News Muncher - searching for approval

Biogen will stop selling its Alzheimer’s treatment Aduhelm, a drug once seen as a potential blockbuster that stumbled after its launch a few years ago. The company also is helping Japanese drugmaker Eisai sell another Alzheimer’s treatment, Leqembi, which received full FDA approval last summer. When Aduhelm debuted in 2021, it was the first new Alzheimer’s drug in nearly two …

Full Approval

The US Food and Drug Administration on Friday approved a new drug designed to slow cognitive decline in those suffering from Alzheimer's disease. It follows the approval of the anti-Alzheimer's drug Aduhelm, which a US congressional investigation criticized for alleged "irregularities." The FDA said in a statement that Leqembi and Aduhelm represent "an important advancement in the ongoing fight to …

Probe: Alzheimer’s drug approval ‘rife with irregularities’

WASHINGTON — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee -- Aduhelm manufacturer Biogen. Thursday’s report urged the agency to “take swift action” …

Alzheimer’s drug approval by FDA ‘rife with irregularities,’ probe finds

The FDA’s contentious approval of the questionable Alzheimer’s drug Aduhelm took another hit, as congressional investigators called the process “rife with irregularities.” The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators …

Approval

An Alzheimer’s patient in a trial of aducanumab, also known as Aduhelm, has been receiving infusions since 2014. The Food and Drug Administration’s surprise approval of Aduhelm for the treatment of Alzheimer’s disease last year was a mess on practically every level. Because this was the first drug ever prescribed to fight the progression of Alzheimer’s, it revealed just how …

The fallout from the Food and Drug Administration’s hasty approval of a new Alzheimer’s drug in June was predicted to be severe: Excessive pricing for a drug lacking strong evidence of effectiveness would impose heavy costs on the healthcare system nationwide, especially on Medicare. The coverage determination process is still underway, but Medicare officials said they’re duty-bound to “plan for …

Biogen’s Aduhelm: US lawmakers launch investigation into FDA approval and price of new Alzheimer’s drug

CNN — Two House committees have launched an investigation into the approval and pricing of the Alzheimer’s disease drug aducanumab, made by the company Biogen and sold under the brand name Aduhelm. “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical …

Column: The FDA’s hasty approval of a new Alzheimer’s drug is looking worse than ever

Why The FDA's Approval Of A New Alzheimer's Drug Should Worry You

LOADING ERROR LOADING You might expect Mariah Robertson to applaud last week’s approval of a new drug for Alzheimer’s disease. In the meantime, the Aduhelm decision could set a precedent for how the FDA approaches other treatments ― an “enormously risky move,” as STAT writer Matthew Herper put it, “that could accelerate the public’s access to medicines but upend the …