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
FDA to Unify Agency’s ‘Fragmented’ Safety Surveillance System
The FDA launched the Adverse Event Monitoring System (AEMS), a unified dashboard that merges seven previously fragmented safety databases into a single platform. Four databases are already live, with the remaining three slated for integration by May, covering drugs, vaccines, cosmetics, and soon medical devices, food, and tobacco products. The consolidation is projected to cut $120 million in costs over five years while providing real‑time access to roughly 6 million annual adverse‑event reports. The agency emphasizes the system’s utility despite inherent data limitations.
FDA to Unify Agency’s ‘Fragmented’ Safety Surveillance System
The FDA has launched the Adverse Event Monitoring System (AEMS), a unified platform that merges seven previously fragmented safety‑surveillance databases. Four of those databases are live today, with the remaining three slated for integration by May 2026. The agency processes...
FDA Clears Intravascular Device Billed as ‘World’s Smallest Camera’ as Physicians Share New Data
Vena Medical secured FDA clearance for its Vena MicroAngioscope System, marketed as the world’s smallest intravascular camera, for peripheral artery imaging. The device provides real‑time color images without X‑ray fluoroscopy by pairing a balloon distal access catheter with a saline...
Non‑psychiatrists Overprescribe Psychiatric Meds, Endangering Patients
Too many physicians who aren't psychiatrists think "they know best" when it comes to psychiatric medications. Nothing could be further from the truth. Or more potentially dangerous for the patient who encounters one of these dung holes.
How AI Is Helping Improve Heart Health in Rural Australia
Google Australia, together with Wesfarmers Health, SISU Health, the Victor Chang Cardiac Research Institute and Latrobe Health Services, is launching a $1 million AI‑driven program to tackle heart disease in remote communities. The initiative uses Google for Health’s Population Health AI,...
Advita Ortho Receives Warning Letter Related to Shoulder System
Advita Ortho, a newly formed orthopedics company that acquired Exactech's assets, received an FDA warning letter in December concerning its Equinoxe Reverse Shoulder System. The letter highlighted undefined product specifications, inadequate supplier audits, incomplete production documentation, and persistent temperature and...
Reviews of Pediatric Studies Conducted Under BPCA and Pediatric Assessments Conducted Under PREA From 2012 – Present
The FDA has compiled reviews of pediatric studies conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) from 2012 to present. A total of 88 products were studied under BPCA, 544 under PREA,...
Lawmakers Seek Coverage for Expedited Fertility Care Under PACT Act
Lawmakers introduced the bipartisan Warrior Infertility Act to designate infertility as a presumptive condition under the 2022 PACT Act. The bill would fast‑track VA coverage for in‑vitro fertilization and other reproductive treatments without requiring veterans to prove a direct service...
The Hepatitis B Birth Dose Trial That Triggered the WHO Alarm
The World Health Organization issued a formal warning on 13 February 2026 about a proposed randomized trial in Guinea‑Bissau that would withhold the hepatitis B birth‑dose vaccine from roughly half of 14,000 newborns. The study seeks to measure non‑specific effects...
Army Guard Medics Strengthen Kosovo Clinic with Lifesaving Training
U.S. Army National Guard medics from NATO’s KFOR conducted lifesaving medical training at a clinic in Obiliq, Kosovo, as part of the routine hand‑over from KFOR 35 to KFOR 36. The program delivered basic Combat Lifesaver, CPR, advanced cardiac life...
RFK Jr Promotes Unproven Peptides, BPC‑157 Lacks Solid Data
RFK Jr is trying to get 14 peptides, without data on safety or efficacy, licensed and approved by FDA. His favorite is BPC-157. "Only three small human studies of BPC-157 exist, for instance, the largest of which is a telephone...
AstraZeneca and Joshua Jackson Partner to Encourage Fans to Get Body Checked Against Cancer
AstraZeneca has partnered with actor Joshua Jackson and the Philadelphia Flyers mascot Gritty for the Get Body Checked Against Cancer campaign. The initiative leverages hockey’s "body check" metaphor to urge fans to discuss cancer‑screening options with their doctors. AstraZeneca highlighted...
