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
Pasithea Therapeutics Corp (KTTA) Q1 2026 Earnings Call Transcript
Definium Therapeutics (DFTX) reported that its lead psychedelic candidate DT120 ODT has fully enrolled the EMERGE Phase III trial in major depressive disorder, with top‑line data expected in late Q2 2026. The VOYAGE Phase III study for generalized anxiety disorder is about 80% enrolled and aims to release results in early Q3, while a blinded sample‑size re‑estimation confirmed no need for additional participants, suggesting statistical power above 99%. The company also activated the first sites for the ASCEND MDD study and noted rapid progress on the PANORAMA GAD trial. Cash and investments total $411.6 million, extending the runway to 2028.
CervoMed Inc (CRVO) Q1 2026 Earnings Call Transcript
CONMED Corp reported Q1 2026 revenue of $317 million, a 1.3% decline, driven by the exit of its gastrointestinal product line. Excluding the GI exit, organic sales rose 2.1% and orthopedics grew 4.5% in constant currency, while general surgery remained flat....
Vyne Therapeutics Inc (VYNE) Q1 2026 Earnings Call Transcript
Vyne Therapeutics reported Q1 2021 revenue of $4.1 million, more than double the prior year, while posting a GAAP net loss of $20.6 million. The company highlighted strong early adoption of its acne drug AMZEEQ and rosacea treatment ZILXI, with...
To Regulate Vaping We Need Pragmatic, Evidence-Based Policy
A coalition of leading public‑health researchers argues that vaping policy must be grounded in pragmatic, evidence‑based standards. The authors synthesize recent data showing e‑cigarettes can lower smoking rates when regulated proportionally, while warning that overly strict rules may push youth...
Silexion Therapeutics Corp (SLXN) Q1 2026 Earnings Call Transcript
Syndax Pharmaceuticals reported $172 million total revenue for 2025, driven by $124.8 million from its menin inhibitor RevuForge and $151.6 million from the chronic GVHD therapy Nictimvo. RevuForge saw 38% quarter‑over‑quarter revenue growth and a 35% rise in prescriptions, with 97% formulary coverage...

Serebral
Serebral’s Halo implant embeds a neural sensor in patients like the narrator’s grandmother, continuously streaming brain‑wave data to a cloud‑based AI platform. The system translates raw activity into semantic vectors, predicts emotions with about 91% confidence, and serves personalized care...
Marker Therapeutics Inc (MRKR) Q1 2026 Earnings Call Transcript
Merck reported first‑quarter 2026 revenue of $16.3 billion, a 5% year‑over‑year increase driven by strong oncology and animal‑health sales. Oncology revenue reached $8 billion, up 8%, while WELIREG surged 43% and CAPVAXIVE grew 31%; however, GARDASIL fell 22% and a $9 billion Cidara...
Citius Oncology Inc (CTOR) Q2 2026 Earnings Call Transcript
CTI BioPharma reported a cash balance of $71.9 million at the end of Q2 2021, while operating losses widened to $19.5 million as the company prepared for a potential U.S. launch of pacritinib. The FDA accepted the pacritinib NDA with priority review, setting...
“We Deserve the Same Rights as Other Health Care Workers:” PSW Day Protest at Doug Ford’s Office on May 19
Personal support workers (PSWs) represented by CUPE are protesting Ontario’s Health and Supportive Care Oversight Authority (HSCPOA), which they say lacks due‑process safeguards and representation. The union plans a rally outside Premier Doug Ford’s Etobicoke office on May 19, 2026, marking PSW Day....

Shyld AI Snags $13M for Device that Disinfects Hospital Rooms Autonomously
Shyld AI announced a $13.4 million seed round led by Aulis Capital to scale its AI‑enabled UV disinfection devices for hospital rooms. The system autonomously detects occupancy, triggers targeted UV exposure, and logs cleaning activity, cutting pathogen levels by 93 % in...

Court Allows for Access to Abortion Pill by Mail for Now
The U.S. Supreme Court issued an order on Thursday extending its pause on the 5th Circuit’s ruling that barred the mailing of mifepristone, the primary drug used in medication abortions. The stay keeps the abortion pill available by mail while the...

CDC’s Hantavirus Briefing Revealed a Public Health System Trying to Avoid Repeating 2020
The CDC held a 20‑minute briefing on the Andes hantavirus outbreak linked to a cruise ship, detailing a sizable response that includes more than 100 staff, deployments to the Canary Islands and Nebraska, and monitoring of exposed Americans. Officials emphasized...
New Radiopharmaceutical Achieves Remission in Difficult-to-Treat Pancreatic Cancer
Researchers have unveiled a novel radiopharmaceutical, ¹⁷⁷Lu‑AKIR001, that homes in on the CD44v6 protein variant prevalent in pancreatic ductal adenocarcinoma (PDAC). In mouse xenograft studies, a single 12 MBq dose achieved complete remission in 40% of subjects when used alone and...

