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.
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By the numbers: Apogee Therapeutics raises $1.3B royalty financing
Isomorphic Labs Raises $2.1 B Series B to Scale AI Drug‑Design Engine
Isomorphic Labs closed a $2.1 billion Series B financing round led by Thrive Capital, with participation from Alphabet, GV, Temasek, CapitalG and the UK Sovereign AI Fund. The capital will be used to scale its IsoDDE AI engine, expand hiring worldwide, and push drug candidates into the clinic, underscoring deep‑tech entrepreneurship’s growing clout in biotech.
SELLAS Life Sciences Posts $8.4M Q1 Loss, Nears Pivotal AML Trial Readout
SELLAS Life Sciences Group posted a wider first‑quarter loss of $8.4 million as it closed in on the final readout of its REGAL Phase 3 trial in acute myeloid leukemia (AML). The company said 78 of the 80 required events have occurred,...
ECO2026: Lilly Gets Serious About Long-Term Obesity Care
At ECO2026 in Istanbul, Eli Lilly unveiled data from two landmark trials that reposition obesity as a chronic condition requiring sustained therapy. The SURMOUNT‑MAINTAIN study in The Lancet showed participants who continued full‑dose tirzepatide for 60 weeks largely preserved weight loss and...
This $250 Million Startup Tracks How Cancer Reacts To Treatment In Real Time
NVision Quantum Technologies announced a $55 million financing round, including $38 million led by diagnostics giant Abbott, to commercialize its metabolic MRI platform that amplifies sugar signals 10,000‑fold for real‑time tumor monitoring. The German‑based startup, valued at over $250 million, plans to roll...
STAT+: Drug Meant to Make Gene Therapy Safer May Also Make It Less Effective
A trial by Encoded Therapeutics investigating a gene‑therapy for Dravet syndrome found that adding the immune‑suppressant sirolimus may blunt therapeutic benefit. The study enrolled 21 children, most of whom received standard steroids, while a high‑dose subgroup also received sirolimus. Researchers...
Genicular Artery Embolization Gains Traction as a Minimally Invasive Solution for Osteoarthritis Knee Pain
Genicular artery embolization (GAE) is gaining attention as a minimally invasive, image‑guided therapy for knee osteoarthritis, targeting inflamed genicular arteries to reduce pain. The procedure is performed outpatient in under 90 minutes with local anesthesia, offering rapid relief without surgery....
State Paid Sick Leave Mandates and Receipt of Pediatric Preventive Dental Care
A new study examined how state‑level paid sick‑leave mandates affect children’s preventive dental visits. Using National Survey of Children’s Health data from 2016‑2023 and a difference‑in‑differences design, researchers compared states that adopted mandates with those that did not. The analysis...
Workforce and Staffing at 988 Suicide & Crisis Lifeline Centers
A cross‑sectional survey of 988 Suicide & Crisis Lifeline centers revealed widespread staffing shortfalls. Seventy‑one percent of the 159 responding centers reported being understaffed, and 89% cited difficulty securing funding for new hires. Centers that offered remote work faced higher...
Trump and Kennedy Seek To Relax Safeguards for AI Healthcare Tools
The Health and Human Services office, led by Robert F. Kennedy Jr., has proposed rolling back user‑centered testing and AI‑transparency rules for electronic health‑record (EHR) systems, including AI‑driven scribe tools. Clinicians like Kaiser Permanente therapist Paul Boyer report that while...
How Digital Booking Systems Can Reduce the Burden of Arranging Non-Emergency Medical Transportation
Non‑emergency medical transportation (NEMT) remains a fragmented, high‑stress process for patients and caregivers, especially for those needing wheelchair, stretcher, or assisted rides. The article outlines critical questions to determine the appropriate vehicle and assistance level, highlighting how mismatched bookings cause...
Opinion: RFK Jr.’s Antidepressant Deprescribing Push Gets One Thing Right — and Others Dangerously Wrong
Robert F. Kennedy Jr.'s recent campaign urging Americans to stop antidepressants mixes a valid concern about over‑prescribing with unsupported, potentially hazardous claims. Clinical professor Jonathan Slater recounts a carefully monitored 18‑month fluoxetine taper followed by a gradual bupropion reduction, illustrating...
