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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Merck To Cut Another 12,000 To 13,000 Jobs
As we reported two weeks ago, Merck is accelerating its cost cutting and plans to eliminate thousands of more jobs (see our earlier story here). The drugmaker now plans to shed another 12,000 to 13,000 jobs by the end of 2015, which amounts to 12 percent to 13 percent of the 100,000 headcount as of […]
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Is That Plastic Shrink Wrap In Your Merck Vaccine?
As if Merck does not have enough problems with vaccine production, the drugmaker apparently distributed charred bits of plastic shrink wrap in vials of various vaccines – including Gardasil for preventing HPV infection, Varivax for chicken pox, Pneumovax for pneumococcal disease, Zostavax for shingles and MMR II for measles, mumps and rubella, according to Dow […]
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FDA issues Eisai with ‘refuse to file’ letter for epilepsy drug
Eisai has suffered a setback with the news that regulators in the USA have turned down the Japanese drugmaker’s submission for its new antiepileptic perampanel. The US Food and Drug Administration has issued a ‘refusal to file’ letter in response to the company’s New Drug Application for perampanel. The drug, which is also known as […]
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