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
EPtalk by Dr. Jayne 3/5/26
A recent LinkedIn post by Wayne Gillis points out that neither Rehoboth McKinley nor Great Falls Clinic uses Epic’s electronic health record platform, contradicting earlier assumptions. The post also notes that Rehoboth McKinley operates a Cerner/Oracle patient portal, highlighting ongoing EHR diversification. Parallel discussions on LinkedIn have revived interest in direct‑to‑consumer (DTC) laboratory testing and its distinction from Direct Access Testing (DAT). These conversations underscore broader industry debates about health‑IT interoperability and consumer‑driven diagnostics.
Can GLP-1 Drugs Help Tackle Addiction?
A new BMJ meta‑analysis of over 600,000 U.S. veterans with type‑2 diabetes found that patients prescribed GLP‑1 agonists such as semaglutide or tirzepatide were 14% less likely to develop substance‑use disorders (SUD) than those on SGLT2 inhibitors. Over a three‑year...
When No Two Spines Are Alike: Inside the First AI-Designed Cervical Implant
UC San Diego Health performed the world’s first fully personalized anterior cervical spine implant, combining high‑resolution imaging, AI‑driven design, and titanium 3D printing. The AI algorithm generated a patient‑specific geometry that matches the vertebral endplates, restores natural lordosis, and optimizes...
Pirtobrutinib
Late 2025 saw the FDA grant traditional approval to pirtobrutinib, an oral, reversible BTK inhibitor targeting multiple B‑cell malignancies. The drug demonstrated robust efficacy in BTK‑resistant chronic lymphocytic leukemia and small lymphocytic lymphoma, backed by positive Phase 3 data and early...
FDA's Extremist Shifts Harm Rare Disease Stakeholders
In this week's Biotech Scorecard newsletter: The extremism of the FDA’s Peter Marks and Vinay Prasad has come with costs Two regulators, two extreme regulatory philosophies, one replacing the other. The rare disease community is suffering whiplash. Drugmakers ( $QURE...
Airiver Medical Receives FDA Breakthrough Device Designation for Airiver DCB and Treats First Patient with Central Airway Stenosis
Airiver Medical announced that the U.S. Food and Drug Administration granted Breakthrough Device Designation to its pulmonary drug‑coated balloon (DCB) for treating central airway stenosis. The company also enrolled and treated the first patient in a pivotal trial that will...
Knee Pain Signals Years of Inactivity, Not Surgery Need
The hardest conversation I have in my office isn't about surgery. It's about time. A 58-year-old sat across from me with knee pain. She’s otherwise healthy, but menopause has been rough on her. Her MRI shows some cartilage changes — age-appropriate,...
Cancer-Eating Bacteria Engineered to Consume Tumors From the Inside Out
University of Waterloo researchers have engineered the anaerobic bacterium Clostridium sporogenes to consume solid tumors from the inside out. The spores infiltrate the oxygen‑free tumor core, proliferate and break down cancerous tissue. By inserting an oxygen‑resistant gene and a quorum‑sensing...
Q&A: AWS Launches Amazon Connect Health to Streamline Healthcare Workflows
Amazon Web Services unveiled Amazon Connect Health, an agentic AI platform that plugs directly into electronic health records to automate patient verification, appointment scheduling, ambient documentation, and medical coding. The service, built on FHIR standards and Amazon HealthLake, offers a...
Targeted Therapies to Join Chemo as Oncology Treatment Backbone
Targeted therapies are reshaping oncology, yet chemotherapy remains essential. Immune checkpoint inhibitors like Keytruda generate $31.7 bn sales in 2025 and cover more than 40 indications. The FDA granted 63 antibody‑drug conjugate review designations in 2024, nearly double the previous peak....
Suffolk and North East Essex ICB Publishes £5.2 Million Contract for GP IT
Suffolk and North East Essex Integrated Care Board has issued a £5.2 million contract to modernise GP IT systems in line with the Primary Care Digital Services Model. The three‑year agreement, starting 1 December 2026, can be extended to 2031 and requires a...
Hansa Closes on FDA Verdict for Transplant Drug Imlifidase
The FDA has begun reviewing Hansa Biopharma’s imlifidase, a drug that desensitises highly sensitised kidney‑transplant patients, with a decision expected by December 19, 2024. If approved, it would be the first U.S. therapy to improve transplant odds for the 10‑15 % of...
