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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FDA Moves to Clean Up Bacteria Prevention Claims for Hand Sanitizers
The Food and Drug Administration wants several manufacturers of hand sanitizers to clean up their marketing act, saying they are going too far by claiming that their products prevent infection from the potentially deadly bacteria known as MRSA, or methicillin-resistant Staphylococcus aureus. Find Qualified Vendors for Contract Lab Testing/Outsourcing – Laboratoryretriever.com FDA warning letters target […]
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FDA insider trading case a ‘nightmare’
A federal chemist who learned from his agency’s database that it was about to approve Vanda Pharmaceuticals’ schizophrenia drug, Fanapt, made more than $1 million trading on the Rockville biotech’s stock with that inside knowledge, authorities claim. Cheng Yi Liang, 57, and his son Andrew Liang, 25, both of Gaithersburg made a nearly 800 percent […]
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Spectrum says stronger Fusilev wins ok from FDA
Spectrum Pharmaceuticals Inc. /quotes/comstock/15*!sppi/quotes/nls/sppi SPPI 0.00% on Thursday said it won U.S. Food and Drug Administration approval for its ready-to-use injection of Fusilev, a treatment that is a higher strength than the currently available formula. Shares climbed 3.5% to $9.40 in recent trading. Fusilev had already won FDA approval for patients with osteosarcoma, a common […]
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Critics Wary of FDA’s REMS for Long-Acting Opioids
With many of their proposed changes ignored, critics of the FDA’s risk evaluation and mitigation strategy (REMS) for long-acting opioids are watchfully waiting to see if an act of Congress will indeed make education mandatory for all doctors who prescribe these painkillers. The Obama administration’s chief of drug control policy, Gil Kerlikowske, expressed utmost confidence […]
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FDA: Hand Sanitizers Make False Claims
Hand sanitizers protect us from germs, don’t they? A new FDA initiative has consumers confused. The FDA yesterday warned consumers not to buy hand sanitizers “that claim to prevent infection from MRSA, E. coli, salmonella, flu, or other bacteria or viruses.” But isn’t that why we use them? May 19 – Webinar – Former FDA […]
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Roche Gets FDA Approval For Cobas HPV Test To Detect Cervical Cancer
Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK: News ) Wednesday said the U.S. Food and Drug Administration has approved its cobas HPV test to identify women at highest risk for developing cervical cancer. Human Papillomavirus or HPV is implicated as the reason for more than 99 percent of cervical cancers worldwide. The cobas test is […]
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Drugstore Hand Sanitizers Don’t Kill MRSA, Warns FDA
Makers of some hand sanitizers and antiseptic products are making false claims they prevent MRSA infection, says a warning issued Wednesday by the U.S. Food and Drug Administration. “Don’t believe them. These statements are unproven,” the agency said. May 19 – Webinar – Former FDA Chief Council Sheldon Bradshaw – Warning Letter Update Save 50% […]
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