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
Pulaski County Schools Seek New Partner After Mainline Health Moves Clinic to Telehealth‑Only Model
The Pulaski County Special School District voted to terminate its partnership with Mainline Health Systems after the nonprofit announced it would convert its on‑site school health clinic to a telehealth‑only model. With the clinic averaging just one visit per day, the district is now scrambling to find a new provider to keep essential medical and behavioral services in schools.
Compass Therapeutics to Unveil Phase 1 CTX‑8371 Data at ASCO 2026
Compass Therapeutics announced that it will present promising Phase 1 data on its bispecific antibody CTX‑8371 at the American Society of Clinical Oncology’s 2026 annual meeting. The data, derived from patients with advanced malignancies who have progressed after checkpoint‑inhibitor therapy, could...
Other News to Note for May 26, 2026
On May 26, 2026 BioWorld highlighted three notable biotech developments. Sangamo Therapeutics presented primate data showing its gene‑regulation candidate ST‑506 can suppress prion replication, a potential breakthrough for neurodegenerative disease treatment. Pfizer disclosed a new patent covering TREM2 agonists aimed...
Laboratory Predictors of Sudden Unexpected Death in Patients Receiving Palliative Care.
A retrospective analysis of 530 palliative‑care patients identified laboratory markers that signal sudden unexpected death (SUD). Twenty‑one percent of the cohort experienced SUD, defined as death within 24 hours of a stable assessment. Multivariable modeling linked prior chemotherapy, serum sodium,...
The Development of Breast Apocrine Carcinoma (BAC) Score that Distinguishes Breast and Cutaneous Apocrine Carcinomas
Researchers have created a Breast Apocrine Carcinoma (BAC) score that reliably separates breast‑origin apocrine cancers from cutaneous apocrine carcinomas. The classifier was built from multi‑cohort transcriptomic data using a LASSO logistic regression model and leverages distinct hormone‑signaling and proliferative signatures....
Adcendo Inks MSD Supply Deal to Run ADC-Keytruda Combination Study
Adcendo, a Copenhagen‑based biotech, has signed a supply agreement with MSD for Keytruda to launch a Phase Ib trial of its tissue‑factor‑directed ADC ADCE‑T02 in combination with the checkpoint inhibitor. The study, slated for the second half of the year, will...
FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria; Janssen Seeks a Preliminary Injunction to Block Their Launch
The FDA approved Accord BioPharma’s IMMGOLIS™ and IMMGOLIS INTRI™ as the first interchangeable biosimilars to Janssen’s Simponi® and Simponi ARIA® on May 15, 2026. Both products treat moderately to severely active rheumatoid arthritis, and IMMGOLIS also covers ulcerative colitis. Accord will commercialize the drugs...
Taxpayer Group Urges Senate To Reject MFN Legislation As TrumpRx Talks Continue
The fiscally conservative Taxpayers Protection Alliance (TPA) is urging Senate members to reject any effort to codify a most‑favored‑nation (MFN) drug‑pricing rule. TPA argues that MFN would function as de facto price controls, jeopardizing pharmaceutical innovation and risking drug shortages. The...
Texas Republicans Invited Me to Testify About Big Insurance
A former health‑insurance executive testified before the Texas House Select Committee on Health Care Affordability, warning that insurer incentives reward cost‑cutting over patient benefit. He highlighted how narrow networks, claim denials, and prior authorizations boost margins while inflating premiums. The...
Alaunos Reports Broad Metabolic Improvements with ALN1003 in Obese Mouse Studies
Alaunos Therapeutics reported that its oral small‑molecule candidate ALN1003 produced broad metabolic improvements in diet‑induced obese mice. Across two non‑GLP studies, treated animals showed up to a 13% reduction in body weight, significant fat loss, lower fasting insulin and HOMA‑IR,...
Banner Health Report Shows Arizona Research Driving National Medical Innovation
Banner Health’s $80.5 million research enterprise reported 1,300 active clinical and translational studies in 2025, delivering an FDA‑approved device for severe mitral annular calcification and launching a $74.5 million NIH‑funded Alzheimer prevention trial in Colombia. The organization enrolled more than 89,000 participants...
DePuy Synthes Announces Agreement to Acquire Miniature Radiofrequency Tracking Technology Across Its Joint Reconstruction Portfolio
DePuy Synthes announced a definitive agreement to acquire selective rights to MinMaxMedical’s Gemtrack miniature radio‑frequency (RF) tracking technology for its joint reconstruction portfolio. The RF tracker will be integrated into the VELYS digital surgery platform, covering shoulder, hip and knee procedures...
