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
Qualified Medical Evaluators and the Medical-Legal Process in California Workers' Compensation
The RAND Health report examines California's Qualified Medical Evaluators (QMEs), physicians certified by the Division of Workers' Compensation to assess injured workers and produce legal reports. Using data from the Department of Industrial Relations and stakeholder interviews, the study evaluates whether the QME system is sustainable and fulfills its intended purpose. Findings highlight growing caseload pressures, inconsistencies in injury assessments, and gaps in data transparency. The report, funded by the state’s DIR, proposes policy adjustments to strengthen the medical‑legal process in workers’ compensation.
HTN Now Webinar Explores What Does Good Look Like for a Digital Patient Journey?
The HTN Now webinar gathered NHS digital leaders and industry experts to define what a good digital patient journey looks like. Panelists stressed that digital tools must be seamless, intuitive and inclusive, so patients never notice the technology layer. They highlighted...
M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
The ICH has issued the M11 Template — Clinical Electronic Structured Harmonised Protocol (CeSHarP) – a draft guidance released in June 2025. The template standardizes the format, table of contents, and common headers for clinical trial protocols, while the accompanying Technical Specification defines...
Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management
Eli Lilly’s phase‑III TRIUMPH‑1 trial showed its triple‑agonist retatrutide produced dramatic weight loss in adults with obesity and at least one weight‑related comorbidity. Across 80‑week endpoints, the 12 mg dose cut mean body weight by 28.3% and waist circumference by 24.1 cm, with...
Telemedicine Use Has Not Led to Increased Visits or Higher Costs, Study Finds
A UCLA‑led analysis published in JAMA Network Open shows that telemedicine use between 2019 and 2023 did not increase overall visit volume or medical spending across Medicare, Medicaid, commercial and other payer types. Telemedicine visits fell 2.4% and total spending...
System C Sets Out 12-Month AI Roadmap Spanning Emergency, Maternity and Social Care
System C unveiled a 12‑month AI roadmap that will extend its ambient AI capabilities to emergency care this autumn and to maternity services shortly thereafter, building on tools that have already halved documentation time in social‑care settings across 15 English...
Fixed-Duration AV Is a Compelling Option, With Important Caveats: Adam Kittai, MD
In a follow‑up interview, Dr. Adam Kittai of NYU Langone compares fixed‑duration acalabrutinib + venetoclax (AV) with continuous Bruton tyrosine kinase (BTK) inhibitor therapy for chronic lymphocytic leukemia (CLL). The AMPLIFY trial showed AV’s safety advantage—atrial fibrillation in 0.7% and major hemorrhage...
Exercise over Supplementation in Fall and Fracture Prevention
A BMJ systematic review of 69 trials involving over 153,000 adults found that calcium and vitamin D supplementation provides little to no clinically meaningful reduction in fractures or falls. The authors of a rapid response argue that, given the modest benefits...
Penn State’s 3D Printed CaroFlex Device Opens a New Front in Drug-Resistant Hypertension
Penn State researchers unveiled CaroFlex, a soft 3‑D‑printed bioelectronic device that adheres to the carotid sinus and delivers gentle electrical signals to regulate blood pressure. In rodent trials the device reduced systolic pressure by more than 15% without causing tissue...
Retatrutide Delivers up to 30% Weight Loss in Phase 3 Trials
Retatrutide just delivered some very impressive phase3 results for $LLY at 4mg, 9mg and 12mg -- https://t.co/7sKbaDoInq Retatrutide is their GLP-3 ie triple agonist which hits the GLP, GIP and Glucagon receptors. At the primary endpoint of 80 weeks... patients on 4mg,...
Primary Care Lacks Mental Health Training, Fueling Deaths
Primary care doctors handle 75 percent of all mental health care in this country. They receive 2 percent of their total training in it. That is not a resource gap. It is a curriculum failure that has not changed in...
On Grant & Archimedes
Anthony Guerra’s column draws leadership lessons from Ulysses S. Grant’s Civil‑War campaigns, emphasizing relentless perseverance and the strategic concentration of forces after Grant assumed unified command in 1864. Grant’s tenacity turned a series of failed “experiments” into the decisive Vicksburg siege, while...
Intellia Files First CRISPR‑Based BLA, Testing FDA’s New Post‑Approval Guidance
Intellia Therapeutics has filed a biologics license application for its in‑vivo CRISPR therapy targeting transthyretin amyloidosis, becoming the first CRISPR‑based product to be reviewed under the FDA’s September 2024 draft guidance on post‑approval monitoring. The move pits the company against...
