Bayer Yasmin Trial Is Postponed For Mediation
On the eve of the first trial in which Bayer faces accusations that it hid the risks of blood clots associated with its Yaz and Yasmin birth control pills, a federal judge has ordered that mediation should instead begin in hopes of reaching a settlement (here is the order). The move comes after a month […]
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Merck Agrees To Disclose Clinical Trial Delays
Three months ago, Merck agreed to settle a derivative shareholder lawsuit over a clinical trial for the Vytorin cholesterol pill, which caused a tremendous controversy due to the handling of the trial data by the drugmaker and its former partner, Schering-Plough, which Merck subsequently acquired. You may recall the Enhance clinical trial was designed to […]
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Size Matters… Even To FDA Reviewers
Now that we have your attention, we must confess this is not about penile matters. Rather, the issue involves generic tablets and the extent to which these differ in size from brand-name meds. To put it simply, generic tablets that are clearly much larger may pose safety and efficacy problems for patients, according to the […]
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Synthes Accuses Stryker of Raiding California Sales Force, Taking Secrets
A unit of Synthes Inc. (SYST), the world’s largest maker of bone-related medical devices, accused Stryker Corp. (SYK) in a lawsuit of raiding its San Francisco sales force and using confidential information from former employees. Stryker seeks to obtain “an improper competitive advantage†in the industry for medical implants and instruments used in spinal surgery, […]
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Novartis Suspends Production At A Key Plant
Late last month, Novartis quietly suspended production at a plant in Lincoln, Nebraska, where various over-the-counter and animal health meds are manufactured. The drugmaker is calling the move a voluntary step that is being taken for “compliance improvement activities†and to “expedite maintenance and improvements and continue to strengthen standards.†As a result, supplies of […]
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Glaxo Is Fined For Vaccine Trials In Argentina
Following an investigation by the National Administration of Medicine, Food and Technology, the Argentine government has fined GlaxoSmithKline the equivalent of roughly $93,000 for its handling of vaccine trials several years ago in which 14 babies died. The probe found the drugmaker and two trial investigators failed to heed proper informed consent procedures, The Buenos […]
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What Data? Alice In Clinical Trial Wonderland
A remarkable series of studies published this week in BMJ discloses various problems with clinical trials – or more specifically, publication of clinical trial data. As it turns out, there is a lot that goes missing. As the BMJ editorial laments: the articles “confirm the fact that a large proportion of evidence from human trials […]
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FDA Issues Social Media Guidance… Well, Sort Of
Two years after first pondering social media guidelines, the FDA has finally issued a draft guidance that addresses, to a limited extent, the sort of communications that drugmakers can have with consumers, physicians and other parties in certain online settings. But the new guidance falls short of articulating any highly specific guidelines, although Twitter and […]
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FDA bans Oridion imports, share prices dive 40%
The FDA banned Oridion Systems Ltd. (PINK:ORDNF) from importing any medical devices into the U.S., after the Israeli med-tech maker failed to fix violations at its Jerusalem manufacturing facility. Shares of Oridion fell 39% on news of the ban, from $11.00 to $6.65 at market opening Dec. 27. Because of the federal watchdog agency’s import […]
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French implants firm was criticised by US inspectors in 2000
American health officials warned the manufacturer at the centre of the breast implant scare that its products were “adulterated” and substandard 11 years ago, it has emerged. Investigators from the Food and Drug Administration wrote to the company in 2000 after inspecting its plant in the south of France. The development triggered questions over why […]
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