Genzyme Angers Patients Over Fabrazyme Supplies
What consent decree? Just one week after sending a July 26 letter to patients that limited allocations of the Fabrazyme medication would remain available this month, Genzyme is now telling patients that unspecified quality control problems have disrupted supplies. Although the disruption is supposed to be brief, Genzyme was unable to say when Fabrazyme would […]
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A Former Bristol Chemist & Her Murdered Spouse
Bristol-Myers Squibb was sued by the family of a New Jersey man whose death earlier this year was blamed on a toxic metal that was allegedly given to him by his estranged wife – who worked at the drugmaker as a chemist, The Star-Ledger of New Jersey reports. Specifically, the lawsuit charges that Bristol-Myers knew […]
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Is An OTC Version Of Lipitor A Good Idea?
On the eve of losing patent protection for its best-selling Lipitor cholesterol pill, Pfizer is considering seeking FDA approval to sell an over-the-counter version. Whether the idea will pass regulatory muster, however, is questionable, given that the agency has previously nixed efforts by Merck to sell an OTC version of the same type of cholesterol […]
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Goat’s Blood, Tall Tales And Insider Trading
Some scams are more interesting than others. Take the one that was allegedly concocted by an imaginative group of execs from Immunosyn and its controlling shareholder, Argyll Biotechnologies. They told investors about plans to seek FDA approval for trials of a compound known as SF-1019, which was derived from goat’s blood and was touted for […]
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NIH Proposal On Conflicts Of Interest Is Gutted
One year after proposing to strengthen conflicts of interest rules for grant recipients, the National Institutes of Health has apparently gutted a key provision that would require universities to disclose financial ties between academic researchers and industry on publicly accessible web sites, according to Nature. New Webinar, Sept. 28 – Prepare for An FDA Pre-Approval […]
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IRB Is Fooled By Phony Clinical Trial Sponsor
Earlier this year, the FDA has issued an alert that some fictitious applications were submitted to several Institutional Review Boards. And the agency noted that the name and address of the clinical investigator listed on a required FDA form are the same as that used in a sting operation conducted by the US Government Accountability […]
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Boston Scientific To Cut Medical Device Jobs
Boston Scientific is planning to cut 1,200 to 1,400 jobs globally through attrition and head-count reductions. The cut in medical device jobs has emerged as the company has come up with a restructuring programme designed to strengthen operational effectiveness and efficiencies, increase competitiveness and support new investments. New Webinar, Sept. 28 – Prepare for An […]
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Update on Pharma’s Worst Nightmare: Reevaluating Studies: A CRO & A Coincidence?
Last week, the FDA announced that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found falsified data and manipulated samples. In explaining its move, the agency maintained there were “significant instances†of […]
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Massachusetts Sues J&J Over Risperdal Marketing
Yet another state has filed a lawsuit alleging that Johnson & Johnson illegally marketed its Risperdal antipsychotic to the detriment of its citizens. This time, Massachusetts alleges J&J promoted the drug to treat elderly dementia and various unapproved uses in children and adolescents. The state also claims J&J failed to disclose serious risks such as […]
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AFL-CIO To Forest Investors: Send Solomon Packing
With the annual Forest Laboratories shareholder meeting just three weeks away, the AFL-CIO is urging shareholders to vote ceo and president Howard Solomon right off the board. The move is in response to the recent disclosure that Solomon faces being excluded from participating in federal healthcare programs by the US Department of Health and Human […]
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