FDA Updates for the Week of Sept. 26, 2022

October 01, 2022

The FDA has approved several new therapies this week, including Amylyx’s oral treatment for ALS, a fourth Avastin biosimilar, a new glaucoma treatment and another indication for Duxipent. The agency also accepted an NDA for therapy for rare immunodeficiency disease.

FDA Updates for the Week of Sept. 19, 2022

September 24, 2022

The FDA approved a tumor agnostic treatment for cancer, a lower dose MRI contrast agent, the first generic of Tazorac gel, and a gene therapy for a rare disease. Advisory committees vote down poziotinib for NSCLC and Pepaxto for multiple myeloma and give positive vote for microbiotic-based C. diff therapy. The agency has accepted sNDA for Tukysa for HER2 positive colorectal cancer.

FDA Updates for the Week of Sept. 12, 2022

September 17, 2022

The FDA has approved new therapies for psoriasis and kidney dysfunction. The agency has also scheduled an advisory committee meeting for nonprescription birth control and accepted applications for longer-acting aripiprazole, Rett syndrome drug, and an enzyme replacement therapy. Additionally, Clovis has submits supplemental applications for Rubraca.

PBMs Can Help Payers Manage Financial Risk for High-Cost Drugs | 2022 PBMI Annual National Conference

September 14, 2022

Timothy Mizak and Nicole Bulochnik of Abarca talked about how can PBMs help payers manage costs through a hybrid network model that leverages value-based and other innovative drug contracts at the Pharmacy Benefit Management Institute (PBMI) annual meeting in Orlando.

Defining Value in Healthcare

September 13, 2022

Greg Warren, partner and consulting actuary at Axene Health Partners, discussed the many solutions that have been put forth to address the prescription drug challenges that could bring value to healthcare.