AGP Executive Report

China–Pakistan Health Tech: China and Pakistan unveiled a Zhejiang-Pakistan joint lab for herbal medicine R&D, aiming to deepen traditional medicine cooperation. Regulatory Milestone: Pakistan secured observer status at ICH, a step meant to modernize DRAP and align standards with global regulators. HIV Prevention Breakthrough: South Africa officially launched the twice-yearly injectable HIV prevention rollout of lenacapavir, backed by major Global Fund and CIFF funding. Cancer & Drug Policy: A U.S. Supreme Court ruling backed Hikma in a “skinny label” patent dispute over generic Vascepa, while a Los Angeles jury sided with J&J in a talc ovarian cancer case. Public Health Watch: India reported suspected Ebola in Jaipur with tests pending, and Argentina expanded its hantavirus outbreak investigation after a cruise-linked cluster. Care Access & Systems: Santa Clara County leaders urged state funding to protect public hospitals from looming federal cuts. Diabetes Prevention Tech: An EHR-based machine learning model flagged adults at high type 2 diabetes risk up to 10 years ahead.

FDA & Biologics Access: The FDA approved ranibizumab-hkdz as an interchangeable biosimilar to Lucentis, available in both vials and prefilled syringes—an uptake boost for high-volume retina practices. Oncology Practice Changes: ASCO 2026 data added momentum for multiple cancers: camrelizumab plus rivoceranib with TACE improved progression-free survival in unresectable HCC; tarlatamab won EU authorization for extensive-stage small cell lung cancer; and SENOMAC showed axillary lymph node dissection can be omitted in select breast cancer without worse long-term survival, with fewer severe arm-function problems. Infectious Disease Preparedness: Infectious disease experts say hantavirus pandemic fears are low, but stress PPE and local/state readiness for rare outbreaks. Women’s Health Policy: The FDA has started a new safety review of mifepristone, focusing on telehealth and mail-order access amid abortion-pill restrictions debate. Digital Care & Pain: A new app connects acute pain patients to clinicians and routes treatment options, prescriptions, and prior authorization. Global Health: South Africa rolled out twice-yearly lenacapavir for HIV prevention, aiming to reach millions over the next three years.

Heart Care Breakthrough: Narayana Health used artificial heart pumps (VADs) to keep three critically ill teenagers alive until donor transplants, with all three now home after successful surgery. Community Health & Access: Brevard County’s Polly Helm is rallying support for a second heart transplant as her transplanted heart fails. MS Specialty Pharmacy: World MS Day coverage highlights how integrated specialty pharmacy support can improve diagnosis navigation, adherence, and long-term disease management. Neurology Drug Update: FENhance MS trials report strong efficacy and favorable safety for fenebrutinib, aiming to target both inflammation and progression. Research Funding Alarm: Radiologists warn a new federal grant rule could politicize research funding and add heavy compliance burdens. Public Health & Equity: US asthma care shows persistent racial and ethnic gaps in long-acting inhaler use, even as overall use declines. Maternal-Infant Screening: A German study finds umbilical cord blood glucose doesn’t reliably predict transitional neonatal hypoglycemia. Cancer Supply Risk: India faces a cisplatin/carboplatin shortage that could delay curative cancer treatment. Healthcare Tech & Safety: A new report flags rising healthcare data breaches driven by hacking, underscoring cybersecurity urgency. NHS Capacity Moves: Hospital@Home expands hospital-level care into patients’ homes to ease pressure and improve outcomes.