Alkermes Reports Encouraging Data From Phase III Study of Lumryz
Alkermes announced positive top‑line results from its Phase III REVITALYZ trial of extended‑release Lumryz (sodium oxybate) in adults with idiopathic hypersomnia. In a double‑blind withdrawal phase, participants who continued Lumryz maintained significantly lower Epworth Sleepiness Scale scores than those switched to...
86% of Maternity Staff Back Empathy Training Driving Seven NHS System Changes
Empathy coaching delivered to 177 maternity staff at University Hospitals of Leicester NHS Trust led to 86% backing the training and sparked seven system changes. 91% of participants felt confident applying the learning, and 76% reported feeling more empathetic a...
Patients Are Discussing Whole-Body MRIs on Reddit, Presenting Opportunity for Radiologists
Researchers analyzed nearly 3,100 Reddit posts about whole-body MRI from 2013‑2024, finding a surge in discussion after a Kardashian endorsement in August 2023. While 47% of commenters expressed opposition and only 4% reported having undergone the $2,500 exam, sentiment was...
Lumexa Acquires Imaging Center as Part of New Joint Venture with UPMC
Lumexa Imaging announced the acquisition of a Wexford, Pennsylvania imaging center as the first step in a new joint venture with University of Pittsburgh Medical Center, while also securing a Concord, North Carolina center with Advocate Health. The company, which...
Novel Urine Test Reduces Need for MR Imaging, Prostate Biopsies
Researchers at Vanderbilt Health introduced MyProstateScore 2.0, a urine‑based assay that outperforms traditional PSA testing and multiparametric MRI in monitoring men on active surveillance for low‑risk prostate cancer. In a cohort of more than 300 patients, the test avoided up to...
Japan's Longevity Edge Stems From Lower LTC Mortality
Understanding Japan’s mortality advantage: a comparison of mortality in independent and dependent older adults in Japan and Sweden "Our findings show that Japan’s longevity advantage in old age is primarily driven by lower mortality in the segment of the population utilizing"...
Boy’s Brain Tumor Tied to Gene Therapy
A 13‑month‑old boy with Hurler syndrome received an in‑vivo AAV‑IDUA gene therapy that later caused a brain tumor when the viral DNA integrated into his genome. The tumor was safely removed and the child remains cognitively advanced, but the case...
The Next Wave of Healthcare Cyber Risk, From IoMT to AI-Enabled Attacks
Healthcare cyber risk is evolving beyond ransomware and data breaches as connected medical devices, remote telehealth services, and cloud platforms expand the attack surface. Legacy equipment lacking modern security controls now coexists with IoT and OT, creating vulnerable footholds for...
Anteris Technologies Global Starts US PARADIGM Trial Enrolment
Anteris Technologies Global announced the start of U.S. patient enrollment in its pivotal PARADIGM trial for the DurAVR transcatheter heart valve. The company raised $320 million in January, including a $230 million public offering and a $90 million private placement with Medtronic, boosting...
What Success Can Look Like, Darn It
Vepdegestrant, marketed as Veppanu, became the first FDA‑approved bifunctional degrader, a new PROTAC‑type therapy that eliminates target proteins. A Phase III trial showed it works but delivered no clear efficacy advantage over the existing degrader fulvestrant. Pfizer and Arvinas have now...
Cannabis and Tobacco Co-Use May Increase Psychosis Risk
A multisite study of over 1,000 participants published in Nature Mental Health found that co‑using cannabis and tobacco markedly raises the risk of developing psychotic disorders in individuals already identified as high‑risk. Researchers tracked substance‑use patterns for two years among...
ATyr Pharma Charts New Phase 3 Path for Efzofitimod After FDA Type C Meeting
aTyr Pharma announced it will submit an IND in June 2026 for a fresh Phase 3 study of efzofitimod in pulmonary sarcoidosis, prioritizing forced vital capacity as the primary endpoint. The move follows FDA Type C meeting feedback and includes...
Actuate Therapeutics Secures FDA IND Clearance for First Oral Elraglusib Tablet
Actuate Therapeutics announced FDA clearance of an Investigational New Drug application for an oral tablet of elraglusib, paving the way for a Phase 1/2 study in solid‑tumor patients. The move follows positive Phase 2 data in metastatic pancreatic cancer and...
Amazon Unveils Health AI Agent to Deliver Personalized Care and Prescription Management
Amazon has launched a Health AI agent that provides personalized health insights, books appointments and manages prescriptions. The service aims to ease the burden for the roughly two‑thirds of Americans who feel overwhelmed by the current health‑care system, marking the...
