Wednesday, May 13, 2026
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Policy•Fierce Pharma•May 13, 2026
FDA Commissioner Marty Makary to resign, capping turbulent tenure: report
background ▾
- •FDA leadership transition mid-term signals internal/external pressure and potential regulatory uncertainty during a period of active pharmaceutical development and approvals
- •Makary's departure may prompt reassessment of FDA policy directions and enforcement priorities depending on interim or permanent successor appointment
- •Industry should monitor successor appointment and any signaled policy shifts regarding approval timelines, real-world evidence standards, and enforcement priorities
Policy•Fierce Pharma•May 13, 2026
As public vaccine criticism quiets, RFK Jr. keeps safety inquiries running in background: NYT
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- •HHS leadership is conducting vaccine safety investigations privately while the administration publicly moderates vaccine criticism
- •This represents a potential divergence between public messaging and behind-the-scenes regulatory activity that could affect vaccine policy and pharmaceutical industry confidence
- •Monitor for any formal policy announcements, regulatory changes to vaccine safety protocols, or shifts in vaccine approval/monitoring processes under continued HHS leadership
Policy•Fierce Pharma•May 13, 2026
Eli Lilly pauses Indian obesity awareness campaign after regulatory notices: report
background ▾
- •Eli Lilly paused its obesity awareness campaign in India due to regulatory non-compliance with prescription medicine advertising rules
- •The incident underscores India's strict enforcement of pharma advertising regulations and the compliance complexity of disease awareness campaigns in emerging markets
Eli Lilly
→ Read original articlePolicy•Fierce Pharma•May 13, 2026
EU advances scheme to bolster manufacturing autonomy, avert drug shortages
background ▾
- •EU is implementing a comprehensive framework to boost domestic pharma manufacturing capacity and reduce reliance on external supply chains, driven by shortage prevention concerns.
- •The initiative signals a broader EU policy pivot toward pharmaceutical sovereignty and supply chain security, with potential implications for manufacturing site selection and investment priorities across the industry.
- •Monitor for: specific regulatory requirements, manufacturing incentives (tax breaks, subsidies, expedited approvals), timeline for framework implementation, and how this integrates with existing EU pharmaceutical regulations and trade agreements.
Policy•STAT News•May 13, 2026
Opinion: RFK Jr.’s antidepressant deprescribing push gets one thing right — and others dangerously wrong
background ▾
- •Deprescribing antidepressants is clinically legitimate but severely understudied and under-resourced—pharmaceutical trials have focused on efficacy, not discontinuation safety, creating a genuine evidence gap that policy should address responsibly
- •The 2025 ASCP consensus identified 44 of 50 evidence-based deprescribing statements, confirming that patients with ≥3 lifetime depression episodes should remain on medication indefinitely, requiring individualized clinical judgment rather than broad population mandates
- •A 2025 JAMA Psychiatry study found psychotherapy gains concentrated among younger, wealthy, urban, college-educated adults with private insurance—redirecting patients away from medication without expanding therapy access will worsen disparities and risks relapse in vulnerable populations
fluoxetineProzacbupropion
→ Read original articleMarket Access
Market Access•Fierce Biotech•May 13, 2026
AstraZeneca pens agentic AI licensing deal with Owkin
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- •AstraZeneca is integrating Owkin's agentic AI platform into its IT infrastructure and decision workflows to automate competitive intelligence, trial planning, and research analysis—part of a broader pharma trend toward autonomous AI agents
- •The deal leverages multimodal patient data from 800+ hospitals and builds on prior AZ-Owkin collaboration on germline BRCA mutation screening, signaling commitment to operationalizing AI across multiple therapeutic areas
- •Watch for evidence of development timeline acceleration or clinical trial efficiency gains, as well as potential expansion of the partnership scope or similar multi-year AI licensing deals across Big Pharma
AstraZenecaOwkin
→ Read original articleMarket Access•Fierce Pharma•May 13, 2026
Pfizer, Arvinas win $85M upfront in Rigel licensing pact for new breast cancer med Veppanu
background ▾
- •Pfizer commits $85M upfront plus up to $320M in milestones for Veppanu breast cancer rights, with evenly split royalties between Arvinas and Pfizer
- •The deal structure indicates market confidence in Veppanu but raises questions about peak sales expectations and competitive positioning in breast cancer treatment
PfizerArvinasRigelVeppanu
→ Read original articleMarket Access•Fierce Pharma•May 13, 2026
BioMarin consolidates staff at Amicus HQ after closing $4.8B deal for rare disease peer
background ▾
- •BioMarin's $4.8B acquisition of Amicus Therapeutics has closed and integration planning is actively underway with headquarters consolidation in New Jersey