FDA Watch: Baxdrostat (Baxfendy) gets FDA approval as a first-in-class aldosterone synthase inhibitor for adults with uncontrolled hypertension despite other meds, adding a new upstream option for primary care. Regulatory Roundup: FDA also approved/expanded multiple primary-care relevant items, including Afrezza for children and adolescents with diabetes and a ready-to-use romidepsin generic for cutaneous T-cell lymphoma. Cancer Screening: The American Cancer Society updated colorectal screening guidance to include a blood test plus newer stool-based options, aiming to boost uptake among adults still unscreened. Transplant Access: HCV+ donor pancreases can shorten wait times for HCV- recipients without worse graft or survival outcomes, supporting broader use of these organs. Dermatology + Metabolism: A trial found ixekizumab plus tirzepatide helped more patients with psoriasis and obesity reach skin clearance and meaningful weight loss than ixekizumab alone. Oncology at ASCO: Real-world data and new tools highlighted shifting practice patterns, including an AI approach to scale prostate cancer guideline interpretation. Pharma Business & Policy: Lilly escalated its 340B claims-data enforcement, while coverage also spotlighted PBM rebate and revenue-cycle pitfalls. Tech in Drug Discovery: Alnylam and Inceptive launched a multi-year AI collaboration to speed RNA interference therapeutic discovery. Pet Safety: Veterinarians warn GLP-1 drugs are increasingly dangerous to pets if swallowed or chewed, urging secure storage.

Healthcare Finance & Growth: RadNet is seeking a $200M term loan to fund imaging expansion and acquisitions, adding to its 440 outpatient centers across 11 states. Medicare Policy: Penn’s Amol Navathe was named chair of the congressional Medicare Payment Advisory Commission, bringing a clinician-researcher view to Medicare payment debates. Physician Workforce & Pay: With a projected physician shortfall, practices are moving toward hybrid compensation models that blend base pay with productivity and quality incentives. Access & Operations: A new survey finds staffing shortages are increasingly limiting patient access, while health systems are turning to hybrid human-and-AI workflows to keep up. Hospital Pharmacy: A Bluesight survey flags drug shortages, staffing strain, and 340B pricing pressures as top hospital pharmacy concerns. Oncology Pipeline: ASCO updates include early signals for a dual-target ADC in mCRPC and multiple new trial readouts across cancers. Infectious Disease & Prevention: NYC malaria cases tied to migration show rising Plasmodium vivax proportions, and a claims-based study links pediatric flu vaccination to fewer influenza diagnoses. Digital Health & AI: Mayo Clinic and Microsoft are co-developing a “safe and trusted” healthcare AI model, and Elsevier is buying Wellsheet to better connect EHR data with clinical decision support. Drug Pricing & Policy: Public Citizen urges action on pharmaceutical patent abuse and monopoly-driven pricing tactics as lawmakers weigh reforms.

Community Eye Care Expansion: Primary Eyecare Services hit a major milestone, delivering more than one million patient assessments in 2025/26 across 800+ neighbourhoods in partnership with Integrated Care Boards, aiming to ease pressure on the wider NHS. Ebola Preparedness: Nepal’s Ministry of Health placed high alert for Ebola prevention and control, boosting surveillance at Tribhuvan International Airport and border areas and preparing testing and infection-control steps for health workers. Medicaid Work Requirements Pushback: The AAMC criticized CMS’s interim final rule on Medicaid work requirements, saying it narrows state flexibility on self-attestation and frailty exemptions, risking coverage losses and more uncompensated care. Urology Innovation: The FDA approved Coloplast’s Titan Prime inflatable penile prosthesis for severe erectile dysfunction, touting durability and improved pump activation. AI in Healthcare Operations: Healthcare Brew’s AI 411 roundup highlights new AI training and adoption efforts across health systems and life sciences, including CVS’s AI Learning Academy and other funding-backed tools. Pharma Supply Chain & Quality: SGS launched GMP-compliant NMR testing in China to strengthen identity, purity, and quality checks for drug development and manufacturing.

