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
A Monocyte‐Targeted Nanoplatform for Phagocytosis Activation and Ferroptosis Inhibition in Intracerebral Hemorrhage
Researchers have engineered a monocyte‑targeted nanoplatform (mPDA@DFO‑CpG‑N1) to accelerate hematoma clearance after intracerebral hemorrhage (ICH). The system combines a high‑affinity aptamer for selective monocyte delivery, a TLR9 agonist that overrides CD47‑SIRPα inhibition, and the iron chelator deferoxamine to block ferroptosis. In mouse ICH models the platform achieved a 3.2‑fold increase in lesion site accumulation, markedly improved erythrophagocytosis, reduced ferroptotic cell death, and restored neurological function. The work highlights monocyte‑derived macrophages as key effectors in ICH resolution.
FDA Delays Leqembi Decision; Artiva Raises $300M; Pharvaris Prices Offering
The FDA has postponed its decision on the subcutaneous formulation of Leqembi, moving the target date to August 24, delaying a potential launch for Eisai and Biogen’s early‑Alzheimer’s therapy. The shift adds uncertainty to the Alzheimer market, where Leqembi could become...
As Federal Government Pulls Back, Colorado Charts Independent Course with Vaccines
Colorado enacted a new law allowing the state to diverge from federal CDC vaccine recommendations, letting Medicaid purchase vaccines based on national medical societies and granting pharmacists authority to prescribe and administer shots. The legislation is part of a broader...
Federation of American Hospitals Taps New Government Relations Head
The Federation of American Hospitals (FAH) appointed Elizabeth Schwartz, former Merck executive director of U.S. policy and government relations, as senior vice president and head of government relations. Schwartz will lead advocacy for roughly 1,000 for‑profit hospitals as the sector...
Kanvas Biosciences Receives New Funding to Develop First-In-Category Microbiome Therapeutic for Improving Maternal, Newborn and Child Health
Kanvas Biosciences announced a new investment from the Gates Foundation to develop the world’s first fully synthetic microbiome therapeutic targeting maternal environmental enteric dysfunction (EED). The product will use a complex, multi‑strain consortium designed with AI‑driven discovery and spatial microbiome...
Urgent Care Clinics Boost Revenue and Throughput with AI Scribe
Experity Health’s AI Scribe, embedded in its urgent‑care EHR, automatically transcribes provider‑patient conversations into structured notes. Since its rollout in October 2025, more than 450 clinics have logged over 400,000 visits, cutting daily documentation time by roughly 40%. The efficiency...
In Florida Court, Sackler Family Member Admits Felony Tied to Her Opioid Addiction
Joss Sackler, wife of former Purdue board member David Sackler, pleaded guilty to a single felony count of obstruction of justice after admitting she deleted WhatsApp messages showing she was the intended recipient of a seized prescription‑drug shipment. The admission...
Abridge Releases Ambient AI Tech for Nurses
Abridge announced that its ambient documentation AI is now available to nurses at every health‑system client nationwide. The technology automatically captures and records patient‑encounter notes, aiming to cut the administrative load that nurses traditionally shoulder. Early adopters include Mayo Clinic,...
Privacy and Security Rules Extend to Paper Records
Health systems that revert to paper charts during electronic health record (EHR) downtime remain subject to HIPAA’s privacy and security rules, warns Polsinelli attorney Rebecca Romine. The guidance emphasizes that paper‑based protected health information (PHI) must be handled, stored, and...
The Week in Hospital M&A
Hospital mergers accelerated this week as Atrium Health and WakeMed announced a $2 billion merger to broaden North Carolina care, while UPMC signed a definitive agreement to acquire CommonSpirit’s Trinity Health System in Ohio. A lawsuit in Tallahassee seeks to block...
NEJM Publishes Moderna Flu Data After FDA Refusal
A Friday footnote: The New England Journal of Medicine has published the Moderna influenza vaccine data -- the same that led the FDA's CBER division to refuse to review the vaccine under Vinay Prasad. (That decision, called a refuse-to-file or...
Health System Downtime Recovery Must Involve All Technologies
Hospital contingency plans for network downtime typically center on electronic health records (EHR), leaving specialty applications unprotected, according to Rebecca Romine of Polsinelli Law Firm. When a network outage occurs, these critical tools can become inaccessible, jeopardizing patient care and...
