Alzheimer’s

The recent announcement by Eisai/Biogen of the positive outcome of the CLARITY study of lecanemab — an antibody that preferentially targets soluble toxic beta-amyloid aggregates (protofibrils and oligomers) — supports the decades of research, overwhelming genetic data, and basic understanding that beta-amyloid is a bad actor in the Alzheimer’s disease process. It is also much-welcomed…

The neurodegeneration-focused biopharma Athira Pharma (Nasdaq:ATHA) has seen its stock drop more than 90% since December 31, 2020. Today alone, the company’s share price was down 66.73%, falling to $2.81, in mid-day trading after the company announced disappointing results from the Phase 2 ACT-AD study focused on fosgonimeton in Alzheimer’s disease. The company announced that…

A recent physician survey found that 89% of neurologists in the U.S. have concerns about the efficacy of the controversial Alzheimer’s drug Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and Eisai Co. (TYO:4523). Nearly as many — 87% — were concerned about the drug’s safety profile. The survey from the physician social media network Sermo (New York City) asked more than…

UsAgainstAlzheimer’s, a nonprofit organization committed to stopping Alzheimer’s disease, is hoping to get more information related to CMS’s national coverage determination related to coverage for Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and other monoclonal antibodies targeting amyloid to treat Alzheimer’s disease. The organization has filed a Freedom of Information Act (FOIA) request for information about the decision. UsAgainstAlzheimer’s…

Researchers at Oregon State University (OSU) have discovered a new class of potential drug targets for diseases like Alzheimer’s, Parkinson’s and amyotrophic lateral sclerosis (ALS). The scientists are working to identify the best method to attack the targets — oxidized proteins. The most potent oxidant of the bunch is peroxynitrite, which is produced in conditions involving inflammation.…

Health insurers in the U.S. are seeking more data from Biogen regarding its $56,000-per-year Alzheimer’s treatment Aduhelm (aducanumab) before agreeing to pay for the treatment, according to Bloomberg. None of the 25 large insurers that took part in a Bloomberg News survey found that the drug was “medically necessary.” Humana Inc. is, however, covering Aduhelm…

Shares of Athira Pharma (NSDQ:ATHA) jumped 9.35% in mid-day trading after the company announced the resignation of embattled CEO Leen Kawas. Kawas will also give up her seat on the Bothell, Washington–based company’s board. Facing allegations that she doctored a series of images in research papers, Leen Kawas was placed on leave in June. Several…

While sales of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) could increase if CMS decides to back the drug, few patients are currently receiving the therapy. Approved in June under FDA’s accelerated review pathway, the drug has generated $2 million in sales to date. Of that sum, $300,000 came from the third quarter. Analysts had expected the…

Cassava Sciences (NSDQ:SAVA) announced that its experimental Alzheimer’s drug simufilam was associated with an improved cognition score at 12 months. Specifically, recipients of the drug showed a 3.2 point improvement on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) from baseline to month 12. Austin, Texas–based Cassava also announced that 68% of study participants demonstrated improved…

COVID-19 vaccines could potentially guard against dementia and Alzheimer’s disease, according to an op-ed in WSJ.  COVID-19 infection itself can lead to long-term cognitive decline in some individuals and can accelerate Alzheimer’s symptoms, concluded an Alzheimer’s Association study. An Alzheimer’s Research & Therapy echoed those findings.  Pointing to data suggesting that vaccinations against tetanus and flu lead to reduced…

PurMinds believes psychedelics hold promise for neurological conditions Interest in psychedelics has ratched up in recent years and a growing number of drug companies are beginning to explore their potential to treat everything from depression to neurodegeneration. “It is a really really exciting time,” said Aron Buchman, chief strategy officer, PurMinds BioPharma, which is exploring…

The backlash surrounding aducanumab post-approval has put Biogen (NSDQ:BIIB) on the defensive, prompting the company’s head of research and development, Dr. Alfred Sandrock, to post an open letter to the Alzheimer’s disease community on Biogen’s website. In the letter, Sandrock lamented that there was “extensive misinformation and misunderstanding” regarding the drug. In recent weeks, the company also requested…

After FDA approved Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Aduhelm (aducanumab) to treat Alzheimer’s disease, the agency faced criticism that the indication was overly broad. While initially indicating aducanumab for all Alzheimer’s patients, the agency has now decided to limit the recommendation to patients with mild forms of the disease. The EMERGE and ENGAGE Phase 3…

FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares. But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist. Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021…

Eli Lilly (NYSE:LLY) has received breakthrough therapy designation from FDA for the investigational antibody donanemab for Alzheimer’s disease. The company plans to file a biologics license application for the drug under the accelerated approval pathway later this year. Like Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) recently approved aducanumab, donanemab is a monoclonal antibody clearing sticky amyloid plaques.…

Biogen (NSDQ:BIIB) has scrapped its development plans for gosuranemab (BIIB092) after the drug candidate failed to hit the primary endpoint in a Phase 2 trial.  Biogen’s aducanumab made waves recently, becoming the first Alzheimer’s drug to win FDA approval in recent memory. Not all, however, are happy with that fact.  Aducanumab is an amyloid beta-protein…

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…

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…

For almost every major common disease, researchers have less understanding of the severe forms than milder cases. And as a result, people with severe forms of diseases often have few treatment options available.   Thus, the significant unmet medical need for many diseases ranging from multiple sclerosis to Alzheimer’s is to halt disease progression and treat severe…

Privately-held Genuity Science and Emory University are collaborating with the hopes to accelerate drug research and development for neurodegenerative diseases such as Alzheimer’s and Parkinson’s. Clinical breakthroughs for neurodegenerative diseases are rare. The most recent drug to win FDA approval for Alzheimer’s, Namenda (memantine) from AbbVie-acquired Allergan, did so in 2003. And Levodopa, one of the most-effective Parkinson’s…