Medicaid Policy Shock: Advocates say the Trump administration’s Medicaid work requirements are getting tougher than expected, with “medical frailty” exemptions harder to qualify for—raising the risk of large, harmful coverage losses for sick and disabled people. Drug Pricing Fight: Eli Lilly says it will deny 340B discounts to providers that miss documentation requirements next week, while the AHA urges federal action as hospitals warn of added administrative burden and patient harm. Hospital Cost Blueprint: The AHA released a blueprint aimed at lowering healthcare costs and expanding access, targeting admin waste, and drug/device pricing and delivery reforms. AI Cybersecurity Push: A White House executive order directs agencies to harden cybersecurity for AI systems, create an AI cybersecurity clearinghouse, and prioritize enforcement against illegal AI-enabled hacking. Insurance Antitrust Lawsuit: Arizona AG Kris Mayes sued major insurers over alleged price-fixing of provider reimbursements using shared data and an algorithm via MultiPlan. CAR-T Access Logistics: Cencora and Kite agreed to expand US distribution for CAR T therapies, aiming to cut operational friction for community sites. Stroke Trial Update: JAMA reports IV tenecteplase before EVT didn’t improve outcomes for late-window proximal MCA occlusion. Acne OTC Expansion: FDA approved Differin Epiduo Acne Gel for over-the-counter use for ages 12+.

End-of-Life Directives: A case of conflicting documents—an old living will versus a newer handwritten plea—shows how, without a named healthcare proxy, families can end up in court to decide whether to withdraw life-sustaining ventilation. Surgical Quality in LMICs: The ACS is pushing practical surgical quality improvement support for resource-constrained settings via a new QI Basics course and webinar. Parkinson’s Care Advances: New clinician and patient discussions highlight managing “OFF time,” including on-demand apomorphine injections, extended-release amantadine, and continuous apomorphine pump therapy; ISSCR also launched a Parkinson stem-cell education program. MS Pregnancy Counseling: Updated registry-style findings suggest ocrelizumab exposure around conception may not raise major adverse pregnancy risks, informing counseling. Cancer Workforce Warning: A Lancet Oncology-commissioned report projects a massive global cancer workforce shortfall by 2050, especially in nursing and diagnostics. Counterfeit-Medicine Tracking: Governments approved track-and-trace and barcode systems aimed at stopping fake drugs. Retinal Treatment Access: Samsung Bioepis launched the aflibercept biosimilar Opuviz across Europe for multiple retinal diseases. Oncology Trial Signals: ASCO updates include steroid mouthwash not reducing oral mucositis in early breast cancer and multiple new phase 2/3 readouts across cancers.

FDA Approvals: FDA approved Xocova (ensitrelvir) as the first oral COVID-19 postexposure prophylaxis for adults and adolescents 12+ after contact, using a 5-day regimen and backed by a phase 3 household trial showing a 67% lower risk of symptomatic illness. Oncology Pipeline: Moderna and Merck shared 5-year follow-up data for intismeran autogene plus KEYTRUDA in high-risk resected melanoma, reporting major reductions in recurrence or distant metastasis risk versus KEYTRUDA alone, with exploratory overall survival signals. Healthcare Policy & Payments: The AHA urged CMS not to finalize several FY 2027 payment provisions for inpatient psychiatric, inpatient rehab, and skilled nursing facilities, and CMS issued an interim final rule requiring some Medicaid adults to meet community engagement work hours starting in 2027. AI & Cybersecurity: AHA released a cyber governance guide for secure AI deployment in healthcare, while new reporting highlights physicians seeing widespread non-FDA regulated peptide use. Workforce & Care Quality: Peterson Health and Agape Care Group earned workplace honors for staff support, underscoring ongoing focus on retention in care settings.

