5 Indian Drug Companies Eager for US Entry After Clean Inspections
FDA has inspected the manufacturing plants of at least half-a-dozen Indian drugmakers, raising hopes that these companies will be able to export medicines to the world’s largest drug market, reports Khomba Singh from New Delhi. Several industry executives said teams of inspectors from the US Food and Drug Administration (FDA) did not find any major […]
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Smoked: Pfizer’s Chantix & Heart Problems
Yet another red flag is being raised about the Chantix smoking-cessation drug and the likelihood of cardiovascular problems. A new meta-analysis found that the Pfizer pill was associated with a 72 percent increased risk of serious adverse cardiovascular risks in smokers without a history of heart disease, and two authors suggest the FDA should consider […]
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FDA Clears Dendreon 2nd Facility
Dendreon Corporation recently received clearance from the U.S. Food and Drug Administration (FDA) to expand manufacturing facility for its cancer vaccine Provenge, in the U.S. The company’s Los Angeles facility can now be operational with 36 workstations. These facilities will be brought online in a staged manner. Earlier, in March 2011, Dendreon’s New Jersey facility […]
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Minnesota Pols Slam FDA For Device Approvals
In the ongoing war between device makers and the FDA, the Minnesota Congressional delegation has sent a terse letter to the agency over what they maintain is a slow-as-molasses approval process. This comes less than three months after a Congressional hearing in which FDA procedures were hotly debated and included testimony from patients who claimed […]
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FDA Issues A Serious Warning For An Abbott Drug
For the second time in less than two years, the FDA has issued a sobering warning about the Depakote epilepsy med sold by Abbott Laboratories. This time, the agency says that children born to mothers who take the anti-seizure drug or related products during pregnancy have an increased risk of lower cognitive test scores than […]
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For Ranbaxy, FDA Audit Is Much More Than Just an Inspection
Ranbaxy expects any day now a ruling from the FDA on whether its new finished dosage manufacturing plant in Mohali, Punjab, is up to GMP snuff. An inspection that began last week is nearing completion, says the Economic Times. Ranbaxy has a lot riding on the inspection. So does its Japanese parent, Daiichi. New Webinar […]
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Avastin & FDA Were Both On Trial: Dan Explains
After months of controversy, an FDA advisory panel yesterday voted unanimously to uphold an earlier agency decision to yank the breast cancer indication for Avastin, a widely used sold by Roche and its Genentech unit (see this). The run-up to the two-day meeting was highly contentious as the drugmaker accused the FDA panel of bias, […]
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Cephalon Warning Letter – June 28, 2011
SILVER SPRING, Md., Jun 28 2011—The FDA has posted on its website a letter sent to Cephalon regarding its website for Trisenox reviewing a number of problems. The letter is below. Franklin Vairinhos, Ph.D. Director, Regulatory Affairs Cephalon, Inc. 41 Moores Road Frazer, PA 19355 USA Dear Dr. Vairinhos: The Division of Drug Marketing, Advertising, […]
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R&D Spending In India Is Projected To Mushroom
Last year, the pharmaceutical industry spent about $2 billion on assorted R&D activities in India, but that figure is expected to reach a whopping $25 billion by 2025. The reasons are varied, but can be traced to expanding activities by Indian companies, additional government investment and a growing pool of qualified researchers, according to a […]
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Spinal Tap: Medtronic Studies Are Repudiated
In a highly unusual move, a medical journal has devoted an entire issue to dissecting a mushrooming controversy over Infuse, a genetically engineered protein that is made by Medtronic and has been widely used in spinal surgeries. But the Spine Journal reviewed 13 studies previously published elsewhere and discovered that side effects were downplayed or […]
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