Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials

Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.

#aduhelm-drug, #alzheimers-assn, #alzheimers-disease, #biogen-inc, #centers-for-medicare-and-medicaid-services, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #health-insurance-and-managed-care, #medicare

In India, Parents of Children with Rare Disease Plea for Help Online

India makes many of the world’s drugs, but treatments for rare diseases like spinal muscular atrophy are imported and prohibitively costly. In desperation, parents are raising funds on social media.

#babies-and-infants, #biogen-inc, #children-and-childhood, #crowdfunding-internet, #drugs-pharmaceuticals, #india, #novartis-ag, #parenting, #roche-holding-ag, #spinal-muscular-atrophy

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

The Alzheimer’s Association has pushed relentlessly to get broad access to Aduhelm, despite safety risks and uncertain evidence that it helps patients.

#aduhelm-drug, #alzheimers-assn, #alzheimers-disease, #antibodies, #biogen-inc, #centers-for-medicare-and-medicaid-services, #drugs-pharmaceuticals, #elderly, #health-insurance-and-managed-care, #medicare, #united-states, #your-feed-healthcare, #your-feed-science

Medicare Proposes to Cover Aduhelm Only for Patients in Clinical Trials

If the preliminary decision is finalized this spring, it would sharply limit the number of patients who use the expensive drug.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #centers-for-medicare-and-medicaid-services, #drugs-pharmaceuticals, #elderly, #medicare, #your-feed-healthcare

Alzheimer’s Drug Aduhelm Faces Crucial Medicare Decision

Medicare officials are trying to determine whether to cover Aduhelm, which the F.D.A. approved despite unclear evidence that it helps patients.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #centers-for-medicare-and-medicaid-services, #drugs-pharmaceuticals, #elderly, #medicare, #your-feed-healthcare, #your-feed-science

Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles

A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for the treatment.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #drugs-pharmaceuticals, #food-and-drug-administration, #prices-fares-fees-and-rates, #your-feed-healthcare, #your-feed-science

Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug

Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #brain, #clinical-trials, #deaths-fatalities, #drugs-pharmaceuticals, #elderly, #food-and-drug-administration, #jama-neurology-journal, #labeling-and-labels-product, #rbc-capital-markets, #research, #your-feed-science

House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval

The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #food-and-drug-administration, #your-feed-science

F.D.A. Requests Investigation of Its Own Alzheimer’s Drug Approval

The agency’s acting head said a federal review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. rules.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #drugs-pharmaceuticals, #food-and-drug-administration, #inspectors-general, #woodcock-janet

In a Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug

The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the drug be given only to patients with mild symptoms.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #labeling-and-labels-product

New Alzheimer’s Drug Could Cost the Government as Much as It Spends on NASA

The Alzheimer’s treatment will cost $56,000 per patient, and millions may use it. The result: “crazy numbers” for Medicare.

#aduhelm-drug, #biogen-inc, #drugs-pharmaceuticals, #federal-budget-us, #medicare

Many Alzheimer’s Experts Say Use of Aduhelm Should Be Sharply Limited

Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.

#aduhelm-drug, #alzheimers-assn, #alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #labeling-and-labels-product, #your-feed-healthcare, #your-feed-science

The F.D.A.’s Approval of Biogen’s Alzheimer’s Drug Is a New Low

The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable. 

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #drugs-pharmaceuticals, #food-and-drug-administration

Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #elderly, #your-feed-science

Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense

Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.

#alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #health-insurance-and-managed-care

Alzheimer’s Drug Poses a Dilemma for the F.D.A.

If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.

#aducanumab-drug, #alzheimers-assn, #alzheimers-disease, #biogen-inc, #brain, #clinical-trials, #drugs-pharmaceuticals, #elderly, #food-and-drug-administration, #memory, #your-feed-healthcare, #your-feed-science

Biogen Conference May Have Spread Virus to 300,000

A February conference by the drug company Biogen was initially thought to have infected 99 people. By the end of October, it was feared that the number had grown as high as 300,000.

#biogen-inc, #boston-mass, #coronavirus-2019-ncov, #disease-rates, #drugs-pharmaceuticals, #science-journal

Controversial Alzheimer’s Drug Faces Critical Test Before F.D.A. Panel

If ultimately approved, the drug, aducanumab, made by Biogen, would be the first new Alzheimer’s treatment in nearly two decades. Some evidence suggests it slows, but does not stop, cognitive decline.

#alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #your-feed-science