AGP Executive Report

NHS Waiting Times: Progress on elective care in England has stalled, with about 65% of patients treated within 18 weeks—well short of the government’s 92% goal for 2029. September also brought record A&E attendance and waits. Medical Training: The Royal College of Physicians says training quality needs the same scrutiny as patient safety, warning that weak education risks future care and workforce capacity. Bladder Cancer: The FDA expanded approval of nogapendekin alfa inbakicept with BCG for certain patients with BCG-unresponsive bladder cancer, offering an option that may help some avoid bladder removal. Rare Diseases: The FDA’s new framework aims to tailor drug development and review for small patient populations; only about 5% of rare diseases have an approved treatment. AI Drug Design: UW researchers used AI to create protein “scissors” that target disease-linked proteins, an early approach being explored for neurodegenerative diseases and other conditions. Cancer Research Deals: Gilead and Vir struck a collaboration worth up to $1.87 billion to develop three masked T-cell engager candidates for solid tumors.

Drug-industry oversight: The FTC and seven states are asking a federal judge to hold Martin Shkreli in contempt, alleging he violated a lifetime ban by trading pharmaceutical stocks and commenting on drugmakers. Home health: ROSE has launched a $399 tap-water test that screens for more than 100 contaminants, including PFAS, and provides personalized recommendations. Cancer research: Vir Biotechnology and Gilead will develop three masked T-cell therapies for solid tumors; Vir could receive up to $1.87 billion in upfront, milestone and royalty payments. Obesity drugs: South Korea’s Hanmi plans to launch its homegrown GLP-1 treatment Eppe this month at wholesale prices below those of Wegovy and Mounjaro. Gene therapy: In a small Phase 1 trial, a single CRISPR treatment cut LDL cholesterol and triglycerides by about half at one year. Regulation and AI: The UK’s MHRA plans faster regulatory reviews and an AI tool to check clinical-trial protocols, while researchers report a way to adapt adult-trained radiology AI for children without moving patient data between hospitals.

Adolescent Cancer: Most adolescents in a colorectal cancer study were diagnosed with advanced disease: 51% had stage III cancer and 29% stage IV. Patients reported symptoms for a median of 12 weeks before diagnosis, and 45% died of the disease during the study. Pharma Oversight: The FTC and seven states are asking a judge to hold Martin Shkreli in contempt, alleging he violated his lifetime industry ban by trading drug-company stocks and commenting on their business. Rural Care: More than 40% of rural hospitals operate at a loss, an American Hospital Association report warns, putting care access at risk for millions as financial and policy pressures mount. Healthcare Costs: Employer health spending per person rose 18.8% from 2019 to 2023, with prices—not increased use—accounting for most of the rise, according to HCCI data. Obesity Drug Deal: Roche agreed to license Rona Therapeutics’ experimental RNAi obesity drug, with potential milestone payments of up to $1.06 billion.

Pharma Workforce: Drugmakers’ U.S. factory expansion faces a talent shortage: the country may need 3.8 million manufacturing workers by 2033, with about half those jobs at risk of going unfilled. Lilly is backing local training, including a $12.5 million college program in Texas. Cancer Equity: Hispanic and Latinx lung cancer patients can face risks beyond smoking and barriers to clinical trials. Experts stress biomarker testing, translated consent forms and more inclusive recruitment. Cancer Care: A Texas Oncology pilot used virtual navigation to help people manage oral cancer drugs at home, adding clinical check-ins and emotional and social support between visits. India’s Pharma Shift: Biocon’s Kiran Mazumdar-Shaw says India should build on its generics success with sustained research investment, faster approvals and a stronger pipeline of new medicines. Industry Accountability: New York’s attorney general and a bipartisan coalition want Martin Shkreli held in contempt for allegedly violating his lifetime ban from the pharmaceutical industry. AI Oversight: Hospitals are adopting AI agents for records, patient questions and scheduling faster than they can monitor them, raising cybersecurity and patient-safety concerns.

Cancer Drug Advances: RYZ101 met its Phase 3 progression-free survival endpoint in advanced gastroenteropancreatic neuroendocrine tumors, offering a potential new option after lutetium-based treatment. Surgical Robotics: Stryker is investing about $400 million in CMR Surgical and will exclusively distribute its soft-tissue surgical robot in the U.S. Imaging Strategy: Siemens Healthineers has stopped selling general ultrasound systems as it shifts toward cardiovascular and image-guided procedures. Patient Safety: Lilly is warning consumers about illegal sales of its investigational obesity drug retatrutide, which has not been approved and may pose risks from poor-quality products, dosing and inadequate monitoring. Workforce Wellbeing: A comparison of doctors in the UK and Australia finds shared pressures—including heavy workloads and training strain—pointing to workplace systems, not individual resilience alone, as a key concern.

