Today's Healthcare Pulse
FDA greenlights durvalumab combo for high‑risk bladder cancer
The FDA approved durvalumab (Imfinzi) combined with Bacillus Calmette‑Guerin for BCG‑naïve, high‑risk non‑muscle invasive bladder cancer. The POTOMAC trial enrolled 1,018 patients and showed a 32% reduction in disease recurrence risk (hazard ratio 0.68, p=0.015). Durvalumab is given at 1,500 mg IV every four weeks for up to 13 cycles.
Also developing:
By the numbers: Apogee Therapeutics raises $1.3B royalty financing
Dora Nginza Hospital Logs 382 Perinatal Deaths in 2025, Highest in Eastern Cape for Third Year
Dora Nginza Hospital in Gqeberha recorded 382 perinatal deaths in 2025, the highest number among Eastern Cape facilities for the third consecutive year. The surge reflects chronic understaffing, infrastructure failures and prolonged wait times for emergency C‑sections, prompting unions and families to demand systemic change.
Global Report Flags Accountability Crisis for Longevity Clinics
A May 2026 report by the International Institute of Longevity and Longevity Think Tank finds 86% of surveyed clinics use biological‑age testing and all plan to expand, but warns the sector lacks validated outcomes. The findings signal a shift toward...
Pharvaris to File FDA NDA for Oral Deucrictibant, First-in-Class HAE Therapy
Pharvaris announced it will submit an FDA New Drug Application for its immediate‑release oral deucrictibant by the end of June. The filing is backed by Phase 3 RAPIDe‑3 data showing symptom relief in a mean of 1.3 hours, far faster than the...
Utah Unveils Early Results From Statewide AI Prescription Renewal Pilot
Utah has released early results from a state‑wide experiment that uses artificial intelligence to automatically renew prescriptions for patients with chronic conditions. The pilot, closely watched by industry and regulators, marks one of the first large‑scale AI prescribing initiatives in...
Independent Researcher Questions Censorship Despite Humanitarian Work
But why GITMO? I make low cost vaccines to help humanity, so far 100 million doses administered at $2-3 per dose bypassing big pharma. Haven’t made a dime. And I write books with academic presses on the history of science...
Developing Drug System Standards in Primary Care Units Using the SMART Model: A Participatory Action Research Study in Northern Thailand
A pharmacist‑led quality improvement program called the SMART model was piloted in five primary care units (PCUs) in northern Thailand from January to September 2025. Using a participatory action research framework, the intervention targeted all five national pharmacy‑standard domains and...
Inocras Announces ASCO 2026 Online Publication: Whole-Genome HRD Phenotyping as a Predictor of PARP Inhibitor Benefit in First-Line Maintenance High-Grade...
Inocras announced that whole‑genome sequencing‑based HRD phenotyping predicts benefit from PARP inhibitor maintenance in high‑grade serous ovarian cancer. In a real‑world study of 84 patients at Severance Hospital, HRD‑positive tumors had a median progression‑free survival of 27.5 months versus 12.0...
House GOP Requests CBO Explain Lacking Budget Benefits From Drug Price Controls
House GOP health‑committee leaders have asked the Congressional Budget Office to explain why its original estimate for the Inflation Reduction Act’s Part D redesign was far too low and why the projected savings from the new drug‑negotiation program have not materialized....
New Indicator for Response to Therapy in Pediatric Cancers Identified
Researchers at the University of Birmingham reported that a high aneuploidy score can predict which children with relapsed solid tumors respond to a combined low‑dose irinotecan and PARP‑inhibitor regimen. The Phase I/II eSMART arm enrolled 70 patients across the UK, France,...
Q&A: Using Advanced Imaging to Improve Brain Cancer Treatment
UCLA Health’s Jonsson Cancer Center is pioneering advanced MRI and PET techniques that map glioblastoma’s blood vessels, metabolism, and microenvironment in real time. The new perfusion and metabolic imaging tools provide early biomarkers of drug target engagement and tumor response,...
Time Ticking Away For OMB To Release Behavioral Health NOFOs
Federal agencies have yet to issue the expected FY 2026 behavioral health Notice of Funding Opportunities (NOFOs), with roughly 50 grants still pending OMB approval. Historically, these announcements arrive in mid‑September to allow states and community organizations to plan before the...
Integrative Medicine in the UK: One Year After the New WHO Traditional Medicine Strategy
One year after the World Health Assembly endorsed the WHO Global Traditional Medicine Strategy 2025‑2034, the United Kingdom still lacks a coherent national framework for traditional, complementary and integrative medicine (TCIM). While some Integrated Care Boards commission acupuncture for cancer...
