Pink Sheet Podcast: RSV Vaccine Questions, Lilly Lowers Insulin Cost, Orphan Drug Act Changes

Pink Sheet reporters and editors discuss US FDA advisory committee members’ concerns about two proposed RSV vaccines, Lilly’s plan to lower the cost of its insulin products, proposed changes to the Orphan Drug Act, and the departure of the influential leader of the FDA’s neuroscience office.

Pink Sheet podcast
Will Lilly's insulin price cut lead other manufacturers to follow suit? • Source: Pink Sheet illustration

Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith, senior editors Brenda Sandburg and Sue Sutter, and Executive Editor Nielsen Hobbs discuss the questions that emerged from two US Food and Drug Administration advisory committee meetings on RSV vaccines, Eli Lilly and Company’s plan to lower insulin prices, a new definition that could be added to the Orphan Drug Act and the departure of Billy Dunn as director of the FDA’s Office of Neuroscience.

Open Media

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Vaccines

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By 

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

More from Pink Sheet

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.