Obesity Care: A new triple-action treatment produced 23% weight loss in people with type 2 diabetes. Lilly Israel is also launching personalized digital support for eligible patients prescribed diabetes or obesity medicines. Patient Safety: Philips recalled ultrasound systems after four reported deaths. Separately, detections of a rare, often-fatal brain fungus quadrupled at a US reference lab from 2023 to 2025, prompting calls for national surveillance. Cancer Screening: An FDA advisory panel voted 7-2 that GRAIL’s Galleri multi-cancer blood test’s benefits outweigh its risks for adults 50 and older; a final decision is expected in the coming months. Drug Supply: Experts cited overseas production dependence, manufacturer incentives and regulatory burdens as contributors to drug shortages. GSK plans to invest more than $800 million in Pennsylvania biologics production, creating over 300 jobs. Heart Failure: At-home subcutaneous furosemide reduced hospitalizations for worsening heart failure, potentially offering patients an alternative to hospital-based treatment.

Doctor Wellbeing: A UK-Australia comparison finds resident doctors face similar workload pressure, moral distress and training strain, pointing to workplace systems—not just individual resilience—as a source of burnout. Heart Failure Care: Early trial data suggest at-home injected furosemide may help patients with worsening heart failure avoid hospital-based IV treatment. Ebola Outbreak: The DRC outbreak has reached 8,750 confirmed cases and 4,208 deaths, making it the second-largest on record and unusually fast-spreading. Ophthalmology Access: A review of 747 hospital transfers found the initial diagnosis was correct in only about one-quarter of cases, while 41% of patients received no intervention—underscoring the value of local eye-care services. Obesity Drugs: South Korean prescriptions for Wegovy and Mounjaro reached 2.8 million through August, about 2.3 times last year’s total, amid concerns about drug shopping and cross-border purchases. Insurance Costs: Colorado’s individual-market premiums are set to rise an average 10% in 2027, with increases topping 15% in Mesa County.

Disease Surveillance: Ebola cases in the Democratic Republic of the Congo have reached 8,787, with 4,242 confirmed deaths, according to WHO figures reported for Oct. 7. Cancer Imaging: A 200-patient study found FAPI PET/CT detected ovarian cancer spread in the abdomen more accurately than conventional CT, potentially helping guide surgery decisions. Drug Development: Merck reported one-year results from its pivotal trial of investigational remigromig for diabetic macular edema; both doses met the trial’s non-inferiority benchmark against ranibizumab, but neither proved superior. Drug Pricing: PhRMA is suing to block a Medicare rule tying some hospital drug prices to costs in other countries, calling it an overreach. Brain Health: A long-term study linked nitrate exposure from tap water and animal products with higher dementia rates, while vegetable-derived nitrates were associated with lower rates; the findings do not prove cause and effect. Drug Safety: A UK watchdog censured CSL Seqirus over more than £730,000 in grants that were undisclosed or did not identify the ultimate recipient.

Drug Approvals: The FDA approved oral pritelivir for hard-to-treat herpes simplex lesions in immunocompromised adults, offering a new option for infections that can be difficult to manage with existing antivirals. The agency also approved a once-monthly olanzapine injection for adults with schizophrenia. Cancer Care: Tecentriq won approval with chemotherapy as adjuvant treatment for stage III dMMR colon cancer. Diagnostic Equity: VisualDx CEO Art Papier says gaps in medical training on skin of color still contribute to missed diagnoses, especially in primary care and emergency settings. Drug Pricing: Pharmaceutical companies are challenging the Trump administration’s most-favored-nation drug-pricing policy in court.

Cancer Costs: India will cap trade margins on non-scheduled cancer drugs at 30%; medical-device makers are seeking similar controls, while experts say any cuts must reach patients without disrupting supply or quality. Maternal Care: Uttar Pradesh is expanding single-dose iron injections for pregnant women after a five-district pilot, aiming to improve treatment access and address anemia-related risks. Treatment Advances: The FDA approved once-monthly olanzapine for adults with schizophrenia and Tecentriq with chemotherapy for stage III dMMR colon cancer. Separately, early data on investigational CAR T therapy prula-cel showed remission in some patients with lupus, but the Phase 1 results involve a small group and need further study. Industry Influence: A new analysis links pharmaceutical company payments to changes in physicians’ prescribing, adding to calls for stronger scrutiny of drug marketing. Healthcare Costs: California’s plan to fine hospitals that exceed spending targets faces industry opposition, with critics arguing the caps may not account for inflation, drug costs, and an aging population.