AI Training for Clinicians: GE HealthCare is offering free “HelloAI Professional” training (20 hours) to help clinicians understand how AI decision support works without needing data-science expertise. Patient Access in Pharma: A new discussion highlights “policy fatigue,” arguing that coverage doesn’t equal access and that pharma must plan years ahead to reduce abandonment driven by prior authorization and affordability friction. FDA & DTC Ads: Coverage examines how leadership changes at the FDA could reshape strategy around direct-to-consumer prescription drug advertising and what regulators can realistically enforce. COVID Prevention Breakthrough: FDA approved Shionogi’s Xocova (ensitrelvir) as the first oral post-exposure prophylaxis option for adults and adolescents 12+ after contact with an infected person. Cell/Gene Therapy Review Hurdles: An analysis finds 42% of cell and gene therapy submissions now end in complete response letters, often tied to manufacturing and documentation issues rather than new safety signals. Rare Disease Dealmaking: Servier agreed to acquire Edgewise Therapeutics’ muscular dystrophy business for up to ~$2.65B, centered on sevasemten for Becker and Duchenne muscular dystrophy. Cybersecurity Update: HIPAA is expected to be updated to require stronger protections like multi-factor authentication and encryption, with concerns that AI could still outpace current safeguards. Public Health Funding for Ebola: CEPI is putting $60M into trials for Bundibugyo Ebola vaccines as the outbreak in DR Congo raises fears of escalation.

China Pharma Deals: JW Therapeutics’ CEO says tighter Beijing scrutiny over sensitive tech deals hasn’t slowed its cross-border collaborations, especially in cell and gene therapies. Rare Disease Access: Sanofi launches AccelRare in India, an AI pre-diagnosis tool aimed at cutting rare-disease diagnostic delays. Biosimilars Policy Gaps: A new study highlights uneven global biosimilar rules that slow development and limit patient access. FDA/Antibiotics Milestone: Wockhardt’s Zaynich (cefepime + zidebactam) wins USFDA approval for complicated UTIs, underscoring the push against antimicrobial resistance. Healthcare Operations: Penn researchers warn extreme heat worsens underlying conditions and argue for expanded cooling assistance tied to energy insecurity. Clinical Highlights (Oncology): ASCO updates include durable survival benefits with pembrolizumab in early TNBC (KEYNOTE-522) and a major pancreatic cancer advance with daraxonrasib nearly doubling median survival vs chemotherapy. Care Delivery Tech: Medical practices are adopting AI receptionists to ease staffing strain and reduce missed calls/no-shows.

Cancer Breakthroughs at ASCO 2026: Ivonescimab (PD-1/VEGF bispecific) plus chemo cut the risk of death by 34% in advanced squamous NSCLC, with overall survival benefits reported regardless of PD-L1 status. Pancreatic Cancer: Daraxonrasib showed “grand slam” results in second-line RAS G12 metastatic pancreatic cancer, nearly doubling overall survival versus chemotherapy. Prostate Cancer Care: New data highlighted cognitive differences between enzalutamide and darolutamide, plus improved rPFS with talazoparib plus enzalutamide in HRR-altered metastatic castration-sensitive prostate cancer. Bladder Cancer Advances: ASCO GU coverage emphasized bladder-sparing strategies in high-grade NMIBC and new perioperative approaches, including EV-304-style shifts toward higher pathologic complete response rates. Medical Device & Sterile Processing: A look back at 30 years of progress in medical device reprocessing underscored how standards and modernization have tightened infection prevention. Access & Delivery: Telehealth is expanding GLP-1 access, but experts warn access alone won’t solve outcomes. Industry Watch: A report flags risks in the fast-rising SlimTide supplement market, including counterfeit and marketing concerns.

Pediatric Long COVID Burden: A prospective PECOS study found 20 symptoms more common in lab-confirmed SARS-CoV-2–infected children and teens, with about two-thirds reporting at least one post-infection symptom at 12 months. Cancer Care Advances: At ASCO 2026, a radiation implant with “seeds” after brain metastasis surgery showed better outcomes than external beam radiation, while SENOMAC data suggest omitting axillary lymph node dissection can be non-inferior with fewer arm complications. Urothelial Carcinoma Survival: Updated EV-302/KEYNOTE-A39 results show enfortumab vedotin plus pembrolizumab continues to improve overall survival vs platinum chemo in first-line locally advanced/metastatic disease. Quality of Life in Neuroendocrine Tumors: 177Lu-edotreotide improved health-related quality of life versus everolimus in GEP-NETs. Diagnostics Coverage Gap: ASCO 2026 coverage gaps persist for molecular testing in children’s cancers, especially bone cancers, with Medicare denials still common. Health System Watch: PacificSource plans layoffs in Oregon as it exits parts of ACA markets, leaving tens of thousands needing new coverage.

