- BIO files suit against local drug take-back law in Calif.
BIO, along with the Pharmaceutical Research and Manufacturers of America and the Generic Pharmaceutical Association, filed a lawsuit against an Alameda County, Calif., law requiring drugmakers to fund take-back programs for medications. In the lawsuit, drugmakers described the ordinance as unfair and unprecedented. "This ordinance, while likely well-intended, would have little impact in protecting patients, safeguarding our environment or curbing possible abuse associated with unused medications," said BIO spokesman Ken Lisaius. San Francisco Chronicle (12/7), The New York Times (tiered subscription model) (12/6)        | | FDA's Next Northera Demand? We Chelsea; Phase III Hits Goal | | Chelsea Therapeutics Inc.'s primary endpoint-hitting Phase III news about Northera (droxidopa) sent the stock south, as Wall Street reacted to word that effects on dizziness - the main goal of the trial - did not last as long as the FDA may want for approval. Find out the details. |  |
| Health Care & Policy |  |  | | - Cubist's antibiotics wins fast-track designation from FDA
The FDA granted qualified infectious disease products designation to CXA-201 and CB-315, two late-stage antibiotics from Cubist Pharmaceuticals. The designation qualifies both drugs for priority review and other considerations. CXA-201 is being developed as a first-line intravenous treatment for urinary tract infections and complicated intra-abdominal infections, while CB-315 is intended as an oral treatment for Clostridium difficile-associated diarrhea. Mass High Tech (Boston) (12/7) - Janssen seeks wider use of psoriasis drug Stelara
Janssen Biologics and Janssen Biotech submitted applications to the FDA and the European Medicines Agency seeking expanded use of Stelara, or ustekinumab, as a treatment for psoriatric arthritis in adults. Stelara is already cleared for the treatment of moderate to severe plaque psoriasis in 69 countries. PharmaTimes (U.K.) (12/7) - GSK, MD Anderson unite to develop cancer drugs
GlaxoSmithKline and the MD Anderson Cancer Center agreed to collaborate on the development of drugs to help the immune system fight cancer. MD Anderson granted GSK exclusive, global rights to develop and market antibodies that activate OX40, a protein on T cells. In addition to an upfront fee and research funding, the cancer center could receive $335 million plus royalties on drugs arising from the collaboration. Reuters (12/7) - Planned British DNA database could boost drug R&D
The British government has allotted $160 million to create a genome database of as many as 100,000 patients with cancer and rare conditions over the next three to five years. The project could change the way complex illnesses are diagnosed and treated as well as enhance the discovery and development of novel drugs, Prime Minister David Cameron said. Reuters (12/10) - Girl with leukemia in remission after new treatment
A girl with acute lymphoblastic leukemia experienced remission after being treated with an experimental therapy that involved using a disabled form of the virus that causes AIDS to reprogram her immune system genetically to fight cancer cells. The girl is considered the first child to undergo the treatment, and some experts said could someday serve in place of bone marrow transplants. Novartis has expressed interest in the treatment and has pledged $20 million for the establishment of a research center at the University of Pennsylvania. The New York Times (tiered subscription model) (12/9) | Company & Financial News | | | | | Food & Agriculture | | | | - U.K. environment secretary supports adoption of biotech foods
Environment Secretary Owen Paterson said the U.K. government "emphatically" should consider biotech crops, adding that biotechnology has real environmental benefits. Concerns about health risks of biotech foods are "complete nonsense," he said. Paterson believes that Prime Minister David Cameron will find an "appropriate moment" to support biotechnology. The Guardian (London) (12/9) | Hot Topics | | | | Top five news stories selected by BIO SmartBrief readers in the past week. - Results based on number of times each story was clicked by readers.
| Industrial & Environmental | | | | - Brazilian agency to build demonstration cellulosic-ethanol plant
Brazilian sugarcane research agency Centro de Tecnologia Canavieira has committed $38.5 million to build a demonstration-scale facility that would convert cane residues into cellulosic ethanol. The plant, which would have the capacity to make nearly 800,000 gallons of ethanol annually, will be built at an existing cane mill in 2013, said Oswaldo Godoy, the agency's projects manager. Bloomberg Businessweek (12/6) | News from BIO | | | | - Are you taking full advantage of your membership?
BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. VWR International, FedEx, Office Depot and Business Wire are just a few of the industry leading providers that offer special pricing through this members-only program. Learn more or enroll here.
| SmartQuote | | | |  | Alas for those that never sing, But die with all their music in them."
--Oliver Wendell Holmes Sr.,
American physician, writer and poet  |
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