Roche to Acquire PathAI in Up‑to‑$1 B AI Cancer‑Diagnostics Deal
Roche announced on May 1, 2026 that it will acquire U.S. digital‑pathology firm PathAI in a transaction valued at up to $1 billion. The move deepens Roche’s investment in artificial‑intelligence tools for cancer testing and positions the group to compete for...
Coya Therapeutics Secures FDA Fast Track for ALS Drug COYA 302
Coya Therapeutics announced that the U.S. Food and Drug Administration granted Fast Track status to its experimental ALS therapy, COYA 302. The designation promises accelerated review and closer agency interaction, underscoring the urgent need for new treatments in amyotrophic lateral sclerosis.
Servier's Emi-Le Secures FDA Breakthrough Therapy Designation for Rare Salivary‑Gland Cancer
Servier announced that the U.S. FDA granted breakthrough therapy designation to its investigational antibody‑drug conjugate Emi-Le for locally advanced, recurrent or metastatic adenoid cystic carcinoma. The designation accelerates the Phase 1 program and underscores the promise of B7‑H4‑directed ADCs in...
Implantable Cytokine Factories Show Promise Against Advanced Ovarian Cancer
Researchers at Rice University and MD Anderson reported first‑in‑human results for AVB‑001, an implantable cell capsule that continuously secretes interleukin‑2 within the peritoneal cavity of patients with high‑grade serous ovarian cancer. In a Phase I dose‑escalation study of 14 platinum‑resistant...
Researchers Studying Chronic Pain Found a Brain Pathway that May Explain Why Pain Keeps Going Long After an Injury Should...
Researchers have identified the caudal granular insular cortex as a key brain region that determines whether pain resolves or becomes chronic. In animal studies, blocking this pathway early prevented chronic pain, while later intervention reduced established pain. The work dovetails...
HHS Launches MAHA Action Plan to Slash Psychiatric Overprescribing
U.S. Health and Human Services Secretary Robert F. Kennedy Jr. unveiled the MAHA Action Plan, a coordinated federal effort to curb overprescribing of psychiatric drugs. The plan emphasizes informed consent, shared decision‑making and a shift toward non‑medication therapies, with a...
FDA Approves Ocrevus for Children 10+ with Relapsing‑Remitting MS
The U.S. Food and Drug Administration has approved Genentech's Ocrevus (ocrelizumab) for pediatric patients aged 10 and up with relapsing‑remitting multiple sclerosis. The decision follows the phase‑3 OPERETTA 2 trial, which showed a 48% lower annualized relapse rate versus fingolimod. The...
MedPAC Calls for $1 B Safety‑Net Hospital Boost in 2027 Payment Update
The Medicare Payment Advisory Commission (MedPAC) endorsed the existing hospital payment framework and urged Congress to add $1 billion to the Medicare Safety‑Net Index for 2027. The recommendation follows data showing stable access, modest utilization growth and improving margins across the...
New Medical Records System Expands in Nova Scotia
Nova Scotia Health launched the One Person One Record (OPOR) electronic medical records system this weekend in hospitals across Halifax, the Eastern Shore and West Hants. While the rollout promises to unify over 50 clinical workflows, staff have flagged incomplete...
PointClickCare Wins Award for Best EHR
PointClickCare has been named the best electronic health record solution in the 2026 MedTech Breakthrough Awards, chosen from over 4,000 global nominations. The ONC‑certified platform serves more than 30,000 provider organizations across skilled‑nursing, senior‑living, and physician practice groups, delivering AI‑infused...
Isomorphic Labs Secures $2.1 B Series B to Scale AI Drug Design Engine
Isomorphic Labs announced a $2.1 billion Series B funding round led by Thrive Capital, with participation from Alphabet, GV, Temasek, CapitalG and the UK Sovereign AI Fund. The capital will expand its IsoDDE AI engine, accelerate its therapeutic pipeline and fund...
Fraser Health Named Runner-Up in Gartner Awards
Fraser Health’s Centre for Advanced Analytics, Data Science and Innovation (CAADSI) earned runner‑up status in the 2025 Gartner Eye on Innovation Awards for its AI‑enabled decision‑intelligence platform. The system combines daily demand forecasting, scenario simulation and scheduling optimization to support...
