Friday, May 22, 2026
← Back to archivePolicy
Policy•Fierce Biotech•May 22, 2026
Chutes & Ladders—Former FDA leader takes new biotech Turn
background ▾
- •Stephen Hahn, former FDA commissioner, brings high-level regulatory expertise to Turn Therapeutics' topical eczema candidate GX-03 currently in phase 2, potentially strengthening its regulatory pathway
Turn TherapeuticsAmgenAntag TherapeuticsGX-03Mounjaro
→ Read original articlePolicy•STAT News•May 22, 2026
Opinion: The seed oil panic is hurting my cardiac patients
background ▾
- •This is an opinion/editorial piece with no direct pharma or biotech news content; it focuses on dietary science policy and RFK Jr.'s influence on food guidelines rather than drug approvals, trials, or market access.
Policy•Fierce Pharma•May 22, 2026
Amgen's Tavneos, facing liver injury scrutiny, gets label update in Japan as patient starts resume
background ▾
- •Tavneos faced a regulatory pause in Japan triggered by hepatotoxicity concerns, requiring label revision before resuming patient enrollment
- •The label update reflects a compromise between market access and safety—allowing continued use with enhanced monitoring rather than full market withdrawal
AmgenTavneosavacopan
→ Read original articlePolicy•Fierce Pharma•May 22, 2026
Lilly accuses church-linked pharmacies, wholesalers and more of running $200M+ rebate fraud scheme
background ▾
- •Eli Lilly claims losses exceeding $200 million from a coordinated rebate fraud involving church-linked entities and Trulicity, signaling potential systemic weaknesses in rebate verification and supply chain controls
- •The multi-entity network structure (mail-order pharmacies, wholesalers, patient services groups) suggests sophisticated scheme design to obscure fraudulent rebate claims across distribution channels
- •Watch for regulatory investigation outcomes, potential criminal referrals, civil litigation results, and whether this triggers broader industry audits of rebate claim verification processes and church/nonprofit pharmacy oversight
Eli LillyTrulicity
→ Read original articlePolicy•Fierce Pharma•May 22, 2026
Inside agency view: Ogilvy Health on AI’s ‘light speed,’ nano influencers and the rise of Ria
background ▾
- •AI is accelerating pharmaceutical marketing operations, though specific regulatory implications remain unclear
Ogilvy Health
→ Read original articleMarket Access
Market Access•Fierce Biotech•May 21, 2026
Struggling Liminatus pays $320M in stock for CAR-T biotech InnocsAI
background ▾
- •Liminatus is in financial distress (only $1.9M cash, Nasdaq delisting threat) and used stock acquisition at depressed valuation ($0.20/share) to access InnocsAI's CAR-T pipeline rather than conducting internal R&D
- •IBC101's dual-antigen CD19xCD22 approach mirrors successful J&J strategies but remains in early-stage development (Phase 1/2 initiation); downstream candidate INC101 with mesothelin/B7-H3 targeting is still preclinical
- •Monitor whether Liminatus can secure funding or partnerships to advance IBC101 through development; contingent value rights structure suggests InnocsAI shareholders retain upside, signaling investor skepticism about near-term value creation
Liminatus PharmaInnocsAIJohnson & JohnsonIBC101INC101IBA101
→ Read original articleMarket Access•Fierce Biotech•May 20, 2026
Medtronic inks $650M deal for SPR Therapeutics
background ▾
- •SPRINT's temporary percutaneous PNS approach fills a critical market gap, offering a minimally invasive intervention before permanent implantation—a key differentiator in Medtronic's neuromodulation portfolio alongside its Inceptiv closed-loop SCS system
- •Real-world data demonstrates strong clinical performance: 71% of 6,160 patients achieved ≥50% pain relief, with some sustaining relief 12 months post-treatment, supporting broader adoption in a post-opioid crisis healthcare environment
- •Watch for integration milestones with Medtronic's Neuromodulation unit and the competitive impact on other PNS manufacturers as expanded Medicare/commercial coverage and physician adoption accelerate in the mid-2020s
MedtronicSPR TherapeuticsSPRINT Peripheral Nerve Stimulation SystemInceptiv
→ Read original articleMarket Access•Fierce Biotech•May 21, 2026
Betting on biotech: Prediction markets set sights on clinical trials
background ▾
- •Prediction markets have expanded into biotech with contracts on specific clinical trial endpoints and FDA decisions, introducing novel financial instruments that isolate single events from broader stock movements.
- •Insider trading detection in prediction markets is significantly weaker than in traditional markets, with only ~15% of traditional insider trading uncovered by the SEC, raising compliance concerns given the CFTC's limited oversight capacity.
