A third member of the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee resigned in protest over the regulatory agency’s approval of Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease.
Two members of a panel of outside advisors to the U.S. Food and Drug Administration resigned in protest at the regulatory agency’s decision to approve Biogen Inc.’s Aduhelm for the treatment of Alzheimer’s disease despite the committee’s recommendation against doing so.
The U.S. Food and Drug Administration approved Biogen’s aducanumab, the first drug to target an underlying cause of Alzheimer’s disease. The drug, to be sold under the brand Aduhelm, is the first new approval of an Alzheimer’s drug since 2003 and the only treatment designed to slow progression of the mind-robbing disease.
U.S. regulators on June 7 approved Biogen Inc.’s aducanumab as the first treatment to attack a likely cause of Alzheimer’s disease despite controversy over whether the clinical evidence proves the drug works, sending the company’s shares soaring.
Alzheimer’s disease is the holy grail of pharmaceutical research, and a team of physicians published results showing that they may have found the key to actually improving cognition in patients with early-stage dementia.
An investigational Alzheimer’s disease (AD) drug from Tetra Therapeutics appeared to improve language ability and learning in adults with Fragile X Syndrome, according to a new study reported in Nature Medicine.
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to Biogen’s experimental drug aducanumab for Alzheimer’s disease in a JAMA article.
Clarivate published the company’s annual “Drugs to Watch” list, and cited several medicines that the analysts expect to be blockbusters – projected to bring in $1 billion in sales annually.
Switzerland-based AC Immune SA announced positive interim results from the company’s ongoing Phase Ib/IIa clinical trial of ACI-35.030 for Alzheimer’s disease.
Biohaven Pharmaceuticals’ third-generation prodrug troriluzole did not show a statistical improvement for patients when compared to those on placebo at the 48-week marker as a symptomatic treatment in mild-to-moderate Alzheimer’s disease (AD).