Safety-Net Providers Tackle AI Adoption as Medicaid Cuts Loom
Safety‑net health providers are bracing for massive Medicaid cuts enacted by the recent "Big Beautiful Bill," which will strip billions from state programs and impose strict work‑requirement reporting. At the 2026 HIMSS conference, experts warned that these changes could trigger...
Heru Showcases PretestPro™ for the Heru VR-Powered Diagnostic Headset at Vision Expo
Heru unveiled PretestPro™ at Vision Expo, a VR‑powered diagnostic headset that completes four essential eye‑pre‑tests in under two minutes. The wearable platform merges visual field, near cover test, extraocular motility and quantitative pupillometry into a single, AI‑guided workflow, replacing multiple...
Alkermes Announces Inaugural Alkermes Pathways APN Research Awards™ Program
Alkermes plc announced the inaugural Alkermes Pathways APN Research Awards™, a competitive grant program offering up to $10,000 per project to licensed psychiatric‑mental health nurse practitioners researching schizophrenia or bipolar I disorder. The application window runs from March 16 to...
Baseimmune Announces Strategic Expansion Into Fibrosis with Lead Program Targeting Idiopathic Pulmonary Fibrosis (IPF)
Baseimmune announced a new fibrosis‑focused pipeline leveraging its computational protein design platform to create multi‑pathway immunotherapies, starting with idiopathic pulmonary fibrosis (IPF). The company aims to deliver proof‑of‑concept efficacy data for its lead IPF program in 2026‑2027, addressing the limitations...
Rhode Island Bill Proposes Age Restrictions on Weight-Loss and Muscle-Building Supplements
Rhode Island Senate Bill 2774, introduced on March 4, would prohibit the sale of over‑the‑counter diet pills and weight‑loss or muscle‑building supplements to anyone under 18. The bill requires retailers to store these products in locked cases or behind counters, limiting...
Oral Anticoagulation Alone Best for Stable CAD Patients With AF: Meta-Analysis
A meta‑analysis of six randomized trials involving 5,924 stable CAD patients with atrial fibrillation found that oral anticoagulant (OAC) monotherapy reduced cardiovascular mortality by 31% and major bleeding by 54% compared with OAC plus a single antiplatelet. The benefit persisted...
How Collective Intelligence Could Soon Reshape Medical Decision-Making
Recent advances in collective intelligence and artificial intelligence are enabling large‑scale, data‑driven collaboration among clinicians. Studies show that pooling independent physician judgments can lift diagnostic accuracy from roughly 46% to 76%, and hybrid human‑AI constellations outperform either humans or models...
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Venomous Snakes Represent a Serious Public Health Problem. Scientists Are Biting Back With a Groundbreaking Antidote
Snakebite envenoming kills over 125,000 people each year and leaves three times as many disabled, while current horse‑derived antivenoms trigger severe allergic reactions in nearly half of patients. The high cost—up to $100,000 per course—and limited hospital access leave rural...
Pediatric and Congenital Heart Disease Series: In-Vivo Assessment of Novel Cardiac Valve Prostheses
On March 12, 2026, TCTMD’s Heart Valve Matters podcast featured Ami Bhatt and John Carney discussing the role of in‑vivo assessments in shaping next‑generation cardiac valve prostheses for children with congenital heart disease. The hosts highlighted how animal studies and...
BridgeBio Builds Case for Early 2027 Launch of Dystrophy Drug
BridgeBio Pharma reported that its small‑molecule candidate BBP‑418 produced a 1.8‑fold increase in the α‑dystroglycan biomarker in a Phase 3 FORTIFY trial for limb‑girdle muscular dystrophy type 2I/R9, with effects sustained through 12 months. The trial enrolled 81 patients and also showed...
I Lost 218 Pounds and My Ability to Walk: A Bariatric Surgery Regret
Stephanie Mojica lost 218 pounds after a duodenal‑switch bariatric surgery performed in Mexico, but severe post‑operative dehydration and nutrient deficiencies left her with permanent mobility loss and vision problems. She now relies on a walker and wheelchair, despite having shed the weight...
Innovaccer, Databricks Partner to Operationalize Healthcare AI
Innovaccer announced its Gravity platform has earned Built on Validated Partner status with Databricks, confirming production use of the lakehouse stack. The partnership integrates Delta Lake, Databricks SQL, and Managed MLflow into Gravity’s AI infrastructure, streamlining data transformation and model...
