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
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How to Manage ADHD Medication Rebound
ADHD medication rebound describes the sudden return of mood swings, fatigue, and heightened ADHD symptoms as short‑acting stimulants wear off. It is driven by rapid metabolism that creates a sharp drop in drug levels, distinguishing it from typical side effects. Clinicians can mitigate rebound by switching to longer‑acting formulations, adjusting doses, or adding a supplemental immediate‑release dose. Parents are advised to track symptoms, maintain consistent diet, sleep, and exercise, and coordinate any changes with a healthcare provider.
FDA Grants First Gene‑Therapy Approval for Rare Pediatric Immune Disorder LAD‑I
The U.S. FDA has approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel) for children with leukocyte adhesion deficiency type I, marking the world’s first gene‑therapy option for the disease. Approval follows a single‑arm trial of nine patients that showed 100% survival and restored...
CDER SBIA Chronicles
The FDA’s CDER Small Business & Industry Assistance (SBIA) Chronicles newsletter delivers regulatory guidance to drug manufacturers through a series of podcasts and a searchable archive. The most recent episodes—released on Dec 13 2024, Nov 14 2024, and May 17 2024—cover centralized statistical monitoring for data...
Pharmacy's Rising Role in Cell and Gene Therapy: Zahra Mamoudjafari, PharmD, MBA
Cell and gene therapies (CGTs) are receiving approvals faster than health‑care institutions can operationalize them. Zahra Mahmoudjafari, a clinical pharmacy leader at the University of Kansas Health System, published a framework outlining eight interdependent domains needed for financially sustainable, patient‑accessible...
Helpful Webinars and Other Resources for Generic Drug Manufacturers
The FDA has compiled a suite of webinars, workshops and seminars aimed at helping generic drug manufacturers improve their abbreviated new drug application (ANDA) submissions. Topics span bioequivalence studies, inactive ingredient databases, sample retention, and product‑specific challenges for oral, inhalation,...
What Johnson & Johnson Earnings Signal for Healthcare ETFs
Johnson & Johnson reported first‑quarter revenue of $24.1 billion, topping the $23.6 billion consensus, and earnings per share of $2.70 versus $2.66 expected. The beat was driven by robust performance in its MedTech division and strong oncology drugs such as Darzalex, offsetting...
Hims & Hers Health, Inc. Dba Hers - 716825 - 09/09/2025
The FDA issued a warning letter to Hims & Hers Health, Inc., alleging that the company’s website falsely marketed its compounded semaglutide as equivalent to FDA‑approved products like Ozempic and Wegovy. The agency cites violations of FDCA sections 502(a), 502(bb)...
The MDO Nitinol Knowledge Webinar Returns with a Medtronic Distinguished Engineer
Medtronic Distinguished Engineer Ramesh Marrey will headline Medical Design & Outsourcing’s 2026 Nitinol Knowledge webinar on May 14. Marrey, a veteran of structural heart, aortic and neurovascular R&D, brings over two decades of expertise in implant biomechanics, finite‑element analysis, and regulatory strategy....
About the Quantitative Medicine Center of Excellence (QM CoE)
The FDA’s Center for Drug Evaluation and Research (CDER) has launched the Quantitative Medicine Center of Excellence (QM CoE) to centralize quantitative expertise across its offices. Governance includes senior leaders from the Offices of Generic Drugs, New Drugs, Pharmaceutical Quality,...
FDA Clears Next-Gen Device for Left-Heart Access
Protaryx Medical received FDA clearance for its next‑generation Transseptal Puncture Device, enabling left‑heart access in minimally invasive cardiac procedures. The system features zero‑exchange delivery, an atraumatic design, an echogenic extendable probe and a standardized RF guidewire compatible with multiple electrosurgical...
Autism Diagnoses Are up, Largely Fuelled by the NDIS. What Happens Next Isn’t Entirely Clear
A recent health‑economics study links Australia’s National Disability Insurance Scheme (NDIS) to a 32% jump in autism prevalence, finding that regions with early NDIS rollout saw diagnosis rates rise by 0.56 percentage points. The surge appears driven by clinicians lowering...
HSAs Without Insurance Could End Perpetual Premium Debt
The one debt you can’t ever pay off ? Your insurance premiums. You literally will pay an insurance premium monthly, till you die. But we don’t look at it like it’s a debt paid to an insurance company that...
