6: From Approval to Access

9: Hope on Hold: Congress Moves to Restore Pediatric Drug Incentives

The Rare Pediatric Disease Priority Review Voucher (PPRV) program has been one of the few market-based incentives pushing biotech companies to develop treatments for children with rare conditions. But when its authorization lapsed in late 2024, the future of dozens of pediatric research programs was suddenly thrown into question. In this episode of The Biotech Brief, we walk through what the PPRV program is, how it has helped incentivize pediatric drug development, and why Congress is now moving swiftly to bring it back. We explore what reauthorization would mean for patients, investors, and developers — and how the biotech ecosystem relies on policies like this to keep innovation flowing.

8: Funding Freeze- How NIH Cuts Are Shaking Biotech

NIH grant cuts have halted hundreds of clinical trials—and now the agency has released a notice confirming delays and gaps in SBIR and STTR funding. In this episode of The Biotech Brief, we connect the dots between shrinking federal support, a stalled biotech innovation pipeline, and the growing pressure on startups and academic researchers alike. What does this mean for drug development timelines, investor confidence, and patient trust? And can the private sector step in fast enough to fill the gap?

7: When Science Isn’t Enough: Sanofi Ends Phase III RSV Trial

Sanofi has officially ended its Phase III trial for a respiratory syncytial virus (RSV) vaccine targeting toddlers—citing futility as the reason for halting development. In this episode of The Biotech Brief, we unpack what happened and why it matters. From the biology of RSV and the unique challenges of vaccinating toddlers, to the competitive market landscape and strategic risks for pharma companies, we take you behind the headlines.   We explore how the program could’ve been salvaged through trial redesign, alternative regulatory strategies in lower-bar jurisdictions, or refined target populations—and why Sanofi may have opted out anyway. We also consider the wider implications for pediatric vaccine development, especially in an era of rising vaccine skepticism and shifting policy dynamics.   If you’re a biotech innovator, investor, or strategist, this episode offers insights into what it really takes to bring a pediatric vaccine to market—and what we can learn when a promising candidate falls short.

6: From Approval to Access

Gilead’s twice-yearly injectable PrEP, Yeztugo was recently approved by the FDA, but the story doesn’t end there. In this episode of The Biotech Brief, we explore how Gilead is leveraging global partnerships, generics, and regulatory streamlining to deliver Yeztugo to low- and middle-income countries without delay. Building on Episode 1, “Changing the Game in HIV Prevention,” this follow-up digs into what equitable access really takes and what drug developers can learn from it.

5: Street Pricing, Corporate Cartels, and the Generic Drug Price War

Southwest Airlines is taking generic drugmakers to court and accusing more than 20 companies of price fixing that inflated costs for millions of Americans, including its own employees. In this episode of The Biotech Brief, we unpack the lawsuit, the history of generic drug cartel behavior, and why drug developers (yes, even biotech innovators) should be paying close attention. This episode explores how drug pricing moves from boardroom strategy to national scandal.