- •Monitor whether regulators (CFTC, SEC, FDA) issue guidance on biotech prediction markets and whether their use expands beyond paper trading to real-money wagering with potential to influence trial protocols or disclosure timing.
Compass PathwaysKalshiPolymarketCOMP360
→ Read original articleMarket Access•Fierce Pharma•May 22, 2026
Gilead pledges 400K AmBisome doses to fight visceral leishmaniasis in expanded WHO collab
background ▾
- •Gilead commits 400,000 AmBisome doses over five years to WHO-supported visceral leishmaniasis programs covering 74% of global disease burden
- •This expanded partnership demonstrates pharmaceutical commitment to neglected tropical disease access in lower-income countries with high disease prevalence
- •Unclear whether this contract includes preferential pricing, how it integrates with existing supply chains, and what happens post-2029
Gilead SciencesWorld Health OrganizationAmBisome
→ Read original articleMarket Access•Fierce Pharma•May 22, 2026
Roche narrowly edges out AstraZeneca for the top-rated oncology MSL team: survey
background ▾
- •Roche/Genentech's oncology MSL team ranked highest, suggesting strong competitive positioning in physician engagement and clinical education
RocheGenentechAstraZeneca
→ Read original articleClinical Trials
Clinical Trials•Fierce Pharma•May 22, 2026
With Voxzogo under pressure, BioMarin touts trial win in label expansion bid
background ▾
- •BioMarin's phase 3 trial for Voxzogo label expansion exceeded expectations, de-risking the regulatory pathway
- •Label expansion is critical to address commercial headwinds facing the company's top-selling product
- •Watch for full trial data disclosure and FDA submission timeline; competitive landscape and payer reimbursement decisions will determine commercial impact
BioMarin PharmaceuticalVoxzogovosoritide
→ Read original articleClinical Trials•Fierce Biotech•May 21, 2026
Lilly’s triple-G drug helps patients lose roughly a quarter of weight, showcasing competitive profile
background ▾
- •Retatrutide achieved 25-28.3% weight loss across dose tiers, establishing a competitive differentiation versus tirzepatide (20.9%) and Wegovy (18.7%), positioning it as a potential market leader if approved
- •Safety profile shows higher discontinuation rates at high dose (11.3% vs 4.9% placebo) and neurological adverse event dysesthesia in 12.5% of high-dose patients—critical tolerability data for commercial uptake
- •Full disclosure of osteoarthritis (WOMAC) and sleep apnea (AHI) secondary endpoint data at ADA June meeting will be decisive for regulatory positioning and real-world competitive advantage; FDA submission expected in 2024
Eli LillyNovo NordiskretatrutidetirzepatideZepbound
→ Read original articleClinical Trials•Fierce Biotech•May 21, 2026
ASCO: Merck, Kelun's sac-TMT ADC combo beats Keytruda by 65% on progression in first-line lung cancer
background ▾
- •Sac-TMT/Keytruda achieved 65% PFS improvement with highly significant p-value (<0.0001) and 70.2% ORR, exceeding analyst expectations of >65% ORR and ~14-month median PFS, establishing the first Phase 3 ADC-checkpoint inhibitor combo win in first-line NSCLC.
- •OS data remain immature but show preliminary 45% death risk reduction favoring the combination, with final PFS analysis expected in H2 2026 and regulatory decisions likely contingent on mature survival findings.
- •Watch for final OS readout in H2 2026 and comparative efficacy/safety data versus ivonescimab (Harmoni-2 showed only 22.3% immature OS benefit) and Daiichi Sankyo/AstraZeneca TROP2 ADC combinations; China regulatory approval pathway and potential U.S./EU filing timelines remain uncertain.
Merck & Co.Kelun-BiotechAkesosacituzumab tirumotecansac-TMTKeytruda
→ Read original articleClinical Trials•STAT News•May 21, 2026
Guarding biotech from China and big bets in longevity
background ▾
- •Retro Biosciences is preparing for its first clinical data readout
BridgeBioRetro Biosciences
→ Read original articleClinical Trials•Fierce Biotech•May 21, 2026
Infex, following in Insmed’s footsteps, advances lung disease candidate after clearing phase 2a
background ▾
- •Phase 2a met primary and secondary endpoints with encouraging efficacy signals (fewer exacerbations vs. 12-month baseline) and excellent safety profile; p-value marginally above significance threshold suggests borderline but potentially clinically meaningful benefit
- •Quarterly dosing regimen supported by 28.8-day half-life and lung epithelial penetration within 48 hours enables a practical treatment schedule for chronic lung disease
- •Watch for regulatory feedback on trial design requirements for phase 2b/3; competitive landscape with Insmed's Brinsupri will influence positioning and clinical development strategy
Infex TherapeuticsShionogiInsmedRESP-XINFEX702Brinsupri
→ Read original article