| December 5, 2008 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- GSK contesting amended patent procedure in appeals court
GlaxoSmithKline is scheduled today to appear before the U.S. Court of Appeals for the Federal Circuit to argue against revisions to the patent process that are designed to prevent abuse and slash a backlog of unreviewed applications. GSK, along with the drug and biotech industries, said the changes would undercut incentives that encourage companies to invest in research and development. CNNMoney.com/Dow Jones Newswires
(12/4)  
- Arthritis drug Actemra faces another FDA setback
Deferring its ruling a second time, the FDA is seeking more clinical data on the possible effects of Actemra, a rheumatoid arthritis drug from Roche Holding and Chugai Pharmaceutical, on pregnancy or fertility. Japanese health care analysts said the agency could reach a decision in October at the earliest or in March 2010 at the latest. Bloomberg
(12/5)
- Indian drugmakers face patent suit over Lilly's Cymbalta
Eli Lilly and Co. filed a lawsuit against Lupin and Aurobindo Pharma over claims that the Indian drugmakers violated its patent for antidepressant Cymbalta by seeking marketing approval for their versions. Lilly also sued three U.S. companies planning to launch copies of Cymbalta, which loses patent protection in June 2013. Business Standard (India)
(12/5)
| Biotechnology | | |
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- U.K. biotech industry asks government for financial aid
Some leading figures in the U.K.'s biotech industry are asking the government and private investors to contribute £500 million, about $734 million, each for two proposed funds designed to bolster and reorganize the sector. One fund would be used to consolidate smaller businesses, resulting in 20 to 30 larger units. The other fund would help more established companies finance clinical studies and acquire assets. Financial Times (free content)
(12/4), The Times (London) (subscription required)
(12/5)
| Food & Dietary Ingredients | | |
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- Monsanto wins EU approval for biotech soybean
The European Union has allowed Monsanto Co. to import MON 89788 for use in food and animal feed across 27 markets for the next decade. All products made from the biotech soybean, which can tolerate glyphosate Roundup Ready herbicides and boost yields for farmers, "will be subject to the EU's strict labeling and traceability rules," the European Commission said. Reuters
(12/4)
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| FDLI Items | | |
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Registration is open for "Pharmaceutical Risk Management" conference, Jan. 13, 2009
The enactment of REMS -- Risk Evaluation and Mitigation Strategy -- has changed the world of drug development and product marketing. Pharmaceutical and biotechnology companies who do not thoroughly understand the strategies and tactics of REMS do so at their own peril. At this conference, experts in the field will provide theoretical and practical enlightenment while engaging the audience to become part of the discussion. Learn more and view the list of speakers. Register online. Register by fax.
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Attention Law School Professors, Students and Academics: FDLI Announces the 2008-2009 H. Thomas Austern Memorial Writing Competitions
As part of its academic mission, FDLI sponsors the H. Thomas Austern Memorial Writing Competitions to encourage law students interested in the areas of law that affect foods, drugs, devices, cosmetics and biologics. Additionally, winning papers will be considered for publication in the Food and Drug Law Journal. Entrants must be currently enrolled in a JD program at any of the nation's law schools. View the list of the 2007-2008 winners here. To learn more about the 2008-200 Writing Competitions, download the flyer.
| Related News | | |
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- Analysis: Daschle to launch health care overhaul
 President-elect Barack Obama's pick for HHS secretary, former Sen. Thomas Daschle, will have dual challenges: running a huge government health care bureaucracy and leading efforts to reform the U.S. health care system. Daschle, in a speech to be delivered in Denver today, is expected to discuss the importance of expanding insurance coverage, cutting costs and improving quality. He also will call on Americans to get involved in the debate on health care reform. The Washington Post
(12/5), The Wall Street Journal (tiered subscription model)
(12/5)
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