In Re Entresto (Sacubitril/Valsartan) Patent Litigation (Novartis Pharms. Corp. V. MSN Labs. Private Ltd.
The Delaware District Court granted Novartis summary judgment in the Entresto patent case, invoking both issue and claim preclusion to bar MSN Labs from relitigating claim construction, validity, and infringement of U.S. Patent No. 8,101,659. The court held that the prior...
Cancer Dependency Map Consortium Launches Phase 3 to Accelerate Next-Generation Therapeutics
The Broad Institute’s Cancer Dependency Map Consortium (DMC) has entered Phase 3, expanding its mission beyond cataloguing tumor vulnerabilities to tackling drug resistance, surface‑protein targets, and high‑dimensional readouts. Backed by 23 pharma partners, the consortium builds on DMC 2.0’s expansion to over...
Elahere Combination Achieves 62.7% ORR in Phase 2 Trial for Platinum-Sensitive Ovarian Cancer at SGO 2026
AbbVie’s Elahere (mirvetuximab soravtansine) combined with carboplatin produced a confirmed objective response rate of 62.7% in patients with FRα‑positive, platinum‑sensitive ovarian cancer, meeting the primary endpoint of the Phase 2 IMGN853‑0420 trial presented at SGO 2026. The study enrolled 125 participants,...
Caregiving Is Now so Crazy Expensive that It’s Financially Devastating to Most Families, New Research Shows
The Roosevelt Institute reports that long‑term‑care costs are crushing middle‑class families, with 56% of Americans who turned 65 between 2022‑2025 needing care and expenses reaching $129,000 a year for a private nursing‑home room. Median retirement savings sit at just $955,...
Nicole Kidman Inspired to Become Death Doula by Mother’s Passing
Actress Nicole Kidman announced she is training to become a death doula after watching her mother’s final days in 2024. She described the role as non‑medical support that offers solace to the dying and their families. Kidman shared the motivation...
Enhancement of Intestinal Barrier Function and Alleviation of Mycophenolic Acid Toxicity by a Probiotic-Conditioned Medium in Vitro
The study demonstrates that an acellular probiotic‑conditioned medium (postbiotic) strengthens intestinal barrier function and mitigates toxicity of the immunosuppressants mycophenolic acid (MPA) and mycophenolate mofetil (MMF) in a CaCo‑2 cell model. The conditioned medium increased transepithelial electrical resistance, up‑regulated tight‑junction...
Relationship Between Iodine Nutritional Status and Low Handgrip Strength in a Northwestern Chinese Cohort: Construction of a Predictive Nomogram Model
A cross‑sectional study of 810 adults in Lanzhou, China identified key predictors of low handgrip strength (LGS), a core marker of sarcopenia. Multivariate analysis showed that female sex, greater height, and excess urinary iodine concentration (UIC) were protective, while advanced...
Editorial: Innovative Approaches to Nutrition Counseling in Pediatric Dietetics - Guidelines, Practices, and Future Directions
Recent research compiled in Frontiers' 2026 editorial highlights that pediatric nutrition counseling is evolving toward standardized, family‑centered, and technology‑enabled models. Studies show that rigorous documentation, frequent dietitian contact, and telehealth improve diagnostic accuracy and continuity of care, especially for infants...
Editorial: Nutrition for Sustainable Weight Management Post-Bariatric Surgery
The editorial introduces a Frontiers Nutrition research collection examining how nutrition, metabolic monitoring, and personalized care can sustain weight loss after metabolic bariatric surgery (MBS). It highlights four studies: a review advocating multimodal strategies—including diet, GLP‑1 agonists, and revisional procedures—to...
Regulation of Bile Acids Homeostasis: A Feasible and Versatile Way to Treat or Diagnose Liver Disorders
The review underscores bile‑acid (BA) homeostasis as a central driver of liver disease, linking imbalances to cholestasis, fibrosis, cirrhosis, hepatocellular carcinoma and MASLD/MASH. It details how hydrophobic BAs provoke mitochondrial and endoplasmic reticulum stress, activate hepatic stellate cells, and interact...
The ROI of Ambient AI in Health Care and Autonomous Coding
Ambient AI is moving beyond a digital scribe to reshape the entire note‑to‑bill continuum in health care. Early pilots showed 20‑40% reductions in documentation time, easing clinician burnout, but CFOs now demand measurable revenue impact. By feeding real‑time documentation into...
