Alzheimer’s disease

FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy. Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.) Last November, eight committee members…

A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy. The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials. STAT…

FDA has approved the Aduhelm (aducanumab) from Biogen (BIIB), the first novel Alzheimer’s drug treatment, in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials. The news caused Biogen’s share price to jump from $286.14 to $395.85 — a 38.34% increase. “Alzheimer’s disease is a devastating illness that can…

A group of scientists from the U.S. and China injected human stem cells into 132 macaque embryos, which then developed for up to 20 days. While the research holds promise for organ transplants, studying disease and testing new drugs, it also prompts controversy. The research was published this month in Cell. The scientists began with blastocysts…

Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab seemed to be a potential blockbuster until an FDA advisory committee voiced skepticism in November about the drug. FDA reviewers had previously assessed the drug’s prospects more positively. The company is preparing for the event of an FDA approval of the drug in June. Biogen’s CEO Michel Vounatsos said in…

Developing disease-modifying therapies for neurodegenerative diseases remains a pressing need. The incidence of neurodegenerative disease is ramping up in the U.S. and elsewhere as much of the global population ages. One out of three seniors dies with Alzheimer’s disease or another form of dementia, according to the Alzheimer’s Association. Parkinson’s disease is also becoming more…

Alzheimer’s disease has one of the highest financial burdens. The Alzheimer’s Association estimates that the cost of the disease in the U.S. will hit $355 billion in 2021. “Not only is Alzheimer’s one of the most expensive, it’s probably one of the most devastating diseases of humans,” said Dr. Allan Levey, professor and chairman of…

Biotechnology traces its roots to the Neolithic era when early civilizations discovered how to ferment grains to prepare alcoholic brews and bread. It wasn’t until genetic engineering became mainstream in the mid-1970s, however, that biotechnology, as we know it today, was launched. The field continues to evolve today. The advent of new technology has revolutionized the market…

The neurodegenerative-diseased-focused biotech Amylyx Pharmaceuticals announced that it had received orphan drug designation for AMX0035, a proprietary blend of sodium phenylbutyrate and tauroursodeoxycholic acid. The Cambridge, Mass.-based company won that designation to treat Wolfram syndrome, a rare genetic disease associated with diabetes, progressive optic atrophy, hearing loss and severe neurological disabilities.  The prognosis for patients…

Aducanumab from Biogen (NSDQ:BIIB) seemed to be on the verge of becoming the first new Alzheimer’s drug to hit the market in almost two decades. Now, its potential fate is murkier given skepticisms voiced during an FDA advisory committee meeting today. BIIB shares skidded 28% in afternoon trading on Nov. 9. Eight of the experts…