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.…
Nine out of ten U.S. neurologists have Aduhelm efficacy doubts
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…
Biogen CEO Michel Vounatsos to step aside as Aduhelm sales continue to sputter
With the blockbuster dreams of the Alzheimer’s drug Aduhelm (aducanumab) dashed for the foreseeable future, Biogen has announced that its CEO Michel Vounatsos will depart. Vounatsos began his tenure as CEO in 2017. Vounatsos’ plans to exit the company came out on the same day that Biogen reported Q1 adjusted earnings per share of $3.62,…
Biogen gives up seeking European approval for aducanumab
After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks. Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021. At that…
Eisai amends Aduhelm collaboration with Biogen
Aduhelm (aducanuamab) co-developer Eisai Co. (TYO:4523) has agreed to modify its economic partnership agreement with Biogen (Nasdaq:BIIB). Starting January 1, 2023, Eisai will receive a tiered royalty on net sales of the Alzheimer’s disease therapy Aduhelm (aducanumab) rather than share profits or losses of the drug. Eisai would receive between 2% and 8% of annual sales…
Biogen unveils FTC aducanumab probe
In its annual SEC report, Biogen reported that the Federal Trade Commission had sent the company a civil investigative demand related to the controversial Alzheimer’s drug aducanumab (Aduhelm). The company received a similar notice from the SEC. Lawmakers in the U.S. House of Representatives and the Office of Inspector General of HHS are also investigating…
Patient groups voice disapproval for CMS proposal to limit coverage of aducanumab
Biogen’s (NSDQ:BIIB) Alzheimer’s drug Aduhelm (aducanumab) continues to be a source of contention. Advocates cite the need for a new therapy for the memory-robbing disease while skeptics remain unconvinced about the benefit-risk profile of the drug. Most recently, Alzheimer’s disease advocates have criticized Medicare’s proposal to constrain coverage for the drug to clinical trial participants. The…
Medicare recommends covering aducanumab for clinical trial volunteers only
Demand for Biogen’s (NSDQ:BIIB) monoclonal antibody Aduhelm (aducanumab) has been weak, leading the company to cut the wholesale cost of the drug in half to $28,200 for patients of average weight. Now, Medicare officials reached a preliminary conclusion that federal coverage of the drug should be limited to clinical trial participants. The agency went further, stating that…
Japan appears to eye Alzheimer’s drug Aduhelm with skepticism
Japan could follow the lead of the European Medicines Agency, which recommended refusing the marketing authorization of the controversial drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (Tokyo). Japan’s First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council recommended further discussion of the application for the drug. The NDC also requested additional information as…
Biogen’s eyeing layoffs as Aduhelm sales sputter: Report
As Biogen (NSDQ:BIIB) continues to struggle to market the controversial drug Aduhelm (aducanumab), the company is eyeing up to 1,000 layoffs, according to a report from STAT. Biogen did not immediately respond to a request for comment. Following FDA approval of the drug in June, BIIB shares soared to a record high. However, its stock has…
U.S. insurers hesitant to cover aducanumab
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…
EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab
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…
Biogen misses on Q3 revenues, posts Street-beating EPS
Biogen (NSDQ:BIIB) shares ticked up today on third-quarter results that were mixed compared to the consensus forecast. The Cambridge, Massachusetts-based company posted profits of $329.2 million, or $2.22 per share, on sales of $2.2 billion for the three months ended Sept. 30, 2021, for a -53.1% bottom-line slide on a sales decline of -18%. Adjusted…
Aduhelm sales sputter in Q3
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…
Report: Congressional committees have questions over Biogen’s Alzheimer’s drug
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…
VA shies away from Biogen’s Aduhelm
The Department of Veterans Affairs (VA) will not include Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) controversial Alzheimer’s drug Aduhelm (aducanumab) in its drug formulary, citing what it deemed to be unclear efficacy paired with a significant risk of adverse events. The department’s pharmacy benefit manager advised against providing the drug given “the lack of evidence of a robust and meaningful…
HHS OIG will review FDA’s approval of Biogen’s aducanumab
The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523). Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. …
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…
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…
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…
Medicare evaluating Aduhelm coverage while Democrats ask Biogen for documents
As Medicare officials review evidence about Biogen’s (NSDQ:BIIB) Aduhelm (aducanumab) to determine if and how it will cover the drug, two high-level House Democrats are asking Biogen about its dealings with FDA. Yesterday, Carolyn Maloney (D-N.Y.) and Frank Pallone, Jr. (D-N.J.) sent a letter to Biogen CEO Michel Vounatsos asking for details about the company’s communications with…
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…
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…