Monday, May 11, 2026
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Policy•STAT News•May 9, 2026
Opinion: RFK Jr. allegedly ‘collected’ a dead raccoon’s penis. Was it bioethically justifiable?
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- •This is an opinion piece about RFK Jr.'s personal conduct and bioethical standards for wildlife specimen collection, not pharmaceutical or biotech industry news
Policy•Fierce Pharma•May 11, 2026
Targeted Protein Degradation and Novel Modalities: Getting on the Frontline
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- •Targeted protein degradation is presented as an enabling technology for tackling difficult-to-drug targets and expanding the druggable genome
Policy•Fierce Pharma•May 11, 2026
How many of these 7 ADC handling considerations are on your radar?
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- •ADC manufacturing requires multifaceted handling controls across safety, stability, and logistics—suggesting this is routine industry guidance rather than a novel regulatory mandate
Policy•Fierce Pharma•May 11, 2026
Trump plans to fire FDA chief Marty Makary: report
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- •FDA Commissioner Marty Makary faces imminent removal, signaling potential major changes to the agency's regulatory stance and leadership philosophy
- •Makary's departure could accelerate deregulatory initiatives and alter FDA approval pathways, given his public advocacy for reducing regulatory burden
- •Watch for: announcement of Makary's successor, shifts in FDA enforcement and approval priorities, and industry response to potential regulatory recalibration
Policy•Fierce Pharma•May 11, 2026
Capricor Therapeutics files breach-of-contract lawsuit against US partner NS Pharma
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- •Capricor's lead DMD asset deramiocel faces an imminent FDA decision while the company pursues litigation against its designated U.S. commercial partner, creating uncertainty around post-approval commercialization.
- •Partnership dissolution or unfavorable judgment could force Capricor to pursue alternative commercialization strategies or secure new distribution partners on an expedited timeline.
- •Monitor FDA deramiocel decision timeline and litigation outcome; assess whether settlement is reached or whether Capricor must identify replacement commercial partner.
Capricor TherapeuticsNS PharmaNippon Shinyakuderamiocel
→ Read original articleMarket Access
Market Access•Fierce Pharma•May 11, 2026
Gilead cranks up Yeztugo first-year sales forecast to $1B on 'unprecedented launch trajectory'
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- •Yeztugo first-year sales guidance increased 25% to $1B, signaling exceptionally strong market penetration for an injectable PrEP in its launch year
- •The rapid uptake suggests physicians and patients are rapidly adopting the twice-yearly injection regimen over daily oral alternatives, validating the convenience-based differentiation strategy
Gilead SciencesYeztugo (lenacapavir)
→ Read original articleMarket Access•Fierce Pharma•May 11, 2026
As new tech, AI sweeps the marketing world, Eversana Intouch’s new CEO is ‘comfortable in the gray’
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- •Eversana Intouch appointed seasoned advertising executive Mike Guarino as CEO, emphasizing leadership experience in technology-driven marketing transformation
EversanaEversana Intouch
→ Read original articleMarket Access•Fierce Pharma•May 11, 2026
Daiichi Sankyo takes $610M profit hit linked to ADC manufacturing overbuild
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- •Daiichi Sankyo faces a $610 million non-cash charge due to over-investment in ADC manufacturing capacity, indicating significant demand forecasting error or slower-than-expected market uptake
- •The charge underscores growing manufacturing complexity and capital intensity in the ADC segment, where multiple competitors are scaling similar platforms
- •Investors should monitor Daiichi Sankyo's near-term ADC clinical and commercial readouts to assess whether the manufacturing overbuild was premature or reflects deeper market headwinds
Daiichi Sankyo
→ Read original articleMarket Access•Fierce Biotech•May 10, 2026
Quantum firm hailed by Amgen tech leader as an ‘extraordinary platform’ plans IPO
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- •Quantinuum's IPO and Amgen's strategic investment/partnership validate pharmaceutical industry interest in quantum computing for drug discovery, though commercial value timelines remain uncertain
- •Multiple Big Pharma companies (Amgen, Boehringer Ingelheim, Pfizer, Merck KGaA) have initiated quantum computing collaborations, suggesting this is becoming a standard exploratory technology bet rather than a differentiated advantage
QuantinuumAmgenHoneywell
→ Read original articleMarket Access•Fierce Biotech•May 9, 2026
New Hepta blood test could predict GLP-1 response
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- •Hepta's blood-based biomarker test identified pre-treatment epigenetic signals that predict GLP-1 response with potential to enable personalized prescribing and reduce treatment failure rates in weight loss and metabolic disease indications.
