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
Apyx Medical Corporation (APYX) Reports a Net Loss for Q4 FY25
Apyx Medical Corporation reported its fourth‑quarter FY25 results, posting a loss of $0.03 per share on $19.2 million of revenue. Revenue surged 34.8% year‑over‑year, propelled by the Advanced Energy and Original Equipment Manufacturing segments. The loss narrowed from $0.06 per share in the prior quarter, suggesting a move toward profitability. Apyx serves customers in the United States and international markets with electrosurgical and medical device solutions.
Procalcitonin Vs. C-Reactive Protein in Neonatal Sepsis
Researchers published a comparative study in Pediatric Research showing that procalcitonin (PCT) rises within 6‑12 hours of infection in very low birth weight infants, while C‑reactive protein (CRP) peaks later at 24‑48 hours. The data reveal that PCT offers higher...
Medical Malpractice and AI: Jurors React Differently Depending on How Radiologists Utilize the Technology
A mock‑trial study published in Nature Health examined how jurors assign liability when radiologists use AI in interpreting CT scans. When AI flagged a brain bleed and the radiologist reviewed the image only once, 75% of jurors held the radiologist...
First-Time Medicare Advantage Enrollees Demonstrate Increasing Demographic and Clinical Diversity
The study of over 5 million first‑time Medicare Advantage (MA) enrollees from 2012‑2022 shows a marked rise in demographic and socioeconomic diversity, with dual‑eligible beneficiaries climbing from 13% to 23% and Black enrollees from 12.7% to 18.3%. Clinical complexity also increased...
Audit Shows Low Rate of Intraoperative IOL-Related Complications
A ten‑year audit at Moorfields Eye Hospital revealed an intraoperative intraocular lens (IOL) complication rate of just 0.11%, with 193 events out of 176,663 cataract surgeries. The most frequent issue, unplanned IOL exchange, accounted for 69% of complications and was...
London’s First-Ever Drug Checking Services to Open in Hackney and Camden
London’s Hackney and Camden boroughs will host the capital’s first drug‑checking services, operated by harm‑reduction charity The Loop. The clinics are fully funded by the councils and backed by the Metropolitan Police, offering free, confidential testing, rapid substance analysis, and...
Toilet Camera Could Detect Colon Cancer Early
Put a camera on your toilet? I have two of these. The freakiest product of my life. But once you get over that you have a camera aimed at your poop it might save your life. My best friend died at...
Docu-Series Goes ‘Behind-the-Curtain’ of Hospice Work
The Nebraska Health Care Foundation has funded a new documentary series that follows hospice clinicians across seven care settings in Nebraska, aiming to demystify hospice, palliative and long‑term care. By showcasing real‑world stories, the series seeks to attract and retain...
UK Junk Food Ad Ban so Diluted It May Be Largely Ineffective, Experts Say
UK's junk‑food advertising ban, introduced Jan 5, will affect only about 1% of the £2.4 bn annual food‑drink ad spend after industry‑driven loopholes. Nesta's analysis shows coverage dropping from £190 m (8%) to £20 m (1%) as brands shift spend to outdoor and owned...
Good News for Intravascular Imaging Continues at 5 Years: RENOVATE-COMPLEX-PCI
The RENOVATE‑COMPLEX‑PCI trial’s 5‑year follow‑up confirms that intravascular imaging guidance markedly lowers target‑lesion failure and cardiac death compared with angiography alone, especially in chronic total occlusions and long diffuse lesions. Across 1,639 patients, target‑lesion failure occurred in 10.5% of the...
Stanford Medicine’s Consumer Health Conference Highlights The Next Wave Of Healthcare Innovation
Stanford Medicine’s inaugural Consumer Health Summit attracted over 400 participants, positioning the university as a nexus for consumer‑health innovation. Attendees—including founders, investors, clinicians, and academics—explored how to turn abundant biometric data into actionable behavior change, earn regulatory trust, and build...
Lundbeck CEO Talks Drug Pricing, Protecting Biotech and European Needs
Lundbeck chief executive Charl van Zyl warned that Europe’s fragmented drug‑pricing regime threatens biotech sustainability and patient access. He cited recent remarks by HHS Secretary Robert F. Kennedy Jr. suggesting Europeans already pay higher prices than Americans. Van Zyl called...