How Ossium Health Is Building an Off-the-Shelf Bone Marrow Transplant Model
Ossium Health is developing an off‑the‑shelf bone‑marrow product sourced from deceased organ donors, aiming to eliminate the timing and dose constraints of traditional live‑donor transplants. The company’s first‑in‑human PRESERVE I trial has treated about 25 patients with cryopreserved marrow and...
Can the ACL Actually Heal Without Surgery?
The Ask Mike Reinold podcast examined the cross‑bracing protocol, a non‑operative approach that immobilizes the knee in 90 degrees flexion for about four weeks to allow an ACL tear to heal. Recent Australian studies report roughly a 30 percent success rate, while a 2026...
Looking for a Lifeline: New Compounds Show Promise Against AMR
Scientists at Umeå University have created a new class of synthetic tricyclic compounds, called TriPcides, that effectively kill MRSA strains resistant to earlier GmPcide antibiotics. By redesigning the molecular scaffold to evade the lmrB efflux pump, the compounds prevent the...
Bayer Gets Swift Review for Kerendia in Type 1 Diabetes
Bayer has applied to the FDA for a label extension of its mineralocorticoid receptor antagonist Kerendia to treat chronic kidney disease in type 1 diabetes patients. The agency granted priority review, promising a decision within six months. Phase 3 FINE‑ONE data showed...
ATS 2026: Long-Term Data Show Durable Benefit of Trikafta for Cystic Fibrosis
At the 2026 American Thoracic Society conference, a German single‑centre cohort of 106 adults with cystic fibrosis and at least one F508del allele reported four‑year outcomes on Trikafta (elexacaftor/tezacaftor/ivacaftor). Patients showed a 0.5 L (15.6%) rise in FEV1, a 28.9% drop...
Could A Nasal Spray Reverse Brain Aging? What A New Study Reveals
A Texas A&M study shows a nasal spray packed with extracellular vesicles (EVs) carrying micro‑RNAs can slash neuroinflammation, revive neuronal mitochondria, and boost memory in mice after just two doses. The intranasal route bypasses the blood‑brain barrier, delivering the cargo...
Immunotherapy Before Surgery May Reduce Colon Cancer Recurrence
A phase II NEOPRISM‑CRC trial at University College London gave 9 weeks of pembrolizumab before surgery to 32 stage 2‑3 colorectal cancer patients with MMR‑deficient/MSI‑high tumors. Fifty‑nine percent achieved no detectable cancer after treatment, and after a median 33‑month follow‑up none experienced recurrence,...
An Air France Flight to the U.S. Was Diverted over Ebola Fear
The U.S. CDC announced a 30‑day entry ban on non‑citizens who have visited the Democratic Republic of Congo, Uganda or South Sudan amid a worsening Ebola outbreak. On May 21, Air France flight AF378 from Paris to Detroit was diverted...
Colorado Charts Its Own Course on Vaccines Amid Federal Pullback
Colorado enacted a law allowing the state to source vaccines for Medicaid and other programs based on recommendations from national medical societies rather than CDC guidance. The legislation also authorizes pharmacists to prescribe and administer vaccines and strengthens legal protections...
Lancet Neurology Consensus Unveils CBI-M Framework to Replace Traditional TBI Silos
The Lancet Neurology has released an international consensus introducing the CBI‑M framework to replace the Glasgow Coma Scale for traumatic brain injury assessment. CBI‑M integrates four pillars—Clinical (14‑day neurological tracking), Biomarker (blood‑based assays), Imaging (advanced neuroimaging), and Modifiers (genomics, age,...
Tampere Team 3D Prints Bone-Like Ceramic That Guides the Body’s Own Repair
Researchers at Tampere University have engineered a 3D‑printed hydroxyapatite ceramic scaffold that mirrors the mineral composition and internal geometry of natural bone. The scaffold features 400 µm pores and roughly 45% porosity, creating a balance of mechanical strength and cellular accessibility...
Novo Nordisk Fight with KBP Bio Will Go to Arbitration
Novo Nordisk has taken its $830 million damages claim against Singapore biotech KBP Bio to arbitration after the Singapore Court of Appeal upheld an injunction freezing KBP and founder Dr Huang Zhenhua's assets. The dispute stems from a $1.3 billion licensing deal for...
