| December 14, 2007 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- FDA delays approval of Neurocrine insomnia drug
Neurocrine Biosciences announced Thursday that the FDA is asking for more studies on its short-acting insomnia treatment, Indiplon, with particular focus on safety issues, elderly patients and pregnant women in their third trimester. The company also announced it is laying off more than half of its work force. San Diego Union-Tribune
(12/13), CNNMoney.com
(12/13)  
- Bone drug may bolster Amgen recovery
Amgen is banking on its experimental osteoporosis drug denosumab to help it bounce back from its anemia drug setbacks. The biotech giant is poised to present a study evaluating D-mab's ability to strengthen the bones of breast cancer patients who became at risk for osteoporosis after taking aromatase inhibitors. The company is expected to file for FDA approval of the drug, which could generate $2 billion in sales, by early 2009. The Wall Street Journal (tiered subscription model)
(12/14)
- Generics are in drugstores' favor, analysts say
Generic drugs are improving profits of drugstore retailers, according to analysts. As more generics enter the market, the higher margin on the cheaper drugs will benefit major drug retailers, although sales figures will slump due to the lower prices, the experts said. "[Generics] accounted for more than 50% of retail community pharmacy prescriptions in 2006 and they will continue to capture the market share," a spokeswoman for the National Association of Chain Drug Stores said. Houston Chronicle/Associated Press
(12/13)
| Biotechnology | | |
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- Study: Blocking cell "addiction" to growth factors may prevent cancer
Mouse cells with two activated copies of the insulin-like growth factor two gene, which in humans is associated with a higher risk of intestinal tumors, are more likely to become "addicted" to the smallest doses of growth factors compared to those with one activated copy of the gene, a U.S. study revealed. Researchers also found that a drug that blocks the cell's ability to respond to IGF-II growth factor led to fewer precancerous lesions in mice. Yahoo!
(12/13)
| Food & Dietary Ingredients | | |
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- USDA foresees higher commodity prices
U.S. stocks of agricultural products, including wheat, corn, oilseed and barley, are expected to drop by the end of 2007/08, according to the USDA. The decline in these stocks has been attributed to the surge in domestic and global demand and is expected to cause commodity prices to rise rapidly. FoodNavigator
(12/13)
- Study: Wine linked to lower lung cancer risk
Wine drinkers have a lower risk of lung cancer compared with nondrinkers and those who drank other types of alcoholic beverages, a new study revealed. However, the findings do not necessarily reflect a direct cause-and-effect relationship between alcohol consumption and lung cancer, the study's author said. Wine Spectator
(12/13)
| Medical Devices | | |
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- FDA to unveil more stringent guidelines for stents
The FDA plans to launch new guidelines on the clinical testing of drug-coated stents in response to concerns about elevated risk of blood clots and other complications. The new rules will not affect stents that are already commercially available. They are expected to cover the size of trials and say how long patients should stay on the anti-clotting drug Plavix after getting a stent. The Wall Street Journal (free content)
(12/14)
- FDA panel supports approval of Hologic sterilization device
An FDA panel has voted in favor of the approval of Hologic's Adiana, a device used in sterilizing women to prevent pregnancies, on the condition that further studies will be conducted to evaluate the long-term risks and effectiveness of the device. Adiana, which has a 98.9% one-year efficacy rate, uses a catheter to implant soft material smaller than a grain of rice into the fallopian tube with the aid of radio signals. MSNBC/Associated Press
(12/13)
| FDLI Items | | |
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FDLI thanks the sponsors of the Dec. 10 Welcome & Awards Holiday Reception. Are you interested in future sponsorship opportunities?
FDLI provides opportunities to market your organization and services to professionals in the FDA-regulated industries. By signing on as a sponsor, exhibitor or advertiser, you will reach a large and diverse group of food and drug decision-makers. A variety of sponsorship packages are available for FDLI's upcoming events. Learn more about sponsorship, exhibiting and advertising. View our new sponsorship brochure describing new business development opportunities for your organization. Sponsors of the Dec. 10 reception are here.
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Sixth Annual Enforcement and Litigation Conference -- Consent decrees, criminal cases and corporate integrity agreements, Feb. 19 and 20
If you want to learn how your peers are dealing (or should be dealing) with increasingly commonplace -- yet strict -- enforcement measures, attend this conference. You'll learn from the experts about how voluntary implementation of measures required by CIAs and Consent Decrees can keep you clear of these expensive and often demoralizing enforcement actions. Join us to hear from top decision-makers at the Food and Drug Administration and the U.S. Department of Justice, and from top legal industry representatives. Get more information here. Ready to register? This conference precedes FDLI's Introduction to Drug Law and Regulation program.
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