FDA Clears New Formulation of Lantheus' PSMA Imaging Agent
The FDA has cleared Pylarify TruVu, a reformulated version of Lantheus’ PSMA‑targeting radiopharmaceutical piflufolastat F‑18. The new formulation improves stability at higher radioactive concentrations, enabling larger batch production and broader distribution. Lantheus plans a Q4 2026 commercial launch with a rolling geographic...
Building Trust and Improving Lives Through Community Partnerships
The American Hospital Association’s Foster G. McGaw Prize spotlights hospitals that extend care beyond their walls through community partnerships. Recent finalists introduced adaptive‑sports programs for disabled children, teen clinical rotations, child‑led playground design, and student navigators for food‑insecure patients. CEOs...
Can Increasing Women's Access to Specialists Decrease Insurance Costs?
Blair Health, a virtual women’s‑health platform, is tackling a $15 billion annual cost gap where female employees spend 18% more out‑of‑pocket than men. By offering specialist‑level care for a flat $200 per employee per year, the startup claims it can redirect...
Telemedicine Use Remains Elevated but Access Gaps Persist After COVID-19
A longitudinal study of 46 million outpatient encounters shows telemedicine use has settled at roughly 5‑6% of visits, far above pre‑pandemic levels. Utilization is higher among younger, female, portal‑savvy, and returning patients, while older adults, men, and new patients are less...
Phase III Data Support Johnson & Johson’s Teclistamab as Second-Line Therapy for RRMM
Johnson & Johnson has filed a Type II variation with the European Medicines Agency to add teclistamab, a bispecific T‑cell‑redirecting antibody, as a second‑line monotherapy for relapsed/refractory multiple myeloma. The Phase III MajesTEC‑9 trial, enrolling 614 patients, demonstrated a 71 % reduction in...
Pharmaceutical Executive Daily: FDA Expands Approval of Leucovorin
The FDA has expanded approval of leucovorin calcium tablets as the first therapy for cerebral folate transport deficiency linked to FOLR1 gene variants. The decision relied on published case literature, showing 87‑89% of patients achieved clinical improvement. In oncology, AstraZeneca...
Tenax Therapeutics Inc (TENX) Reports Q4 Earnings
Tenax Therapeutics Inc. posted a Q4 2025 net loss of $0.38 per share, reflecting continued investment in its clinical-stage pipeline. The company’s cardiopulmonary portfolio includes TNX-101, TNX-102 and TNX-103, which have all cleared Phase II trials for pulmonary hypertension in...
Shockwave Medical’s New Coronary IVL Catheter, Now Twice as Fast, Impresses After 30 Days
Shockwave Medical, a Johnson & Johnson MedTech unit, unveiled a next‑generation coronary intravascular lithotripsy (IVL) catheter that operates at 2 Hz, delivering ten pulses in five seconds—twice the speed of its current 1 Hz system. Early data from the multicenter Disrupt CAD...
VA’s Early Uses of Robots Have Shown Mixed Success, but Excitement Remains
The U.S. Department of Veterans Affairs surveyed 90 medical facilities, with 65 reporting 121 robot deployments across delivery, pharmacy, and cleaning tasks. While the Houston VA Medical Center demonstrated the most effective use, many robots were underutilized or required staff...
Weight‑loss Meds Cut Alcohol Use in Half of Users
Study shows nearly half of weight loss participants reduced alcohol use after starting anti-obesity medication (GLP-1 agonists, metformin, naltrexone). https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2827069 https://www.gatlan.com/ @GatlanHealth
New Trial Trains Future Doctors in Evidence Generation
One new trial is underway to teach future doctors how evidence is generated and evaluated. https://t.co/UaDJW1e28g #sustainability #infrastructure #IoT #AI #5G #cloud #edge #futureofwork https://t.co/lETrJfupXu
HIMSS 2026 OpenClaw Strikes Back
Day one of HIMSS 2026 highlighted a growing momentum in health‑tech interoperability, with real‑world data exchanges like Clover Health’s CMS network monitor demonstration. The conference underscored pharmacists’ untapped potential as data‑rich care partners, yet noted fragmented systems limit their impact....
