News

In COVID-19 news, the FDA has approved Olumiant for new COVID-19 indication, but had limited Janssen’s COVID-19 vaccine. The agency has launched a new program for rare disease drug development and approved a new oral form of ALS therapy. Regulators have also extended the review time for both a new Pompe disease therapy and the sNDA for Myfembree for endometriosis. Additionally, Eisai has completed its submission of lecanemab for Alzheimer’s disease.

Research and discussion about the high cancer rates among Black Americans used to be dominated by genetics and the search for biological differences. Now attention has shifted to the social determinants of health.

The FDA has approved a rare disease therapy and an additional indication for Enhertu, and grants priority review for Imfinzi in biliary tract cancer. Regulators have issued complete response letters for three therapies. The agency also has scheduled an advisory committee for Nuplazid in Alzheimer’s psychosis.

At the 2022 Asembia Specialty Pharmacy Summit, healthcare policy experts at Avalere shared insights into the politics of a less ambitious Build Back Better bill and the healthcare provisions it might include. If a "skinny bill" doesn't get passed, the healthcare action of the Biden administration might shift to CMS Innovation Center and payment models, including a successor to the Oncology Care Model, they said.

Jayne Hornung, Chief Clinical Officer, Pharmacy, MMIT addresses the difference between digital therapeutics in the pharmacy and medical benefit space, and digs into the potential causes of the slow uptake in digital therapeutics among payers during this year's Asembia Specialty Pharmacy Summit in Las Vegas.