Healthcare Cybersecurity Has Become an Operational Risk, Not Just a Security Function
Healthcare cybersecurity has moved from a back‑office IT issue to a core operational risk that directly affects patient care, revenue, and regulatory compliance. Ransomware and other attacks now disrupt electronic health records, scheduling, imaging and connected devices, forcing hospitals into...
Three Wins for AI in the Revenue Cycle
Brian Kenah, CTO of EnableComp, outlines three early AI wins in hospital revenue cycle management. First, document intelligence converts unstructured PDFs—contracts, fee schedules, regulations—into real‑time decision data for reimbursement. Second, intelligent integration leverages APIs and robotic process automation to replace...
Willis Knighton Health Taps AI Scribe Vendor
Willis Knighton Health, a four‑hospital network in Shreveport, Louisiana, has chosen Commure as its enterprise ambient AI scribe vendor. The partnership integrates Commure’s AI‑driven documentation tool with the system’s Meditech Expanse EHR. A seven‑specialty pilot showed 88% of providers experienced...
‘Financially and Operationally Unsustainable’: North Carolina Hospital to Drop Blue Cross Blue Shield, UnitedHealthcare Medicare Advantage Plans
CarolinaEast Medical Center, a 350‑bed hospital in New Bern, North Carolina, announced it will terminate its contracts with Blue Cross Blue Shield and UnitedHealthcare Medicare Advantage plans effective July 1. The hospital cited burdensome payment policies, frequent claim denials, and reimbursement...
Healthcare Adds 37,300 Jobs in April: 4 Things to Know
Healthcare employment rose by 37,300 jobs in April, aligning with the sector’s 12‑month average of 32,000 monthly gains, according to the U.S. Bureau of Labor Statistics. Ambulatory services led the surge with 18,200 new positions, while hospitals added 4,300 and...
Ninth Circuit Affirms Legacy Health's Vaccine Mandate over Religious Exemption Claims
The Ninth Circuit affirmed Legacy Health’s COVID‑19 vaccine mandate, rejecting the religious exemption claims of nine employees. The court applied the Supreme Court’s 2023 Groff undue‑hardship standard, emphasizing that non‑financial burdens such as staffing shortages and patient safety constitute substantial...
Unexplained Infertility Is a Diagnostic Shortcut, Not a Mystery
"Unexplained infertility" is the most overused diagnosis in fertility medicine. It almost never means there is no cause. It means the standard panel did not find a cause. Almost every couple we meet at Ferta who was told they had...
AI Struggles with Basic Data Tasks for Hospital Administrators: Study
A study by Mount Sinai and Mayo Clinic evaluated nine large language models on two basic administrative data tasks using 50,000 emergency department records. Simple prompts like “how many patients were admitted?” yielded poor accuracy across all models. Adding chain‑of‑thought...
Minnesota's Main Safety Net Hospital Seeks State Rescue
Hennepin County Medical Center, Minnesota’s largest safety‑net hospital, is on the brink of closure as early as June unless the state provides emergency funding. The Minnesota Senate has passed a $150 million rescue package, while lawmakers debate additional measures such as...
On World Ovarian Cancer Day, LGSOC Resource Guide Launches to Support People Living with Low-Grade Serous Ovarian Cancer
STAAR Low‑Grade Serous Ovarian Cancer Foundation, Not These Ovaries, and Verastem Oncology have launched the LGSOC Resource Guide on World Ovarian Cancer Day. The guide aggregates trusted educational content, videos, and FAQs to help patients, caregivers, and advocates navigate diagnosis,...
Vistagen Announces Completion of Last Patient Visit in PALISADE-4 Phase 3 Public Speaking Challenge Study of Fasedienol for Acute Treatment...
Vistagen announced that the final participant has finished the randomized, double‑blind portion of its Phase 3 PALISADE‑4 trial evaluating fasedienol nasal spray for acute social anxiety disorder. The company expects to release topline efficacy and safety data in the second quarter...
Etripamil
Etripamil (Cardamyst®) received FDA approval as a rapid‑acting, intranasal L‑type calcium channel blocker for converting acute paroxysmal supraventricular tachycardia (PSVT) episodes to sinus rhythm in adults. The drug leverages an ester‑sensitive phenylalkylamine scaffold to achieve fast onset and a short...
