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FDA Issues Draft Guidance For Investigator Conflicts
In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance.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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Financial Conflict of Interest Makes FDA Advisory Committee Vacancies Tough to Fill
Last week at the Reuter’s Health Summit held in New York, Janet Woodcock, the head of the Center for Drug Evaluation and Research was quoted as saying that she expected drug approvals to increase this year, but that the financial conflict of interest standards for advisory committee membership has made recruitment difficult. New Webinar – […]
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New Pharma Hires This Week
Bionor Pharma hired Frode Hellesnes as vp of business development; Vertex Pharmaceuticals added Terrence Kearney to its board; Optivia hired Dominique Bridon as exec vp and chief operating officer; Kinex Pharmaceuticals hired David Hangauer as chief scientific officer; Xanodyine Pharmaceuticals hired Fabrice Egros as chief operating officer; The California Institute for Regenerative Medicine hired Stephen […]
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Apotex Creeps Out Of The FDA Dog House
Two years after the FDA warned Apotex about severe manufacturing problems at one of its plants, the agency has issued a so-called close out letter that, essentially, gives the drugmaker a green light to resume shipments to the US. However, the FDA notice did not mention problems cited with another plant that were noted in […]
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FDA: Agency Asked Pfizer To Resubmit ‘Large Number’ Of Chantix Adverse Reports
The Food and Drug Administration said it asked Pfizer Inc. (PFE) to resubmit a large number of adverse-event reports last year involving the company’s smoking-cessation treatment Chantix. The FDA said in a statement posted on its website Thursday that it became aware that Pfizer and a few other manufacturers the agency wouldn’t name were submitting […]
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New REMS for Avandia restricts access, signaling new way to restrict drugs from market
Last September, the FDA decided to allow the controversial Avandia diabetes pill to remain on the market. The move came after more than three years of debate over the cardiovascular risks of the which the GlaxoSmithKline drug and charges that the drugmaker failed to sufficiently disclose clinical trial data showing the magnitude of those risks. […]
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