The Prior Auth Panic: WEDI Survey Reveals Providers Are Stalling as the CMS API Deadline Looms
The CMS Advancing Interoperability and Improving Prior Authorization Final Rule requires all health‑care entities to deploy specific prior‑auth APIs by January 1, 2027. A February 2026 WEDI survey shows payers have largely caught up, with only 10% still idle, down from 43% a...
Lantern CFO Greg Chisholm Talks Health Care, AI and Capital Allocation
Lantern appointed Greg Chisholm as CFO, leveraging experience from HelloFresh, Wayfair, and McKinsey. He is focused on mapping the health‑care business’s complexity and shaping capital‑allocation decisions as the company scales at roughly 50% annual growth. Chisholm points to structural cost...
NHS England Image Reading Design Sprint: Two Weeks Inside Breast Screening Reporting
dxw conducted a two‑week design sprint with NHS England to overhaul reporting for breast‑screening image readers. The team mapped the end‑to‑end workflow, built a unified data model, and defined key performance indicators for readers, unit directors, and the Screening Quality...
AMA Finds 70 Percent of Physicians See AI as a Burnout-Reduction Tool
The AMA’s 2026 Physician Survey shows AI adoption has more than doubled, with 81% of doctors now using AI tools versus 38% in 2023. Physicians average 2.3 AI use cases, driven by clinical documentation and research summarization. Seventy percent view...
Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia
Aplagon Therapeutics has administered the first dose of its intravenous APAC candidate to a patient in a Phase 2a (HEALING) trial for peripheral arterial occlusive disease leading to chronic limb‑threatening ischemia in Finland. The study will enroll approximately 42 CLTI...
AI Pre-Visit Chat Delivers Concise Summaries for Doctors
A very important prospective (!) study from Google and Beth Israel Deaconess Medical Center about using AI before a new ambulatory primary care visit. The patient talks with a conversational AI that will summarize every important detail for the physician by...
Trump Must Nominate CDC Director by March 25
A deadline is looming for the Trump administration. If it wants to be able to have an acting director at #CDC it must nominate a director candidate by March 25. Complicated situation laid out in this piece written before Jay...
Patients Lose Out From Blind Spot in NHS Staff Survey
The Recruitment and Employment Confederation (REC) is urging the NHS to add agency workers to its annual Staff Survey, highlighting a critical blind spot that excludes a sizable portion of the workforce. While the survey recently expanded to include Bank‑only...
Call for Federal Men’s Health Office Gains Momentum
Yup, as Dr Bernie says, public health is not a zero-sum game, need a focus on women's AND men's health/ Momentum builds for a federal office of men’s health focused on disease prevention https://t.co/ONPLMEzKWv via @statnews https://t.co/ASKuoMrJSO
Healthcare Costs Forcing Debt, Hunger, and Retirement Delays
Such a dismal conclusion. Taking on debt, skipping meals, delaying retirement, etc, etc, in order to cover healthcare costs. When does America come to grips with healthcare costs? Something has to give. https://t.co/L48u4W2CDG
Bridging Promise and Evidence in Psychedelic Medicine
Jacobs and colleagues present a state‑of‑the‑art review of psilocybin and MDMA‑assisted therapies, highlighting their potential for treatment‑resistant depression and PTSD. The authors emphasize the distinct, session‑based paradigm that leverages acute neurobiological changes to produce lasting clinical benefits. However, they also...
GenAI Health Tools Multiply: ChatGPT, Claude, CoPilot
In January there was ChatGPT Health, Claude Health. Today there's Microsoft CoPilot Health. And more to come in the genAI -> health landscape https://t.co/TInH9YTvwA
Pierre Fabre, ATRA to Meet FDA on Ebvallo CRL Soon
Pierre Fabre and $ATRA said FDA meeting to discuss the Ebvallo CRL has been scheduled. (Likely occuring within the next month.)
Colon Cancer Now Leading Cause of Cancer Deaths Under 50 in US
A new American Cancer Society analysis shows colorectal cancer has become the leading cause of cancer death for Americans under 50, overtaking all other malignancies. Roughly three‑quarters of these young patients are diagnosed at an advanced stage because routine colonoscopies...
