| April 10, 2012 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- FDA postpones decision on Vivus' Qnexa by 3 months
The FDA told Vivus it won't rule on weight-loss pill Qnexa until July 17 because the agency needs extra time to look at the drugmaker's risk evaluation and mitigation strategy. In February, an advisory panel decided that Qnexa's benefits outweigh risks. Reuters
(4/9)  
- Appeals court upholds invalidation of 2 Sanofi patents for Taxotere
The U.S. Court of Appeals for the Federal Circuit said a judge was right to invalidate two patents for Sanofi's cancer drug Taxotere because they are an obvious variation of prior research. The court also upheld a finding that Sanofi misled the issuing agency to
acquire the patents, which were challenged by generics-makers Apotex and Hospira. Bloomberg
(4/9)
- Express Scripts, Medco seek dismissal of lawsuit over merger
Express Scripts and Medco Health Solutions asked a federal judge to dismiss a lawsuit by pharmacies and trade groups that were trying
to prevent a $29.1 billion merger between the pharmacy-benefit managers.
The judge is scheduled to hear arguments today on the plaintiffs' injunction request. Bloomberg
(4/7)
| Food & Dietary Supplements | | |
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- FDA should reconsider dietary ingredient guidance, group says
The Council for Responsible Nutrition said Monday that the FDA's New Dietary Ingredient Draft Guidance should not require premarket approval for new dietary supplements. "It is time for [the] FDA to reconsider its efforts to redistribute the safety burdens allocated by Congress in DSHEA, and to recognize that the premarket paradigm of food additives is not what Congress intended for dietary supplements," according to a CRN statement in Regulatory Toxicology and Pharmacology. Drug Store News
(4/9)
- Del Bueno stops operations due to Listeria contamination
FDA officials announced on Monday that Del Bueno has agreed not to process or distribute its cheese products until it has proven that its Listeria problems have been controlled. "When a company continues to produce food that presents a risk for consumers, the FDA will take action," FDA official Dara Corrigan said in a news release. FoodSafetyNews.com
(4/9)
| Medical Devices | | |
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- FDA to unveil stricter device monitoring program this month
The FDA aims to introduce this month a tracking system for medical technologies that includes designating a unique number to each device to allow the agency to better monitor system malfunctions. "The ability of the unique device identifier number to strengthen our post-market surveillance is enormous," the FDA's Peper Long said. The Wall Street Journal
(4/9)
- EMG-guided injection device from Intronix gets FDA OK
Canadian firm Intronix Technologies has received 510(k) clearance from the FDA for Myoguide, an electromyographic-guided injection device used in managing pain and other applications. The device has already been clinically used in Canada and Europe and helps doctors spot active muscle regions by amplifying EMG signals from muscles and transmitting audio feedback. BeckersASC.com
(4/9)
- Edwards' Sapien device slated for FDA panel review in June
A panel of FDA advisers will meet June 13 to evaluate the premarket application of Edwards Lifesciences for use of its Sapien heart valve in aortic stenosis patients who most likely need surgery. The device, which has been cleared by the FDA for treating certain patients who aren't fit for surgery, is awaiting U.S. approval for use in high-risk patients. CardiovascularBusiness.com
(4/9)
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