Palantir Defends Its Record as MPs Demand More Scrutiny of Data Use
Palantir’s UK arm is defending a £300 million (~$380 million) NHS contract as MPs from Labour, the Liberal Democrats, the Greens and the Conservatives call for tighter scrutiny of its data handling. The company’s Foundry federated data platform is intended to link...
Does CMS Hate Specialists?
Orthopedic surgeons see Medicare reimbursement for joint replacements plunge 57% over two decades while CMS rolls out value‑based programs that shift financial risk to primary‑care‑led entities. Initiatives such as ACCESS, TEAM, ACO LEAD and the new CJR‑X model deliberately limit specialist...
Whoop Joins Medicare via CMS ACCESS Program
WHOOP 🤝 MEDICARE This week marks a defining moment for @whoop - and a major leap forward for Medicare with eligible individuals now able to receive Whoop as part of their care. Our affiliated healthcare provider, Whoop Physician Services, PC, has been...
Targeting Aging: Epigenetic Reprogramming Tackles Disease Root
Aging is arguably the root cause of most major diseases. Our cells lose function as we age, allowing various conditions to manifest, which is why most major diseases correlate with age. Yes, it is more complex than this, but this is...
Helping Healthcare IT Teams Do More and Avoid Burnout
UVA Health’s chief technology officer, Zeb Elliott, used the HIMSS Executive Connect program to redesign how his IT department engages staff. By adopting agile sprint cycles, mental‑health check‑ins, and automation tools, the team lifted output while curbing overtime. The changes...
Low‑cost Vaccines Bypass Big Pharma, Influencers Profit
No, the opposite. I develop low cost vaccines that bypass big pharma. The only shills are those connected to the corrupt wellness influencer industry, which buys whatever it can in bulk cheap so they can jack up the price with...
Executive Coaching Helps Leaders Grow Through Discomfort
UVA Health Chief Technology Officer Zeb Elliott credits executive coaching from the Healthcare Leadership Institute, delivered via HIMSS Executive Connect, for surfacing uncomfortable but honest feedback that highlighted gaps in his leadership style. The coaching program prompted Elliott to confront...
FDA Bolsters Bespoke Therapy Framework with New Draft Safety Guidelines
The FDA’s Center for Biologics Evaluation and Research issued draft guidance to standardize safety assessments for genome‑editing therapies, covering both ex vivo and in vivo products that use next‑generation sequencing to detect off‑target effects. The recommendations target nonclinical studies supporting IND and...
New Alzheimer’s Blood Test Promises Earlier Detection
Researchers at Mass General Brigham have shown that the blood‑based pTau217 biomarker can predict amyloid and tau plaque buildup years before PET scans turn positive, even in asymptomatic adults aged 50 to 90. The study of 317 participants demonstrated that...
Nasal EV Spray Reverses Neuroinflammation and Boosts Memory
A nasal spray delivering extracellular vesicles reversed neuroinflammation, restored mitochondrial function, and improved memory in aging brain models, suggesting a noninvasive approach to counteract cognitive decline. neuroscience
Why Is Alcohol Use Declining in Canada?
Canada’s per‑capita alcohol sales have dropped sharply, falling 18% from 8.3 L ethanol in 2020‑21 to 6.8 L (about 399 standard drinks) in 2024‑25, marking the fourth consecutive year of decline. The trend mirrors a similar downturn in the United States, suggesting...
Apple Studio Display XDR Now Cleared for Diagnostic Radiology
Apple’s Studio Display XDR has received FDA clearance for diagnostic radiology, allowing U.S. radiologists to view medical images on the consumer‑grade monitor. The display supports DICOM presets on macOS 26.4, eliminating the need for dedicated imaging screens. Priced at $2,899,...
HFA Launches New End-of-Life Dementia Care Training
The Hospice Foundation of America (HFA) has launched a new educational program, Best Practices in Hospice Care for Advanced Dementia, to help hospice and palliative teams address the complex needs of patients with Alzheimer’s disease and related dementias. The curriculum...
Fordham 33 (Report 4): Life Sciences and Healthcare Innovation
A multinational panel at Fordham’s IPKat event dissected life‑science patent strategies across the U.S., Europe, Japan and the upcoming Unified Patent Court. Speakers highlighted how European protocol disclosures reveal methods but not results, making anticipatory rejections rare, while U.S. product‑for‑use...