AI Augments, Not Replaces, Human Insight in Complex Biology
"AI will not replace biological reasoning, but it may become indispensable for navigating biological systems whose complexity exceeds human intuition." A perspective on future applications for cancer neuroscience https://t.co/TnDFZ7NRFN @scisignal https://t.co/ijbhfbjXcs
AI Adoption Soars, Strategic Roadmaps Lag Behind
AI adoption is everywhere. AI strategy is not. 98% using it 7.5% with a roadmap Adam Turinas on the healthcare AI maturity gap... https://t.co/YWIbRTtFT9 #HealthLaunchpad #AIforMarketing #hcmktg https://t.co/pGsi557iIJ
Nursing-Home Ratings Are Unreliable and Raise Disturbing Questions. What’s a Family to Do?
The federal Centers for Medicare & Medicaid Services’ five‑star rating system, used by families to choose nursing homes, is under fire after new research shows extreme volatility and opaque calculations. Georgetown, Northwestern and Texas A&M researchers found that individual homes can...
TALK Commands ~3× Revenue Multiple, Outpacing Digital Health
This is actually good news for health-tech. TALK’s takeout multiple of ~3.0x revenues actually represents a fairly healthy premium to the recent digital health average (recall ACCD was taken out at ~1x). https://t.co/4FyXzAiny4
Burnout Is Blocked Energy, Not Just Exhaustion
Physician burnout isn't an empty battery. It’s an engine revving while stuck in park. 🏎️💨 It’s not just exhaustion; it’s blocked energy. When your moral agency is stripped away, your "aliveness" turns into cynicism. It’s time to reframe the problem. 🧵 👇 Link...
Nearly Half of All Surgeons Have Considered Leaving the Profession Due to Burnout
A Johnson & Johnson MedTech survey of 1,500 surgeons across five countries reveals that 43% have considered leaving surgery, rising to 65% among those experiencing burnout. Only 36% report positive mental health, while family‑time strain (48%), administrative burdens (47%) and long hours (44%)...
Regulatory Pharmaceutical Fellowship Program
Several U.S. universities have launched two‑year medication safety fellowships that rotate participants through academic training, a major pharmaceutical company, and the FDA. Butler University offers two tracks with Regeneron and Eli Lilly, Purdue partners with AbbVie, and Rutgers collaborates with Pfizer....
STAT+: What’s Next for RFK Jr.’s MAHA Allies on Vaccine Policy?
Vinay Prasad, the director of the FDA's Center for Biologics Evaluation and Research, announced his abrupt departure after a series of contentious decisions on rare‑disease drug approvals. His exit has reignited debate over the agency’s approach to vaccine safety and...
Leucovorin Approved for Limited Autism Subgroup, Not Mass Treatment
Last fall the administration was talking about leucovorin as a potential treatment for large numbers of people with #autism. Today's approval suggests the evidence supports its use in a much smaller group of people, @rosebroderick_ reports. https://t.co/NlJR8KlaqP
Warning Signs of Alcohol-Use Disorder Relapse
Harvard researchers led by John Kelly published a new study identifying early warning signs of alcohol‑use disorder relapse among people with long‑term sobriety. The analysis grouped predictors into biological, psychological, social, and treatment‑support domains, highlighting pain, recreational drug use, anxiety,...
National Registry of EMTs Launches New Podcast 'From Science to the Scene'
The National Registry of Emergency Medical Technicians has launched a short‑form podcast called “From Science to the Scene.” Each episode runs about ten minutes and translates the latest EMS research into practical field guidance. Early topics include tranexamic acid in...
Johns Hopkins Leads $24M Multinational Consortium to Find Hepatitis B Cure
Johns Hopkins Medicine is heading a five‑year, $24 million NIH‑funded Hepatitis B and HIV Cure Consortium that brings together research teams from the United States, Brazil, India, Senegal and Uganda. The first year will enroll 450 participants co‑infected with HIV and chronic...
Fujifilm Highlights AI-Driven Products That Help Enhance Enterprise Imaging Workflows
Fujifilm Healthcare Americas showcased its AI‑driven Synapse enterprise imaging portfolio at HIMSS 2026 in Las Vegas. The lineup highlighted the Synapse AI Orchestrator, which embeds diverse AI algorithms into PACS workflows, and the Synapse Worklist Orchestrator, which uses AI learning...
