Monday, May 18, 2026
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Policy•STAT News•May 18, 2026
Opinion: How to restore credibility to the CDC’s vaccine advisory committee
background ▾
- •Federal court invalidated HHS Secretary Kennedy's January 2025 reconstitution of ACIP and removal of six vaccines, restoring prior recommendations and signaling likely illegality of the administration's actions
- •ACIP's evidence-to-recommendation framework and traditional transparent deliberation processes were abandoned in favor of politically-driven decision-making that contradicted federal scientific experts and medical societies
- •The committee remains non-functional for new vaccine recommendations pending resolution of the legal challenge; stakeholders must act to restore institutional integrity and public confidence in vaccine advisory processes
Policy•Fierce Pharma•May 18, 2026
Roche's ctDNA-guided approach in post-surgical bladder cancer pays off with Tecentriq nod
background ▾
- •FDA approved Tecentriq label expansion for post-surgical bladder cancer using ctDNA-guided patient selection via Signatera companion diagnostic, representing a precision medicine approach to adjuvant immunotherapy.
- •This approval establishes Signatera as a clinically validated biomarker tool in bladder cancer management and strengthens Natera's companion diagnostic portfolio alongside Roche's therapeutic franchise.
- •Watch for payer coverage decisions, real-world implementation rates in urology practices, and potential competitive responses from other checkpoint inhibitors seeking similar MRD-guided indications in bladder and other solid tumors.
RocheNateraTecentriqatezolizumabSignatera
→ Read original articlePolicy•Fierce Pharma•May 18, 2026
After Makary departure, CDER chief Tracy Beth Høeg likely headed out at FDA: report
background ▾
- •Two senior FDA leaders departing in rapid succession creates uncertainty around drug review leadership and potential policy shifts at CDER, the division responsible for evaluating most pharmaceutical submissions
- •Leadership turnover at this level could affect review timelines, approval standards, and regulatory priorities for the industry
- •Watch for confirmation of Høeg's departure and identification of interim/permanent replacements; any signaling about changes to review standards or drug approval philosophy
Policy•Fierce Pharma•May 18, 2026
SCOTUS temporarily restores telehealth access to abortion pill mifepristone
background ▾
- •SCOTUS temporarily preserved telehealth and mail-order access to mifepristone, blocking the Fifth Circuit's more restrictive ruling that would have immediately eliminated remote prescribing
- •The underlying legal challenge to mifepristone's availability remains active; this emergency order does not resolve the case on the merits and access could still be restricted by future court decisions
- •Monitor SCOTUS's handling of the full case and any emergency motions—this issue will likely return to the Court and could result in either expanded protections or significant access restrictions
mifepristone
→ Read original articlePolicy•Fierce Pharma•May 18, 2026
Health execs persevere in new policy landscape
background ▾
- •Healthcare executives are finding strategic opportunities despite sustained U.S. policy uncertainty and international market volatility
Market Access
Market Access•Fierce Biotech•May 18, 2026
Ardent Health taps Fujifilm’s AI-enabled patient imaging platform
background ▾
- •Fujifilm's Synapse PACS secured deployment across a significant regional health system (30+ hospitals, 280+ sites), validating market demand for unified imaging and EHR integration
- •AI-enabled prioritization and remote mobile access position diagnostic imaging as a workflow efficiency tool, reflecting industry shift toward clinician-centric design
Fujifilm Healthcare Americas Corp.Ardent Health
→ Read original articleMarket Access•Fierce Pharma•May 18, 2026
Eisai's slow push toward blockbuster Leqembi sales gains steam with $900M forecast
background ▾
- •Leqembi sales doubled year-over-year with $900M forecast, demonstrating the early-stage amyloid antibody market is expanding beyond niche early-symptomatic AD population
- •The revenue trajectory suggests overcoming prior bottlenecks in diagnosis, patient selection, infusion center capacity, and payer reimbursement that constrained 2024 uptake
- •Monitor competitive dynamics as donanemab gains market share, potential label expansions to milder cognitive impairment, and whether Leqembi can sustain blockbuster status amid safety signal scrutiny (amyloid-related imaging abnormalities)
EisaiBiogenLeqembilecanemab
→ Read original articleMarket Access•Fierce Pharma•May 18, 2026
