Wednesday, May 27, 2026
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Policy•Fierce Pharma•May 27, 2026
FDA delays ruling on AstraZeneca’s breast cancer drug after negative adcomm vote
background ▾
- •FDA advisory committee voted against camizestrant approval, triggering a regulatory delay rather than outright rejection
- •Company has submitted additional analyses post-adcomm for FDA reconsideration, indicating a pathway forward but not a guaranteed approval
- •Watch for FDA's final decision timeline and the nature of safety/efficacy concerns raised by the adcomm to assess viability of this competitive breast cancer asset
AstraZenecacamizestrant
→ Read original articlePolicy•Fierce Pharma•May 27, 2026
As calls for COINS Act expansion grow, will new rules sweep up China biotech licensing?
background ▾
- •COINS Act expansion to biotech would impose new outbound investment restrictions on cross-border drug licensing and biotech partnerships, fundamentally altering deal-making with Chinese entities
- •The policy debate reflects broader U.S. geopolitical concerns about China's biotech competitiveness and signals potential regulatory friction ahead for multinational pharma companies with China collaborations
- •Monitor Treasury Department guidance on COINS Act scope definition and how biotech licensing deals will be categorized—this will directly affect future partnership negotiations and M&A strategy
Policy•Fierce Pharma•May 27, 2026
After prior FDA manufacturing snub, Gilead's hepatitis D med Hepcludex nabs US nod
background ▾
- •Bulevirtide becomes the first FDA-approved therapy for chronic hepatitis D, addressing a previously untreated rare disease with significant unmet medical need.
- •Gilead successfully addressed FDA's prior manufacturing and delivery concerns, demonstrating regulatory persistence on a complex biologics program.
- •Rare disease approval creates both opportunity and uncertainty around market size, payer willingness-to-pay, and actual patient access in hepatitis D.
Gilead SciencesbulevirtideHepcludex
→ Read original articlePolicy•STAT News•May 27, 2026
Opinion: Sen. Dick Durbin: Trump is letting Big Tobacco target children
background ▾
- •FDA authorized flavored e-cigarettes from a major tobacco company and allowed thousands of unauthorized e-cigarette products to remain on market without legally required premarket review, reversing years of regulatory caution around youth-appealing flavors.
- •The regulatory shift followed FDA Commissioner Marty Makary's departure and occurred after pressure from President Trump, raising questions about politicization of tobacco regulation and potential industry access.
- •Watch for: Congressional action on pending bipartisan e-cigarette flavor legislation, FDA enforcement response to unlawfully marketed products, litigation challenging the authorization decisions, and pediatric vaping use trend data.
Policy•STAT News•May 27, 2026
Opinion: The patients demanding unvaccinated blood transfusions
background ▾
- •Some patients and families are requesting directed blood donations from unvaccinated donors due to Covid-19 vaccine misinformation, creating potential clinical delays in critical care situations
Market Access
Market Access•Fierce Biotech•May 26, 2026
Lilly inks deals to buy 3 vaccine developers for up to $3.8B as M&A spree continues
background ▾
- •Lilly is aggressively entering the vaccine market with $3.8B in acquisitions, signaling a major strategic shift toward prevention-based therapeutics and leveraging GLP-1 profitability to fund new pipelines
- •Curevo's amezosvatein shingles vaccine directly targets GSK's Shingrix market with a differentiator (improved tolerability), but phase 3 timeline has slipped and requires additional phase 2 enrollment in 2025
- •Watch for Curevo phase 3 initiation timing, competitive positioning against Shingrix in the shingles vaccine market, and clinical progress on bacterial S. aureus and EBV vaccine candidates under Lilly's development resources
Eli LillyCurevoLimmaTech BiologicsamezosvateinShingrix
→ Read original articleMarket Access•Fierce Biotech•May 26, 2026
Facing looming Xtandi patent cliff, Astellas pins hopes on more deals while still cutting costs
background ▾
- •Astellas expects Xtandi sales to peak at $13 billion in 2025 with material decline beginning post-2029, forcing the company to pursue a dual strategy of in-licensing moderately derisked assets and potential large-scale M&A to maintain revenue growth into the mid-2030s.
- •The company aims to generate $1.3 billion in cumulative cost savings through 2030 via organizational restructuring and SG&A reduction (targeting 800 billion yen in FY2026, down 7% year-over-year), with additional unspecified initiatives planned.
