The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab). Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval. About a week later, nonprofit watchdog group Public Citizen called for high-profile resignations of […]
Biogen
Baxter, 3M, Abbott near the top of Newsweek’s most responsible companies list
Several medtech, healthcare and life sciences companies, including big names like Abbott (NYSE:ABT), 3M (NYSE:MMM) and Baxter (NYSE:BAX), 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 […]
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 Sept. 16, […]
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. […]
Unraveling aducanumab’s impact remains a challenge
The FDA’s conditional approval of Biogen’s (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 […]
10 of the best pharma companies to work for
The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research. The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries. To get a sense of which pharmaceutical companies […]
Pharma’s top 20 R&D spenders in 2020
The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. While the […]
Apple, Biogen partner on using smart devices to track cognitive health
Biogen (NSDQ:BIIB) today announced a virtual research study in collaboration with Apple (NSDQ:AAPL) for monitoring and screening cognitive health. The multi-year, observational research study, set to be launched later this year, is slated to investigate the role Apple Watch and iPhone could play in monitoring cognitive performance and screening for a decline in cognitive health, including […]
Biogen’s controversial Alzheimer’s drug hits snag
Aducanumab from Biogen (NSDQ:BIIB) seemed to be on the verge of becoming the first new Alzheimer’s drug to hit the market in almost two decades. Now, its potential fate is murkier given skepticisms voiced during an FDA advisory committee meeting today. Eight of the experts in the committee disagreed that there was strong evidence in […]
Report: 20,000 COVID cases traced to Boston medtech company’s conference
The “super-spreading” event held by Biogen (NSDQ:BIIB) in February reportedly led to approximately 20,000 COVID-19 cases across four Massachusetts counties. According to a Boston Globe report, the international company meeting at the Marriott Long Wharf hotel in Boston was said to have resulted in 99 identified cases of the virus, but, according to scientists studying early cases, that […]
Biogen to sell Denmark-based manufacturing site to FujiFilm for $890m
Biogen (NSDQ:BIIB) said yesterday that it inked an $890 million deal to sell a Denmark-based manufacturing site to Fujifilm (TSE:4901). The site, located in Hillerød, includes a biologics production facility with assembly, labeling and packing capabilities as well as quality control laboratories and warehouses, Cambridge, Mass.-based Biogen said. The facility also has approximately 800 employees who are […]