Pfizer Settles Norplant Lawsuits For $29.5 Million
After 17 years of litigation, Pfizer has reached a preliminary agreement to settle a Norplant contraceptive class action lawsuit for $29.5 million, according to Mealey’s Drugs & Devices Report. The lawsuit, which was scheduled to go to trial in Louisiana, was brought by 3,500 to 4,000 women. The move comes a decade after Wyeth, which […]
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Merck Gets A Vioxx Loss In Australia Overturned
In a potentially significant victory, an Australian court has overturned a ruling last year that found merck liable for a heart attack that a Melbourne man suffered after taking the Vioxx painkiller, which was withdrawn in 2004 over links to heart attacks and strokes. The move by the drugmaker turned Vioxx into a poster child […]
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Teva, Baxter, Mckesson to Pay $162 Million Punitive Damages Over Propofol
A jury said Teva Pharmaceutical Industries Ltd. (TEVA) unit and two other drugmakers must pay $162.5 million in punitive damages for selling the anesthetic Propofol in a way that led three colonoscopy patients to develop Hepatitis C. Jurors in state court Las Vegas ordered Teva Parenteral Medicines Inc., Baxter Healthcare Corp. and McKesson Corp. to […]
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Reversal Of Fortune? A J&J Pill And Provenge
After years of controversy, the Provenge prostate cancer vaccine that was hailed as a breakthrough medication was finally approved last year. Many patients and investors cheered. The saga – which was replete with contoversy engulfing the FDA and its approval process – appeared set for a happy ending in which prostate cancer treatment would enter […]
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Warning Letter For Herbal Nitro Inc. 9/22/11
Mr. Dante Spano, President Herbal Nitro Inc. Yucaipa, CA 92399 Dear Mr. Spano: On May 3 through May 10, 2011, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement firm located at 35133 Ravencrest Ct., Yucaipa, CA. During the inspection, you informed our investigators that your firm is an own-label dietary supplement distributor […]
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Company Warned for Arbitrarily Assigning Pill Expiration Dates
File this under Inventory Management 101. Want to know a novel way to determine an expiration date for your pills? Align it with sales performance. No, a drugmaker did not engage in such unusual thinking, but a dietary supplement maker has done so. And while this site generally does not venture often into the supplement […]
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India Will Not Cap Foreign Investment In Pharma
After more than a year of intense debate, the Indian government has decided not to proceed with a proposal to place a 49 percent cap on foreign investment in its domestic pharmaceutical industry, The Economic Times reports. The decision comes amid concerns that unhampered foreign investment would render India unable to pursue its policy of […]
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Glaxo R&D Chief Offers A Progress Report
Every so often, an update appears on how GlaxoSmithKline is faring with its so-called DPUs. These are known inside the drugmaker as drug performance units and were formed in 2008 to prompt the R&D folks to think differently about their budgets, goals and performance (back story). The upshot: every three years, they make a pitch […]
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FDA Publishes Final Guidance For Industry On Applications For Nonprescription Drug Products
The U.S. Food and Drug Administration (FDA) recently released a guidance on “Time and Extent Applications for Nonprescription Drug Products” (the “Guidance”). The Guidance describes the FDA’s latest thinking on the information applicants should provide when requesting that conditions be added to the FDA’s over-the-counter (OTC) drug monograph system. Specifically, the Guidance focuses on the […]
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FDA Wants to Ease Way for Innovation
The FDA has announced a new “blueprint” to spur biomedical innovation, which contains a plan to make it easier for drugs and devices that are considered “personalized medicine” to come to market. FDA Commissioner Margaret Hamburg told reporters on Wednesday that the overall plan — released as part of a sweeping report on improving innovation […]
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