Cybersecurity: The FBI warned that the “Silent Ransom Group” (also known as Luna Moth, Chatty Spider, UNC3753) is targeting healthcare with phone impersonation and phishing, urging organizations to harden defenses. Transplant Policy: CMS finalized updates to the Increasing Organ Transplant Access Model, including raising the low-volume threshold to 15 kidney transplants and adding Medicare Advantage beneficiaries to risk calculations. Legal/340B: The full 4th Circuit will rehear challenges to state contract pharmacy rules after earlier rulings found them unconstitutional—an outcome with major implications for pharmacy access and revenue. FDA Approvals: FDA granted pediatric approval for Afrezza inhaled insulin (ages 6+), and also advanced bevacizumab-vikg for neovascular AMD after an appeal process. Oncology Updates (ASCO): Multiple studies reported new signals across cancers, including strong efficacy for elranatamab in high-risk smoldering myeloma and long-term survival modeling for dostarlimab-based endometrial cancer regimens. Public Health/Wellness: A blood test study suggests Alzheimer’s biomarkers in midlife may flag risk decades early, while new guidance highlights tanning bed dangers and safer alternatives.

FDA & Diabetes Care: FDA approved Afrezza (inhaled human insulin) for children and adolescents age 6+ with type 1 or type 2 diabetes, adding a needle-free mealtime option with pulmonary safety monitoring. Cancer Immunotherapy: AstraZeneca’s Imfinzi (durvalumab) plus BCG induction/maintenance won FDA approval for BCG-naïve, high-risk non-muscle-invasive bladder cancer, expanding a growing oncology footprint. Ebola Therapeutics: WHO named three priority experimental options for the Bundibugyo strain—Regeneron’s maftivimab, Gilead’s remdesivir, and Mapp Biopharmaceutical’s MBP134—urging urgent trial evaluation as cases rise in DRC and Uganda. Maternal Health Education: A US survey found broad awareness of preconception health, but notable gaps on alcohol avoidance before pregnancy, iron supplementation, and recommended gestational weight gain. Pharma Deals & Pipeline: Pfizer struck a major China-focused cancer alliance with Innovent, potentially worth $10B+, while FDA accepted a bezuclastinib/sunitinib NDA for previously treated GIST with priority review. Patient Safety Ops: Sterile processing leaders are calling for more autonomy, visibility, and recognition, citing reporting-structure limits that can affect perioperative safety.

AI in Trials: A Pistoia Alliance poll finds 50% of clinical trial professionals see trust and regulatory uncertainty as the biggest barriers to AI adoption, urging validated, auditable approaches. Drug Discovery Push: Multiple reports highlight pharma’s push to speed trials and cut costs with AI-driven platforms and automation, while one commentary warns AI can cost more than clinicians once compute, oversight, and liability are counted. Imaging Equity: A Vanderbilt-led study of nearly 5,800 Medicare beneficiaries finds Black and Hispanic groups are less likely to show Alzheimer’s pathology on amyloid PET, raising concerns about downstream diagnosis and treatment gaps. Cancer Care Funding: A widow donates $1M to install a permanent PET/CT scanner at Hancock Health, after demand rose ~60% and mobile imaging created bottlenecks. Public Health Tech: NIH funds a $1.7M project to improve deep-vessel ultrasound imaging using light and nanoparticles. Maternal Care Model: UAMS pilots a toolkit to integrate doulas into hospital maternity teams. Tobacco Warning: IIT Gandhinagar and University of Illinois find herbal cigarettes can emit harmful particles comparable to or worse than tobacco. Food Safety: UK FSA recalls a frozen dessert due to undeclared hazelnuts and soya for allergy risk.