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Teva
loses appeal in patent dispute with P&G 2:41 PM 5/13/2009 Forbes - NY,USA Teva Pharmaceutical Industries said a US appeals court upheld a lower court's decision to stop generic versions of Procter & Gamble's osteoporosis drug Actonel (risedronate) until 2014.
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Pozen
says it will ask for pain drug approval 7:21 AM 5/13/2009 Forbes - NY,USA Pozen Inc will ask the US FDA to approve its chronic pain drug candidate PN 400 it is developing with AstraZeneca.
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Medicines
Co. stops 2 anti-clotting drug trials 6:27 AM 5/13/2009P Forbes - NY,USA Medicines Co stopped late-stage testing of anti-clotting drug candidate cangrelor for failing to meet its goals in two clinical trials.
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Health
authorities prepare to limit flu drug use 4:50 AM 5/13/2009 Reuters - USA Global health officials say that drugs used to treat H1N1 swine influenza should be limited to chronically ill, pregnant women, and other vulnerable patients.
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AMAG
says FDA accepts resubmission of anemia drug NDA 12:50 AM 5/13/2009 Reuters - USA AMAG Pharmaceuticals said that the US FDA accepted the resubmission of the new drug application (NDA) for its experimental anemia drug ferumoxytol. The FDA will probably review the NDA within a 60-day period.
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Blood-Thinning
Drug Eyed in Hospital Deaths 5:41 AM 5/12/2009 NBC Philadelphia - Philadelphia,PA,USA Three people suffered cerebral hemorrhaging after being given a pre-mix of heparin made by the Baxter Healthcare Corporation which sent representatives to the hospital.
The US FDA is also investigating the deaths.
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Targacept
ADHD drug meets mid-stage goal, shares up 9:26 AM 5/11/2009 Reuters - USA Targacept Inc said its drug AZD3480 gave patients statistically significant improvement in symptoms in a mid-stage study in adults with attention deficit/hyperactivity disorder (ADHD).
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Lupin
Settles Antidepressant Drug Litigation With Wyeth 4:12 AM 5/11/2009 Wall Street Journal - USA India's Lupin Ltd has settled all ongoing litigation relating to Venlafaxine extended release capsules.
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AstraZeneca's
drug Brilinta beats Plavix in trial 2:22 AM 5/11/2009 Reuters - USA AstraZeneca's experimental heart drug Brilinta (AZD6140) beat Sanofi-Aventis/Bristol-Myers Squibb Co's blockbuster Plavix (clopidogrel) in a head-to-head study of the two drugs.
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Merck
Wins Halt on California Vioxx Class-Action 6:38 AM 5/9/2009 Bloomberg - USA Merck & Co won’t face a class-action lawsuit for costs tied to the painkiller Vioxx. Uniformity in how much plaintiffs paid for Vioxx is lacking. Each medical history and prescription decision is different.
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New
warnings for Tarceva cancer drug-US FDA 3:44 PM 5/8/2009 Reuters - USA New warnings have been added to Genentech/OSI Pharmaceutical's cancer drug Tarceva to describe skin reactions, eye problems, and holes in the digestive tract. The US FDA said that patients have died in some cases.
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Nycomed
submits Daxas lung drug for EU approval 4:11 AM 5/8/2009 Reuters - USA Nycomed submitted its "smoker's lung" drug Daxas for regulatory approval in Europe and is preparing for a submission in the United States.
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Obama
seeks FDA budget hike, generic drug fees 3:01 AM 5/8/2009 Reuters - USA The proposal calls for $36 million from manufacturers to review generic versions of human drugs under the FDA's generic drug office.
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Stent
patients advised to switch heartburn drugs 9:52 PM 5/6/2009 Reuters - USA Patients taking the blood thinner Plavix (clopidogrel) should avoid certain acid reflux drugs after a study showed that combining the two raises the risk of heart attack or stroke. Proton pump inhibitors (PPI) reduce the anti-clotting benefits of Plavix.
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Vanda
gets FDA nod for schizophrenia drug 6:56 PM 5/6/2009 Reuters - USA Vanda Pharmaceuticals Inc said the US FDA approved its Fanapta (iloperidone) treatment for schizophrenia.
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