Arizona Cardiology Group to Pay $4.75M to Resolve Allegations of Unnecessary Vein Ablations
Tri‑City Cardiology, a Phoenix‑based physician group, and three doctors agreed to pay $4.75 million to settle False Claims Act allegations that they performed medically unnecessary vein ablations between 2017 and 2022. The government alleges the physicians falsified vein measurements, symptom documentation,...
New FDA Guidance Could Elevate Pharma’s Biosimilar Market
The FDA issued draft guidance that could lower biosimilar testing requirements by permitting foreign comparator data, potentially cutting development costs by about half. Over 80 biosimilars have been approved in the U.S. since the first approval 11 years ago, yet...
I'm an American Who Got a Full Medical Checkup in Japan. In 4 Hours, I Learned More About My Health...
An American physician underwent a full “Ningen Dock” preventive checkup at a Tokyo hospital, completing more than 20 tests in just four hours. The $1,800 exam delivered immediate lab results and a physician consultation, contrasting sharply with the fragmented, often...
The Longevity Industry Has a Blind Spot. MedicBite Was Built to Fix It.
MedicBite Clinic Madeira opened in Funchal as Europe’s first multidisciplinary facility dedicated to structural alignment medicine, emphasizing the link between posture and longevity. Backed by over €11.5 million in investment and the Guinness‑record‑holding Coolzoone brand, the clinic combines digital‑navigated therapies targeting...
FDA Cracks Down on Misleading GLP‑1 Telehealth Marketing
The FDA is targeting telehealth marketing of GLP-1 drugs. Who’s prescribing them? Medical groups face ‘tricky’ questions when partners make misleading claims via @KatieMPalmer https://t.co/pf4Fwa7W7r
Industry Investment Is Reshaping US Research: Roche’s Expansion at Harvard and the Additive Manufacturing in Pharma
Roche announced a three‑fold expansion of its footprint at Harvard University’s Enterprise Research Campus, increasing space from 30,000 to 100,000 square feet. The move is part of a broader $50 billion U.S. R&D investment plan that aims to add more than...
Nearly 9 in 10 Workers Report Satisfaction with Employer Sponsored Health Coverage
A recent AHIP survey shows nearly nine in ten U.S. workers are satisfied with their employer‑provided health insurance, citing financial security and peace of mind. Health coverage ranks as the top workplace benefit, with 68% naming it most valuable, and...
Insulet Reports EVOLUTION 2 Study Results for FCL Automated Insulin Delivery System in Type 2 Diabetes
Insulet presented data from its EVOLUTION 2C feasibility study of a fully closed‑loop (FCL) automated insulin delivery system for adults with type 2 diabetes at ATTD'26. In the 24‑patient trial, the final algorithm raised time‑in‑range (TIR) to an average 68%,...
Bavarian Nordic and SII Sign Agreement for Chikungunya Vaccine Production
Bavarian Nordic has signed a manufacturing agreement with the Serum Institute of India to transfer full technology for its chikungunya vaccine, CHIKV VLP (branded Vimkunya). The deal replaces an earlier partnership with Biological E and builds on the companies' existing mpox‑vaccine collaboration....
Whiteboard Tactics Unlock Big NHS Negotiation Wins
The Whiteboard Windfall: A Lesson in NHS Negotiations by @Timothy_Hughes https://t.co/dOWFQNFRXU @DLAIgnite #SocialSelling #DigitalSelling #Sales #SalesTips #SalesLeader #Salesforce #SalesEnablement #RevOps #Leadership #Marketing #SalesNegotiation https://t.co/sWTVEyWdht
Hospitals Still Miss Half of Patient Harm Events — And the Reasons Why Should Trouble Us
The HHS Office of Inspector General’s July 2025 report found that hospitals failed to capture 49% of patient‑harm events among Medicare inpatients, a modest improvement from the 86% miss rate reported in 2012. Staff most often dismissed events as expected complications...
UnitedHealth at Barclays: Pricing for a New Baseline
UnitedHealth used its Barclays Healthcare Forum to lay out a cautious 2026 outlook anchored by a 10% Medicare cost trend and modest Medicaid rate gains, while flagging that 2027 should see the payoff from AI‑driven efficiency and OptumHealth margin recovery....