Dexcom Unveils Next-Generation G8 CGM for Real-Time Glucose Monitoring
Dexcom announced its next‑generation G8 continuous glucose monitor at Investor Day, branding it as a completely new product platform built on a novel silicon chip and adaptive algorithm. The G8 offers a 50% smaller form factor than the G7 and...

World Clinical Trials Day 2026 Looks at the Science, Setbacks and Systems Behind New Medicines
World Clinical Trials Day 2026, observed on May 20, highlighted the “Research Rising” theme to honor the clinical‑research workforce and patients. Phase II studies now comprise 43% of the 584,000 active global trials, while oncology still drives 38% of Phase I‑III starts despite...

Sick and Wrong: Ontario Auditors Find Doctors' AI Note Takers Routinely Blow Basic Facts
Ontario’s Auditor General audited 20 AI‑scribe vendors and found pervasive errors. Nine systems fabricated treatment suggestions, twelve inserted wrong drug data, and seventeen missed key mental‑health details. The evaluation framework gave minimal weight to accuracy, with only 4% of the...
Magen David Adom Launches First Dedicated Mental‑Health Emergency Unit
Magen David Adom (MDA) announced the creation of a dedicated mental‑health emergency response unit in partnership with Israel’s Health Ministry, moving mental‑crisis calls to specially trained dispatchers. The move follows a pilot program and a 45% surge in mental‑health emergency...
REDOX-AHF: Less Oxygen May Be More for Hospitalized Acute HF Patients
The REDOX‑AHF trial randomized 135 hospitalized acute heart‑failure patients to either a restrictive oxygen strategy (target SpO₂ 90%) or a liberal strategy (target SpO₂ 96%). The restrictive arm achieved a greater 24‑hour drop in lung‑fluid content (2.4 % absolute difference, p = 0.01) and showed...

CMS Moratorium: What A Nationwide Freeze Means For Home Health Growth
CMS announced a six‑month nationwide moratorium on new Medicare‑certified home health and hospice agency enrollments, extending a tool first used in 2013. The freeze blocks de novo growth, forcing providers to rely on existing locations for revenue expansion. While current...
WHOOP Launches Telehealth as Fitbit Becomes Google Health App
WHOOP announced a U.S. summer rollout of in‑app telehealth that ties continuous biometric data to medical consultations, and Fitbit’s consumer app will be rebranded as Google Health on May 19, 2026. The moves signal a decisive shift from pure fitness tracking...
Roche Signs Agreement to Acquire AI Pathology Leader PathAI
Roche announced it has signed a definitive agreement to acquire PathAI, the AI‑focused digital pathology company, pending regulatory approval. The deal is intended to accelerate Roche’s use of artificial‑intelligence tools for drug discovery, companion diagnostics and clinical trial enrichment.
Medicare Launches AI‑Driven ACCESS Payment Model, Pair Team Among First 150 Testers
The Centers for Medicare & Medicaid Services (CMS) announced the ACCESS program, a 10‑year AI‑enabled payment model that rewards health outcomes. Pair Team was named one of 150 initial participants, positioning the firm at the forefront of a federal shift...

CMS Releases Details to Download Upcoming CAH Payment Patterns Report
The Centers for Medicare & Medicaid Services (CMS) announced details for downloading its fiscal year 2025 Program for Evaluating Payment Patterns Electronic Report (PEPPER) focused on critical access hospitals. The report, slated for release later this month, aggregates provider‑specific Medicare...
Cincinnati Public Schools Report 23% Kindergarten Vaccination Rate, Lowest in Ohio
Cincinnati Public Schools posted a 23% kindergarten vaccination rate, the lowest among Ohio districts, far below the state average of 85%. The figure, drawn from the Ohio Department of Health’s new dashboard, raises alarms about outbreak preparedness and may prompt...
Sapu Nano Doses First Patient in Phase 1b Trial of IV Deciparticle Everolimus
Sapu Nano announced that the first patient has been dosed in its Phase 1b trial of Sapu003, an intravenous Deciparticle™ formulation of everolimus. The trial targets advanced mTOR‑sensitive solid tumors and aims to overcome oral delivery limits of the existing drug....
Harima B.Stem Corp. Posts 38% Profit Rise on Strong Stem‑Cell Revenue Surge
Harima B.Stem Corp. announced full‑year earnings of ¥1.183 billion ($7.6 million), a 38% increase over the prior year, while revenue rose 10.4% to ¥30.944 billion ($200 million). The results underscore growing demand for its stem‑cell‑based therapeutics in Japan and abroad.
UPDATE - Ongoing Salmonella Outbreaks Linked to Backyard Poultry Sickens 150 More People with over a Quarter of Cases in...
The CDC has added 150 new Salmonella infections to three multistate outbreaks tied to backyard poultry, raising the total to 184 cases across 18 states. The surge includes 53 hospitalizations and one death, with more than a quarter of patients...

