M. Nielsen Hobbs

2 weeks ago | insights.citeline.com | Derrick Gingery |Francesca Bruce |Cathy Kelly |M. Nielsen Hobbs

Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug PricingPink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry. Would EU nations accept higher drug prices so the US could pay less? • Source: Citeline/Shutterstock

3 weeks ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget CutsPink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts. Could the FDA budget request offer clues on the agency's strategy for user fee reauthorization negotiations? • Source: Citeline/Shutterstock

4 weeks ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine AdvicePink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters. What will pharma CEOs tell FDA leadership during the private CEO forums? • Source: Citeline/Shutterstock

1 month ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: US FDA’s Big Vaccine Policy WeekPink 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. How will the new FDA COVID-19 vaccine development framework impact the Pfizer/BioNTech and Moderna products? • Source: Citeline/Shutterstock

1 month ago | insights.citeline.com | Derrick Gingery |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production SlowdownsPink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents. How will industry react to continued delays in guidance development and other user fee-funded services? • Source: Citeline/Shutterstock