- •The company is actively engaging drugmakers in metabolic disease space and planning additional studies to validate the test across other medication classes, signaling near-term commercial validation pathway.
- •Watch for: prospective clinical validation studies, payer coverage decisions, and partnerships with major GLP-1 manufacturers (Novo Nordisk, Eli Lilly, Viking) that could accelerate market adoption and reimbursement.
HeptaNovo NordiskIlluminasemaglutideOzempicWegovy
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•May 11, 2026
MRD as a Decision Engine: Rethinking Oncology Trial Design from Early Phase to Registration
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- •MRD is transitioning from a prognostic biomarker to an active intervention trigger in solid tumor development, fundamentally changing how sponsors design protocols and make real-time treatment escalation/de-escalation decisions.
- •Regulatory validation of MRD as a surrogate endpoint is cancer-specific and not automatic; solid tumor developers must build rigorous, prespecified statistical plans with clear thresholds and confirmation rules to position MRD credibly with regulators.
- •Watch for how sponsor protocols incorporate MRD into adaptive designs in breast, colorectal, and head and neck cancer programs; early execution failures at the site and data interpretation level will determine whether MRD becomes a reliable decision engine or a source of variability.
Syneos Health
→ Read original articleClinical Trials•STAT News•May 11, 2026
Animal skin disease confirmed in clusters of European men who have sex with men
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- •Dermatophilosis clusters detected across France, Spain, and Germany in MSM networks with confirmed human-to-human transmission and high genomic relatedness between isolates, suggesting a novel epidemiological pattern for a typically zoonotic pathogen
- •All cases to date present as mild cutaneous infections responsive to standard antibiotics, with no severe disease reported, contrasting with mpox emergence in similar populations
- •Critical gaps remain regarding transmission from asymptomatic carriers and cross-border spread—the Lyon cohort expanded from 9 to 25 cases post-publication, warranting continued surveillance and comparative genomic analysis between European clusters
Clinical Trials•Fierce Biotech•May 8, 2026
Analysts cut enGene cancer sales forecast after updated data widen gap to J&J
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- •Phase 2 efficacy gap is now seen as insurmountable: 43% six-month complete response rate vs. ~60% for competitors, fundamentally reshaping the commercial outlook
- •Analyst conviction on approvability remains relatively high (60%) but commercial viability severely undermined, suggesting potential label claim but constrained market opportunity
- •Peak sales forecast cut 65% to $350M and market penetration halved in both settings, indicating the asset may survive regulatory review but face steep competition and limited uptake
enGene TherapeuticsJohnson & JohnsonCG Oncologydetalimogene voraplasmidInlexzocretostimogene grenadenorepvec
→ Read original articleClinical Trials•Fierce Biotech•May 8, 2026
A protective gene sent to the liver cleared amyloid from mouse brains, sparking hope for an Alzheimer’s gene therapy
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- •APOE3 Christch807 gene therapy delivered to liver (not brain) cleared amyloid plaques and improved cognition in APOE4 transgenic mice—a surprising finding suggesting peripheral amyloid clearance can drive brain pathology reduction
- •The approach is mechanistically distinct from prior APOE-targeting strategies and offers practical advantages (liver is standard gene therapy target) over blood-brain barrier penetration challenges
- •Key uncertainties: mechanism requires clarification (why APOE3Ch is superior to other APOE isoforms), preclinical primate studies are next gate, and clinical translation timeline remains unclear
Army Medical UniversityAPOE3 Christchurch
→ Read original article