AGP Executive Report

AI in Prescribing: Utah’s AI prescribing pilot (Doctronic) is showing early traction—AI recommended renewals in 72% of cases, and physicians agreed 91% of the time, with escalations usually triggered by missing labs or complications. Duchenne Drug Push: Dyne submitted a biologics license application to the FDA for z-rostudirsen (exon 51 skipping), aiming for accelerated approval; Priority Review is being sought with a potential 2027 U.S. launch. FDA Animal-Drug Funding: The FDA is accepting FY2027 grant applications for its MUMS program to support development of animal drugs for uncommon diseases. Hospital Care Continuity: Massachusetts DOC rolled out tablets for clinicians to access real-time inmate medical and mental health records, responding to recommendations after suicide deaths. Cardio Tech Update: PROACTIVE-HF 2-year data says the Cordella pulmonary artery sensor improved heart-failure status across ejection-fraction groups. Oncology Diagnostics: FDA approved FoundationOne CDx for tepotinib in MET exon 14 skipping NSCLC. Weight-Loss Generics: Brazil’s Anvisa approved EMS’s semaglutide pen (Ozivy) after Ozempic patent expiry, pending pricing and SUS inclusion steps.

Workforce & Benefits Overhaul: England is piloting a new approach to “fit notes,” aiming to cut the dead-end tick-box sick note system and route some patients to community support so they can stay in work or return sooner. AI in Biopharma: Celltrion says it’s rolling out an AI transformation across R&D, manufacturing, and corporate operations to speed decisions and improve production efficiency. Biomanufacturing Push: Kazakhstan approved a $71M full-cycle biopharmaceutical plant in Almaty, targeting cancer, rare disease, and immunobiological products by the early 2030s. Oncology Pipeline Spotlight: Akeso is bringing more than 40 oncology studies to ASCO 2026, including HARMONi-6 overall survival data for ivonescimab plus chemo in first-line sq-NSCLC. Public Health Watch: Bangladesh’s measles outbreak has reached 545 deaths, with warnings that Eid travel could worsen spread. Climate & Care: A WHO-led push is now tracking product-level healthcare carbon footprints via the Lancet MedZero initiative.

Ebola Escalation: WHO says Congo’s Ebola response is falling behind as suspected deaths hit 220 and Uganda reports two more confirmed cases, pushing total confirmed to seven—while the U.S. tightens entry rules for travelers. Obesity Race: Eli Lilly’s retatrutide Phase 3 data show average weight loss up to 28.3% (and 45% of patients hit 30%+), intensifying pressure on GLP-1 rivals. Hepatitis Delta Breakthrough: Gilead wins FDA approval for Hepcludex (bulevirtide), the first U.S. treatment for chronic hepatitis D, after a prior rejection tied to manufacturing and supply issues. Clinical Safety Check: A large Singapore study finds no link between contaminated endoscopes and post-procedure bloodstream infections across 316,000+ procedures. Consumer Health Alert: Costco’s Kirkland Signature Women 50+ multivitamin is recalled in Canada over possible metal fragments. AI in Care: A new debate piece argues “artificial intelligence” is a misleading label, proposing “participatory intelligence” instead.

Obesity Drug Race: Eli Lilly escalated the fight for obesity care with late-stage TRIUMPH-1 data for retatrutide, showing up to 28.3% average weight loss at 80 weeks (and 45.3% of patients hitting at least 30% loss), tightening pressure on GLP-1 leaders. Regulatory Crackdown: South Africa’s Sahpra and Pharmacy Council seized unregistered injectable GLP-1 products tied to compounding claims, as demand for weight-loss drugs keeps outpacing oversight. Ebola Watch: A suspected Ebola patient in the Netherlands was cleared after negative blood tests, while DR Congo’s outbreak continues to expand. Workplace Safety: UK HSE guidance reiterates there’s no single maximum indoor temperature to stop work, but employers must keep conditions “reasonable” and include heat in risk assessments. Healthcare Business: KPJ Healthcare reported Q1 profit up 22% amid integration efforts, while Kazakhstan approved a major biopharma complex aimed at cutting medicine import dependence. Cancer Care: Real-world monarchE data suggest 75% persistence at 6 months for adjuvant abemaciclib, with discontinuation often driven by adverse events.

