Trial of New Alzheimer’s Drug Reports Disappointed Results

A closely watched clinical trial of a potential Alzheimer’s drug failed to prevent or slow cognitive decline; this was another disappointment in the long and arduous efforts to find a solution to the disease. this ten year trial It is the first time that a drug intended to stop or delay decline has been given […]

Scientists Question the Data Behind an Experimental Alzheimer’s Drug

“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 signs […]

In a Campaign to Get Medicare Coverage for a New Alzheimer’s Drug

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 coordinated […]

Medicare Recommends Sharply Limiting Alzheimer’s Drug Coverage

Medicare’s coverage decision is considered crucial to the future of Aduhelm, which is priced at $28,200 per patient per year. About 80 percent of patients eligible for medication are old enough to be covered under Medicare. Biogen initially priced the drug at $56,000 per year, but cut the price in half last month after months […]

House Committees Request FDA Registrations for Alzheimer’s Drug Approval

Two strong 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 in a letter released Thursday, making it clear that committee leaders were annoyed by the unusual actions the agency took. during the evaluation and approval of the drug. “We are […]

How Unproven Alzheimer’s Drug Approved?

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, Dr. […]

FDA Is Investigating Its Own Alzheimer’s Drug Approval

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 and […]

In A Reversal, FDA Calls for Limits on Who Takes Alzheimer’s Drugs

Faced with harsh criticism for approving a controversial drug for all Alzheimer’s patients, the Food and Drug Administration has largely narrowed his recommendationsuggests that only those with mild memory or thinking problems should take it. The FDA’s turn, quite unusual for a drug that has only been on the market for a few weeks, could […]

A New Alzheimer’s Drug Offers More Questions Than Answers

A geriatrician at the University of Nebraska Medical Center, Dr. “This puts us in a bad place,” Karina Bishop agreed. Ethically, he added, “if this drug were available now, I wouldn’t be able to prescribe it.” Even as individual doctors struggle to advise patients, hospitals and healthcare systems are developing protocols for when Aduhelm will […]