Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast bringing you the latest insights shaping patient access, regulatory policy, and healthcare innovation. I'm your host, and let's get into today's headlines.
First up, a new annual drug shortages report from the US Pharmacopeia reveals that while the total count of active drug shortages fell 23% in 2025, discontinuations jumped 60% year-over-year — the largest single-year increase since 2019 — and median shortage duration climbed to 5 years, up from 4.3 years in 2024 and just 2 years in 2019. More than 64% of drugs currently in shortage have been in that status for over three years, with 29 products in shortage for more than five years. The report connects the discontinuation surge to unsustainable economics: two-thirds of discontinued oral solid dosage products were priced below $1 per unit, with median prices falling 78% in a single year, and more than a third of discontinued injectable drugs were priced below $15 per unit. Geographic concentration compounds the risk, with 44% of drugs in shortage relying on at least one key starting material manufactured in a single country. USP's executive vice president for global external affairs Anthony Lakavage said the findings point to a market that does not reward resilience and called on policymakers to realign incentives and advance structural reforms to the medicines supply chain.
In regulatory and market access news, a CBS News investigation has brought new urgency to an illegal marketplace growing around retatrutide, Eli Lilly's investigational obesity drug that remains unapproved, with regulatory submission not anticipated until late 2026 and a commercial launch unlikely before early 2028. The investigation identified more than 120 websites and over 50 US clinics actively selling or promoting the drug — many staffed by licensed physicians and nurse practitioners who argue that phase 3 trial results are strong enough to justify bypassing the regulatory timeline. The TRIUMPH-1 trial did report an average weight loss of 28.3% over 80 weeks at the 12 mg dose, with nearly half of participants losing 30% or more of their body weight — but the FDA has been explicit that retatrutide cannot be legally used in compounding because it is not a component of any approved drug. The safety stakes are already visible in real-world data: human exposures reported to US poison control centers surged 265% in the first four months of 2026 compared to the end of 2025.
In M&A news, two transactions announced this week signal that targeted protein degradation has crossed from emerging science into strategic priority for the industry's largest players. Johnson & Johnson announced a $1 billion cash acquisition of Firefly Bio, centered on its Firelink degrader antibody conjugate platform — designed to deliver a selective protein degrader directly to KRAS-driven tumor cells while sparing healthy tissue, targeting a cancer type where patients with advanced disease have historically faced survival measured in months. In a parallel deal, Roche and Nurix Therapeutics entered an exclusive licensing and collaboration agreement to co-develop bexobrutideg, an investigational oral BTK degrader engineered to eliminate the target protein entirely, removing both its kinase and scaffolding functions. Nurix will receive a $700 million upfront payment and is eligible for development, regulatory, and sales milestones totaling up to $2.3 billion, with Phase III initiation in chronic lymphocytic leukemia planned for summer 2026.
And finally, biopreservation company X-Therma has commercially launched its XT-NoVo and TimeSeal platform, an end-to-end cold chain system designed to extend the viable storage and transport window for cell-based therapies from the current industry standard of two to four hours under hypothermic conditions to up to five days — without freezing or the use of DMSO, a solvent conventional to cryopreservation that carries cytotoxicity concerns. The system uses proprietary peptoid antifreeze technology to prevent ice formation at −5°C, while the companion TimeSeal Smart Sensored Transporter provides real-time temperature tracking throughout transit with no external power required. The launch arrives as the cell and gene therapy cold chain logistics market is projected to reach $4.47 billion by 2031, with pressure building across the industry to build distribution infrastructure that is both temperature-controlled and commercially scalable — and represents a meaningful expansion of X-Therma's platform, which previously received FDA Breakthrough Device designation for its kidney preservation system.
That's it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access, visit pharmaceuticalcommerce.com. Thanks for listening — until next time, stay well and stay informed.
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