Drug Approvals: The FDA approved Teva’s once-monthly injectable olanzapine for adults with schizophrenia. Unlike an older injectable version, it requires no loading dose, oral add-on or post-injection monitoring. Roche’s Tecentriq plus chemotherapy also won approval for stage III dMMR colon cancer, after trial data showed a 50% lower risk of recurrence or death. Measles Outbreak: U.S. cases topped 4,080, including 1,136 in Pennsylvania, where five people have died. Nationwide, 95% of cases were in people who were unvaccinated or whose status was unknown. Hospital Finances: The American Hospital Association and Maine hospitals sued to block a planned 340B drug rebate program, warning it could add more than $1 billion in annual administrative costs. Medicare & Rural Care: CMS released 2027 Medicare Advantage star ratings ahead of open enrollment; about 71% of enrollees are in plans rated four stars or higher. The agency also issued its first report on states’ use of a $50 billion rural health fund. Cybersecurity: U.S. and international agencies warned that China-linked hackers are targeting critical infrastructure, including healthcare organizations, to steal sensitive data.

Drug Pricing: India has capped trade margins on non-scheduled cancer medicines at 30% of retail price, a move expected to cut some prices by up to 70%. The Supreme Court also told the government to form a panel on pharmaceutical freebies to doctors and unethical marketing. Prescribing Practices: A Cochrane review of more than 93 studies found that industry payments, gifts and sales visits are linked to doctors prescribing promoted drugs more often, including potentially inappropriate treatments. New Treatments: The FDA granted fast track status to VIR-5500, an experimental therapy for advanced prostate cancer. A trial of a daily GLP-1 pill for type 2 diabetes reported HbA1c reductions of up to 1.6%. Care and Coverage: Doctors and radiologists are pushing back against a proposed change to the No Surprises Act, warning that replacing independent payment arbitration with median in-network rates could weaken safeguards against low insurer payments. Clinical Guidance: New UTI guidelines emphasize infection severity when choosing initial antibiotics, while noting that local resistance data may not reflect risk for every patient.

Cancer Care: The FDA approved atezolizumab with chemotherapy for stage III dMMR colon cancer. In multiple myeloma, the iberdomide triplet more than doubled median progression-free survival versus standard therapy in a phase 3 trial. New Treatment Options: The FDA also cleared remibrutinib for symptomatic dermographism and approved a Tukysa combination as maintenance therapy for HER2-positive metastatic breast cancer. Heart Failure: An FDA-cleared CardioMEMS update lets patients view pressure readings on their phones. Prescribing Oversight: A Cochrane review found pharma gifts and payments were linked to more inappropriate and costly prescribing. India’s Supreme Court ordered a panel to recommend rules on industry freebies to doctors. Drug Pricing: PhRMA sued to block Medicare’s GLOBE model, which would tie rebates for some Part B drugs to prices in 19 countries.

Ebola Alert: Kenya confirmed its first imported Bundibugyo case, prompting contact tracing and quarantines as officials respond to the deadly outbreak. Cancer Care: The FDA approved Tukysa with trastuzumab and pertuzumab as first-line maintenance treatment for HER2-positive metastatic breast cancer. India capped trade margins on non-scheduled cancer drugs at 30%, which could cut some prices by up to 70%; the Supreme Court also ordered a panel to recommend safeguards against drug-company gifts to doctors. Heart Health: GLP-1 therapies featured prominently at the 2026 European cardiology congress, reflecting their expanding role beyond weight and diabetes care. Parkinson’s: Solengepras met its primary endpoint in a Phase 3 trial, reducing daily “off” time compared with placebo. Skin Care: The FDA approved remibrutinib for symptomatic dermographism, a condition that causes itchy skin welts.

Cancer Treatment: The FDA approved Tukysa with trastuzumab and pertuzumab as first-line maintenance therapy for HER2-positive metastatic breast cancer. In a trial, median progression-free survival was 24.9 months, versus 16.3 months with placebo; an overall-survival benefit has not yet been established. Drug Pricing: PhRMA sued to block a Medicare rule linking some Part B drug payments to prices abroad, arguing the administration lacks authority to impose the policy. Infectious Disease: Kenya reported its first case in the current Ebola outbreak after a man arriving from the Democratic Republic of Congo died in Nairobi. Ten people are quarantined as officials trace 57 contacts. Biotech: Caribou Biosciences is ending two CAR-T programs and weighing strategic options, citing a difficult funding environment. Manufacturing: Thermo Fisher is expanding sterile-drug production in the US and Italy, including capacity for vials, prefilled syringes and monoclonal antibodies.

Vaccine Progress: Vaxcyte says its Phase 3 VAX-31 pneumococcal vaccine met primary endpoints, with immune responses across 31 strains and a safety profile similar to existing vaccines. Drug Development: CSL and Alentis struck a deal worth up to $1.55 billion to develop a kidney and liver disease drug; Genentech licensed Alector’s experimental Parkinson’s therapy in a deal worth up to $1.27 billion. Market Access: Celltrion has launched Omlyclo in the US, the first interchangeable biosimilar to Xolair. Infectious Disease: Florida reported 252 locally acquired dengue cases by late September, far above recent years. India is also launching youth-led TB awareness teams in 55 districts, alongside an AI-powered public information chatbot. Earlier Intervention: Experts are urging primary care to play a larger role in liver disease as cases linked to obesity and alcohol rise.