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[ad_1] biogenic said on Tuesday He said he would replace his CEO and effectively abandon the marketing of a high-profile Alzheimer’s drug that has failed commercially since its controversial approval nearly a year ago. Biogen said Michel Vounatsos, who has led the drugmaker for more than five years and presided over the approval and launch …
Continue reading “Biogen CEO to Retire Following Alzheimer’s Drug Release,”
[ad_1] “There is no possibility, no logical way for this to happen,” he said. Elisabeth Bik, a leading expert In image manipulation, short sellers became aware of the company last summer after the FDA filed its petition. In a series of twitter posts, blog posts, and posts on the PubPeer website, Dr. Bik pointed to …
Continue reading “Scientists Question the Data Behind an Experimental Alzheimer’s Drug”
[ad_1] In the interview, Mr. Johns repeated these statements. When asked if association officials have contacted Biogen since Medicare’s recommendation, he said, “I think some of our friends had a chat or more in the process,” and that Biogen staff “transmits information from time to time, but I can say this.” Because we are not …
Continue reading “In a Campaign to Get Medicare Coverage for a New Alzheimer’s Drug”
[ad_1] Federal officials are grappling with a decision that could go a long way in determining the future of the controversial new Alzheimer’s drug, Aduhelm, and whether a significant number of patients are using it. In January, Medicare, the federal health insurance program for people 65 and older, plans to issue a preliminary ruling on …
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[ad_1] Biogen lowered the price of its controversial new Alzheimer’s drug, Aduhelm, on Monday as the drug faced weak sales and growing criticism. The price was lowered from $56,000 to $28,200 a year on the day a group of Alzheimer’s experts and health advocates called on the Food and Drug Administration to pull the drug …
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[ad_1] Pharmaceutical manufacturer Biogen said on Wednesday The latest setback for a controversial drug since it was approved in the United States in June, when a drug review panel in the European Union said the new Alzheimer’s drug is unlikely to be approved there. Biogen said a committee of experts advising the European Medicines Agency …
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[ad_1] Pharmaceutical manufacturer Biogen reported On Wednesday, the new Alzheimer’s drug, Aduhelm, brought in $300,000 from July to September, well below the company’s targets and Wall Street expectations. The sales figures Biogen announced in its third-quarter financial report, the drug’s first period of full availability, represented a rather slow start for a treatment that was …
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[ad_1] Two powerful congressional committees investigating the controversial federal approval of Biogen’s Alzheimer’s drug Aduhelm requested extensive information and documentation from the Food and Drug Administration on Thursday, making it clear that committee leaders are dismayed by the unusual actions taken by the agency. evaluation and approval of the drug. “We are concerned about the …
Continue reading “House Committees Request FDA Registrations for Alzheimer’s Drug Approval”
[ad_1] When I was a kid, my parents got into big fights about some of the books my dad stole from the fabulous library of the university he studied at GI Bill. It was the 10-volume Harper’s Bazaar from the 19th century. Growing up, I studied them all and found them fascinating. My father died …
Continue reading “My stepfather has Alzheimer’s. Can My Mom Date Someone Else?”
[ad_1] The idea of expedited approval was proposed by the FDA’s oncology center chair and non-council member Dr. It was brought up by Rick Pazdur. It wasn’t discussed in detail, but after the meeting, expedited approval seemed the only way to make the drug available, given the council’s refusal to standardize approval. On April 26, …
[ad_1] The Food and Drug Administration on Friday called for a federal investigation of the process that led to the approval of a new drug for Alzheimer’s disease, which has drawn sharp criticism from lawmakers and the medical community. In a letter To the independent Office of the Inspector General of the Department of Health …
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[ad_1] Under fire for approving a questionable drug for all Alzheimer’s‘s patients, the Food and Drug Administration on Thursday largely narrowed down the previous recommendation and now recommends that only those with mild memory or thinking problems should take it. This turnaround, quite unusual for a drug that has only been on the market for …
Continue reading “In Reversal, FDA Calls for Limits on Who Takes Alzheimer’s Drugs”