| May 1, 2012 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- Pozen faces regulatory hurdle for aspirin-omeprazole combo
The FDA suggested that Pozen seek approval for combination aspirin product PA32540 at a lower dose, the company said in a regulatory filing. The market for PA32540 could be limited without a lower dose because the FDA might restrict a higher dose to patients who underwent surgery for a coronary artery bypass graft. MedCityNews.com
(4/30)  
- Court rules for Mylan and Impax in Doryx patent case
U.S. District Judge William Martini ruled that Mylan and Impax Laboratories did not infringe Warner Chilcott's patent for antibiotic Doryx that is set to expire in 2022. The ruling forces Warner Chilcott to book an impairment charge of $90 million to $108 million, the firm said. Bloomberg
(4/30)
| Global Focus | | |
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| Food & Dietary Supplements | | |
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- USDA inspector reviews FSIS humane-handling enforcement
The USDA's Office of Inspector General has issued a positive report on how the Food Safety and Inspection Service's review of appeals from the industry regarding its humane-handling enforcement actions. "As OIG noted, FSIS has taken many steps to improve its inspectors' understanding of humane handling requirements and the tools they have to ensure the humane handling of livestock," says Undersecretary for Food Safety Elisabeth Hagen in a news release. FoodSafetyNews.com
(5/1)
| Medical Devices | | |
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- 5 governors call for repeal of medical device tax
The governors of Pennsylvania, Indiana, South Carolina, Virginia and Wisconsin -- five states with large clusters of medtech companies -- wrote a letter urging Senate and House leaders to strike down the 2.3% medical device tax. "We believe that this tax could harm U.S. global competitiveness, stunt medical innovation and result in the loss of 10s of thousands of good-paying jobs," the governors wrote. MassDevice.com (Boston)
(4/30)
- Nephros wins FDA nod for chronic renal failure device
The FDA has granted Nephros 510(k) clearance for its Hemodiafiltration system, which is used to help treat patients with chronic renal failure. The device features the company's OLpur MD220 Hemodiafilter and OLpur H2H Hemodiafiltration module. Reuters
(4/30)
| Tobacco | | |
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- Australia plans joint legal action against Big Tobacco
Australia's Minister for Health Tanya Plibersek will ask for legal advice on a proposed nationwide class-action suit against Big Tobacco to retrieve costs of smoking-related illnesses. Tasmania Health Minister Michelle O'Byrne said governments should not stop finding ways to limit smoking's impact on the health system. The Australian (subscription required)
(5/1)
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