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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The Bayer Discrimination Lawsuit & A Sliding Donut
A class action law suit alleging that Bayer HealthCare Pharmaceuticals discriminated against female employees has now been expanded to include female sales reps and all women in the Bayer HealthCare Consumer Care unit, two groups of employees who were not originally part of a discrimination complaint filed two months ago The initial lawsuit, filed by […]
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FDA process pushes innovative medical devices abroad, survey shows
Companies developing some of the most-innovative medical devices are launching them abroad first, well before they reach U.S. shores, according to a new study by researchers at Northwestern University. New Webinar – July 28 – Dangerous Documents: How to Avoid Landmines in Your FDA Documents and Emails Speaker: Nancy Singer, President, Compliance-Alliance LLC, former DOJ […]
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Congress Probes Pricing On Two Repurposed Drugs
Earlier this year, a scandal erupted after KV Pharmaceuticals won approval for its Makena drug to prevent premature births and charged $1,500 for treatment, an eye-popping increase for a med that was previously available from compounding pharmacies for $10 to $20 for decades. The move was possible because the FDA approval came with marketing exclusivity […]
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FDA Issues Draft Guidance For Investigator Conflicts
In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years. […]
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With Botanicals, No Patent, No Expiry, says Sanofi Exec
What if a new drug could be trademarked instead of patented, keeping generics companies at bay for the life of the trademark, i.e., forever? That was one of the ideas floated to reporters yesterday by Sanofi-Aventis’ Ray Jupp, VP of the fibrosis and wound repair therapeutic strategic unit, an early-stage research division created as part […]
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