Biogen
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BioPharma, Consumer / Employer, Devices & Diagnostics, Health Tech
Healthcare Moves: A Monthly Summary of Hires and Layoffs
Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry.
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Biogen Bulks Up in Rare Disease With $7.3B Reata Pharmaceuticals Acquisition
Biogen’s Reata Pharmaceuticals acquisition brings Skyclarys, the first and only FDA-approved therapy for the rare neuromuscular disease Friedreich’s ataxia. Biogen says Skyclarys complements the other neuromuscular drugs in its portfolio.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert
Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.
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Biogen Drug Wins Accelerated FDA Nod for Treating Rare Genetic Form of ALS
The Biogen amyotrophic lateral sclerosis drug, Qalsody, treats patients whose disease is driven by mutations to a gene called SOD1. It’s the first drug approved to target a genetic cause of ALS.
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Eisai Alzheimer’s Drug Gets FDA Decision Date; Advisory Meeting Is Planned
Leqembi, the Eisai Alzheimer’s disease drug awarded accelerated FDA approval in January, could receive a decision on full approval in early July. But in setting the target date for a regulatory decision, the agency also said it plans to convene an advisory committee meeting to discuss the drug.
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FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review
Eisai Alzheimer’s disease drug Leqembi is now approved for the treatment of patients with an early form of the memory-robbing disease. In granting the antibody accelerated approval, the FDA employed reasoning that was the also basis for the controversial speedy regulatory nod for Biogen’s drug, Aduhelm.
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Eisai Alzheimer’s Drug Data Show Slowing of Decline But Safety Questions Linger
Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder. While an accelerated approval decision is expected in early 2023, the latest trial data are key because they represent the confirmatory study that could support an application for full FDA approval.
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GoodRx goes ‘provider mode’ with new platform
GoodRx is arguably most well-known for its search platform that allows consumers to compare drug prices across different pharmacies. Now, it has launched a similar platform for healthcare providers. The new platform, called “Provider Mode,” is designed to help providers search for drug cost information while they are conducting appointments with their patients.
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Eisai, Biogen beat expectations with data that support Alzheimer’s drug approval
Eisai Alzheimer’s disease drug candidate lecanemab now has data from a pivotal study showing a statistically significant reduction in cognitive decline. Lecanemab is already under FDA review for potential accelerated approval but the agency has said that results from this larger study could support full approval of the antibody drug.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Biogen bolsters case for ALS drug under FDA review with new published data
A Biogen drug designed for a genetically defined form of amyotrophic lateral sclerosis led to patient improvement at a 12-month analysis, according to data now published in the New England Journal of Medicine. Biogen had already filed an application seeking FDA approval of the ALS drug, tofersen; a regulatory decision is expected by January.
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Aduhelm’s loss is a win for value-based drug pricing
Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based contracts are the only way to figure that out.
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Devices & Diagnostics, BioPharma
Biogen gets in tune with MedRhythms to develop new digital therapeutic for MS
Biogen struck a deal that could bring a digital therapeutic to its multiple sclerosis product portfolio. The drugmaker is partnering with startup MedRhythms in the development of a therapy that combines sensors, software, and music to improve walking problems in multiple sclerosis patients.
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Biogen pulls Alzheimer’s drug application in Europe as EMA calls data insufficient
Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.
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Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical trials
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.
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CMS proposes limited coverage of Biogen Alzheimer’s drug, only in clinical trials
The Center for Medicare and Medicaid Services proposes covering Biogen Alzheimer’s disease drug Aduhelm only for people enrolled in a clinical trial. In explaining this proposal, the agency cited the unclear benefit to patients as well as the documented safety risks associated with the drug, which can be best monitored within the context of a clinical trial.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
Promoted
Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
