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…

An international team of researchers has identified a technique that uses fluoride nanoparticles to potentially eliminate protein deformations. The method, which also can promote positive structural changes, could lead to the prevention and treatment of Alzheimer’s disease. The scientists from Tokyo University of Science (TUS) in Japan and Nazarbayev University in Kazakhstan published the research…

Biogen (Nasdaq:BIIB) has terminated a study of the controversial Alzheimer’s disease drug Aduhelm (aducanumab) as a result of limited national policy for coverage. In a listing on clinicaltrials.gov, the company notes that it anticipates there will limited prescriptions of the drug in routine clinical practice, which would provide limited enrollment for the planned ICARE AD study.…

The biopharma Athira Pharma (Nasdaq: ATHA) has lengthened the current open-label extension (OLEX) study for its Phase 3 LIFT-AD and Phase 2 ACT-AD trials of fosgonimeton (ATH-1017, NDX-1017), hepatocyte growth factor receptor agonist, focused on mild-to-moderate Alzheimer’s disease. The Bothell, Washington–based company made the decision based on feedback from its independent data and safety monitoring…

IntelGenx Corp. (TSX:IGX/OTCQB:IGXT) has dosed the first patient in a resumed Phase 2a clinical trial involving an oral film of montelukast for Alzheimer’s disease (AD).  The COVID-19 pandemic previously interrupted the study for more than one year.  In 2019, IntelGenx initially announced that the study would enroll roughly 70 individuals with mild-to-moderate AD and test a…

Denali Therapeutics (NASDAQ:DNLI) has announced that the FDA has placed a clinical hold on the Investigational New Drug (IND) application for DNL919. The large-molecule drug candidate targets TREM2 or triggering receptor expressed on myeloid cells 2. South San Francisco–based Denali said it received an email from FDA stating that the agency had placed the IND…

Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.” The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December…

Athira Pharma (NSDQ:ATHA) announced that its lead development candidate, ATH-1017, had balanced baseline characteristics to date in two ongoing late-stage Alzheimer’s studies. Presenting the data at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, the company’s chief medical officer Dr. Hans Moebius said that the baseline characteristics are consistent between the ACT-AD…

Roche (OTCQX: RHHBY) has announced that its investigational anti-amyloid beta antibody gantenerumab for Alzheimer’s disease received breakthrough therapy designation from FDA.  The agency has granted the status to a range of investigational Alzheimer’s, including lecanemab from Eisai and Biogen and donanemab from Eli Lilly. Biogen’s aducanumab had also received the designation before FDA approved it in…

The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug. According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by…

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…

Given the demand for a potential disease-modifying therapy for the disease, early demand for Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) is considerable from patients. Many neurologists, however, continue to view the drug with skepticism. Fewer than half of neurologists expect they will prescribe the drug in the first six months of availability, according…

The drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available.  The company’s stock dropped 6.79% to $328.16.  After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and…

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…

While the COVID-19 pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and…

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…

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” over FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm). Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider…

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…