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The Food and Drug Administration on Friday approved the first pill for postpartum depression, a milestone considered likely to increase recognition and treatment of a debilitating condition that afflicts about a half-million women in the United States every year. Clinical trial data show the pill works quickly, beginning to ease depression in as little as […]
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The F.D.A. also required Biogen to conduct another clinical trial to determine if the drug provided any evidence of benefit. In the years it will take for that trial to be completed, Aduhelm will be available to patients. Medicare’s coverage decision is considered pivotal to the future of Aduhelm, which is priced at $28,200 a […]
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Posts supporting coverage include comments from people who have consulted for Biogen, like Dr. Jeffrey Cummings, a research professor in the department of brain health at the University of Nevada Las Vegas. He wrote that the drug “prolongs the mental life of our declining patients,” adding, “Medicare should unequivocally support coverage for aducanumab, and they […]
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Biogen slashed the price of its controversial new Alzheimer’s drug Aduhelm on Monday as the drug faces weak sales and mounting criticism. The price was reduced to $28,200 a year from $56,000 on the same day that a group of Alzheimer’s experts and health advocates called on the Food and Drug Administration to pull the […]
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Safety data from those trials was published Monday in the journal JAMA Neurology in a study whose authors included eight Biogen employees. The data showed that 425 of 1,029 patients, or 41 percent, who received the high dose of the drug — the dose that the F.D.A. later approved — experienced either brain swelling or […]
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The Food and Drug Administration is on the verge of announcing one of its most contentious decisions in years: the fate of an Alzheimer’s drug that could be the first treatment approved after nearly two decades of failed efforts to find ways to curb the debilitating disease. On Monday, the agency will rule on the […]
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