Ardent Health, Fujifilm Team Up to Deliver Enterprise Imaging Solutions
Ardent Health has partnered with Fujifilm Healthcare Americas to roll out the Synapse enterprise imaging platform across its acute‑care hospitals in six states. The solution unifies radiology, cardiology and mammography images into a single PACS viewer and integrates directly with...
Integrating Sarcopenia Into ICU-Acquired Weakness Risk Stratification: A Machine Learning–Based Prediction Model for Critical Care
A retrospective study of 1,324 ICU patients found that sarcopenia significantly predicts ICU‑acquired weakness (ICU‑AW). Using six variables—age, APACHE II score, sarcopenia, sepsis, mechanical ventilation, and lactate—the researchers trained ten machine‑learning models and identified XGBoost as the top performer (AUC ≈ 0.84). SHAP...

AHA Healthier Together Conference Concludes with Sessions on AI, Person-Centered Care
The American Heart Association concluded its first Healthier Together Conference in Dallas with a plenary on AI‑driven tools reshaping community health. Data science chief Jennifer Hall and Houston Methodist’s innovation officer Roberta Levy Schwartz outlined emerging AI applications and cautioned about...

Blood Pressure Drug Recalled After Failed Test
The FDA announced a Class II recall of 675 bottles of 20‑mg Enalapril Maleate tablets after a failed organic impurities test. The affected product, manufactured by Unique Pharmaceutical Laboratories (J.B. Chemicals & Pharmaceuticals) in India, was distributed across the U.S. by...

Encoded's Gene Therapy Reduced Seizures in Dravet Syndrome
Encoded Therapeutics reported that its experimental gene therapy cut seizure frequency by 76 % in three children with Dravet syndrome, a severe childhood epilepsy. The effect was seen in patients receiving the second‑highest dose among four dose levels in a small...
Transforming Clinical Trial Design and Avoiding AI Wrappers: Q&A with Angela Schwab
Trialynx CEO Angela Schwab explains how AI is reshaping clinical trial design by moving away from manual copy‑and‑paste protocols toward data‑driven, predictive modeling. AI can scan millions of past studies to suggest optimal endpoints, procedures, and patient pathways, reducing missed...

Innovaccer 2026 Payer AI Report: Nearly 80% of Insurers to Buy or Co-Develop AI Capabilities
Innovaccer’s 2026 Payer AI Report finds nearly 80% of health‑plan executives now prefer buying or co‑developing AI solutions, a stark reversal from 2024’s internal‑build focus. About three‑quarters of payers plan to allocate more than $10 million to AI‑driven payment and outcome...
“Totally Unexpected” – Scientists Discover Pancreatic Cancer’s Fatal Addiction
Researchers at The Wistar Institute and ChristianaCare have uncovered a critical weakness in pancreatic cancer. They found that damaged mitochondria within tumor cells activate the TLR3‑TRAF6 signaling pathway, creating inflammation that the cancer depends on for growth. Blocking this pathway...