FDA Approvals: Langlara, the FDA’s third interchangeable biosimilar to Lantus (insulin glargine), has been approved—aimed at making long-acting insulin easier to substitute at the pharmacy level without re-contacting prescribers. Clinical Pipeline: In multiple system atrophy, Lundbeck’s amlenetug missed its phase 2 primary goal, though results hint at a possible slowing signal and support a phase 3 follow-up. Public Health Watch: Ebola remains a fast-moving threat in DR Congo and Uganda; India advises against non-essential travel, while Lagos says it has no suspected or confirmed cases and is ramping surveillance. Health Equity & Access: New reporting highlights how “AI as the front door” can leave millions of patients behind—especially people with disabilities who face barriers in digital care. EMS & Safety: Acadian Ambulance named medics of the year, spotlighting frontline training and patient care quality. Environment & Brain Development: A study links high neighborhood air pollution to slower brain and cognitive development in young teens.

Cross-Border Care Breakthrough: An Indian urologist in Wuhan remotely performed a robot-assisted bladder reconnection surgery on a patient in Hyderabad—reported as a 90-minute procedure using China-developed robotics and ultra-fast 5G, with teams coordinating via online record review and robotic arm path planning. Ebola Watch: India advised citizens to avoid non-essential travel to Congo, Uganda, and South Sudan as WHO flags the situation as a Public Health Emergency of International Concern, with WHO and Africa CDC urging tighter surveillance at points of entry. Policy & Access: A nonprofit coalition (CHAI) released Medicaid AI best-practice guides to help states avoid improper coverage loss as new Medicaid eligibility requirements roll out. Industry Moves: PacificSource will exit Montana’s insurance market by year-end, citing mounting industry pressures. Clinical Research: Real-world data from China suggests ofatumumab may reduce relapses in MOGAD more than off-label rituximab, with a favorable safety profile.

Trade & Supply Chains: Mexico and the EU finally signed a long-stalled free trade deal that broadens coverage beyond industrial goods to services, procurement, digital trade, investment and farm produce—explicitly aimed at reducing dependence on the US. Infectious Disease Watch: Ebola in eastern DR Congo keeps worsening: WHO reports 82 lab-confirmed cases and 7 deaths, alongside nearly 750 suspected cases and 177 suspected deaths, while three Red Cross volunteers died after likely exposure in a morgue—underscoring how hard early detection and containment remain. Health System Resilience: In the UK, the Royal College of Physicians is urging urgent NHS climate action as heatwaves loom, citing physician survey findings that many workplaces are unprepared. Regulatory Moves: The FDA accepted Bayer’s asundexian NDA for priority review in secondary stroke prevention after non-cardioembolic stroke/TIA. Oncology Pipeline: A phase 2 AML study reports strong remission rates for quizartinib plus omacetaxine in FLT3-ITD+ disease. Access & Coverage: Nepal’s Jumla shows declining health insurance renewals, with tens of thousands not renewing after free-renewal changes.

FDA Approvals: The FDA cleared AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) for adults with metastatic triple-negative breast cancer who can’t take PD-1/PD-L1 inhibitors, adding a new first-line option backed by Phase 3 survival and progression-free results. Infectious Disease Watch: In DR Congo, Ebola fears are rising as the outbreak reaches nearly 750 suspected cases and 177 deaths, with the WHO upgrading risk to “very high” and noting the Bundibugyo strain has no approved targeted tools. Policy & Access: HHS is launching AI-powered audit enforcement to flag persistent fraud, waste, and abuse across federal programs. Healthcare Delivery: Glasgow’s Queen Elizabeth University Hospital helipad hit 3,000+ emergency helicopter landings since 2015, underscoring the role of rapid transfers for critically ill patients. Industry Moves: Biogen completed its acquisition of Apellis, bringing SYFOVRE (pegcetacoplan) under a new complement-focused umbrella. Local Tensions: Oklahoma’s family-backed epilepsy bill was vetoed by Gov. Stitt, keeping coverage expansion for SUDEP-prevention therapies off the books.