What Intermountain’s CEO Didn’t Anticipate About Its Epic EHR Launch
Intermountain Health completed the largest single‑site Epic EHR rollout in September 2024, migrating all 34 hospitals and 400 clinics at once rather than in phases. CEO Rob Allen chose the “big‑bang” approach to avoid a multi‑year fragmented transition that would...
Hantavirus Revives Fears of Covid-19 Pandemic in East Africa
A hantavirus outbreak on the Atlantic‑bound cruise liner MV Hondius has triggered health alerts at Kenya’s Mombasa port and Jomo Kenyatta International Airport. The incident arrives as East African cruise tourism, which has been rebounding after Covid‑19, sees a surge...
Participating Faculty: Clinical Management and Economic Drivers of Heart Failure With Preserved or Mildly Reduced Ejection Fraction
A multidisciplinary faculty has been announced for a session on clinical management and economic drivers of heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF). The panel includes senior HEOR leaders from Bayer and evidence‑generation specialists from Cencora, alongside...
What's the Playbook for Continuity and Compliance when IT Systems Are Down
Rebecca Romine of Polsinelli outlines a practical playbook for health‑care providers to preserve patient privacy when cyberattacks force a switch from electronic health records to paper‑based workflows. She stresses pre‑approved paper‑form templates, strict access controls, and real‑time documentation of manual...
Psilocybin Shows Promise After Decades of Failed Cocaine Treatments
For 50 years the National Institute on Drug Abuse has spent hundreds of millions of dollars to find an effective cocaine addiction medication. After 100+ molecules & many hundreds of studies nothing has been FDA approved. It's the Holy Grail...
U.S. Death Rates Remain Higher Than Peers Despite Equal Tech
"Despite similar access to advanced medical technology, the US has experienced persistently higher death rates than other high income countries" https://t.co/iIe8UJbUCs
HCA, Tenet, CHS and UHS Stand Firm on 2026 Financial Projections After Q1
The four largest for‑profit health systems—HCA, Tenet, Community Health Systems (CHS) and Universal Health Services (UHS)—reaffirmed their 2026 financial guidance after reporting Q1 results. HCA posted $1.62 B net income and expects $6.5‑$7 B net income in 2026, while Tenet’s net income...
Measles Cases Surge: 80% of 2026 Total in 4 Months
#Measles is still doing in the US what measles does super well — spreading. As of 5/7, there have been 1,842 confirmed cases this year, which is 80% of the 2026 total in just over 4 months. https://t.co/fMaSWEJiUL
Nobel Laureate: Decriminalizing Taboo Markets Saves Lives
What do kidney sales, surrogacy and sex work have in common? A Nobel laureate says decriminalizing these taboo markets can save lives https://t.co/qWXRewcWH7 via @felixsalmon https://t.co/zUV2oscgvq
ChatGPT Adds Mental Health Safety Feature
OpenAI is introducing Trusted Contact, an optional safety feature that lets adult ChatGPT users nominate a single trusted person to be alerted if the AI detects serious self‑harm language. The system first notifies the user, then a trained human reviewer...
Metformin's Primary Action Is Gut, Not Liver
Metformin, one of the most commonly prescribed drugs, was thought to work via the liver. Check that. It's primarily through the gut. @NatMetabolism https://t.co/i2CpZip61B https://t.co/bhsI7p7SYx
Pulse Biosciences to Present at the BofA Securities 2026 Healthcare Conference
Pulse Biosciences (NASDAQ: PLSE) announced it will present at the Bank of America Securities 2026 Healthcare Conference in Las Vegas on May 13. The company will showcase its proprietary nPulse™ nanosecond pulsed field ablation (nsPFA™) platform, which aims to treat...
Pharmaceutical Supply Chain’s Strategic Moment: Lessons From Health System Leaders
Health system leaders at Becker’s 16th Annual Meeting highlighted a turning point in pharmaceutical distribution, emphasizing that poor data quality hampers AI forecasting and that clean, centralized inventory data is now a prerequisite. Executives described initiatives such as RFID deployments...
Bristol Myers Squibb Receives European Commission Approval of Sotyktu (Deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults
Bristol Myers Squibb announced that the European Commission has approved Sotyktu (deucravacitinib) for adults with active psoriatic arthritis, either as monotherapy or with methotrexate. The approval follows positive Phase 3 POETYK PsA‑1 and POETYK PsA‑2 trials, which demonstrated statistically significant improvements in ACR20...
