Monday, September 28, 2026
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Policy•Fierce Biotech•Sep 25, 2026
Chutes & Ladders—Travere chief makes way for former Amicus CEO
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- •Bradley Campbell, who led Amicus through its $4.8B acquisition by BioMarin, is now taking over as CEO of Travere Therapeutics, which recently achieved FDA accelerated approval for Filspari in IgA nephropathy
Travere TherapeuticsAmicus TherapeuticsBioMarinFilspariPombilitiOpfolda
→ Read original articlePolicy•Endpoints News•Sep 26, 2026
AbbVie's next-gen dopamine therapy for Parkinson's gets FDA approval
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- •FDA approval of tavapadon marks a next-generation dopamine agonist with improved tolerability profile for Parkinson's disease
- •Improved side effect profile versus predecessors could drive market share gains in the dopamine agonist segment, which includes established competitors like Mirapex and Requip
- •Watch for: formulary placement and payer coverage decisions, Phase 4 safety/efficacy data, and market adoption rates relative to entrenched alternatives
AbbVietavapadon
→ Read original articlePolicy•STAT News•Sep 28, 2026
Opinion: AI is eroding the barriers that kept biological weapons rare
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- •This is opinion commentary, not reporting on pharmaceutical or biotech industry developments, regulatory decisions, or clinical outcomes
AnthropicOpenAI
→ Read original articlePolicy•STAT News•Sep 26, 2026
Opinion: I worked on the CDC investigation of the anthrax letters. 25 years later, are we ready for the next biothreat?
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- •The 2001 antthrax investigation revealed that existing pre-attack knowledge and guidance significantly underestimated risks of anthrax aerosolization and resuspension, particularly in postal processing facilities, resulting in deaths among workers not directly exposed to envelopes.
- •Evidence suggested the attacks may have involved testing different anthrax formulations (clumpy vs. fine powder) with varying transmissibility, raising concerns about sophisticated biological attack capabilities and the potential for larger planned releases.
- •Current public health preparedness frameworks may remain inadequate for modern biothreat scenarios, including synthetic pathogens, requiring reassessment of surveillance systems, decontamination protocols, and prophylaxis strategies.
Policy•KFF•Sep 25, 2026
Key Facts on Abortion in the United States
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Market Access
Market Access•Fierce Biotech•Sep 25, 2026
Pioneer of China NewCo model sued in US over trade secret misuse, double-dealing
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- •Su Zhang, architect of the high-profile China NewCo model (Hengrui-Hercules/Kailera deal worth billions), is accused of simultaneous undisclosed representation of competing firms while serving as Lepu's exclusive dealmaking consultant
- •The dispute highlights governance and conflict-of-interest risks embedded in the increasingly popular NewCo model, which has become a major dealmaking mechanism for accessing Chinese biotech assets in Western markets
- •Watch for outcome of federal court ruling on trade secret protections and implications for similar consulting arrangements in cross-border pharma partnerships; broader impact on NewCo model adoption pending
Lepu Medical TechnologyLepu BiopharmaBrightGene PharmaceuticalGLP-1 weight-loss candidatesobesity and metabolic disease candidatesType 2 diabetes candidates
→ Read original articleMarket Access•Endpoints News•Sep 26, 2026
The drug industry’s care gap; Novo aims to diversify; and more
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- •Novo Nordisk is pursuing diversification strategy beyond its core therapeutic areas
Novo Nordisk
→ Read original articleMarket Access•Fierce Biotech•Sep 25, 2026
Lundbeck to move US digs to Boston as it eyes bigger innovation frontiers
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- •Lundbeck is moving its U.S. headquarters to Boston to position itself within a premier biotech hub and gain access to academic, tech, and AI talent to support its 'neurospecialty' strategy
LundbeckOtsukaVyeptiRexulti
→ Read original articleMarket Access•Fierce Biotech•Sep 25, 2026
ADARx scores upsized $446M IPO, while fellow RNA biotech City maps out Nasdaq plans
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- •ADARx raised $446.3M gross ($513.2M including AbbVie placement and underwriter option), 27% above original guidance, signaling strong institutional investor confidence in internally-developed siRNA platform.
- •Five-asset pipeline with defined clinical milestones in 2027-2028 (agazisiran in multiple complement diseases, onvuzosiran in hereditary angioedema phase 3, ADX-626 for stroke prevention, plus two preclinical obesity and Alzheimer's programs) provides multiple near-term catalysts.
- •AbbVie's $100M placement and prior $335M option agreement suggest validation of ADARx's siRNA durability claims and long-acting profile, reducing genome-modification safety concerns versus competing RNA modalities; upcoming phase 2/3 readouts will be critical de-risking events.
ADARx PharmaceuticalsAbbVieCity TherapeuticsagazisiranonvuzosiranADX-626
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•Sep 28, 2026
Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal
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- •FDA rejected accelerated approval for I-DXd in ES-SCLC despite phase 2 showing 'promising' efficacy, signaling a higher evidence bar than anticipated by sponsors
- •This is the second approval setback for the Merck-Daiichi ADC deal in 18 months, undermining the strategic rationale of the $4B upfront investment
- •Phase 3 primary completion dates for I-DXd programs extend to 2028, materially delaying potential market entry and return on capital; competitive threat from Amgen's Imdelltra and GSK's B7-H3 ADC risvutatug rezetecan intensifies
Merck & Co.Daiichi SankyoAmgenifinatamab deruxtecan (I-DXd)patritumab deruxtecan (HER3-DXd)raludotatug deruxtecan (R-DXd)
→ Read original articleClinical Trials•STAT News•Sep 28, 2026
Opinion: I discovered a new structure in the heart — just by looking closely
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- •First randomized trial demonstrates transcatheter LASP elimination is feasible and associated with marked reduction in recurrent MRI-detected ischemic brain lesions versus medical therapy
- •LASP is present in ~33% of adult hearts but remained undiscovered until 2010; recent observational data suggest it may contribute to cryptogenic (unexplained) strokes due to blood stagnation and clot formation
- •Watch for larger confirmatory trials and regulatory pathway development for septal occluder devices targeting LASP indication; potential expansion of transcatheter intervention market in stroke prevention
Fuwai Hospital
→ Read original articleClinical Trials•Endpoints News•Sep 25, 2026
Legend's five-year data suggests Carvykti could be a cure; Addex, Indivior split
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- •Five-year Carvykti data suggest durable remissions and potential cure in multiple myeloma, providing rare long-term efficacy evidence in the CAR-T space.
- •Extended follow-up strengthens Legend/J&J's competitive differentiation in a crowded CAR-T market and supports arguments for premium pricing and broad reimbursement.
- •Watch for regulatory communications (label updates), payer coverage decisions, and head-to-head comparisons with Tecartus and other approved CAR-T agents in the same indication.
Legend BiotechJohnson & JohnsonAddexCarvykti
→ Read original articleClinical Trials•Endpoints News•Sep 25, 2026
Endpoints 11 2026 winner Azalea melds gene editing and CAR-T
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- •Azalea Therapeutics has developed a proprietary platform combining gene editing and CAR-T cell therapy, representing a meaningful technological convergence in two of pharma's most active modalities.
- •The Endpoints News 2026 award validates Azalea's approach as a differentiated strategy to address known CAR-T limitations such as tumor microenvironment suppression and antigen escape.
- •Watch for Azalea's clinical trial initiation, first-in-human data readouts, and potential partnership announcements that could accelerate development or validate the gene-editing/CAR-T combination approach.
Azalea Therapeutics
→ Read original article