Tag Archives: Food and Drug Administration

Judgment Day for Avandia

By Oriana Schwindt | Published: July 14, 2010
Judgment Day has finally arrived for GSK’s Avandia. FDA’s Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees met July 13 and 14 to finally recommend, after months of deck-stacking against GSK, that the drug be severely restricted, if not outright pulled from the market. In the vote, 12 of 33 panelists [...]
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InterMune Denied Approval for Lung Treatment

By George Koroneos | Published: May 5, 2010
Image via Wikipedia Biotech firm InterMune took an ugly hit on Tuesday as news broke that its lung disease drug Esbriet (pirfenidone) will require additional clinical studies, and won’t be getting the seal of approval from FDA any time soon. The news caused InterMune’s stock to drop a staggering 78 percent, according to Reuters. Analysts have [...]
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FDA to Review Prostate Cancer Meds

By George Koroneos | Published: May 4, 2010
Image via Wikipedia FDA, on Monday, announced that it was reviewing whether a certain class of prostate cancer drugs could lead to diabetes, stroke, death, or heart problems. The drugs in question are gonadotropin-Releasing Hormone (GnRH) agonists, marketed under a number of monikers, including Vantas and Lupron. These treatments are used to slow the growth of prostate [...]
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FDA and GSK on the Hunt for Stolen Drugs

By George Koroneos | Published: February 24, 2010
Image by Johnny Grim via Flickr We typically don’t get emails from FDA  asking for information about stolen goods with massive bold letters, but that’s what just came into our inbox. Looks like a transport truck containing a mix of GlaxoSmithKline’s pharmaceutical and over-the-counter medications was jacked in Puerto Rico on January 29, and the feds [...]
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Pharma Unplugged #2 Layoffs & Bonuses

By George Koroneos | Published: December 7, 2009
Pharma Unplugged #2— Layoffs & Bonuses Recorded: 12/3/2009 Air Date: 12/7/2009 Host: George Koroneos, Pharm Exec Cohost: Reid Paul, Pharm Rep Magazine Show Notes: This week we discuss: Pfizer’s medical education relationship with the Canadian Medical Association Journalists take FDA to task for not being transparent enough Layoffs and job cuts at Sanofi-Aventis New report shows that DTC receives more funding than sales calls in [...]
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