MHRA Proposes New Regulatory Pathway for Rare Disease Therapies
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on a new, technology‑agnostic regulatory pathway for rare disease therapies. Central to the proposal is an Investigational Marketing Authorisation (IMA) that merges clinical trial approval with a...
Development of the Revised CAHPS Hospice Survey
The Centers for Medicare & Medicaid Services (CMS) has released a revised CAHPS Hospice Survey, streamlining the instrument used by more than 4,000 hospices each month. Stakeholder feedback prompted a shorter questionnaire that adds questions on patient wishes and cultural...
CU Anschutz Researchers Reinvent the Denture: Faster, Smarter, and Built to Fight Bacteria
Researchers at CU Anschutz School of Dental Medicine are pioneering multimaterial inkjet 3D printing to fabricate dentures as a single, monolithic piece. The new photo‑curable polymers promise higher durability, faster production and lower costs, while an embedded antimicrobial additive can...
Re: Government Axes 1000 New Training Posts in England as Resident Doctor Dispute Deepens
The UK government has eliminated 1,000 resident doctor training posts in England, intensifying an already volatile dispute between junior doctors and the Department of Health. The cuts arrive amid growing concerns over NHS capacity, long waiting lists, and rising chronic...
New Model of Care Uses Video Calls to Bring Specialist Rheumatology Input Into Primary Care
The Connected Health Network pilot at Northern Lincolnshire and Goole NHS Foundation Trust uses video calls to embed specialist rheumatology expertise within primary care. A GP with a special interest triages patients, and a lead consultant joins via video to...
The Neurotech CRO: Kordata Launches To Power Next-Gen Clinical Trials
Kordata Dynamics has emerged from stealth to tackle a $26 billion backlog in central nervous system (CNS) clinical trials, using patient‑facing neurotechnology and a B2B playbook. The company partners with large health systems and academic centers, deploying BIOS Health’s NeuroTune platform...
Huawei Xinghe Intelligent High-Quality Hospital Network: Empowering Global Smart Healthcare Development
Huawei introduced the Xinghe Intelligent Campus Network, a full‑stack solution that combines Wi‑Fi 7 zero‑roaming, high‑quality optical Ethernet, Twins dual‑engine switches and AI‑driven SDN control. The platform delivers uninterrupted 24/7 connectivity, sub‑second failover and proactive fault prediction for hospitals worldwide. By...
Workflow First Digital Strategy
Healthcare digital transformation remains a top priority but often fails due to misaligned technology and clinical workflows. A World Economic Forum survey shows 90% of executives prioritize digital change, yet McKinsey finds 75% lack sufficient funds or planning. Investments concentrate...
FemTech Mid 2026 : Future Landscape, IPO Pipeline, Capital Trends & AI Threats
FemTech is evolving from simple cycle‑tracking apps into a precision‑medicine sector that now includes hormonal intelligence, AI‑driven diagnostics, cardiometabolic care, and regulated devices. The market, worth roughly $9.5 bn in 2025, is expected to hit $10.7 bn in 2026 and could expand...
Data-Driven Insights Informs NHS Trust's Patient Care
Countess of Chester Hospital NHS Foundation Trust finished an eight‑month medical workforce planning programme with SARD, creating 285 detailed consultant job plans across 18 key services. The data‑driven approach revealed capacity gaps and enabled the trust to rebalance resources for...
Sharp Rise in Number of Parents Refusing Newborn Vitamin K Shots, Putting Babies at 81-Fold Higher Risk of Severe Bleeding
A new JAMA study shows 5.2% of U.S. newborns in 2024 did not receive the recommended vitamin K injection, up from 2.9% in 2017 – a 77% increase. Infants who miss the shot face an 81‑fold higher risk of vitamin...
Targeting Inflammation in Depression: A Proof-of-Concept Worth Following
A proof‑of‑concept randomized trial examined a single intravenous dose of tocilizumab, an IL‑6 receptor blocker, in 29 adults with treatment‑resistant major depressive disorder and low‑grade inflammation (CRP ≥ 3 mg/L). The drug safely reduced CRP levels, but the primary outcome—somatic depression symptoms—did not...
How AI Is Shaping Biotech? Expert Insights From James Bilotta
In this episode of Biotech Bytes, SVP and Chief Digital Information Officer Jim Bellotta discusses how AI and digital transformation are reshaping biotech, emphasizing the shift of the CIO role from a back‑office tech function to a strategic business partner...
