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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OTC hand sanitizer manufacturers recieve FDA warning letters
The companies which manufacture and market over-the-counter (OTC) drugs, including hand sanitizers, and claim to prevent methicillin-resistant Staphylococcus aureus bacteria (MRSA) infection have received warning letters from the U.S. Food and Drug Administration (FDA). Labeling and marketing materials for the affected products claim that they can prevent infection from other disease-causing agents. May 19 – […]
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J&J’s Stent Business Continues Struggles, Has Market-Share Losses
Johnson & Johnson’s (JNJ) stent franchise continued to slump and cede business to rivals in the first quarter, and J&J offered no updates on a stalled project for a new device that could help revive its fortunes. J&J’s stent-making Cordis unit faces numerous challenges, including the effects of recent U.S. sales-force cuts, the loss of […]
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Layoffs at Anulex follow FDA’s warning letter
Following a February warning letter from the U.S. Food and Drug Administration, Anulex Technologies has had to adjust by having a round of layoffs. President and General Manager Tim Miller declined to say how many people were let go but acknowledged that such letters were “extremely disruptive to business.†The Minnetonka-based medical device company develops […]
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FDA Approves New Device for Brain Tumor Treatment
The FDA has approved a new noninvasive portable device for the treatment of a deadly type of brain tumor. The device uses electrical fields to slow and possibly reverse tumor growth. The device, manufactured by Novocure, is called the NovoTTF-100A System and is meant for adults with glioblastoma multiforme that recurs or progresses after chemotherapy […]
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New FDA Rule Regarding Medical Device Data Systems Takes Effect
On April 18 an FDA rule governing the use of medical device data systems went into effect, implementing guidelines for IT companies that develop medical devices A new U.S. Food and Drug Administration rule went into effect April 18 that regulates how hardware manufacturers can introduce new mobile medical devices for use by health care […]
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