HTN Now: Exploring and Tackling the Real Pain Points Around the Use of Digital Systems
A recent HTN audience survey, presented by Aire Innovate’s Ian Dove and Fiona Costello, identified persistent pain points in NHS digital systems. Staff cite inadequate training, top‑down development, poor interoperability and extensive manual workarounds, while IT capacity backlogs stretch change...
Xtalks Featured Member: Giorgia Palano, Life Science Consultant, Knightec Group
Xtalks has spotlighted Giorgia Palano, PhD, a Life Science Consultant at Knightec Group, highlighting her expertise in validation strategies and regulatory compliance. Palano works with cross‑functional teams to ensure quality documentation and continuous improvement across complex life‑science operations. She emphasizes...
The Ongoing Impact of MFN Pricing
The pharmaceutical industry is grappling with evolving Most‑Favored‑Nation (MFN) pricing rules as the TrumpRx initiative clarifies administration expectations. Recent Supreme Court rulings on IEEPA tariffs, distinct from Section 232 tariffs used in MFN negotiations, add uncertainty to pricing strategies. Manufacturers must...
Endometriosis Now Takes 9 Years and 4 Months to Be Diagnosed
Endometriosis UK reports the average diagnosis time in Britain has risen to nine years and four months, up from eight years in 2020. The survey shows 39% of women needed ten or more GP visits before suspicion, while 55% presented...
Akeso Presents P-II (COMPASSION-03) Trial Data on Cadonilimab for R/M Cervical Cancer at ESGO 2026
Akeso presented Phase‑II COMPASSION‑03 data for cadonilimab in patients with recurrent or metastatic cervical cancer who progressed after platinum chemotherapy. The trial reported a median overall survival of 17.5 months across the cohort, with 24‑month OS rates of 40.9% irrespective...
Philips Launches Rembra CT System for Acute Imaging
Philips has introduced Rembra, a next‑generation CT system built for acute and high‑throughput imaging environments. The scanner delivers ultra‑fast reconstruction speeds of up to 106 images per second and can support as many as 270 examinations per day. It features...
Next-Gen Malaria Vaccine Overcomes Major Hurdle
Researchers at WEHI and the Burnet Institute have mapped the human immune response to Plasmodium vivax, revealing how antibodies neutralize the parasite. The study, published in Immunity, shows that protective immunity depends on antibody function and simultaneous targeting of multiple...
Hampshire Hospitals Celebrates 100th Surgical Procedure Using Pioneering State-of-the-Art Robotic System
Surgeons at Hampshire Hospitals NHS Foundation Trust have performed their 100th operation using the da Vinci 5 robotic‑assisted surgical system, just six months after becoming the first UK NHS trust to install the next‑generation robot. The system, deployed at Basingstoke...
Mosaic Clinical Technologies Announces FDA Breakthrough Device Designation for Cognita’s Generative AI Model for Radiology
Mosaic Clinical Technologies announced that its AI unit Cognita received FDA Breakthrough Device Designation for Cognita Chest X‑Ray (CXR), the first generative vision‑language model in radiology to earn this status. The designation grants prioritized FDA interaction, potentially accelerating clearance. Internal...
GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.
GAIA and Daiichi Sankyo Europe announced an exclusive partnership to commercialize lipodia, a next‑generation digital therapeutic for hypercholesterolemia, pending regulatory approval. The deal grants Daiichi exclusive rights in Germany with expansion mechanisms for other European markets, leveraging GAIA’s validated behavioral...
GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.
GAIA and Daiichi Sankyo Europe announced an exclusive partnership to commercialize lipodia, a digital therapeutic for hypercholesterolemia, pending regulatory approval. The agreement gives Daiichi Sankyo exclusive rights in Germany with plans to expand across Europe, leveraging GAIA’s evidence‑based platform and Daiichi’s cardiovascular...
Listen: What To Do When Health Insurance Slips Out of Reach
Health insurance coverage is slipping for many Americans as ACA marketplace sign‑ups fell by roughly one million this year and federal subsidies expired, driving premiums higher. Stricter Medicaid eligibility rules further limit options for low‑income households. KFF Health News correspondent...