Phoenix and Raven Become First Canadian Telehealth Platforms to Offer Generic Semaglutide Direct to Patients
Canadian telehealth leaders Phoenix and Raven have become the first digital health platforms in Canada to offer Health Canada‑approved generic semaglutide directly to patients. The medication, priced at CAD 124.99 (about US $92) per course, is available by prescription with free coast‑to‑coast...
AFT Pharmaceuticals Targets Minimum $300m Revenue After Record Earnings
AFT Pharmaceuticals reported FY26 operating revenue of $254.7 million (≈$168 million USD), a 22% increase, and net profit of $14.1 million (≈$9.3 million USD). International sales and royalties surged 66% to $28.5 million (≈$19 million USD), driven by stronger offshore hubs and a 41% jump in...
Trump Administration Appoints Temporary Surgeon General as Radiologist Nominee Awaits Hearings
The Trump administration has installed family physician Stephanie Haridopolos as interim surgeon general while awaiting Senate hearings for nominee Dr. Nicole Saphier, a breast‑cancer specialist and former Fox News commentator. Haridopolos, chief of staff for the Office of the Surgeon...
Medtronic to Acquire SPR Therapeutics for $650 Million, Expanding Chronic Pain Portfolio
Medtronic announced an agreement to purchase privately held SPR Therapeutics for roughly $650 million in cash. The deal adds SPR’s 60‑day SPRINT peripheral nerve stimulation (PNS) system to Medtronic’s neuromodulation suite, aiming to broaden early‑stage chronic‑pain treatment options.
FDA Clears Prostate AI Solution From RadNet Subsidiary DeepHealth
The U.S. Food and Drug Administration has cleared DeepHealth's Prostate Suite, an AI‑driven tool that assists radiologists throughout the prostate MRI workflow. The platform automatically detects lesions, assigns risk, segments anatomy, and generates PI‑RADS‑compliant reports, and it works with 11...
Fixing Eligibility at the Point of Care: The Missing Link in Medical Device Reimbursement Integrity
Hospitals rely on real‑time Medicaid eligibility data to decide whether costly medical devices, imaging, or digital therapeutics will be reimbursed. In FY 2024, improper Medicaid payments reached roughly $31.1 billion, a 5.09 % error rate driven largely by incomplete enrollment verification. Fragmented eligibility...
Rovex and Sphaira Launch First Autonomous Patient Transport Pilot at Florida Hospital
Rovex Technologies and robotics partner Sphaira have begun the first autonomous patient‑transport pilot in Florida, deploying towing robots at Morton Plant Hospital. The system promises to slash the hour‑long, 200‑yard trips that currently delay care, while addressing high injury rates...
Clinical AI Falls Short on Point‑of‑Care Decisions, Experts Warn
Healthcare AI leaders argue that despite a surge in imaging and data, clinical AI has not enhanced point‑of‑care decision‑making. They cite doubled CT and MRI use and call for AI that integrates into physician workflows, not just dashboards.
Where PBM Reform Stands Across the US
States nationwide are tightening rules on pharmacy benefit managers (PBMs), targeting practices like spread pricing, patient steering, and PBM ownership of pharmacies. Arkansas pioneered a ban on PBM‑owned pharmacies, but a federal judge issued an injunction; meanwhile California, Colorado, Illinois,...
Radiology Groups Urge Congress to Pass Bill that Would Cap Pay Cuts in Medicare
Radiology groups, including the American College of Radiology, Society of Interventional Radiology and American Society of Neuroradiology, have urged Congress to pass the Provider Reimbursement Stability Act of 2026 to cap Medicare physician payment cuts. The bill would limit annual...
Pennington and Vanderbilt Launch $13.8 Million COACH Trial to Combat Childhood Obesity
Pennington Biomedical Research Center and Vanderbilt University Medical Center have begun the COACH trial, a five‑year, $13.8 million study enrolling 900 children with obesity across Louisiana and Tennessee. The trial will test primary‑care‑based lifestyle interventions and could reshape how parents access...
Lantern Pharma Gets FDA Type C Clearance for LP-300 Phase 2 Trial in Never‑Smoker NSCLC
Lantern Pharma announced that the FDA issued a successful Type C meeting response, clearing protocol amendments for its LP-300 Phase 2 HARMONIC trial. The agency raised no objections to focusing enrollment on EGFR exon 21 L858R‑mutant never‑smokers and extending treatment...