Biogen Inc.’s pricing of its newly approved Alzheimer’s drug, Aduhelm (aducanumab), has made it the latest bull’s eye for lawmakers and advocacy groups targeting U.S. drug prices, especially given the controversy surrounding the drug’s approval, which has resulted in the resignation of three of the 11 members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
Researchers have demonstrated that enhancing myelin renewal in the brains of transgenic APP/PS1 mouse models of Alzheimer's disease (AD) can improve their task-related hippocampal activity.
Developers of blood tests for the early diagnosis of Alzheimer’s disease (AD) are poised to see a spike in demand, following the FDA’s accelerated approval on Tuesday of Cambridge, Mass.-based Biogen Inc.’s AD drug treatment Aduhelm (aducanumab). The FDA’s decision paves the way for AD assays to move beyond aiding in drug development toward addressing ongoing issues with undiagnosed cases.
During a conference call with investors, Biogen Inc. officials defended the price of Aduhelm (aducanumab) for Alzheimer’s disease (AD), with CEO Michel Vounatsos saying the $56,000 per year price tag was based on “the value it is expected to bring to patients, caregivers, and society.”
By granting accelerated approval for Biogen Inc.’s Aduhelm (aducanumab) for Alzheimer’s disease (AD), the FDA is “essentially confirming that the beta-amyloid hypothesis has been validated,” Mizuho analyst Salim Syed said in an alert to investors. Shares of Cambridge, Mass.-based Biogen (NASDAQ:BIIB) closed $395.85, up $109.71, or 38.3%, as Wall Street hailed the first new AD therapy to reach the market since 2003.
LONDON – In a sizeable seed round for a U.K. biotech, Transine Therapeutics Ltd. has raised £9.1 million (US$12.9 million) to take forward a novel method for up-regulating endogenous protein production using a naturally occurring class of long noncoding RNAs.
Public biopharmaceutical companies did manage to attract some investors off the sidelines in May with medical conference season getting into full gear. However, it was generally another lackluster month, with the Nasdaq Biotech index dropping 2% in the period in contrast to the broader markets with the Dow Jones Industrial Average growing by 2%. The sector, however, could get a significant boost in the next few days if the FDA gives the green light to Biogen Inc. and Eisai Co. Ltd.’s experimental Alzheimer’s disease therapy, aducanumab, a recombinant chimeric human IgG1 monoclonal antibody targeting beta-amyloid, that could be the first disease-modifying therapy for an indication that has seen no novel therapies approved in more than 15 years.
Single-cell gene studies at Duke-NUS Medical School in Singapore and Monash University in Melbourne, Australia, have shown that gene expression signatures underlie the microglial phagocytosis of beta-amyloid (Abeta) plaque in patients with Alzheimer's disease (AD), the authors reported in the May 20, 2021, edition of Nature Communications.
Shares of Annovis Bio Inc. (NYSE:ANVS) leapt 127.3% to $60 May 21 on news that, following 25 days of treatment with its lead candidate, ANVS-401 (posiphen), 14 early Alzheimer's disease patients enrolled in its ongoing phase IIa study showed cognitive improvement of 22% vs. those who received placebo. Pending successful completion of the study, the company is targeting advancement to late-stage studies later this year.
LONDON – Cumulus Neuroscience Ltd. has raised £6 million (US$8.3 million) to advance development of its home use wearable headset for tracking response to treatment in clinical trials in psychiatric disorders and neurodegenerative diseases, including Alzheimer’s.