- •Astellas' internal pipeline is expected to contribute only $6 billion in combined potential revenue by mid-2030s, with setidegrasib (KRAS G12D protein degrader in phase 3 for pancreatic cancer and NSCLC) as the most advanced candidate—watch for phase 3 readouts and the company's actual BD announcements to assess credibility of revenue recovery targets.
AstellasPfizerXtandisetidegrasibASP2138
→ Read original articleMarket Access•Fierce Biotech•May 27, 2026
Kardigan itching for IPO to fund late-stage cardiovascular pipeline
background ▾
- •Kardigan is pursuing IPO to self-commercialize a cardiovascular pipeline with three assets in late-stage development, leveraging leadership experience from the successful MyoKardia acquisition by BMS for $13.1 billion
- •Danicamtiv (the lead asset and MyoKardia legacy program) is in phase 2b/3 for genetic dilated cardiomyopathy; tonlamarsen recently missed its primary blood pressure endpoint in phase 2, introducing execution risk
- •Watch for IPO completion timing and valuation, and upcoming phase 2b/3 readouts for danicamtiv and ataciguat, which will be critical catalysts for post-IPO stock performance
KardiganBristol Myers SquibbSanofidanicamtivataciguattonlamarsen
→ Read original articleMarket Access•Fierce Pharma•May 27, 2026
Radiopharmaceutical outfit Lantheus mulls potential $7B takeover by Curium: Bloomberg
background ▾
- •Curium pursuing ~$7B acquisition of Lantheus in radiopharmaceutical consolidation play, deal potentially imminent
- •Combined entity would create a dominant force in molecular imaging and therapeutic radiopharmaceuticals with expanded pipeline and market reach
- •Deal completion contingent on final negotiations, regulatory clearance, and shareholder approval
Lantheus HoldingsCurium
→ Read original articleMarket Access•Fierce Pharma•May 27, 2026
SK bioscience links up with Colombia to enable local production of varicella vaccine
background ▾
- •SK bioscience is establishing local manufacturing capability for SKYVaricella in Colombia through technology transfer, improving regional supply and market access
- •The deal signals SK bioscience's strategy to expand in emerging markets by enabling government partners to produce vaccines locally rather than relying solely on imports
SK bioscienceColombian governmentSKYVaricella
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•May 26, 2026
Kura posts Krazati combo data on drug designed to unleash KRAS inhibitors’ potential
background ▾
- •Darlifarnib + Krazati achieved 67% response rate in treatment-naive pancreatic ductal adenocarcinoma (4/6 patients) versus Krazati's 43% monotherapy ORR, suggesting a meaningful combination signal in a disease with high unmet need.
- •Response rates diverged sharply by prior KRAS inhibitor exposure and tumor type: 50% in NSCLC, 29% in inhibitor-naive colorectal cancer, and 0% in pretreated colorectal patients, indicating combination efficacy may be limited to frontline settings.
- •Watch for Phase 1b/2 enrollment and tumor-type-specific cohort expansion; Kura's decision to drop the 8 mg dose and the 37% on-treatment rate suggest tolerability was acceptable but efficacy durability and optimal dosing remain undefined.
Kura OncologyBristol Myers SquibbAmgendarlifarnibKrazatisotorasib
→ Read original articleClinical Trials•Endpoints News•May 26, 2026
Can AI do scientific research? Billions chase hopes of superintelligence
background ▾
- •Lila Sciences is applying AI models to mRNA candidate selection, reflecting industry-wide investment in computational drug discovery platforms
- •Significant capital flowing into AI-driven biotech research, but clinical validation and translation to successful therapeutics remain unproven
Lila Sciences
→ Read original articleClinical Trials•Endpoints News•May 26, 2026
Lilly reports new data on PCSK9 base editing gene therapy from Verve buyout
background ▾
- •Base editing gene therapy for PCSK9 inhibition shows positive Phase 1b results, validating Lilly's Verve acquisition strategy in a potentially transformative modality for genetic cardiovascular disease
- •Early safety and efficacy signals support progression to pivotal trials, though magnitude of LDL reduction and long-term durability data remain to be disclosed
- •Monitor for Phase 2b initiation timeline and competitive landscape from other PCSK9 gene therapies (Regeneron/Ultragenyx, Sangamo, others) currently in development
Eli LillyVerve TherapeuticsPCSK9 base editing gene therapy
→ Read original article