CARE for Women: Investing in Care Delivery to Improve Women’s Lives and Livelihoods
The McKinsey Health Institute report finds that roughly one‑third of the women’s health gap stems from care‑delivery inequities such as underscreening, underdiagnosis and undertreatment. By standardizing screening, referral pathways and reporting, the proposed CARE framework could close this gap, averting...
Talphera Inc (TLPH) Q1 2026 Earnings Call Transcript
Talphera reported a $21.1 million cash balance and closed a $4.1 million financing tranche, with two additional conditional tranches of $16 million tied to study milestones. The nephro CRRT trial has surpassed the 50% enrollment target and is on track for full enrollment...
Allogene Therapeutics Inc (ALLO) Q1 2026 Earnings Call Transcript
Allogene Therapeutics reported interim data from its pivotal ALPHA-3 trial, showing SemiCell achieved a 58.3% MRD clearance rate versus 16.7% in the observation arm—a 41.6% absolute improvement—alongside a near‑98% median ctDNA reduction. The safety profile was clean, with no cases...
Beyondspring Inc (BYSI) Q1 2026 Earnings Call Transcript
BeyondSpring Inc. reported that its lead asset plinabulin received FDA priority review with a PDUFA decision deadline of November 30, 2021. The company completed enrollment of 559 patients in the global Phase 3 DUBLIN‑3 trial for second‑line non‑small cell lung cancer...
Sustaining Microglial Reparative Function Enhances Stroke Recovery
A Nature study led by Jun Tsuyama and colleagues demonstrates that preserving the reparative phenotype of microglia markedly improves recovery after ischemic stroke. Using conditional knockout mice and antisense oligonucleotides (ASOs) targeting the transcription factor Zfp384, the researchers boosted IGF1 and...
Compass Pathways PLC (CMPS) Q1 2026 Earnings Call Transcript
Compass Pathways reported robust Phase 2 results for its COMP360 psilocybin program in treatment‑resistant PTSD, showing a roughly 30‑point reduction in CAPS‑5 scores and high response and remission rates. The trial was well tolerated with no serious adverse events and...
PolyPid Ltd (PYPD) Q1 2026 Earnings Call Transcript
PolyPid announced that its D‑PLEX100 product achieved primary and all key secondary endpoints in the SHIELD II Phase III trial, confirming a meaningful reduction in surgical site infections. The FDA provided written feedback endorsing a rolling new drug application, with...
VTv Therapeutics Inc (VTVT) Q1 2026 Earnings Call Transcript
Travere Therapeutics announced the first full FDA approval of its kidney drug Filspari for focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome, expanding the product’s label beyond IgA nephropathy. In Q1 2026, Filspari net sales jumped 88% year‑over‑year to $105.2 million, driving...
Dyadic International Inc (DYAI) Q1 2026 Earnings Call Transcript
Dyadic International reported FY 2025 results, highlighting a revenue decline to $3.1 million driven by reduced R&D collaborations, partially offset by $1.9 million in grant income. The company launched its first commercial products, including recombinant albumin and animal‑free DNase I, under profit‑sharing and...
Omeros Corp (OMER) Q1 2026 Earnings Call Transcript
Omeros Corp reported Q1 2020 results, highlighting progress on its lead antibody narsoplimab as it nears completion of a rolling biologics license application (BLA) with breakthrough therapy designation and anticipated priority review. The company also detailed its Omidria cataract‑surgery product,...
Weight Loss Maintained Seven Times More Effectively with Continued Maximum Dose of Tirzepatide, Study Finds
A Phase 3b trial presented at ECO 2026 showed that continuing tirzepatide at the maximum tolerated dose (10 mg or 15 mg) after an initial 60‑week weight‑loss phase preserved a 21.9% reduction from baseline after a further 52 weeks, compared with only 9.9% in the...
Hengrui’s 13-Program BMS Deal Is Latest Move Toward Globalization
Jiangsu Hengrui Pharmaceuticals signed a two‑way licensing agreement with Bristol Myers Squibb, marking another milestone in the Chinese firm’s global expansion. The deal provides Hengrui with $600 million upfront and $350 million in near‑term payments, with two $175 million installments due in 2027...
On‑device Optical Sensors Enable Real‑time Decisions in Surgery, Space
New optical sensors can analyze data within the device itself, enabling real-time decision-making in applications like surgery and space exploration while reducing reliance on external computing. innovation