CRO Employees Indicted For Falsifying Study Data
A doctor and a clinical research coordinator working for a contract research organization hired by the former Schering-Plough were indicted by the feds for falsifying study data. The clinical trial was designed to test a tablet the drugmaker was developing to treat allergies. June 21 – Webinar – Former FDA Chief Council Sheldon Bradshaw – […]
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Merial Fired Exec For Protecting Dogs
A former regulatory employee at the Merial animal health operation has filed a sensational lawsuit charging the Sanofi unit with deliberately covering up adverse event reports for its Heartgard Plus heartworm product for dogs and repeatedly rebuffing FDA admonitions to alter promotional material that overstated effectiveness. The trouble began in 2006, when Kari Blaho-Owens joined […]
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FDA signals it will regulate medical apps
As more medical mobile applications get developed, one thorny question has arisen: Is there anyone who should be verifying whether these apps are effective and safe? The question has come up, in particular, because of apps that claim to have a clinical component. They’re a small part of the app universe, but experts expect clinical […]
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South Carolina AG Sues Glaxo Over Avandia
And still another state attorney general has filed a lawsuit charging GlaxoSmithKline with fraudulently marketing its controversial Avandia diabetes pill. This time, South Carolina Attorney General Alan Wilson has gone to court, joining his counterparts in Louisiana and Utah . And the same issue is being raised – allegations that the drugmaker knowingly marketed a […]
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FDA Launches Web Portal on Enforcement Activities
The FDA announced May 26 the launch of a Web portal on the agency’s enforcement activities. The portal includes a searchable database of inspection information, including the names and addresses of inspected facilities, inspection dates, type of products involved and the final inspectional classification — no action indicated (NAI), voluntary action indicated (VAI) or official […]
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FDA Posts Inspection Findings, Common Violations
Facility inspection results, court actions and details of drugmaker practices that may jeopardize public health are now easier to find thanks to an FDA web portal dedicated to enforcement activities. The agency’s goal, part of Phase II of its Transparency Initiative, is to make its compliance-related activities “more accessible, downloadable and searchable.” June 21 – […]
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Abbott Cholesterol Pill Fails To Protect The Heart
A study run by the National Institutes of Health was ended 18 months early after finding that adding Niaspan to a statin in people with heart disease did not reduce the risk of cardiovascular events, including heart attacks and strokes. Moreover, Niaspan may have boosted the risk of ischemic events, raising questions about the benefit […]
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Parexel CEO: ‘We’re Undergoing Significant Change’
Yesterday, Pfizer reached an outsourcing deal with two large clinical research organizations – Parexel International and Icon. The move comes not long after the big drugmaker announced plans to close or shift various R&D operations and slash 3,500 jobs in order to save $1.5 billion. Such deals, of course, are not new as large drugmakers […]
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Amylin Wins The First Round In Suit Against Lilly
The bitter skirmish between Amylin Pharmaceuticals and Eli Lilly just grew more heated. A federal judge has issued a temporary restraining order that prevents the big drugmaker from proceeding with plans to use the same sales force to sell both Byetta – which both currently promote – and a rival drug made by Boehringer Ingelheim. […]
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Court Raises Standards For Invalidating Patents
Thanks to a federal appeals court, the standards have been raised for declaring that a patent is invalid due to so-called inequitable conduct. In a precedential ruling, the US Court of Appeals for the Federal Circuit decided that errors or omissions in patent applications could only be used to invalidate a patent if the withheld […]
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