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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry.
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.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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.
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.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
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.
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.
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.
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.