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Biogen

CMS will limit coverage of Aduhelm to people in clinical trials

April 8, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Medicare, Neurological, News Well, Pharmaceutical, Regulatory/Compliance Tagged With: Aduhelm, Alzheimer's, Biogen, Centers for Medicare and Medicaid Services (CMS), Eisai

Baxter, 3M, Abbott near the top of Newsweek’s most responsible companies list

December 3, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, News Well Tagged With: 3m, Abbott, Amerisource Bergen, Avanos Medical (formerly Halyard Health), Baxter, BD, Biogen, Boston Scientific, Cantel Medical Corp., Cardinal Health, Edwards Lifesciences, Gilead Sciences, Henry Schein, Hillrom, Hologic, Illumina Inc., Insulet, LabCorp, Merck, Pfizer, Quest Diagnostics Inc., ResMed, Thermo Fisher Scientific, Varex Imaging, Varian Medical Systems

Report: Congressional committees have questions over Biogen’s Alzheimer’s drug

September 8, 2021 By Sean Whooley

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, […]

Filed Under: Food & Drug Administration (FDA), Legal News, Neurological, Pharmaceutical, Regulatory/Compliance Tagged With: Biogen, FDA

HHS OIG will review FDA’s approval of Biogen’s aducanumab

August 4, 2021 By Brian Buntz

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.  […]

Filed Under: Featured, Pharmaceutical Tagged With: Aducanumab, Aduhelm, Biogen, Eisai, FDA, HHS

Unraveling aducanumab’s impact remains a challenge

June 16, 2021 By Brian Buntz

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Imaging, Neurological, Pharmaceutical, Regulatory/Compliance Tagged With: Alzheimer's disease, Biogen, Cardinal Health, Eisai

10 of the best pharma companies to work for

May 26, 2021 By Brian Buntz

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 […]

Filed Under: Featured, Pharmaceutical Tagged With: AstraZeneca, Biogen, Eisai, Janssen, Johnson & Johnson, Merck, Moderna, Novartis, Pfizer, Roche, Roche Pharmaceuticals, Sage Therapeutics

Pharma’s top 20 R&D spenders in 2020

May 13, 2021 By Brian Buntz

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 […]

Filed Under: Featured, Pharmaceutical, Research & Development Tagged With: AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, H. Lundbeck, Incyte, Janssen, Merck, Novartis, Otsuka Holdings, Pfizer, Regeneron Pharmaceuticals, Roche, Roche Group, Roche Pharmaceuticals, Sumitomo Danippon Pharma, UCB, Vertex Pharmaceuticals

Apple, Biogen partner on using smart devices to track cognitive health

January 11, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Clinical Trials, Featured, Health Technology, Neurological, Software / IT Tagged With: Apple, Biogen

Biogen’s controversial Alzheimer’s drug hits snag

November 6, 2020 By Brian Buntz

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 […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Biogen

Report: 20,000 COVID cases traced to Boston medtech company’s conference

August 25, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured Tagged With: Biogen, Boston, coronavirus, COVID-19

Biogen to sell Denmark-based manufacturing site to FujiFilm for $890m

March 13, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Biogen, Fujifilm

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