Obama, A Billionaire Donor & A No-Bid Contract
What happens when you cross a billionaire, who controls a small biotech with a smallpox drug and who donates lots of money to politicians, with a White House that is pushing biodefense measures? You may get a questionable no-bid contract awarded to the little biotech to supply an experimental vaccine for a threat that may […]
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Heart Stopping News For Sanofi & Its Sales Reps
In the latest blow to Sanofi, the final results of a study confirm that its Multaq heart med increases rates of heart failure, stroke and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Known as the Pallas trial, the study had been stopped last July […]
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Clinical Investigator In FDA Hot Water for Not Opening Mail
When doctors and researchers sign up to participate in a clinical trial, they are expected to do a few basic things. Among them is keeping up to date with the clinical trial doings. One way to accomplish this is to open the mail. But not everyone does. As a result, one investigator was forced to […]
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FDA Debars Doc In Pfizer Research Scandal
Do you remember Scott Reuben? He was accused of faking research for a dozen years in published studies suggesting after-surgery benefits from Vioxx and Celebrex. Last year, he was sentenced to six months in jail plus three years supervised release after pleading guilty to fraud. The former chief of acute pain at Baystate Medical Center […]
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FDA cites 1,200 tobacco retailers
The Food and Drug Administration said Thursday it has issued about 1,200 warning letters to retailers in 15 states for violating federal tobacco regulations since beginning inspections under a 2009 law giving it authority to regulate the industry. The agency’s Center for Tobacco Products, using state contractors, has conducted more than 27,500 inspections of stores […]
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Abbott, A Clinical Trial And A Doctor’s Allegiance
drugmakers that are battling claims a med caused someone harm is to use a doctor as a shield. In legal parlance, this is known as the learned intermediary doctrine, which, basically, states that a drugmaker has fulfilled its responsibility for providing all necessary information to a doctor, who then interacts with a patient. But Abbott […]
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FDA Inspects How Many Clinical Trial Investigators?
Thanks to numerous scandals, the FDA is under mounting pressure to step up its oversight of drug development and manufacturing. But what do the metrics look like? Well, the agency has now released numbers showing its efforts to inspect and audit facilities that are involved in drug development specifically, such as clinical trial investigators and […]
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Merck CEO To Head Penn State Sex Abuse Probe
Fresh off a day in which he courted Wall Street with an increased dividend and pipeline promises, Merck ceo Ken Frazier is now shifting his sights toward college scandals and sexual abuse. The Penn State University Board of Trustees have tapped Frazier to head the investigation into child sex abuse that has turned the school […]
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FDA releases two new draft guidances
The FDA this week issued two new draft guidances and launched a new standard operating protocol for requesting new data from products undergoing pre-market review. In two draft guidances the federal watchdog agency offered new approaches to feasibility studies for products under investigational device exemption and outlined the process for device makers who want to […]
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GlaxoSmithKline sets up $50 mln life sciences fund in Canada
Pharmaceutical major GlaxoSmithKline is setting up a $50 million fund in Canada to invest in early stage research. The GSK Canada Life Sciences Innovation fund will be managed by GSK in Canada and the company’s venture capital division, SR One. “The GSK Canada Life Sciences Innovation Fund will provide a competitive advantage to Canada’s life […]
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