As biologics dominate biopharma pipelines, manufacturing hurdles trip up new launches: report
background ▾
- •Manufacturing complexity and capacity constraints are becoming a material bottleneck for biologic launches—a systemic industry problem rather than isolated to individual companies
- •Cell and gene therapies face particularly acute manufacturing hurdles due to process complexity and limited CDMO capacity
Market Access•Fierce Pharma•May 18, 2026
Doceree launches Daily Command, an AI platform for brand teams co-built by pharma leaders
background ▾
- •Doceree introduces Daily Command as a new AI-powered software category targeting pharmaceutical brand teams to streamline campaign management and deployment
Doceree
→ Read original articleMarket Access•Fierce Pharma•May 18, 2026
Fierce Pharma Asia—BMS-Hengrui's $15B deal; Takeda’s 4.5K layoffs; Daiichi’s oncology ambition
background ▾
- •BMS-Hengrui's $15.2B deal represents one of the largest pharma partnerships with a Chinese biotech, signaling major strategic shifts in China market access and innovation collaboration
- •Takeda's 4,500-person layoff (fiscal 2026 target) indicates cost-pressure across the industry and potential portfolio/pipeline rationalization
- •Daiichi Sankyo's oncology expansion beyond ADCs reflects competitive pressure in the oncology space and suggests potential M&A or licensing activity to achieve top-5 status
Bristol Myers SquibbHengrui PharmaceuticalsTakeda
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•May 18, 2026
Analysts ‘shaking heads’ after Regeneron melanoma drug fails to beat Keytruda in phase 3 trial
background ▾
- •Fianlimab + Libtayo missed statistical significance versus Keytruda monotherapy in first-line melanoma despite numerically superior median PFS, driven by late curve separation and marginal p-value
- •This is Regeneron's second major phase 3 pipeline failure in 12 months (following itepekimab's COPD trial failure), significantly damaging investor confidence and forcing major analysts to remove fianlimab from models entirely
- •Regeneron's near-term credibility now rests on Factor XI antibodies (pivotal data expected 2027) and cemdisiran-pozelimab combination readouts (geographic atrophy and PNH trials due in 2024); failure to deliver clean positives would compound the pipeline crisis
RegeneronMerck & Co.SanofifianlimabLibtayoKeytruda
→ Read original articleClinical Trials•Endpoints News•May 15, 2026
Aardvark's next move after clinical hold; Alumis' verdict on Acelyrin asset
background ▾
- •Aardvark is unblinding its rare disease trial after receiving a clinical hold from the FDA, indicating active engagement with regulators to resolve safety or efficacy concerns
- •Multiple companies have concurrent pipeline developments (Aardvark, Alumis, Tenaya, Taihо) suggesting broad industry activity in specialized therapeutics
Aardvark TherapeuticsAlumisTenaya TherapeuticsTN-401Inqovi
→ Read original articleClinical Trials•Fierce Biotech•May 18, 2026
Ipsen unveils data for Botox rival that drove long-acting anti-wrinkle jab into phase 3
background ▾
- •Corabotase demonstrated clinically meaningful superiority over Dysport at week 24 (60.8% vs 36.7%), suggesting potential for extended durability in the $7+ billion global botulinum toxin market
- •Phase 2 onset of action was rapid (0.84 days) with 66% achieving two-grade improvement by week 4, supporting patient satisfaction (83%) and commercial viability
- •Ipsen secured full ownership following January tribunal dismissal of Galderma's claim, positioning the company to capture full value; phase 3 advancement and two additional aesthetic indications under investigation represent near-term catalysts
IpsenAbbVieAllergancorabotaseIPN10200Botox
→ Read original articleClinical Trials•Fierce Biotech•May 18, 2026
Transforming neurodegenerative disease treatment
background ▾
- •Zervimesine demonstrates clinical efficacy in slowing AD progression and substantially reducing neuropsychiatric symptoms in DLB patients, with particularly strong effects on psychosis, delusions, and hallucinations
- •DLB remains significantly underdiagnosed and underfunded relative to Alzheimer's, creating both a clinical need and commercial opportunity for novel therapies in this indication
- •Watch for regulatory milestones including FDA guidance meetings, IND/NDA filings, and Phase 3 trial readout timelines for both AD and DLB indications
Cognition Therapeuticszervimesine
→ Read original articleClinical Trials•Fierce Biotech•May 18, 2026
Executing biomarker-driven oncology trials
background ▾
- •Biomarker-gated trials further narrow patient populations, driving high screen failure rates and increased site burden—a critical operational challenge for sponsors developing precision oncology drugs
Allucent
→ Read original article