Investors mobilize in fight to shake up the FDA
In the 1990s, the Food and Drug Administration felt the heat when AIDS activists marched in the streets, shouting about how bureaucratic foot-dragging meant that patients died while waiting for new drugs. The FDA listened. It started completing safety and effectiveness reviews faster. May 19 – Webinar – Former FDA Chief Council Sheldon Bradshaw – […]
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US FDA looks to improve design and cleaning instructions for reusable medical devices
The US Food and Drug Administration announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of disease. Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process which includes […]
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FDA Panel Backs Vertex’s Hepatitis C Drug 18-0
In an 18-0 vote, an FDA advisory committee has voted to recommend approval of Vertex’s ($VRTX) telaprevir for people with genotype 1 chronic hepatitis C. The vote comes a day after the same panel offered its unanimous support for Merck’s hepatitis C treatment boceprevir. And the experts’ ready embrace of these breakthrough meds left both […]
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Does Forest Labs Case Signal New Era in White-Collar Prosecution?
All you white-collar defense lawyers should sit up and take notice of this story, by the WSJ’s Alicia Mundy, out in Tuesday’s paper. The reason: because it hints at an interesting trend that just might be on the rise. For now, a bit of background: Last year, the Department of Health and Human Services startle […]
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FDA warns doctor: Stop touting camera as disease screening tool
On Dr. Joseph Mercola’s popular website, women are warned against getting mammograms to screen for breast cancer. Instead, the Chicago-area physician touts thermograms — digital images of skin surface temperatures — as an early detection tool for a wide range of conditions from cancer to back pain, from lupus to arthritis. May 19 – Webinar […]
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Excipient screening initiative kicks off at FDA, IPEC
The US Food and Drug Administration (FDA) has enlisted the aid of industry to develop a screening programme for pharmaceutical excipients in order to prevent counterfeit, contaminated and mislabelled substances from entering the supply chain and causing patient harm. The agency is working with IPEC Americas, an industry group representing manufacturers and users of pharmaceutical […]
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Hepatitis C Drugs Await FDA Approval
A Food and Drug Administration staff review of Merck & Co.’s proposed hepatitis C drug boceprevir has raised safety concerns about anemia and other blood disorders. But the review also said it agreed with Merck’s analysis showing adding boceprevir to other drugs currently used to treat hepatitis C was significantly more effective at treating the […]
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U.S. Effort to Remove Drug CEO Jolts Firms
A government attempt to oust a longtime drug-company chief executive over his company’s marketing violations is raising alarms in that industry and beyond about a potential expansion of federal involvement in the business world. The Department of Health and Human Services this month notified Howard Solomon of Forest Laboratories Inc. that it intends to exclude […]
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Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week
Vertex Pharmaceuticals is heading down the home stretch in its bid to transform treatment of hepatitis C, and this week the public will get an up-close look at the risks and benefits of its drug that could change the standard of care for millions of people. Cambridge, MA-based Vertex (NASDAQ: VRTX) will have its big […]
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Merck’s Hepatitis C Drug Increases Cure Rates in Clinical Trial, FDA Says
Merck & Co.’s experimental hepatitis C drug cures more patients than current therapies, according to U.S. regulators considering whether to clear the first treatment for the liver disease in more than a decade. Boceprevir, combined with standard treatments, worked better than those drugs alone in clinical trials, Food and Drug Administration staff said today in […]
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