Pharma R&D Rankings: Idea Pharma’s Global Innovation and Invention indexes put Eli Lilly at No. 1 on both lists, cementing its “innovation machine” status as pipeline spending and dealmaking (including a $202M Engage Biologics buy) keep momentum. Regulatory Wins: The FDA approved the first treatment for chronic hepatitis delta virus infection (bulevirtide-gmod), while it also cleared an expanded Guardant360 Liquid CDx liquid biopsy panel for broader molecular profiling. Oncology Advances: In breast cancer, dato-DXd won FDA approval for first-line metastatic TNBC patients ineligible for PD-1/PD-L1 therapy, and imlunestrant updated overall survival readouts from EMBER-3. Care Delivery & Devices: Medtronic is creating a European cardiac software hub in Galway, and subcutaneous isatuximab Q4W data highlight easier clinic workflows. Policy Shock: Tennessee’s FAIR Rx Act bars PBMs from owning pharmacies, with CVS already signaling a federal court fight. Public Health: NHS urged “call 111” for a bullseye Lyme rash as confirmed cases topped 1,000.

India Pharmacy Crackdown: India’s chemists and druggists shut down for a one-day token strike, citing illegal online medicine sales, prescription bypassing, and predatory deep discounts—AIOCD says 12 lakh chemists backed the move and now wants authorities to act. Infection Readiness: Sentara Princess Anne Hospital in Virginia is spotlighting its Level III isolation unit, built during the 2014 Ebola outbreak, stressing it’s ready even as no confirmed cases are reported locally. New Drug Signals: FDA priority review was granted for Bayer’s Kerendia (finerenone) for adults with type 1 diabetes plus CKD, while early trial readouts include promising HIV CAR-T phase 1/2a data and ASCO 2026 reports tying GLP-1 use to lower advanced cancer risk in real-world analyses. Obesity Competition: Reuters reports lower-cost oral GLP-1s from Novo and Lilly are pulling patients away from compounded versions. Policy & Access: ICMR replaced India’s fragmented ethics approvals for multicentre studies with a single ethics review to cut delays.

Medicare Coverage Shake-Up: Providence Health Plan says it will end most of its insurance business in 2027, pushing Individual/Family and Employer/Commercial members to find new coverage while Medicare Advantage talks continue. Cancer Screening Gap: New JAMA Internal Medicine data show only about 1 in 4 eligible U.S. adults are up to date on lung cancer screening—progress since 2022, but uneven and still leaving major groups behind. Regulatory Moves in Oncology Diagnostics: Guardant wins FDA approval for an expanded liquid biopsy that profiles 740+ genes, setting up pricing leverage as customers shift from its older test. Big Pharma Dealmaking: Gilead completes its $3.15B upfront acquisition of Tubulis, adding next-gen ADC assets. AI in Healthcare Operations: A survey finds hospitals are moving AI from pilots to production in revenue cycle, but many leaders worry about errors and skills readiness. Workforce Policy Fight: California and other states sue over new federal loan limits for nursing and allied health students, arguing it will worsen staffing shortages.

Medicare Pay Fight: Radiology groups are urging Congress to pass the Provider Reimbursement Stability Act of 2026 to cap Medicare physician pay cuts and stabilize the conversion factor. Leadership Shake-Up: The Trump administration named a temporary surgeon general—Stephanie Haridopolos, MD—while radiologist Nicole B. Saphier awaits confirmation hearings. Stroke Prevention Push: The FDA granted Priority Review to Bayer’s asundexian for secondary stroke prevention after noncardioembolic stroke/TIA. Ebola Escalation: WHO declared the 2026 Ebola outbreak a global health emergency as it spreads across the DRC and Uganda, with concerns about insufficient resources. Gut Repair Breakthrough: MIT researchers found the amino acid cysteine may help the intestine regenerate after injury, pointing to new recovery strategies after chemo/radiation. Rural Workforce Pressure: Rural surgeons warn burnout and isolation are worsening access gaps, even as transplant and care advances continue.

