| October 30, 2009 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- AstraZeneca agrees to $520M settlement in Seroquel cases
AstraZeneca agreed to pay $520 million to end two federal investigations and two whistle-blower lawsuits related to an alleged improper sale and promotion of antipsychotic Seroquel. A spokesman for AstraZeneca said the company is in final talks with the Justice Department for a corporate-integrity agreement and declined to give further details of the settlement. NYTimes.com
(10/29)  
- Transcept fails to gain FDA approval for insomnia drug
The FDA delayed approving sleep drug Intermezzo and asked Transcept Pharmaceuticals for more information on dosing as well as other potential next-day side effects. The company, which plans to talk to the FDA regarding the complete-response letter, might have to conduct an additional safety trial to address the concerns. Forbes/The Associated Press
(10/29)
- Trust challenges Enbrel patent from Amgen, Wyeth
The Mathilda and Terence Kennedy Institute of Rheumatology Trust in the U.K. sued Wyeth and Amgen for allegedly infringing a patent for rheumatoid arthritis drug Enbrel. In a complaint filed in federal court in Delaware, the trust said its 2001 patent relates to an arthritis treatment combining methotrexate and tumor necrosis factor blockers, such as Enbrel, a technique developed by two researchers at Imperial College London. Reuters
(10/28)
| Health Care in Transition | | |
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- Drug, device industries give mixed reactions on House health bill
The House health reform bill unveiled Thursday would require drug makers to pay an estimated $60 billion in Medicare reimbursements over the next 10 years and allow the federal government to negotiate prices directly with companies. The bill also would grant brand-name biotech-drug manufacturers 12 years' exclusivity before generic rivals can be launched. The Advanced Medical Technology Association commended the legislation, which cuts proposed medical-device makers' tax to roughly $20 billion over the next decade. The Wall Street Journal (tiered subscription model)
(10/30), The Hill
(10/29)
- Public option survives in health bill backed by House Democrats
After a final huddle at the Capitol to urge unity, House Democrats announced their proposal to overhaul the U.S. health care system. The measure includes government-run health insurance, which would compete with private insurers' plans. However, the public option would be required to negotiate fees with providers, rather than imposing them unilaterally. Although the public option dominated the final days of negotiations among House Democrats, the Congressional Budget Office said only 6 million people would enroll in it, making the plan a relatively small part of a package that could cover 36 million uninsured Americans. The Washington Post
(10/30), Los Angeles Times
(10/30), NYTimes.com
(10/29), The Wall Street Journal (tiered subscription model)
(10/30)
| Biotechnology | | |
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- Sequenom faces fraud suit from Xenomics
New York-based Xenomics has filed a lawsuit against Sequenom claiming that the San Diego firm committed fraud by misrepresenting the status of its Down syndrome test, which influenced the company to grant Sequenom exclusive license to its patent rights for prenatal and diagnostic products. Xenomics is seeking up to $300 million in damages and asking for the termination of license. A Sequenom representative did not comment on the case. Xconomy
(10/29)
| Food & Dietary Ingredients | | |
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- Monsanto seeks Supreme Court review of biotech alfalfa injunction
Monsanto has filed a petition asking the U.S. Supreme Court to review a federal appeals court's decision to block the cultivation of the company's Roundup Ready alfalfa until the USDA completes its environmental assessment. "We feel the court took some real drastic actions when it didn't need do," said Garrett Kasper, the company spokesman. St. Louis Post-Dispatch
(10/30)
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| Medical Devices | | |
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- HHS report faults FDA's device center over use of adverse event reports
The FDA's Center for Devices and Radiological Health failed to efficiently use reports of serious adverse events linked to medical devices to act on potential safety concerns despite the increase in such reports received by the agency between 2003 and 2007, according to a study by the HHS Office of Inspector General. The office advised the device center to set up a system that would record and monitor the actions initiated to solve adverse events. Modern Healthcare (free registration)
(10/29)
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