News

An advisory committee recommends against approving an anemia drug. Darzalex Faspro receives another indication, Bayer receives approval for Kerendia for chronic kidney disease, and FDA delays its decision on sNDAs for JAK inhibitor therapies for atopic dermatitis.

In this week's episode, Associate Editor, Briana Contreras spoke with Dr. Florian Otto, co-founder and CEO for Cedar, a complete healthcare financial engagement platform. Dr. Otto discussed the topic of compassionate billing and how this particular payment model is becoming triumphant over traditional healthcare payment models where patients are experiencing an increase in insurance deductibles and out-of-pocket medical expenses.

Biogen officials defended the company's Alzheimer's drug and criticized ICER's cost-effectiveness report today at a meeting of one of the group's advisory committees. But the committee cast a series of votes that showed the members have a low opinion of the drug.

The review will determine whether there should be a national Medicare coverage policy for the Alzheimer’s therapy.

Findings from industry studies show major cost savings for beneficiaries in Medicare Advantage plans. Some say the cost per enrollee for the government is higher than that for traditional Medicare.

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.