CMS Targeting Georgia, Ohio in Fraud Fight
The U.S. Centers for Medicare & Medicaid Services (CMS) has broadened its provisional enhanced‑oversight program, originally applied to California, Arizona, Nevada and Texas, to include Georgia and Ohio retroactive to Dec. 31, 2025. Both states are experiencing a surge of new...
The BioPharm Brief: Oncology, Growth, Validation
Kelun‑Biotech announced that its antibody‑drug conjugate sac‑TMT achieved a statistically significant improvement in progression‑free survival versus chemotherapy in a Phase 3 trial for first‑line metastatic triple‑negative breast cancer. BioMarin reported that its growth‑hormone analog vosoritide met the primary endpoint in a...
ASU’s Osteopathic School Saves $50 M with Tech‑Driven Remote Learning Model
Arkansas State University’s College of Osteopathic Medicine, in partnership with the New York Institute of Technology, launched a technology‑driven remote‑learning curriculum that trims $50 million in state costs, drives a 99.9% residency match rate and aims to flood underserved Arkansas with...
Providers Protest RFK Jr.’s Firing of USPSTF Vice Chairs, Warn of Politicized Preventive Care
HHS Secretary Robert F. Kennedy Jr. dismissed USPSTF vice chairs John Wong and Esa Davis, igniting a backlash from physicians and health‑policy groups. The American Medical Association and AcademyHealth argue the move threatens the panel’s scientific independence and could jeopardize...
HHS’s AERO Initiative - What Hospitals Need to Do Right Now
On May 21, 2026, the U.S. Department of Health and Human Services launched the Audit Enforcement and Risk Oversight (AERO) initiative, using artificial intelligence to re‑score at least five years of Single Audit Act data for any entity receiving $1 million...
AI Implementation Is a Marathon, Not a Sprint
Seoul National University Bundang Hospital CIO Dr. Seyoung Jung cautioned healthcare leaders that AI adoption is a marathon, not a sprint. Executives must first pinpoint precise clinical tasks where AI can add value before committing to expensive tools. He emphasized...
Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data From Study 108, a Phase 2a/2b Open-Label Extension...
Abivax reported Q1 2026 results, highlighting €491.6 million (≈$540 million) in cash and a runway extending into Q4 2027. The company released three‑year interim data from Study 108, showing that 68% of 130 ulcerative colitis patients remained in clinical remission after 144 weeks of obefazimod...
HHS Deploys AI to Scan State Audits, Targeting $1 Million‑Plus Health‑Care Payments
The U.S. Department of Health and Human Services announced Thursday that it will use generative AI, such as ChatGPT, to examine audit reports from every state, seeking to flag fraud in federal health‑care programs that exceed $1 million in funding. The...
CODX Leads Biotech Rally with 55% Surge on Ebola Assay Breakthrough
Co-Diagnostics (CODX) surged 55.23% to $3.71 after announcing completion of an assay for the Bundibugyo Ebola virus, sparking a broader market rally that saw Sunshine Biopharma (SBFM) rise on generic Amoxicillin approval, GOVX highlight its Ebola strategy, and RegeneRx (RGNX)...
Medicare Will Pay for the Work Your Nurses Already Do
Since January 2024 Medicare’s Physician Fee Schedule has added three reimbursable codes—Community Health Integration (CHI), Principal Illness Navigation (PIN) and Chronic Care Management (CCM)—to pay for the care‑coordination tasks nurses already perform in independent primary‑care offices. While the clinical work is...
Leukemia Drug HHT Delays Aging, Extends Mouse Lifespan
Homoharringtonine exhibits senotherapeutic activity that mitigates diet- and age-associated obesity and insulin resistance and extends lifespan in mice [an FDA-approved anti-leukemic drug; authors found that "HHT treatment delays aging and extends the lifespan in progeroid and aged mice"] https://t.co/LEegM8XUtR
How the HIMSS AMAM Model Helps Benchmark Data Maturity
The HIMSS Analytics Maturity Assessment Model (AMAM) was validated at Seoul National University’s Bundang Hospital, giving leaders a clear benchmark of their data maturity. The assessment highlighted gaps in data governance, integration, and analytics infrastructure, shaping a roadmap for AI...
Justice Department Charges 15 for $90M+ in Alleged Healthcare Fraud, Expands Strike Force
The Justice Department indicted 15 individuals in Minnesota for more than $90 million in alleged Medicaid fraud, including the state’s largest autism‑related scheme valued at $46.6 million. The alleged wrongdoing spanned autism services, integrated community supports, individualized home supports, housing stabilization and...
