Here are the latest stories being discussed in biopharma today:
1. Moderna’s chief commercial officer, Arpa Garay, has left her role as the company moves to “increase executive focus” on sales. This news follows Moderna’s announcement last month that it expects Covid sales to “hit a low point” in 2024.
2. The House passed a wide-ranging bill aiming to enhance transparency in the healthcare industry. This includes increased reporting requirements for insurers and a ban on spread pricing for pharmacy benefit managers.
3. Novo Nordisk is challenging CMS guidance around Medicare price negotiations in a New Jersey federal court, arguing that the Inflation Reduction Act’s “plain text” is violated by grouping its insulin aspart products together.
4. The FDA has organized a new advisory committee to assess potential treatments for genetic metabolic diseases. The panel will consist of experts in metabolic genetics, inborn errors of metabolism, small populations, trial design, translational science, pediatrics, epidemiology or statistics, and related specialties.
5. J&J and Genmab expanded their case to move the subcutaneous version of cancer drug Darzalex into earlier treatment lines. The drug, administered in both an induction phase and a maintenance phase, resulted in cancer progression being 58% less likely compared to the chemo regimen on its own.
6. Bispecific antibodies from Regeneron, Johnson & Johnson, AbbVie, and Roche continue to demonstrate significant efficacy in lymphoma and myeloma according to new data presented at the American Society of Hematology’s annual meeting.
7. Dizal announced that its peripheral T-cell lymphoma drug candidate has shown positive efficacy and safety in a Phase II registrational trial, opening the pathway for a US filing.
8. Over 200 medicines potentially at risk of shortages have been listed as critical by the European Commission, the Heads of Medicines Agencies, and the EMA.
9. GSK is looking to imitate the successful uptake of pediatric vaccines in adults following major advancements in RSV vaccine development in 2023. The company is adopting a policy approach focusing on local communities to improve access to adult vaccines.
