Biogen

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…

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 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 (NSDQ:BIIB) has announced that it is cutting the wholesale acquisition cost of the controversial Alzheimer’s drug Aduhelm (aducanumab) by roughly half. Starting January 1, 2022, the annual cost for a 100 mg/mL injection of the drug will be $28,200 for a patient who weighs 74 kg (163 pounds). In related news, the Committee for…

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…

A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek. The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall…

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…

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 (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…

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…

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…

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…

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 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…

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…

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…

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…

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 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…

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…