Neurological Disease

Many researchers are exploring the potential of the psychedelic compound psilocybin to treat conditions such as depression and post-traumatic stress disorder. But psilocybin offers broader therapeutic promise as it appears to spur neuroplasticity, according to Greg McKee, CEO of Tryp Therapeutics (San Diego). The company is exploring the use of psilocybin-based drugs for treating eating disorders…

Last year, FDA approved the celecoxib oral solution Elyxyb from Dr. Reddy’s Laboratories as an acute treatment of migraine with or without aura in adults. Formerly known as DFN-15, Elyxyb is a novel selective inhibitor of cyclooxygenase-2. The company received FDA approval for the drug in May 2020. The company formulated the drug as an oral solution…

Reyvow (lasmiditan) is an FDA-approved treatment from Lilly for the acute treatment of migraine with or without aura in adults. FDA has not approved it as a preventive treatment of migraine. In October, Lilly announced that the drug showed superior pain freedom after two hours of ingestion in two-thirds of migraine attacks in a Phase…

FDA indicates Biohaven Pharmaceuticals‘ Nurtec ODT for the acute treatment of migraine with or without aura in adults. The agency recently extended the indication to include the preventive treatment of migraines. Nurtech is currently the only drug to win FDA approval as both an acute and preventive migraine treatment. The expanded indication has launched the…

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…

The Food and Drug Administration has concluded that the COVID-19 vaccine from Johnson & Johnson’s (NYSE:JNJ) could rarely cause Guillain–Barré syndrome in which the immune system attacks the nervous system. A warning is forthcoming, according to media reports. Researchers have also linked prior vaccines, including a swine flu vaccine introduced in the 1970s, with the syndrome, which destroys…

Acting FDA Commissioner Dr. Janet Woodcock is responding to criticism about the agency’s controversial decision a month ago to approve aducanumab, Biogen’s and Eisai’s Alzheimer’s drug. In a letter to Principal Deputy Inspector General Christi Grimm, Woodcock called for an independent investigation into the contacts between Biogen and FDA during the approval process. Biden has…

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…

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.…

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave. The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020. The company had its initial public…

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…

The FDA’s conditional approval of Biogen (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact. There are 6 million people with Alzheimer’s in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely…

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…

Migraines are an ancient condition. In about 400 B.C., Hippocrates described visual symptoms of migraine aura that precede headache onset. But up until recently, neurologists had relatively few tools at their disposal to help migraine patients. The treatment landscape has evolved considerably in recent years, explains Alexander Feoktistov, a neurologist at the Synergy Integrative Headache…

Bayer announced today that its BlueRock Therapeutics subsidiary successfully administered the first dose of its Parkinson’s disease therapies. Berlin-based Bayer said in a news release that BlueRock successfully administered the dose of its investigational pluripotent stem cell-derived dopaminergic neruons, called DA01, to a Parkinson’s disease patient in an open-label Phase 1 clinical safety and tolerability…

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…

Migraines are a prevalent condition, affecting about one billion people across the world. “In the U.S., about 13% of the population experiences migraine headaches regularly,” said Dr. Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago.  In the following interview, Feoktistov shed light on the prevalence of the condition and shares his…

FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B). The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use. In clinical trials, Novo Nordisk people…

The pandemic has heightened interest in COVID-19 therapies, sometimes stealing attention from other pharmaceutical breakthroughs. But the pandemic has also served as a reminder that investment in new drugs can pay dividends while leading to a greater societal appreciation for the industry. A 2019 study published in International Health concluded that pharmaceuticals that have launched…

A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform.  Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, and, although…

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…