ViaLase Announces Global Commercial Introduction of the FLIGHT Procedure
ViaLase, Inc. has begun the global commercial rollout of its FLIGHT procedure, the first femtosecond laser‑guided, incision‑free trabeculotomy for open‑angle glaucoma. The inaugural treatments were performed at Centre for Sight in London and Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf...
How Medicare and Medicaid Rely on Private Health Insurance
The latest Journal of Economic Perspectives articles detail how the majority of Medicare and Medicaid beneficiaries receive care through private insurers. About 57% of Medicare enrollees are in Medicare Advantage, where the government contracts with private plans that often receive...
Unio Health Partners and Thesis Care Announce Partnership to Scale AI-Powered Clinical Teams Across Specialty Care
Unio Health Partners, California's largest multi‑specialty physician platform, has partnered with AI‑driven care team provider Thesis Care to embed multiple AI agents across its urology, gastroenterology and radiation oncology practices. The collaboration will automate high‑volume tasks such as care‑gap closure,...
Niva Bupa Eyes Top Two Spots in Retail Health Insurance Space in 3 Years
Niva Bupa Health Insurance, currently third among standalone health insurers with a 10.1% retail market share, aims to break into the top two spots in India’s retail health‑insurance segment within three years. The company plans to outpace the market by...
How The Joint Commission & CHAI Are Quietly Building A Parallel FDA For Hospital AI & Why The Governance Infrastructure...
The Joint Commission, which accredits roughly 80% of U.S. hospitals, partnered with the Coalition for Health AI (CHAI) to issue September 2025 guidance that embeds AI governance into accreditation standards. This creates a de‑facto regulatory layer that rivals the FDA...
WellSky Launches CareQueue Feature to Embed Proactive AI Triage Inside Long-Term Care EHRs
WellSky has launched CareQueue, an AI‑powered triage and workflow prioritization module built directly into its Long‑Term Care EHR. The feature converts fragmented resident data into real‑time acuity scores, surfacing high‑priority clinical actions for nurses and care coordinators. Designed with a...
Partnerships, Governance Can Help Ensure No-Code AI Adoption
Advocate Health’s SVP and chief digital and AI officer Andy Crowder urges health systems embarking on no‑code AI projects to partner with vetted vendors and institute rigorous data‑protection policies. He stresses that strong governance structures are essential to mitigate privacy...
Beta Bionics to Launch Its First Insulin Patch Pump to Compete with Insulet
Beta Bionics announced it will debut its first insulin patch pump, called Mint, by the end of Q2 2027 pending FDA clearance. The three‑day wearable features a 200‑unit reservoir and blends reusable and disposable components, linking to the company’s adaptive dosing...
Two Years of TEFCA: What Works, What Doesn’t
Brad Thorson, Pryce Ancona and I are back, but we’re trying something a bit different this time. Given a little Memorial Day lead-up lull afflicting the industry, we decided to give a primer and run-down on the successes and failures...
AI Risks Undermining Skills of New Physicians
We've written about AI-induced physician deskilling that has already surfaced https://t.co/iMy6zyWnhZ @tberzin AI-induced never-skilling among newly trained doctors, while not yet proven, is a serious concern that needs to be addressed @NatureMedicine @nliulab https://t.co/yov3YvsGti
b.well Connected Health Partners with myTomorrows to Launch AI-Driven Clinical Trial Matching Stack
b.well Connected Health has teamed with myTomorrows to launch an AI‑driven clinical‑trial matching stack. The partnership layers myTomorrows’ pre‑screening engine onto b.well’s FHIR‑based data network, which aggregates records from roughly 2.4 million providers, 330 health plans and multiple state HIEs. By...
AI Health Check: No Governance, No Trust
AI’s potential in healthcare is huge, but a recent sepsis‑prediction tool performed no better than a coin flip, shaking clinician confidence. The failure underscores that without solid governance, AI hallucinations, bias, and data drift can quickly erode trust. Trust loss...
Next-Generation Platforms Poised to Redefine Crowded HAE Landscape
The hereditary angioedema (HAE) market has accelerated, with three FDA approvals in 2025 bringing the U.S. total to 11 marketed treatments. Nearly half of the 15 global pipeline candidates—46%—are now in Phase III, signaling a wave of imminent approvals. While most...
