The FDA had asked Biogen and Sage Therapeutics to provide more clinical data supporting Zurzuvae in major depressive disorder. Citing the time and expense of additional clinical trials, the partners decided against further development in this indication
The EMA’s Committee for Medicinal Products for Human Use expressed concern about brain complications associated with the Eisai Alzheimer’s drug, Leqembi. Eisai said it will ask the committee to reconsider the negative opinion.
A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices.
Biogen’s acquisition of Human Immunology Biosciences brings a drug candidate with potential applications in multiple immune-mediated disorders. The deal comes just prior to the scheduled presentation of clinical data in two of them.
Biogen has returned its Aduhelm rights to Neurimmune, the company that initially developed the antibody Alzheimer’s disease drug. But Biogen isn’t abandoning Alzheimer’s, and its pipeline includes drugs that take other approaches to the neurodegenerative disorder.
Generic competition has eroded sales of multiple sclerosis drug Ampyra, marketed as Fampyra outside the U.S. Biogen told Acorda Therapeutics that it’s terminating its ex-U.S. rights to Fampyra in order to focus on other priorities, which include expanding beyond MS.
Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
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.
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.
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.
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.
3D medical animation services have emerged as a groundbreaking tool in the healthcare industry, revolutionizing the way medical concepts are taught, understood, and marketed.
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.
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.
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.
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.
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.