| December 18, 2007 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- FDA OKs hypertension drug Bystolic
The FDA on Monday granted marketing approval for Bystolic, a blood pressure drug developed by Mylan and Forest Laboratories. Forest Labs will be responsible for marketing the drug, also known as nebivolol, while Mylan will receive a share of the royalties and an option to join future co-promotions. Reuters
(12/17), Bloomberg
(12/17)  
- New funding model could aid orphan drug development
One physician has found little support from the drug industry, patient advocacy groups, grant-giving organizations and federal regulators in his effort to develop a new treatment for lead poisoning in children. However, Dr. Michael Shannon teamed up with a venture capitalist to create a front company to attract funding from investors who will accept smaller profits to fill a crucial need; a model that could aid research efforts for other rare diseases. The Wall Street Journal (free content)
(12/18)
| Biotechnology | | |
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- Experts, officials evaluate benefits of energy bill to ethanol
Some analysts say the goals set by Congress for the ethanol industry as part of the recently passed compromise energy bill may be too broad and ambitious. The new legislation includes bolstering the production of biofuel crops, which also would require increasing biomass production and addressing significant transportation and logistics costs. NYTimes.com
(12/18)
| Food & Dietary Ingredients | | |
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- Senate farm bill calls for more studies on cloned food
An amendment to the Senate version of the 2007 farm bill calls on the National Academy of Sciences to conduct two studies that would review the FDA's assessment that food from cloned animals is safe. The amendment also urges the USDA to study consumer acceptance of cloned foods and the effect it could have on the U.S. and international markets. FoodNavigator
(12/17)
- WTO investigates U.S. farm subsidies
The World Trade Organization on Monday launched an inquiry into complaints from Brazil and Canada that the U.S. has exceeded its annual WTO farm subsidy commitment levels by billions of dollars since 1999, except in 2003. The U.S. expressed disappointment about the complaint, saying its farm programs abide by WTO rules. International Herald Tribune/Reuters
(12/17)
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| The Buzz(CORPORATE ANNOUNCEMENTS)
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Interested in learning more about advertising in FDLI SmartBrief? Contact Chris Pope at 202 737-5500 ext 295 or cpope@smartbrief.com.
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FDLI/FDA 51st Annual Conference, March 26 and 27, 2008: Scientific Revolution and Legal Evolution: Keeping pace with science & policy issues in food & drug law, L'Enfant Plaza Hotel, Washington, D.C.
Scientific breakthroughs are offering hope to an aging public seeking healthier lives through enhanced nutrition, genetic testing for disease and revolutionary new cures. These advances often pose significant policy issues and challenge the legal and regulatory systems. This year's conference will include a focus on these dynamic tensions while informing attendees about what the food and drug laws and regulations are today after FDAAA, and what policy issues may be expected to emerge in the future given the pace of scientific advances. FDLI is pleased to announce that Justice Antonin Scalia will be the lunch March 27 speaker. Please mark your calendars today for this important event. Registration is opening soon! Also, sponsorship opportunities are available for the 51st Annual Conference. Learn more about sponsorship, exhibiting and advertising. View our new sponsorship brochure describing new business development opportunities for your organization.
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