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2 days ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith |Mandy Jackson |Mary Jo Laffler
Post-BIO Podcast: Thoughts From The FrontlinesScrip and Pink Sheet journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry. Scrip and Pink Sheet editors discuss this year's BIO meeting. • Source: Shutterstock
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1 week ago | 
insights.citeline.com | Mandy Jackson |Joseph Haas |Sarah Karlin-Smith |Sarah Karlin-Smith
BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains ConstrainedUpdates From Day 4 Of BIO Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
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1 week ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith |Mandy Jackson |Alaric DeArment
BIO Notebook: MFN Pricing, Next-Gen Obesity R&D, FDA’s Rare Disease Hub & Reaction To Review ProgramUpdates From Day 3 Of BIOHighlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.
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1 week ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith |Mandy Jackson
BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.
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1 week ago | 
insights.citeline.com | Mandy Jackson |Sarah Karlin-Smith |Sarah Karlin-Smith
BIO Notebook: IPO Window Stays Shut, PRVs Need To Be A Priority, And Focusing On Gene Therapy SafetyUpdates From Day One Of BIOHighlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
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2 weeks ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith |Derrick Gingery
US FDA Could Miss User Fee Spending Triggers With House FY 2026 FundingFDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work. The House FY 2026 FDA appropriations bill could force non-user fee program cuts to ensure minimum spending levels are met, agency sources told the Pink Sheet. (Shutterstock)
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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
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3 weeks ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun. HHS Secretary Robert F. Kennedy Jr., CMS Administrator Mehmet Oz and NIH Director Jay Bhattacharya spoke at the FDA's 5 June cell and gene therapy panel. (Derrick Gingery)
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3 weeks ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER DirectorsThe remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions, a different approach than FDA Commissioner Martin Makary has suggested Prasad wants. New CBER Director Vinay Prasad said his role in product reviews will remain within the norms upheld by previous center directors. (Shutterstock)
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3 weeks ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products. The FDA has been able to help revive stuck rare disease programs as its thinking and experience with clinical trial designs evolved. (Shutterstock)
