M. Nielsen Hobbs

1 week 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

2 weeks 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

4 weeks 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

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

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems? Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts. Could states and the courts continue pro-vaccine policies even if the federal governments turn away from them?

1 month ago | insights.citeline.com | Joseph Haas |M. Nielsen Hobbs

How Tumult At US FDA Could Impact Merger and Acquisition StrategyWith review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings. Delays at the FDA could preclude acquisitions by big pharma, but drive biotechs to merge. (Shutterstock/AI generated)