Time for ‘Novel Ideals’: Rural Health Leaders Share Strategies Amid Budget Constraints
Sanford Health, the nation’s largest rural health system, is leveraging a $350 million virtual‑care initiative and a 60,000‑sq‑ft Virtual Care Center to sustain profitability while serving over 2 million patients across 300,000 square miles. The system’s hybrid model, which routes two‑thirds of virtual...
Anshar AI Cuts Prior Auth From Hours to Minutes
What if prior auth didn’t take 10 hours—but minutes? Anshar AI is applying agentic AI to one of healthcare’s biggest bottlenecks. Check out the interview. ⬇️ https://t.co/LPxKHPOWGk #AnsharAI #RCM #HIMSS26 #HITSM
Carrot Expands AI Metabolic Health Program to Menopause
Carrot, the fertility‑focused health platform, is extending its AI‑driven Sprints metabolic program to address menopause. The expansion adds personalized nutrition, activity, sleep, and stress guidance, plus 24/7 coaching, specialist therapists, and access to hormone‑replacement therapy and GLP‑1 drugs when appropriate....
Analysts See 11% Upside for Teva Despite 100% Rally
Thirteen analysts surveyed by S&P Global in May rated Teva Pharmaceutical as a buy or strong buy, forecasting an 11% price target upside even after the stock doubled in the past year. The optimism rests on strong branded drug sales,...
Forus Raises $160 Million to Scale AI Platform that Streamlines Prescriptions Across the U.S.
Forus, the AI‑powered medicine platform formerly known as Tandem, announced a $160 million financing round led by Thrive Capital and other top VCs. The funding will accelerate rollout of its workflow‑automation tool that connects clinicians, insurers and pharmacies, a move investors...
Cardiologists Are First in World to Use New Leaflet-Splitting Technique During TAVR
Interventional cardiologists performed the first‑in‑human transcatheter aortic root tricuspidization (ART) during transcatheter aortic valve replacement (TAVR) to treat bicuspid aortic stenosis. Seven symptomatic patients, average age 64.6, underwent ART‑assisted TAVR via transfemoral access with no 30‑day deaths or strokes. The...

Multimodal AI Beats Physicians on 29 of 32 Metrics
A multimodal AI (AIME) had superior performance compared with 18 physicians for almost every metric (29 of 32 axes). Randomized, but simulated, not real-world clinical practice. @GoogleDeepMind @alan_karthi @RyutaroTanno https://t.co/PIs9VZmlMi https://t.co/nDC8p2jmus

The Gender Pain Gap - More than 50% of Women Say Their Pain Is Ignored by Doctors
The Gender Pain Gap Index released by Nurofen reveals that over half of UK women feel their pain is dismissed by doctors, with the figure climbing to 73% among 18‑24‑year‑olds. Racial disparities are stark: 74% of Black women and 65%...
Hantavirus Outbreak on MV Hondius Triggers Cruise Schedule Delays and Expert Reassurance
The MV Hondius cruise ship has reported ten hantavirus infections, including three fatalities, prompting itinerary cancellations and strict quarantine measures. Virologist Dr. Shahid Jameel and ECDC microbiologist Andreas Hoefer stress the virus’s limited transmissibility, easing fears of a broader pandemic.
Healthcare Philanthropy as Strategic Revenue: Why More Hospitals Are Rethinking Financial Growth
Hospitals face razor‑thin margins—just 1.3% in 2025—while labor costs rise 5.6% and Medicare reimburses only 83 cents per dollar of care. These pressures have pushed health systems to treat philanthropy as a strategic revenue source rather than a peripheral fundraiser....
Aquestive Therapeutics Narrows Q1 Loss, Boosts Revenue as Anaphylm Advances
Aquestive Therapeutics posted a first‑quarter net loss of $8.1 million, a sharp improvement from $22.9 million a year earlier, while revenue jumped 66% to $14.4 million. The company also moved its sublingual epinephrine film, Anaphylm, closer to a Q3 2026 NDA resubmission after...

Hospitals Are Treating Burnout as a Wellness Problem. It Is an Operating Model Problem
Hospitals treat physician burnout as a wellness issue, but the root cause is an operating model that piles administrative load, financial risk, and decision‑making away from clinicians. Studies show wellness interventions have little impact, while physicians now spend 15‑25 hours...

Glooko Announces FDA 510(k) Clearance for EndoTool IV Cloud
Glooko announced that the U.S. Food and Drug Administration granted 510(k) clearance for EndoTool IV Cloud, the first cloud‑based, patient‑specific insulin dosing platform for hospitals. The solution mirrors the proven algorithm of the on‑premise EndoTool IV but adds scalable, centralized deployment and reduced...
EP511: The Tension When Clinical Teams Take On Risk for Policymakers and Others Looking to Rustle Up Future Perverse Incentives,...
In this episode, Dr. Siva and Dr. Monica Lypson discuss the perverse incentives created when clinical teams assume financial risk in value‑based contracts, especially around upcoding, downcoding, and the resulting cherry‑picking or "lemon‑dropping" of patients. They argue that without transparent,...
Ontario to Let Pharmacists Administer More Vaccines, Prescribe for More Ailments
Ontario announced a July 2026 expansion of pharmacists' scope, allowing them to administer six publicly funded vaccines—including tetanus, RSV and shingles—and to assess and prescribe for nine common minor ailments such as dandruff and mild headache. Pharmacy technicians will also...