HUTCHMED Begins Phase I/IIa Trial of HMPL-A580 for Solid Tumours
HUTCHMED has launched a first‑in‑human Phase I/IIa trial of HMPL‑A580, its second antibody‑targeted therapy conjugate, in the United States and China. The multi‑centre, open‑label study will evaluate safety, tolerability, immunogenicity, pharmacokinetics and early efficacy across dose‑escalation and expansion cohorts. HMPL‑A580...
Affinia Receives FDA Fast Track Designation for AFTX-201
Affinia Therapeutics announced that the FDA has granted fast‑track designation to its gene‑therapy candidate AFTX‑201 for BAG3‑associated dilated cardiomyopathy. The one‑time intravenous treatment delivers a full‑length BAG3 transgene via an engineered capsid that requires doses five to ten times lower...
Guiding Nano Assembly for Drug Delivery with Machine Learning
Researchers repurposed the FAP inhibitor SP‑13786 as a co‑assembly excipient to create SP co‑assembled nanoparticles (SCAN) that encapsulate hydrophobic drugs. Using molecular dynamics and a random‑forest machine‑learning model, they identified 228 physicochemical descriptors that predict successful nano‑co‑assembly, highlighting aromaticity and...
Samoco Begins Prototyping Flagship Product with PHTA Makerspace
Samoco, a smart medical transport device firm, has begun prototyping its flagship blood‑preservation system in the PHTA Makerspace. The device actively cools and agitates blood during road or drone transport, aiming to keep units viable in hot, remote environments. Up...
Why the Future of MedTech Is Being Led by Consumers
MedTech is moving from a hospital‑centric model to a consumer‑driven ecosystem, with at‑home diagnostics, wellness tools, and direct‑to‑consumer devices reshaping adoption. Design teams must prioritize motivation, habit and identity over pure clinical protocol, making products feel like lifestyle accessories rather...
AI Will Redefine Doctor-Patient Dynamics, Says Henry Blodget
I loved my interview with legendary business analyst & founder of "Business Insider", Henry Blodget (@hblodget), on his podcast, "Solutions." Lots of smart questions about AI and healthcare, and how it'll change what it means to be a doctor and...
STAT+: Gilead and South Africa Are Negotiating a License for Local Production of New HIV Drug
Gilead Sciences is in talks with the South African government to issue a voluntary licence for the local manufacture of lenacapavir, a novel HIV‑prevention drug. The agreement would enable South African firms, identified with help from Unitaid and the US...
Using Clinical NLP to Unlock Untapped Quality Data for HEDIS Compliance
Tim O’Connell, CEO of emtelligent, argues that most HEDIS‑critical information resides in unstructured clinical text, not traditional fields. Over 80% of healthcare data is narrative, leaving a compliance gap that can cost plans millions in lower Star Ratings. He highlights...
Watch the Lean Hospitals Coach in Action — Live, Unscripted, With Your Questions
The author will host a LinkedIn Live demo on March 10 to showcase the Lean Hospitals Coach, an AI‑powered tool built around the *Lean Hospitals* book. The coach offers two query modes—Book Search with citations and Book Plus with broader Lean insights—and...
Tandem Mobi Now Compatible with Android Smartphones
Tandem Diabetes Care announced that its Tandem Mobi insulin pump is now compatible with Android smartphones in the United States via a newly released mobile app. The Android version received FDA clearance in November 2025 and entered a limited rollout in...
Using Tiny Ripples at Skin Level to Monitor for Possible Health Problems Below
Caltech researchers unveiled visual surface wave elastography, a technique that captures imperceptible skin vibrations with a smartphone camera to infer the stiffness and thickness of underlying tissue. By applying phase‑based motion processing and spectral analysis, the method extracts subpixel movements...
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers
The FDA released a draft Level 1 guidance titled “New Clinical Investigation Exclusivity (3‑Year Exclusivity) for Drug Products: Questions and Answers.” The document clarifies statutory and regulatory criteria for obtaining three‑year market exclusivity on new drug applications or supplements. It outlines...
Menopause Hormone Therapy: The Myths, the Medicine, and the “Why Didn’t Anyone Tell Me?” Moment
The article debunks long‑standing myths about menopausal hormone therapy (MHT) by highlighting how the 2002 Women’s Health Initiative (WHI) trial was misapplied to all women. It explains that the WHI tested an older cohort using a specific estrogen‑progestin combo, leading...