How Technology Supports Children With Hearing Loss
Pediatric hearing loss hampers language development, classroom engagement, and social interaction, making early detection essential. Screening in infancy and early childhood enables timely interventions such as hearing aids, cochlear implants, and speech‑to‑text tools. Classroom technologies—including assistive listening systems and captioning—reduce...
Reproxalap Safe for Use in Patients With Dry Eye Disease
A Phase 3 trial of 0.25 % reproxalap eye drops in 757 dry‑eye disease patients found no serious treatment‑related adverse events. Mild ocular irritation was the most common side effect, occurring more often in older women. Visual acuity showed modest improvement, especially...
AWS Launches Amazon Bio Discovery for AI-Powered Scientific Experimentation
Amazon Web Services unveiled Amazon Bio Discovery, a cloud‑based platform that supplies scientists with a curated library of biological foundation models (bioFMs) for generating and evaluating drug molecules. The service lets researchers train custom models on their own experimental data...
Telehealth Prescribing Laws in 2026: Navigating Controlled Substance Rules
The DEA has extended its COVID‑era telemedicine flexibilities for prescribing controlled substances until Dec. 31 2026, keeping the federal waiver on the in‑person exam requirement alive. However, many states have enacted stricter telehealth prescribing rules that can supersede the federal allowance, especially...
FDA Eases Digital Health Oversight as Approval Delays Continue to Shape Patient Access
The FDA announced a shift toward lighter regulatory oversight for digital health products, aiming to cut the lengthy approval timelines that have constrained patient access. Meanwhile, telehealth usage continues its surge, now representing 43% of Medicare mental‑health visits and prompting...
Unpaid Call Still Required for Hospital Privileges
Your hospital privileges are tied to taking call. No call, no practice. That is the condition, not a choice. Corinne Sundar Rao calls it what it is: unpaid labor baked so deeply into the system that most physicians absorb it...
High Blood Glucose Linked to Cognitive Decline via Lactate Pathway
How do high glucose levels in the blood impair cognition and predict mild cognitive impairment in people with diabetes? @scisignal Elevated plasma lactate and related pathway, with a peptide intervention to potentially address it https://t.co/ai1369HWVU https://t.co/JcszZT2Tt2
Updated: FDA Asks for Data on Lilly’s Foundayo to Assess Heart, Liver Risks
The U.S. Food and Drug Administration has asked Eli Lilly for additional safety data on its newly approved obesity medication, Foundayo. The agency is specifically seeking information on any cardiovascular events and liver‑related adverse effects observed in clinical trials and post‑marketing...
Seven-Year Longitudinal Respiratory Morbidity in Ohtahara Syndrome: A Case Emphasizing Integrated Airway and Seizure Care in a Resource-Limited Setting
A seven‑year longitudinal case study of a girl with Ohtahara syndrome (OS) reveals that recurrent pneumonia and bronchopneumonia dominate her morbidity, accounting for over 15 hospitalizations between ages one and seven. Despite aggressive antiseizure regimens, her respiratory complications often coincided...
GLP-1 Drugs Reshape Consumer Spending, Eating and Wellness Habits: Report
A new Acosta Group study of 2,117 U.S. adults, including 213 GLP‑1 users, finds the weight‑loss drugs are reshaping shopping, eating and wellness habits. Users are buying more fresh produce, protein foods and supplements while cutting sweets and sugary drinks....
Air Ambulance Costs Soar Despite Limited Use in Workers Compensation
Air ambulance transports remain rare in workers‑comp claims, affecting fewer than 1.2% of rural lost‑time cases, yet they dominate cost drivers. Average payments have surged more than 60% since 2013, topping $25,000 per flight by 2022. Utilization spikes in very...
Introducing a Group-Based Cannabis Prevention Program for Adolescents in Youth Residential Care in Germany (CANJuStop): Study Protocol for an Exploratory...
A new group‑based cannabis prevention program, CAN Ju Stop, is being tested among adolescents in German residential youth care. The exploratory cluster‑randomized trial compares the adapted six‑session intervention with a waitlist control, measuring abstinence or reduction in cannabis use over 30 days....
5 of the Top 10 U.S. Health Systems Are Moving to This New Health IT Category. Here’s Why.
Health systems have built fragmented AI "agent" stacks that operate on isolated data slices, leading to mis‑aligned decisions and limited impact. The core issue is a lack of unified context across clinical, financial and operational information. Innovaccer’s Gravity platform introduces...