FDA Finds 12.7% of Chinese Pharma Plants Produce Unsafe Capsules
Source The next PDUFA is not a done deal, but the notion that additional funding will be made available for the FDA to inspect manufacturing facilities near and far increasingly sounds like a good idea. Consider the latest development in China, where many pharmaceutical ingredients are made and have caused anxiety about the global supply […]
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Roche Limits Drug Billing Credit for Spanish, Portuguese Clinics
Roche Holding AG (ROG) tightened its bill- collecting policy for hospitals in Spain and Portugal, requiring clinics with the worst arrears to pay down debts before they can get more drugs on credit, and may do the same in Italy. The policy applies to a dozen Spanish hospitals and 23 hospitals in Portugal, about a […]
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FDA Reviewer Slams Pfizer Drug as Ineffective
Source In late 2010, Pfizer trumpeted the purchase of a small, privately held drugmaker called FoldRx Pharmaceuticals, which developed its own discovery platform technology and was completing testing for it lead candidate. Called Tafamidis, the medicine is designed to treat familial amyloid polyneuropathy, a rare and progressively fatal genetic neurodegenerative disease for which liver transplant […]
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New Safety Concerns on Spiriva
Source Several months after concerns were raised about the safety of the blockbuster Spiriva inhaler that is used to treat chronic obstructive pulmonary disease, a previously unpublished epidemiological study has surfaced. And the data, which has been published in BMJ Open, indicates the medication is associated with an increased risk of angina, heart attacks and […]
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Is FDA Guidance on Direct to Consumer Ads Unconstitutional?
Source Two months ago, the FDA issued a draft guidance that stipulates when drugmakers must submit their direct-to-consumer TV ads for agency review. These include initial ads for any prescription drug, or for a new or expanded indication; all TV ads for drugs that are subject to a Risk Evaluation and Mitigation Strategy; all TV […]
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Caution Urged for Bisphosphonate Osteoporosis Drugs
Source For the second time this month, concerns have been raised about a group of drugs called bisphosphonates that are used to combat osteoporosis. The newest cautionary note appears in a study published this week in the Archives of Internal Medicine that found the incidence of atypical thigh fractures in women who use these medicines […]
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Is the End Near for DTC TV Ads? Sanofi Says Yes
Source Two months ago, the FDA issued a draft guidance that stipulates when drugmakers must submit their TV ads for agency review. The FDA has had the authority to review ads ever since the Food and Drug Administration Amendments Act of 2007 was enacted and the recent draft guidance makes clear that reviews are required […]
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FDA Seizes Products at Crescendo Therapeutics
Source For months, Crescendo Therapeutics appears to have been thumbing its corporate nose at the FDA. Last November, the agency warned the little company for failing to maintain a system for collecting adverse event reports for its HybriSil topical treatment for scars. Crescendo offered a novel explanation – side effect reports simply had not been […]
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J&J Feeling the Pain with Immodium – Another Recall
Source Just one month after becoming Johnson & Johnson ceo, Alex Gorsky is presiding over a product recall, the latest in an endless stream of such actions taken by the health care giant over the past two years. This time, the McNeil Consumer Healthcare unit, which has been responsible for the majority of recalls, is […]
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Pfizer Rep Canned For Getting Pregnant?
Source Early last year, former King Pharmaceuticals sales rep Anne Marie Hand notified her district manager that she was pregnant. She delivered the news just weeks after her manager was installed in this position and amid a transition in which the mid-sized drugmaker was being purchased by Pfizer. Her announcement did not go over well, […]
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