Geisinger and Eisai to test real-world validity of AI-powered Passive Digital Marker (PDM) in detecting early cognitive impairment and dementia

Research collaboration will test novel algorithm’s effectiveness on Geisinger data (press release):. Geisinger and Eisai Inc. today announced a collaborative effort to study the potential effectiveness of an artificial intelligence (AI) tool in the detection of cognitive impairment that could identify dementias, including Alzheimer’s disease (AD). If effective, the AI tool could potentially be developed to support the early detection and staging of cognitive impairment and dementia, leading to appropriate additional testing for the clinical, biological diagnosis and treatment of dementias such as AD.
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Fierce Pharma Asia—Lilly, Innovent’s PD-1 saga; Biogen, Eisai’s Aduhelm rebuttal; Surprise FDA foreign inspections?

Eli Lilly and Innovent Biologics' non-small cell lung cancer application for PD-1 inhibitor Tyvyt looks like a dud after harsh FDA criticism and a thumbs-down from an advisory committee. Biogen and Eisai have filed their formal complaint against a limited Medicare coverage proposal for Alzheimer's disease drug Aduhelm. The U.S. Government Accountability Office made several recommendations for the FDA to revamp its foreign inspections, including conducting unannounced check-ups. And more.

Biogen, Eisai strike back against CMS' stifling Aduhelm coverage proposal

After The Centers for Medicare and Medicaid Services (CMS) proposed to limit coverage of Biogen’s Alzheimer’s disease drug Aduhelm to patients in approved clinical trials, the company and its partner Eisai have made their dissent official. Biogen and Eisai on Thursday submitted formal comments to CMS in opposition...

Japan regulator to continue deliberations on Biogen and Eisai's Alzheimer's drug

An advisory panel to the Japanese drug regulator is continuing deliberations on the new drug application filed by Biogen Inc. , the companies said Wednesday. "The NDC (New Drugs Committee) is seeking additional data to be submitted as part of this process," said the statement. "The companies will continue to actively engage with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to agree on additional data requirements. Biogen and Eisai remain committed to bringing aducanumab to patients in Japan expeditiously." Aduhelm was granted approval in the U.S. by the Food and Drug Administration last June, but has been mired in controversy over that decision ever since. In July, Biogen asked for a narrower indication. Several members of the FDA's advisory committee who had voted against the agency's approving Aduhelm quit in response, and acting FDA commissioner Janet Woodcock in July announced a federal investigation into the process behind the Aduhelm approval. Earlier this week, Biogen said it will halve the price of the treatment in January after it failed to gain traction in the U.S. Biogen shares were slightly lower premarket and have fallen 4% in 2021, while the S&P 500.

Biogen and Eisai say EU regulatory committee adopted negative opinion for its Alzheimer's treatment

Biogen Inc. and partner Eisai Co. Ltd said Friday an advisory committee to the European Medicines Agency has adopted a negative opinion on its Alzheimer's treatment aducanumab, known as aduhelm in the U.S. The company was seeking an authorization for the treatment in patients in the early stages of the disease known as mild cognitive impairment. "This decision is aligned to the negative trend vote of the committee in November 2021. Biogen will seek a re-examination of the opinion by the CHMP," said Biogen, referring to the Committee for Medicinal Products for Human Use. Biogen shares slid 3% premarket on the news. The drug has been approved by the U.S. Food and Drug Administration but that decision was viewed as controversial. Biogen in July requested a narrower indication -- the initial approval was for all people with the disease. Several members of the FDA's advisory committee that voted against the agency approving aduhelm quit in response, and acting FDA commissioner Janet Woodcock in July announced a federal investigation into the approval process.

Sean Spears of Eisai honored with 2021 Nexus Award for Lifetime Achievement

ARLINGTON, Va. — The HDA Research Foundation recognized Sean Spears of Eisai, Inc., with the 2021 Nexus Award for Lifetime Achievement last night at the Thirteenth Annual CEO Roundtable Fundraiser in Washington, D.C. The award is the healthcare distribution industry’s highest honor recognizing career accomplishments. Now in its 65th year,...

Eisai and Biogen start rolling submission of BLA for Alzheimer’s therapy

Eisai and Biogen have commenced a rolling submission of a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the experimental drug, lecanemab (BAN2401), to treat early Alzheimer’s disease (early AD). lecanemab was developed by the partnership between Eisai and BioArctic and is an investigational, humanised...