- •Workforce consolidation suggests BioMarin is pursuing near-term cost synergy realization and operational efficiency gains from the deal
- •Monitor for further announcements on portfolio rationalization, pipeline prioritization, and total cost savings targets from the combined entity
BioMarin PharmaceuticalAmicus Therapeutics
→ Read original articleMarket Access•Fierce Pharma•May 13, 2026
Bayer's Eylea declines by 24%, bearing the brunt of biosmilar competition
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- •Eylea's 24% Q1 sales drop signals that biosimilar penetration has reached a critical tipping point after the franchise previously showed greater resilience to competitive pressure
- •The steepness of the decline suggests multiple biosimilars are now gaining meaningful market share simultaneously, reshaping the competitive dynamics in wet AMD and diabetic retinopathy treatment
- •Monitor Bayer's upcoming guidance revisions, pipeline alternatives (including newer anti-VEGF candidates), and biosimilar adoption rates across major markets to assess long-term franchise recovery potential
BayerEyleaaflibercept
→ Read original articleMarket Access•Fierce Pharma•May 13, 2026
Bicara Therapeutics hires Replimune, Sanofi alum as chief commercial officer
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- •Bicara is preparing commercial infrastructure for a potential accelerated cancer drug approval in 2025
Bicara TherapeuticsReplimuneSanofi
→ Read original articleClinical Trials
Clinical Trials•Fierce Pharma•May 13, 2026
Alkermes’ Lumryz hits phase 3 mark in another sleep disorder, fueling momentum from $2.4B Avadel acquisition
background ▾
- •Lumryz phase 3 study achieved all primary and key secondary endpoints in a rare sleep disorder, validating the strategic rationale for Alkermes' substantial acquisition investment
- •The positive readout indicates rapid clinical momentum and suggests potential for label expansion and revenue diversification from an already-marketed asset
- •Monitor for regulatory submissions, competitive sodium oxybate landscape developments, and pipeline plans for additional sleep disorder indications to assess full value realization from the Avadel deal
AlkermesAvadelLumryzsodium oxybate
→ Read original articleClinical Trials•Fierce Biotech•May 12, 2026
AstraZeneca’s $800M bet undermined by immunogenicity in phase 3
background ▾
- •Eneboparatide's 31.1% response rate substantially trails Yorvipath's 68.9-79%, with immunogenicity confirmed as a major driver of lost efficacy over treatment duration
- •AstraZeneca's $800M acquisition of Amolyt Pharma is now at risk; the efficacy gap may be difficult to overcome in regulatory review or payer negotiations versus an already-approved comparator
- •Watch for: regulatory feedback on immunogenicity mitigation strategies, whether AstraZeneca pursues label restrictions/patient selection, and competitive implications for other PTH-1 agonist programs (MBX Biosciences)
AstraZenecaAscendis PharmaMBX BioscienceseneboparatideYorvipath
→ Read original articleClinical Trials•Fierce Biotech•May 12, 2026
Kyverna begins rolling submission for autoimmune CAR-T as FDA requests more natural history analysis
background ▾
- •FDA agreed that single-arm KYSA-8 data is sufficient for BLA support, resolving a major regulatory risk that has shadowed cell/gene therapy approvals since the uniQure Huntington's pushback
- •KYSA-8 showed 46% median improvement on timed 25-foot walk at 16 weeks in 26 SPS patients versus no/minimal improvement in natural history cohort over 10 years, providing compelling comparative context
- •Monitor Q4 2026 BLA completion and H2 2026 one-year KYSA-8 follow-up data release for potential accelerated approval timeline and label implications for durability
Kyverna TherapeuticsOmerosAbbViemiv-celmivocabtagene autoleucel
→ Read original articleClinical Trials•Fierce Biotech•May 13, 2026
Takeda 0 for 4 against nausea and vomiting after axing another asset
background ▾
- •Takeda has now terminated four consecutive nausea and vomiting programs (TAK-951, TAK-105, TAK-510, TAK-906, and now TAK-004) between 2022 and early 2025, indicating systematic failure in this franchise
- •TAK-004 was re-entered into human testing in late 2024 but faced immediate discontinuation post-phase 1, suggesting early-stage safety, tolerability, or immunogenicity signals warranted halting development
- •Takeda's explicit pivot away from nausea and vomiting represents a strategic retreat from a therapeutic area; investors should monitor whether the company signals re-entry or confirms permanent exit from this indication
TakedaTAK-004TAK-951TAK-105
→ Read original articleClinical Trials•Endpoints News•May 12, 2026
Alkermes' narcolepsy Phase 3 success; Boehringer's antibody deal
background ▾
- •Alkermes' narcolepsy drug Lumryz met primary endpoints in Phase 3, de-risking the regulatory pathway toward approval
- •Positive Phase 3 data strengthens Alkermes' CNS franchise and enhances the company's commercial prospects in the narcolepsy market
- •Monitor for FDA submission timing and potential competitive positioning against existing narcolepsy therapies
AlkermesBoehringer IngelheimVistagentherLumryz
→ Read original article