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Stryker names Kevin Lobo as new CEO
(Reuters) - Medical device maker Stryker Corp on Monday named Kevin Lobo, head of its orthopedics unit, as president and chief executive following an eight-month search. Lobo, who joined Stryker in...
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Did U.S. regulators go easy on firm now linked to deadly meningitis outbreak?
BOSTON (Reuters) - The pharmacy tied to a deadly U.S. meningitis outbreak escaped harsh punishment from health regulators several times in the years leading up to a deadly U.S. meningitis outbreak that...
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More meningitis outbreak fallout: Targeted company had issues almost from the...
BOSTON (Reuters) - A cracked vial here, a missing label there. The complaints coming into New England Compounding Center, the firm at the heart of the deadly U.S. meningitis outbreak, were piling up....
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Biogen’s hemophilia-A drug meets late-stage trial goal
BOSTON (Reuters) - Biogen Idec Inc said on Wednesday its experimental treatment for patients with hemophilia A, a disorder that inhibits coagulation of the blood, controlled bleeding in a late-stage...
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Ameridose lays off 90% of staff
BOSTON (Reuters) - Ameridose LLC, an affiliate of the New England Compounding Center at the heart of the deadly U.S. meningitis outbreak, is laying off about 90 percent of its workforce. The action...
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Boehringer Ingelheim to start late-stage hepatitis C drug trial
BOSTON (Reuters) - Boehringer Ingelheim said on Saturday it plans to initiate a late-stage clinical trial of its experimental hepatitis C treatment following promising results from earlier studies. The...
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FDA OKs J&J med for drug-resistant tuberculosis that uses energy-producing...
(Reuters) - U.S. health regulators have approved a new Johnson & Johnson drug for patients with tuberculosis who do not respond to other treatments, the company said. The drug is the first in 40...
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Narcolepsy link to Glaxo vaccine poses challenge for FDA
(Reuters) - Growing evidence of a link between GlaxoSmithKline Plc's pandemic flu vaccine and an increase in narcolepsy cases among children who received it in Europe, is giving pause to health...
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Amid revamp, U.S. FDA names acting head of generic drugs office
(Reuters) - The U.S. Food and Drug Administration has named Dr Kathleen Uhl acting director of its generic drugs division as it implements the biggest revamp of the department in more than a decade....
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FDA seeks to damp criticism over mobile health app proposals
(Reuters) SILVER SPRING - The U.S. Food and Drug Administration said its plans for regulating certain healthcare apps used on smartphones and tablets will not impose undue burdens on developers or...
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FDA approves Biogen’s multiple sclerosis therapy Tecfidera; pill to go...
WASHINGTON (Reuters) - U.S. regulators on Wednesday approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with...
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FDA ups pressure on specialty pharmacies ahead of hearing
(Reuters) WASHINGTON - The Food and Drug Administration is stepping up pressure on firms that make drugs for specific individuals, known as compounding pharmacies, as it seeks greater regulatory...
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FDA chief grilled on meningitis outbreak as new documents emerge
WASHINGTON (Reuters) - The head of the U.S. Food and Drug Administration conceded on Tuesday that the agency could have been more aggressive in its oversight of the compounding pharmacy at the center...
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FDA chief calls agency a “true bargain” for Americans
[caption id="attachment_12470" align="alignright" width="240"] Dr. Margaret Hamburg[/caption]WASHINGTON (Reuters) - The head of the Food and Drug Administration asked Congress for more money on...
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FDA to launch handheld tool to detect fake, substandard malaria drugs
(Reuters) - The U.S. Food and Drug Administration has developed a hand-held device capable of identifying counterfeit or substandard malaria drugs and has signed a letter of intent with Corning Inc to...
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Draft bill gives FDA authority over certain pharmacies
(Reuters) WASHINGTON - The Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs for tailored use and ship them across state lines, under proposed...
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FDA staff to ask expert panel if new trial needed for Aveo drug
(Reuters) WASHINGTON - Staff reviewers for the Food and Drug Administration will ask a panel of outside medical experts if another clinical trial is needed before an experimental kidney cancer drug...
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FDA strengthens warnings on tanning beds to reduce cancer risk
Washington (Reuters) - Tanning beds and sunlamps will be required to carry stronger warning labels under new regulations proposed by the U.S. Food and Drug Administration, which is also recommending...
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Experimental insomnia drug appears effective, but FDA question dosing levels
(Reuters) - Merck & Co's experimental insomnia drug suvorexant appears generally effective, according to reviewers at the U.S. Food and Drug Administration, but they questioned the company's...
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Orexo gets FDA approval for its drug to treat opioid addiction
(Reuters) - The U.S. Food and Drug Administration has approved Swedish drugmaker Orexo AB's drug to treat opioid addiction, the company said on Thursday, sending its shares up as much as 14.3 percent...
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