Heart Attacks Release Toxin That Damages Brain Function
University of Ottawa researchers have identified methylglyoxal (MG) as a toxin that spikes in the bloodstream after a myocardial infarction and accumulates in brain regions governing mood and memory. The excess MG provokes neuroinflammation, driving depression, anxiety and cognitive decline...
Tennessee Becomes 2nd State to Ban PBMs From Owning Pharmacies
Governor Bill Lee signed the Freedom, Access and Integrity in Registered Pharmacy Act, making Tennessee the second state to bar pharmacy benefit managers (PBMs) from owning or operating pharmacies. The legislation survived a $7 million opposition campaign that deployed more than...
BATMAN to the Rescue: TMVR Technique Helps Cardiologists Reduce Risk of LVOT Obstruction
A new study in JACC: Cardiovascular Interventions shows that Balloon‑Assisted Translocation of the Mitral Anterior Leaflet (BATMAN) can dramatically lower left ventricular outflow tract (LVOT) obstruction risk during transcatheter mitral valve replacement (TMVR). The analysis of 83 high‑risk patients treated...
AI's Promise Meets the Pediatric Frontline
Children’s Hospital of Orange County (CHOC) has begun deploying agentic and generative AI tools to streamline chart reviews, reducing tasks that once took an hour to mere minutes. The technology integrates structured and unstructured patient data, delivering annotated insights directly...
Proposed Community-Based Palliative Care Model Aims to Expand Access to Care
The National Partnership for Healthcare and Hospice Innovation (NPHI) and the Coalition to Transform Advance Care (C‑TAC) are developing a federal fee‑for‑service, community‑based palliative care model that would deliver services earlier in a patient’s serious‑illness trajectory. The proposal focuses on...
DOJ Aims Enforcement At Reducing Anticompetitive Health Practices
The Department of Justice’s Antitrust Division announced that it will intensify enforcement against anticompetitive practices in the pharmacy‑benefit manager (PBM) market. Deputy Assistant Attorney General Nicole Sarrine highlighted consolidation and vertical integration as priority concerns, even though a recent HHS...
Cotiviti VP: Patients Need Education to Combat Hospice Fraud
Cotiviti’s fraud‑prevention VP Erin Rutzler warns that patient and family education is a missing piece in the fight against hospice fraud. She notes that fraud not only drains Medicare, Medicaid and commercial payer funds but also harms honest providers by...
FDA Clears Gilead's Hepatitis D Drug, Four Years After Prior Rejection
Gilead’s hepatitis D therapy Hepcludex (bulevirtide) has finally secured FDA approval after a prior rejection over manufacturing and distribution flaws. The drug becomes the first U.S.‑cleared treatment for chronic hepatitis D, a rare but aggressive liver infection affecting roughly 70,000 Americans. Phase 3...
Did AI Really Beat ER Doctors At Diagnosis? Here’s What The Study Showed
A recent *Science* paper found OpenAI’s o1 model correctly identified the diagnosis in 67% of 76 emergency‑department triage cases, outpacing two internal‑medicine physicians who scored 55% and 50%. The experiment used raw electronic health‑record data available at the point of...
Shared Risk Factors May Drive CVD Mortality in Patients With Early-Onset CRC: Meng-Han Tsai, PhD
A recent research letter in the Journal of the American Heart Association examined 83,433 early‑onset colorectal cancer (CRC) patients and found that men and racial‑ethnic minorities living in urban areas face markedly higher cardiovascular disease (CVD) mortality. Age‑adjusted rates were...
Advocacy Group Sues Trump Administration over Access to Abortion for Veterans
The Veterans Affairs (VA) has reinstated a near‑ban on abortions for veterans and their families, limiting coverage to life‑threatening cases only. Minority Veterans of America, representing over 3,600 members, filed a federal lawsuit alleging the rule violates the Administrative Procedures...
The American Diabetes Association Honors Senator Scott Wiener with a Lifetime Achievement Award
The American Diabetes Association presented Senator Scott Wiener with its Lifetime Achievement Award, recognizing his long‑standing advocacy for people with diabetes. Wiener’s leadership helped pass California Senate Bill 40, which caps insulin cost‑sharing at $35 per month for state‑regulated health...
Expanded Federal Scrutiny Reshapes How Hospitals Govern Risk, Compliance
Federal enforcement in health care has intensified, targeting medical school admissions, Medicaid payments and gender‑affirming care. Hospital systems are responding by tightening compliance cultures, assigning dedicated officers, and fostering cross‑functional collaboration. Leaders at ProMedica, Bayhealth, UofL Health and Wellstar highlight...
Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (Mitapivat) Approval in the European Union for Adults with Thalassaemia
Avanzanite Bioscience announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat) to treat anaemia in adults with transfusion‑dependent or non‑transfusion‑dependent alpha‑ or beta‑thalassaemia. The approval follows positive CHMP opinion and data from the Phase 3 ENERGIZE and ENERGIZE‑T...
As AI Identifies More At-Risk Patients, Health Systems Face a Capacity Challenge
Healthcare AI is increasingly able to flag at‑risk patients and subtle clinical anomalies, but the surge in alerts is outpacing the capacity of clinicians to act on them. Leaders at Stanford Health Care, Penn Medicine and Jefferson Health warned that...
PharmaEssentia to Present New Clinical Data Supporting the Use of Ropeginterferon Alfa-2b in Essential Thrombocythemia at ASCO and EHA 2026
PharmaEssentia will unveil new Phase 3 SURPASS‑ET data at ASCO and EHA 2026, highlighting that early initiation of ropeginterferon alfa‑2b yields markedly higher two‑year progression‑free survival (76.9% vs 43.1%) in high‑risk essential thrombocythemia (ET). Integrated analyses of SURPASS‑ET and Phase 2b EXCEED‑ET,...
The Next Pandemic Will Come From a Conflict Zone
A new Ebola outbreak was declared in the Democratic Republic of Congo’s Ituri province and quickly spread to Uganda, prompting the WHO to issue a public‑health emergency of international concern without an emergency committee—a first. The authors argue that the...
Health Equity & Access Weekly Roundup: May 22, 2026
Women’s health is undergoing rapid change in 2026, with personalized transdermal hormone therapy gaining traction for menopause and potential Alzheimer risk reduction, while telehealth access to mifepristone remains contested. The HHS Secretary’s dismissal of USPSTF leaders has unsettled the preventive‑care...
Expanded Label for Efgartigimod Offers Fast-Acting Treatment for gMG: James F. Howard, MD
On May 11, 2026, the FDA broadened the indication for efgartigimod, approving it for all adult patients with generalized myasthenia gravis, including AChR‑positive, MuSK‑positive, LRP4‑positive, and triple‑seronegative subtypes. The decision follows the phase‑3 ADAPT SERON trial, which enrolled 119 patients...
Biopharma Money Raised: Jan. 1-May 21, 2026
BioWorld’s May 22 briefing highlights three early‑stage biotech advances. A detargeted gene‑therapy approach demonstrated enhanced enzyme activity in Pompe disease models, suggesting a more efficient lysosomal correction. Genescience presented its STAT6 PROTAC degrader, GenSciP166, aimed at treating atopic dermatitis by...
Sun Pharma Q4 Net Profit up 26 per Cent
Sun Pharmaceutical Industries posted a 26.2% jump in Q4 net profit to roughly ₹2,714 crore ($327 million) and a 13.6% rise in sales to ₹14,559 crore ($1.75 billion). R&D spending reached 6.7% of sales, amounting to about ₹975 crore ($117 million) for the quarter. The company’s...
How TAVR Valve Implant Depth Impacts Clinical Outcomes
A large observational analysis published in JACC: Cardiovascular Interventions found that a higher transcatheter aortic valve replacement (TAVR) implantation position yields better early clinical outcomes. One‑year combined mortality and stroke was 9.7% across all depth groups, but permanent pacemaker implantation...
AstraZeneca Wins EU Backing for Breast Cancer Drug, Splitting with FDA Panel
AstraZeneca’s breast‑cancer therapy, identified as [drug], received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, clearing the path for EU approval. In contrast, an FDA advisory committee voted against the drug last month,...
Team Finds Markers of Inflammatory Breast Cancer in Blood
University of Texas researchers have discovered blood‑based RNA biomarkers that reliably differentiate inflammatory breast cancer (IBC) from other breast cancer subtypes. Using the Thermostable Group II Intron Reverse Transcriptase (TGIRT) sequencing platform, they captured complex and fragmented RNAs missed by...
96‑Bed Behavioral Health Hospital Opens in Council Bluffs to Ease Iowa’s Psychiatric Bed Shortage
Methodist Jennie Edmundson Hospital and Acadia Healthcare opened a 96‑bed behavioral health hospital in Council Bluffs, Iowa, in mid‑June. The facility aims to close a regional gap in inpatient psychiatric capacity, offering whole‑person care and accepting patients regardless of insurance...