Debunking Vaccine, Tylenol, Leucovorin Myths in Autism
In my recent @BakerInstitute article, “reframing autism,“ I debunk the nonsense around vaccines, Tylenol, and leucovorin https://t.co/pxLaDLInlf
Efgartigimod Effective in Treating Juvenile Myasthenia Gravis
A multicenter retrospective study of 17 Chinese patients with juvenile myasthenia gravis found that weekly efgartigimod 10 mg/kg for four weeks produced rapid and substantial clinical improvement. Clinically meaningful improvement was observed in 70.6% of patients by week 1 and 91.7% by...
BioNTech Co-Founders Launch New mRNA Company
BioNTech announced it will create an independent biotech company dedicated to next‑generation mRNA technologies. The spin‑out will be led by co‑founders Ugur Sahin and Özlem Türeci, who will assume management by the end of 2026. BioNTech will contribute core mRNA assets in...
CSL Breaks Ground on $1.5B Illinois Immunoglobulin Plant Expansion
CSL‑Behring broke ground on a $1.5 billion expansion of its Kankakee, Illinois manufacturing complex, slated to be operational by 2031. The project will add at least 300 pharmaceutical positions and roughly 800 construction jobs, with the state offering more than $200 million...
BioNTech Founders Leave to Launch New mRNA Venture
BioNTech founders to step down and helm new mRNA startup https://t.co/yjvsVRQH2D by @Lilah_Alvarado $BNTX - 20%
Scientists Successfully Freeze and Rewarm Mouse Brain Slices
Researchers at Friedrich‑Alexander‑Universität Erlangen‑Nürnberg successfully vitrified mouse brain slices and, in a limited trial, an entire mouse brain, preserving neuronal structure and function after rewarming. By using a high‑concentration cryoprotective agent cocktail, they avoided ice crystal formation, maintained synaptic architecture,...
Menopause and the Drop in Cervical Cancer Screening
A recent Health and Retirement Study analysis shows that women who have entered menopause are about 24 percent less likely to receive a Pap smear within four years compared with pre‑menopausal peers. This decline coincides with the average cervical‑cancer diagnosis age...
Antibiotic Resistance Can Vary Depending on Where the Bacteria Live
Researchers at the Technical University of Denmark discovered that antibiotic resistance measurements can shift dramatically when test conditions change. Standard laboratory assays use fixed, uniform environments, but altering factors such as growth medium or temperature can make the same bacterium...
Everything’s Bigger in Texas (Pleading Standard Edition)
The Texas Attorney General filed an opposition to Epic’s motion to dismiss, arguing that Epic cannot import federal summary‑judgment standards into a state‑court pleading under Texas Rule 91a. The brief emphasizes that Epic’s reliance on a patchwork of federal cases...
Xenon Scores Epilepsy Win; FDA Revives Duchenne Cell Therapy Review
Xenon hits a ‘home run’ in epilepsy; FDA restarts review of Duchenne cell therapy https://t.co/l40xYeW2Xh $XENE $CAPR + 15% $REGN $PFE $ABBV $GSK #biotech
Taiwan's AI Pavilion Showcases Hospital-Ready Integration
Can it run inside your hospital? Taiwan’s debut pavilion at #HIMSS26 showcases AI built for integration, uptime & scale. Booth #6035. Mixer TODAY | 1:30 PM. Get the info: https://t.co/YmpW6r2H5Y #TaiwanExcellence #HITSM
ARPA-H Launches Program to Develop Biosensors that Can Track Multiple Signals
The Advanced Research Projects Agency for Health (ARPA‑H) has launched the Delphi program to develop modular biosensors that can monitor multiple physiological signals such as inflammation markers, hormones, and drug levels. The initiative relies on electronic "chiplet" technology, allowing developers...
ARPA-H Launches Program to Develop Biosensors that Can Track Multiple Signals
The Advanced Research Projects Agency for Health (ARPA‑H) has unveiled the Delphi program to create modular biosensors that can monitor multiple biomarkers such as inflammation markers, hormones, and drug levels. The initiative relies on electronic "chiplet" technology, allowing developers to...