Communicating Benefit and Risk Information
The FDA’s Division of Drug Information highlighted its dual‑track approach to benefit‑risk communication: direct patient‑oriented counseling and sponsor‑directed guidance for manufacturers. Since 1999, the agency has mandated Medication Guides for drugs with serious adverse‑effect potential, and it enforces balanced risk...
Drug Promotion
The FDA oversees all promotional materials for prescription drugs, ranging from TV spots to website content, while the FTC handles over‑the‑counter products. Companies cannot obtain pre‑approval, but must submit their ads to the agency at the time they go public,...
Trump Administration Lifts a Hold on Immigration Applications for Doctors, but Leaves Others in Limbo
The Trump administration has lifted a hold on immigration applications for physicians, allowing pending visa and green‑card cases to be reviewed again. The exemption comes after a broader pause that halted green‑card and visa processing for nationals of dozens of...
Adapting Healthcare Payments While Facing Financial Pressure and Economic Uncertainty
Healthcare providers face mounting financial strain as uncompensated care is projected to increase by $2.2 billion for hospitals and $1 billion for physician offices in 2026, while non‑labor expenses climb from 6 % to 10 % of budgets. Rising administrative costs and volatile patient...
Canada Allocates $30.3 Million to 21 Youth‑Mental‑Health Projects
On National Child and Youth Mental Health Day, Health Minister Marjorie Michel unveiled a $30.3 million (≈ $22 million USD) investment in 21 community‑based youth‑mental‑health projects across Canada. The funding aims to broaden culturally safe, early‑intervention services and launch the country’s first clinical...
Brief Mindfulness and Gratitude Practices Cut Systolic Blood Pressure by Up to 7.6 Mm Hg
A review of 18 randomized trials led by Rosalba Hernandez of the University of Illinois shows that daily mindfulness, gratitude journaling and optimism exercises can lower systolic blood pressure by as much as 7.6 mm Hg within weeks. The findings suggest brief...
When There’s No Appointment Available, Patients Are Opening ChatGPT
Patients facing weeks‑long waitlists and $150‑plus out‑of‑pocket fees are increasingly turning to ChatGPT for immediate emotional support. While the AI offers instant, non‑judgmental replies, it was not engineered for mental‑health care and lacks therapeutic safeguards. Experts argue that purpose‑built mental‑wellness...
Tellihealth Wins Virtual Care Innovation Award at 2026 MedTech Breakthrough Awards
Tellihealth secured the Virtual Care Innovation Award at the 10th annual MedTech Breakthrough Awards, underscoring its integrated remote patient monitoring and chronic care management platform. The win reflects growing market demand for scalable virtual‑care solutions that go beyond video visits.
STAT+: Pharmalittle: We’re Reading About an FDA Gender Rule Change, Its Program for One-Day Inspections, and More
The U.S. Food and Drug Administration announced a proposed rule to strip references to “gender” from its regulations, aligning with a 2025 Trump administration executive order that stresses biological sex. While the agency claims the change won’t affect industry practice,...
Capricor Sues Partner Nippon Shinyaku in DMD Therapy Spat
Capricor Therapeutics has filed a lawsuit against its Japanese partner Nippon Shinyaku and its U.S. subsidiary NS Pharma, alleging a fundamental pricing flaw in their distribution agreement for the Duchenne muscular dystrophy (DMD) cell therapy deramiocel. The biotech claims the...
Tele‑ICU Rollout Sparks Staffing Crisis and Patient‑Safety Concerns at Ascension Wisconsin
Ascension Wisconsin announced plans to replace on‑site intensivists with remote tele‑ICU physicians at three Milwaukee‑area hospitals, prompting nurses and families to warn that the model could worsen staffing gaps and jeopardize patient outcomes. The move follows a high‑profile lawsuit alleging...
ASGCT Honors Mohamed Abou‑el‑Enein as Outstanding New Investigator
Mohamed Abou‑el‑Enein, MD, PhD, received the American Society of Gene and Cell Therapy’s 2026 Outstanding New Investigator Award and his lab earned the Best of Molecular Therapy Award. His team’s high‑dimensional spectral flow cytometry platform maps CAR‑T cell states, pinpointing...