The Silent Threat — Why Early Lymphedema Detection Matters for Breast Cancer Survivors
Breast cancer survivorship is increasingly threatened by lymphedema, a fluid‑retention condition that can lead to infection and high medical costs of $14,877‑$23,167 over two years. Bioimpedance Spectroscopy (BIS) now detects subclinical swelling in under a minute and has been added...
Medicare Fraud Conviction Exposes $1 Billion Waste in Federal Health Insurance
A federal jury in Florida found HealthSplash founder Brett Blackman guilty of orchestrating a $1 billion Medicare fraud operation that cost taxpayers more than $450 million. The case spotlights deep‑seated policy gaps in Medicare that enable large‑scale abuse and fuel waste in...
Utah’s AI Prescription Experiment
In January 2026 Utah became the first U.S. state to pilot an AI‑driven prescription‑renewal program, partnering with Doctronic under a regulatory sandbox that lets an autonomous system evaluate renewal requests for 192 chronic‑care drugs. The AI recommends renewals in 72%...
Nanobiotix Raises $100 Million in Global Offering, ABIVAX Posts €52 Million Q1 Loss
Nanobiotix (NBTX) completed a global offering that raised $100 million after underwriters exercised their option, while ABIVAX (ABVX) posted a €52 million (≈$56.6 million) loss for Q1 2026 as R&D spending surged. The contrasting results underscore divergent trajectories among Euro‑listed biotech firms.
Lancet Study Shows 1.2 Billion People Living with Mental Disorders in 2023, Up 95% Since 1990
A new Lancet study estimates 1.2 billion people lived with a mental disorder in 2023, a 95.5% increase since 1990. Anxiety and depression drove most of the surge, with women and adolescents disproportionately affected, prompting calls for coordinated global action.
Biotech Surge Powers Nasdaq: AKTX Jumps 255% on KRAS Data
Akari Therapeutics (AKTX) surged more than 255% for a second straight day after preclinical data showed synergistic activity of its AKTX-101 drug with KRAS inhibition in pancreatic cancer models. The rally lifted the broader biotech sector, with Govix (GOVX) and...
AstraZeneca, Daiichi Sankyo Win EU CHMP Nod for Enhertu in HER2 Tumors
AstraZeneca and Daiichi Sankyo received a positive opinion from the European Medicines Agency's CHMP for Enhertu, expanding the antibody‑drug conjugate to HER2‑positive solid tumours after prior therapy. The endorsement is based on subgroup analyses from Phase II DESTINY trials that showed...
Turning AI Into Real Support for Skilled Nursing Teams
Artificial intelligence is transitioning from concept to daily workflow in skilled‑nursing facilities, but its impact hinges on data interoperability and seamless integration into existing clinical processes. Leaders must first resolve fragmented resident information to feed reliable predictive models, then embed...
How States’ Moves to Call Abortion Drugs ‘Controlled Substances’ Can Make Childbirth More Dangerous and Interfere with Legal, Safe and...
Louisiana enacted Act 246 in 2024, reclassifying the abortion pills mifepristone and misoprostol as Schedule IV controlled substances, a designation previously reserved for drugs with abuse potential. The change forces the medications into locked cabinets, adding minutes to emergency retrieval and delaying...
China’s Cornerstone Robotics Receives Approval in Europe for Its Sentire Endoscopic Surgical System
Hong Kong‑based Cornerstone Robotics announced that its Sentire® Endoscopic Surgical System has earned European Union CE‑mark certification under the Medical Device Regulation, granting market access across general surgery, gynecology, thoracic and urology. The platform has been under clinical investigation in...
Peter Marks Drives Lilly’s Three‑vaccine Developer Acquisition
It looks like Peter Marks is making his mark. Eli Lilly to acquire three small vaccine developers https://t.co/vdkObEYWjj
Lilly Gets Back in Infectious Disease, via Three M&A Deals
Eli Lilly is re‑entering infectious disease with three acquisitions totaling over $3.8 billion: Curevo, LimmaTech Biologics and Vaccine Company. The deals give Lilly a shingles vaccine candidate (CRV‑101) that could challenge GSK’s Shingrix, a portfolio of antibacterial vaccines against resistant pathogens, and...
