Satsuma Pharmaceuticals (NSDQ:STSA) has announced that it has enrolled the first patient in its SUMMIT Phase 3 efficacy trial of STS101, a drug-device product that is a potential acute treatment of migraine. STS101 is a nasal powder containing dihydroergotamine (DHE), an analgesic already available to treat migraines and cluster headaches. In fact, migraine patients have…
FDA grants breakthrough therapy designation to Takeda narcolepsy drug candidate
Takeda (NYSE:TAK) has won breakthrough therapy designation from FDA for TAK-994, an experimental oral orexin agonist. Now in a Phase 2 trial, TAK-994 is formulated to selectively target orexin 2 receptors. Orexin is a neuropeptide that supports normal wakefulness. Orexin deficiency is associated with narcolepsy. Takeda is testing the potential of TAK-994 to treat excessive…
Aducanumab continues to face scrutiny as Biogen aims to woo neurologists and Alzheimer’s patients
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…
Man experiences facial palsy twice after receiving both COVID-19 vaccine doses
The possibility of mRNA causing facial palsy continues to make headlines. A month after a JAMA study found no link between the Pfizer-BioNTech vaccine and facial paralysis, an article in BMJ Case Reports describes the case of a 61-year-old U.K. man who experienced facial palsy episodes after receiving both doses of the Pfizer-BioNTech vaccine. The journal reports that…
Why FDA’s approval of aducanumab was unprecedented
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…
Extended-release Adhansia XR has a clinical effect up to 16 hours
Adhansia XR from Adlon Therapeutics is a long-acting central nervous system stimulant indicated for attention deficit hyperactivity disorder (ADHD) in children aged 6 and older. Adlon recently announced that in a clinical trial, ADHD patients had a significant improvement in symptoms starting after one hour after taking the drug and up to 16 hours. Adlon recently…
34 of the most innovative pharmaceutical products
The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…
Why Tryp Therapeutics is exploring the use of psilocybin to treat chronic pain
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…
Elyxyb remains a novel migraine therapy
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 indicated for treating migraines
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…
Nurtec ODT wins approval as a preventive treatment of migraine
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…
Cleveland Clinic, Mount Sinai decide to not use aducanumab for the foreseeable future
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 links J&J vaccine to rare cases of Guillain–Barré
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…
FDA asks for an independent federal review of its aducanumab approval
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…
FDA narrows indication of Biogen’s aducanumab
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…
Lilly’s donanemab may outclass aducanumab, but questions remain
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…
Pandemic and disease burden are ‘existential’ threats, experts argue
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…
Lilly’s push for accelerated FDA approval of Alzheimer’s drug donanemab
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.…
Athira Pharma’s stock falls 39% after placing its CEO on leave
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’s gosuranemab fails in Phase 2 study
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…
Public Citizen demands FDA resignations after aducanumab approval
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…
Unraveling aducanumab’s impact on pharma remains a challenge
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…
Three members of FDA advisory committee resign after aducanumab approval
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 advisory committee member reportedly resigns over Alzheimer’s therapy approval
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…
Meet the drugs and devices giving hope to millions of migraine patients
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…