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Monday, August 3, 2026

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Policy

Policy•Endpoints News•Aug 2, 2026

AstraZeneca, Bristol Myers in talks about merger — report

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  • •Potential merger between AstraZeneca and Bristol Myers Squibb would be one of the largest pharma M&A transactions ever
  • •Combined entity would possess substantial scale across oncology, immunology, and cardiovascular therapeutic areas
  • •Regulatory and antitrust review timelines, final deal terms, and integration strategy remain to be determined
AstraZenecaBristol Myers Squibb
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Policy•STAT News•Aug 3, 2026

Opinion: I’m a neurologist. I’ve delivered ALS diagnoses. Then I received one myself

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  • •ALS diagnosis is frequently delayed even in well-resourced, well-insured populations due to unfamiliarity with early signs and physician discomfort with the diagnosis, extending decision uncertainty for patients
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Policy•STAT News•Aug 3, 2026

Opinion: We lead the Federation of State Medical Boards. Here’s what we think about licensing AI to practice medicine

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  • •FSMB explicitly rejects independent AI licensing, positioning AI as a regulated tool under physician accountability rather than as a separate practitioner—a stance that will shape emerging state-level AI regulation
  • •Failed 2024 legislation in Idaho and Iowa reveals imminent policy risk: multiple states are actively considering separate AI licensing frameworks outside traditional medical boards, creating regulatory fragmentation risk
  • •Watch for: state-level AI licensing proposals in 2025, interplay between FSMB guidance and actual state legislation, and how medical boards operationalize physician accountability for AI-related harms
Federation of State Medical Boards
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Policy•KFF•Jul 31, 2026

Five Key Facts About People Experiencing Homelessness

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    Policy•Fierce Biotech•Jul 31, 2026

    Chutes & Ladders—Legend CEO departs without successor in place

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    • •Legend Biotech CEO departure creates near-term leadership uncertainty, though the company emphasized no operational or financial disagreements precipitated the move
    Legend BiotechSarepta TherapeuticsNasus PharmaCarvyktiTSRA-196Rinvoq
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    Market Access

    Market Access•Endpoints News•Aug 1, 2026

    Alnylam's slump deepens; Q2 earnings roundup; and more

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    • •Alnylam's financial performance deteriorated in Q2, indicating potential commercial headwinds or pipeline challenges
    Alnylam
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    Market Access•Fierce Biotech•Jul 31, 2026

    From Abu Dhabi to Brazil, every region is vying for the ‘new emerging economy’ of biotech

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    • •Abu Dhabi's HELM cluster and 5-million-specimen biobank, coupled with its rare disease prevalence due to consanguinity, position it as a differentiated hub for gene therapy development and diverse clinical trial recruitment.
    • •Both Abu Dhabi and Brazil are exploiting population diversity and underrepresented ethnic groups in Western trials to address a persistent biotech bottleneck: assembling clinically representative trial cohorts.
    Vesper Biotechnologies
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    Market Access•Endpoints News•Jul 31, 2026

    AbbVie touts strong momentum for Skyrizi despite rising competition

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    • •AbbVie reports continued strong performance for Skyrizi amid growing competitive threats in immunology
    AbbVieSkyrizi
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    Market Access•Fierce Biotech•Jul 30, 2026

    Boston Scientific cuts guidance again after unveiling restructuring plan

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    • •Boston Scientific faces sustained competitive headwinds in core franchises (electrophysiology vs. Abbott/J&J, Watchman slowdown) that management expects to persist through 2027, suggesting market share pressure rather than temporary disruption
    • •Two consecutive quarterly guidance cuts signal deteriorating visibility and forecasting confidence, raising questions about management's strategic positioning in high-growth medtech segments
    • •Monitor 2028 guidance revisions and restructuring execution metrics, particularly whether the $500M cost savings and reinvestment strategy successfully arrest competitive losses or merely manage decline
    Boston ScientificAbbottJohnson & JohnsonWatchman
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    Market Access•KFF•Jul 28, 2026

    How Has ACA Marketplace Enrollment Changed Across States in 2026?

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    • •ACA Marketplace effectuated enrollment fell 12% year-over-year (2.6 million people) in 2026 when enhanced federal premium tax credits expired, reversing seven consecutive years of growth and marking the largest single-year decline since the Marketplaces opened.
    • •Average net premium payments surged 58% for 2026 enrollees without enhanced credits, with cost cited by 80% of enrollees who changed or dropped coverage and 17% of continuing enrollees worried about affording premiums year-round.
    • •State-level variation in enrollment trends demonstrates the critical role of subsidies: New Mexico's 14% enrollment growth through its replacement state subsidy program contrasts sharply with widespread declines elsewhere, signaling that coverage sustainability depends on continuous financial support mechanisms.
    → Read original article

    Clinical Trials

    Clinical Trials•STAT News•Aug 3, 2026

    Heart transplant candidates fail if they get too weak. New program tries inpatient prehab

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    • •56-62% of initially ineligible heart transplant candidates regained sufficient fitness to meet listing criteria through inpatient prehab, addressing frailty-based disqualification
    • •The program directly counters the well-documented phenomenon where one day of bed rest requires three days of recovery, preventing patient deconditioning during critical waiting periods
    • •Monitor for broader adoption across transplant centers and potential impact on overall transplant waitlist qualification rates and post-transplant outcomes
    Banner–University Medical Center Phoenix
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    Clinical Trials•Fierce Biotech•Jul 31, 2026

    Novo Nordisk left praying to Artemis and Hermes to salvage CKD program after phase 3 fail

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    • •Zeus trial missed primary endpoint with hazard ratio of 0.99 versus the clinically significant 0.85 (15% benefit) that analysts had modeled, eliminating a projected multibillion-dollar opportunity in inflammation-driven cardiovascular disease
    • •Novo's remaining hopes rest on Artemis and Hermes trials (data expected H1 2025), but BMO Capital Markets now views positive outcomes as unlikely following Zeus failure
    • •Analysts suggest Novo may accelerate M&A activity in cardiovascular, metabolic, or rare disease to offset pipeline disappointment and reduce investor focus on GLP-1 dependency
    Novo Nordiskziltivekimab
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    Clinical Trials•Endpoints News•Jul 31, 2026

    Moderna's norovirus vaccine readout is delayed because of too few infections

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    • •Moderna's norovirus vaccine efficacy readout delayed due to lower-than-expected infection rates in the trial population
    • •Additional trial cohort being enrolled to generate sufficient efficacy data, with results expected after the next norovirus season
    ModernaModerna norovirus vaccine
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    Clinical Trials•Endpoints News•Jul 31, 2026

    Novo Nordisk rocked by late-stage cardiovascular drug failure

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    • •Phase 3 failure of an anti-inflammatory cardiovascular agent challenges the inflammatory hypothesis as a therapeutic target in heart disease
    • •Significant setback for Novo Nordisk's cardiovascular pipeline with potential impact on R&D strategy and investor confidence in this mechanism class
    • •Clarification needed on whether failure was mechanism-related or compound-specific, and whether the program will be discontinued or redesigned
    Novo Nordisk
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    Clinical Trials•Endpoints News•Jul 31, 2026

    Ratio collects $70M for its radiopharmaceutical trials; Vogenx plans $67M IPO

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    • •Ratio Therapeutics secured $70M Series C to fund radiopharmaceutical clinical development, indicating continued investor confidence in this emerging modality
    • •Radiopharmaceutical sector continues attracting capital as a differentiated approach to targeted cancer therapy and molecular imaging
    Ratio TherapeuticsVogenxDuquesne Family Office
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