Two Decades of Evolving ASCO Clinical Trial Trends
Trends and characteristics of clinical trials presented in ASCO plenary sessions (2011–2025) - Overheu #ASCO26 Abstract # 11024, Poster Bd # 7 https://t.co/JYI0LY7FbU #ClinicalTrials #ctsm @ASCO
Ivonescimab Shows
#ASCO26 LBA4 - Zhiwei - Ivonescimab + chemo vs tislelizumab + chemo 1L sq NSCLC - Ph3 HARMONi-6 [May 31, 2026] Zhiwei et al. https://t.co/oWEeVo2oyq #NCT05840016 #lcsm #ImmunoOnc
Exclusive: How AI Can Use Blood Biopsies to Make Precision Oncology More Accessible
Mayo Clinic and Stanford Medicine unveiled an AI-driven liquid‑biopsy platform that reads methylation tags in blood to map tumor microenvironments (TMEs) across 17 solid cancers. The two‑stage framework—Spatial Ecotyper for tissue data and Liquid Ecotyper for plasma—discovers nine conserved spatial...
Phase 3 Trial
#ASCO26 LBA2 - Dickson -SARC041: Ph3 DBRCT abemaciclib vs placebo in Pts w/ adv dedifferentiated liposarcoma [May 31, 2026] https://t.co/oWEeVo2oyq #NCT04967521 #scmsm
Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao
Merz Therapeutics has licensed its inhaled levodopa product Inbrija to Chinese biotech Kvvit for exclusive commercialization in mainland China, Hong Kong and Macao. The agreement assigns Merz responsibility for drug supply, global quality oversight and holding the overseas registration certificate,...
Arthrosi Drug Trial in Gout Delivers for New Owner Sobi
Swedish biotech Sobi’s $1.5 billion acquisition of Arthrosi is yielding results as its gout drug pozdeutinurad met primary goals in the phase 3 REDUCE‑2 trial. The URAT1 inhibitor lowered serum uric acid to ≤6 mg/dl in 69.2% of patients at a 75 mg dose...
Whole‑Health Model Slashes Pain Disruption for 764 Veterans in Year‑Long Trial
A randomized trial led by Yale and UCSF researchers found that a whole‑health team intervention lowered pain‑related disruption for 764 veterans after one year, delivering better outcomes than cognitive‑behavioral therapy or standard care. The results bolster calls for broader non‑medication...
NerveCentre: Competitive Analysis and Framework Performance
Nervecentre Software Ltd, the UK’s second‑largest EPR provider by hospital beds, is rapidly scaling its workforce to 400 staff and securing multi‑year, high‑value contracts—including a £53.6 million deal with Liverpool University Hospitals and a £38 million agreement with Mid Yorkshire Trust. The...
EU Approves Wegovy 7.2 Mg Pen Amid Expert Warnings of Bone Loss
The European Medicines Agency’s CHMP has recommended approval of Novo Nordisk’s Wegovy 7.2 mg single‑dose pen, which delivered a 20.7% average weight loss in trials. At the same time, orthopedic experts caution that rapid weight loss from GLP‑1 drugs can erode muscle...
Olympus to Acquire BioProtect for ~$270M
Olympus announced a definitive agreement to acquire BioProtect for approximately $270 million, targeting the company’s Balloon Spacer system that safeguards healthy tissue during prostate cancer radiotherapy. The transaction includes escrow provisions tied to uninterrupted business operations, with closing slated for the...
EU Biotech Act Raises Competition Stakes for Greece, Industry Warns
Greek pharma executives warned that the EU Biotech Act turns Europe into a competitive arena, stressing that only €161 m of the €52 bn EU R&D pool reached Greece in 2023. They argue that speed, predictable regulation and investment‑friendly policies are now...
Therapists Adopt AI Note‑Taking Tools Amid Privacy Pushback
Therapists across the United States are piloting AI‑driven note‑taking platforms such as Berries, SimplePractice and Blueprint, promising to save hours of administrative work each week. Patients, however, voice strong concerns about data privacy and the erosion of trust, highlighting a...
Florida Blue Faces $11,500 ER Bill Dispute, Spotlighting Out‑of‑network Emergency Billing
Kendra Fletcher, a Florida Blue subscriber, is contesting an $11,517 emergency‑room bill after her daughter’s visit to Broward Health, highlighting a clash between insurers and hospitals over out‑of‑network emergency coverage. Florida Blue has paid $5,000 and refuses additional payment, while...