Capital Markets: AIM ImmunoTech secured about $2.4M via a registered direct stock offering at $0.325/share, paired with a concurrent private placement of Series I warrants (exercise price $0.325, subject to stockholder approval). Regulatory Watch (Urology): The FDA accepted ImmunityBio’s sBLA for nogapendekin alfa inbakicept + BCG in BCG-unresponsive papillary NMIBC, setting a PDUFA target date of Jan. 6, 2027. Diagnostics: Valar Labs’ Vesta Bladder Risk Stratify Dx won FDA Breakthrough Device status as an AI digital pathology prognostic tool using routine H&E slides. Clinical Practice (Oncology): A new analysis suggests ureteroscopy after nephroureterectomy raises bladder recurrence risk, especially in patients without hydronephrosis. Public Health: Nepal’s health ministry says hantavirus risk is very low and urges people not to spread rumors. Care Access & Workforce: Texas approved $103M in new cancer grants, while a coalition of states sued over Trump-era limits on student loans for nurses and other healthcare trainees.

Patient Access & Cost Pressure: A new study finds financial toxicity is linked to families not following imaging recommendations, with some delaying or skipping children’s scans due to cost—highlighting a care gap radiology rarely screens for. Public Health & Outbreaks: The Ebola situation is escalating again, with WHO warning about spread and a global public health emergency declared as cases rise in Central Africa. Regulatory & Pharma Business: The Trump administration is expanding TrumpRx to add 600+ generic drugs, plus price-comparison tools and pharmacy/home-delivery partnerships aimed at cash-paying patients. Clinical Updates: In COPD, mepolizumab added to inhaled triple therapy reduced exacerbations needing ER visits or hospitalization in eosinophilic patients. Biotech Pipeline: Design Therapeutics reported dose-dependent frataxin increases and clinical improvements after 4 weeks of IV DT-216P2 in Friedreich ataxia.

Gaza Health Collapse: Reports say Gaza’s imaging capacity has been badly crippled by the conflict, with up to 76% of equipment destroyed since 2023—MRI services gone and only a fraction of CT/X-ray/fluoroscopy still working, while staff struggle to get parts like MRI helium, forcing clinics to limit new patients and delay diagnoses. Direct-to-Patient Radiology: Braid Health is launching an online radiologist second-opinion service for $199 per read, aiming to cut scheduling and referral friction. New Tech for Transplants: NASA and UNOS are testing drone delivery for organs to reduce transport delays and improve outcomes. Stroke Prevention Push: FDA granted Priority Review to Bayer’s asundexian for secondary stroke prevention after non-cardioembolic stroke/TIA. AI Governance Pressure: Clinicians are increasingly using “shadow AI,” raising safety, privacy, and compliance risks as demand outpaces oversight. Biopharma Cost Pressure: The Supreme Court declined drug-price negotiation challenges, keeping Medicare discounts in place. Clinical Updates: A short methylprednisolone taper showed promise for reducing acute post-traumatic headache after mild TBI.

Taiwan–China Health Diplomacy Clash: Taiwan’s foreign minister arrived in Geneva for WHA-linked events, and China hit back—calling the trip “petty clowns”—as Taiwan’s MOFA argues Beijing has no right to represent it in global health forums. NHI Policy Shock in South Africa: South Africa’s Constitutional Court struck down Certificate of Need provisions tied to where doctors can work, dealing a blow to NHI’s control model. Transplant Drug Deal: SERB will pay €115M to acquire EU/UK/Switzerland and MENA rights to Idefirix (imlifidase) to help desensitize highly sensitized kidney transplant patients. Ebola Escalation Watch: WHO declared the DRC/ Uganda Ebola outbreak a global health emergency, prompting countries like Australia to consider tighter border screening if spread grows. Care Access & Capacity: Liberia’s dental training clinic story highlights workforce gaps; in Nepal, Bharatpur Hospital saw OPD load jump after weekend holiday changes. Pediatric Mental Health Trend: A Massachusetts claims study finds anxiety-related mental health visits in primary care rose sharply from 2014–2023.