Denise Myshko

May 14, 2022

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.

May 09, 2022

The administration of adult stem cells increased survival in patients with both acute and chronic graft-versus-host disease in a compassionate use program.

May 07, 2022

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.

May 03, 2022

The Build Back Better legislation would have had far-reaching effects on Medicare Parts B and D but the legislation has stalled, and it is unclear if any significant federal legislation affecting specialty pharamcy will pass this year. Meanwhile, several states are addressing white bagging, according to Tracy Russell of CoverMyMeds.

April 30, 2022

It’s been a busy week at the FDA. The agency has approved mavacamten for hypertrophic cardiomyopathy, an oral therapy for yeast infections, an additional indication for Ultomiris, Rinvoq and Veklury. Additionally, Moderna seek EUA for vaccine for young children and the FDA will hold an advisory committee meeting for both Xphozah in kidney disease and Novavax’s COVID-19 vaccine.

April 23, 2022

The FDA has approved a generic of Zavesca for Gaucher disease and has accepted applications for a supplement indication for Enhertu and a novel therapy for CKD-related anemia. The regulatory agency also issued a CRL for Teva’s schizophrenia drug.