Year: 2013
The Unexpected Way Exercise Can Jumpstart Your Career
Expert panel recommends FDA approve Takeda bowel disease drug
(Reuters) – An advisory panel of medical experts on Monday voted to recommend that U.S. health regulators approve an experimental drug for ulcerative colitis and Crohn's disease developed by Takeda Pharmaceutical Co. There were specific safety and efficacy questions for each of the two conditions put before the panel. It ultimately found by wide margins that the benefits outweigh the risks of the biotech drug, vedolizumab, and advised the Food and Drug Administration to approve it for ulcerative colitis and Crohn's disease in patients who have not been helped by prior therapies. The FDA typically follows the recommendations of its expert advisory panels but is not obligated to do so.
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Merck agrees to proposed $27.7 million settlement over Fosamax lawsuits
By Nate Raymond and Jessica Dye NEW YORK (Reuters) – Merck & Co Inc said on Monday that it was prepared to pay $27.7 million to settle lawsuits by hundreds of people who sued the company over allegations that its osteoporosis drug Fosamax caused bones in the jaw to deteriorate. Lawyers for Merck and plaintiffs disclosed the proposed settlement at a court hearing in New York to resolve 1,140 lawsuits pending in federal and state courts. Merck, which confirmed the agreement later on Monday, said the accord requires a 100 percent participation rate and evidence that the claimants satisfy eligibility requirements. “We hope to bring this to a successful conclusion,” Paul Strain, a lawyer for Merck, said at the hearing in U.S. District Court in Manhattan before Judge John Keenan, who has presided over federal litigation by plaintiffs claiming that they developed osteonecrosis of the jaw from taking Fosamax.