced cells that hinder tissue regeneration, according to a study in Nature Cell Biology. Researchers believe that the manipulation of BMI1 and other regulatory molecules may one day be useful in the development of techniques that need specialized cell development switches for the treatment of tissue damage brought about by injury, disease or aging. Yahoo/Asian News International (7/21)
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Company & Financial NewsSponsored By
Mass. firm gets $15.4M funding boost for autism test
SynapDx secured $15.4 million in a funding round led by Google Ventures. The Massachusetts-based firm will use the money to develop a blood-based diagnostic assay for early detection of autism spectrum disorder in children. GenomeWeb Daily News (free registration) (7/22)
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Funding round brings in $1.4M for lymphoma immunotherapy developer
Bullet Biotechnology secured $1.4 million in its latest funding round, a securities filing showed. The California-based firm is developing an active immunotherapy designed to mobilize the immune system to fight a marker of B-cell lymphoma. The drug candidate could enter clinical trials in early 2015, CEO Willie Quinn said. MedCityNews.com (7/22)
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EvaluatePharma World Preview 2013, Outlook to 2018
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The Latest From BIO ...
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Global Developments
S. Korea will invest in global pharmaceutical expansion
South Korea plans to invest $8.9 billion to develop 20 new drugs in collaboration with local drug manufacturers. The plan is part of a five-year effort to develop the country into a global pharmaceutical center. It includes tax breaks for research and development, and a fund valued at around $447 million to help Korean companies expand internationally. Yonhap News Agency (South Korea) (7/21)
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Food & Agriculture
Monsanto's Europe withdrawal disappoints farmer in England
Farmer and former U.K. National Farmers Union Vice President Paul Temple of Driffield, England, said his past participation in a biotech field trial left him particularly disappointed at Monsanto's decision to withdraw regulatory applications in Europe. "Look at maize production across North and South America. Those farmers and those countries have effectively responded to the food security, the food supply debate. And Europe has got itself stuck in a strange position where we're depending on GM crops for feeding everybody, but we aren't providing the choice," he said. Bloomberg (7/19)
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Industrial & Environmental
Fuels America responds to oil industry with its own ad campaign
Fuels America kicked off a new ad campaign highlighting the ability of the Renewable Fuel Standard to boost fuel choices for consumers. The ads also indicate that the oil industry's opposition to the RFS is rooted in a desire to maintain its hold on the fuel market. Bob Dinneen, president and CEO of the Renewable Fuels Association, maintains there is no need for legislation to address concerns about the RFS because the Environmental Protection Agency has "more than enough flexibility" to deal with them. The Hill/E2 Wire blog (7/22), DomesticFuel.com (7/22)
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News from BIO
Save on energy costs through BIO's newest cost-savings program
BIO has recently aligned with APPI Energy, an energy consulting firm, to assist member companies with reducing their energy expenses. APPI Energy, the preferred energy consultant of 140 trade associations and chambers of commerce nationwide, provides solutions to reduce electricity and natural gas costs at no risk or obligation to member companies. Through this program, APPI Energy offers specialized energy cost reduction services, including the identification of reliable and competitive energy suppliers for member companies and the obtaining of competitive bids from the preferred suppliers in deregulated energy markets. Learn more.
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SmartQuote
Opinions are made to be changed -- or how is truth to be got at?"
-- Lord Byron,
British poet
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