Tracing Extracellular Vesicles' Journey From Cancer Cells to Urine
Researchers at the Institute of Science Tokyo directly traced small extracellular vesicles (sEVs) from tumors to urine in mouse models of brain, lung and pancreatic cancer. Using engineered RNA tracers and luminescent‑fluorescent reporters, they showed tumor‑derived sEVs appear in urine...
![Rest Is a Holy Practice: Reclaiming the Soul of Medicine [PODCAST]](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://kevinmd.com/wp-content/uploads/Design-1-1-scaled.jpg)
Rest Is a Holy Practice: Reclaiming the Soul of Medicine [PODCAST]
Dr. Roxanne Almas, a developmental‑behavioral pediatrician, discusses how chronic burnout stems from medicine’s nonstop, transactional culture and shares her personal journey through grief and caregiving. She advocates for deep rest practices—such as Yoga Nidra, narrative medicine, and mindful pauses—to restore empathy,...
Methode Electronics Inc (MEI) Q3 2026 Earnings Call Transcript
Medtronic reported Q3 2026 revenue of $9 billion, up 8.7% YoY, driven by an 11% surge in its cardiovascular portfolio and an 80% jump in Cardiac Ablation Solutions (CAS) where pulse‑field ablation now accounts for 80% of the segment. Gross margin...
CorMedix Inc (CRMD) Q4 2025 Earnings Call Transcript
CONMED reported Q4 2025 revenue of $373.2 million, a 7.9% year‑over‑year increase, and full‑year sales of $1.375 billion, up 5.2%. Orthopedic sales jumped 12.1% in the quarter, while international sales surged 15.4%, offsetting modest U.S. growth. Adjusted EPS rose 6.7% to $1.43,...
Kura Oncology Inc (KURA) Q4 2025 Earnings Call Transcript
Syndax Pharmaceuticals reported $172 million total revenue for 2025, driven by $125 million from its menin inhibitor RevuForge and $152 million from chronic GVHD therapy Nictimvo. RevuForge saw 38% quarter‑over‑quarter revenue growth and a 35% rise in prescriptions, bolstered by an expanded NPM1...
Nutex Health Inc (NUTX) Q4 2025 Earnings Call Transcript
Sensus Healthcare reported Q4 2025 revenue of $4.9 million, an 84% decline from the prior year, driven by the loss of its largest customer. Gross margin fell to 38.8% as servicing costs rose, while the company posted a $3.2 million net loss....
TriSalus Life Sciences Inc (TLSI) Q4 2025 Earnings Call Transcript
TriSalus Life Sciences reported Q3 2025 revenue of $11.6 million, a 57% year‑over‑year increase, while adjusted EBITDA loss narrowed to $5.4 million despite one‑time study charges. Gross margin slipped to 84% as new product launches strained manufacturing efficiency, but cash burn improved,...
Aligos Therapeutics Inc (ALGS) Q4 2025 Earnings Call Transcript
Agilon Health reported FY 2025 revenue of $5.93 billion, with Q4 revenue of $1.57 billion, but both medical margin and adjusted EBITDA remained negative, driven by higher inpatient claims and market exits. The company cut operating expenses by $35 million and extended its...
Contineum Therapeutics Inc (CTNM) Q4 2025 Earnings Call Transcript
Compugen Ltd. reported a dramatic financial turnaround in its Q4 2025 earnings, posting a $56.8 million quarterly profit and $35.3 million annual profit after a year of losses. A $65 million upfront royalty monetization from AstraZeneca boosted cash to $145.6 million, extending the cash runway...
‘AI, AI And AI’: CommonSpirit Health at Home CEO On The Forces Shaping 2026
CommonSpirit Health at Home is charting a 2026 roadmap that moves care upstream by using EHR‑based eligibility triggers to engage patients earlier in hospice and home‑health pathways. The provider plans a measured AI rollout focused on predictive analytics and operational...
Low Insulin Can Be Healthy—Check HbA1c and Liver
Insulin has an inverse U-shape during aging, so by itself low values may be optimal, but also indicative of B-cell failure Adding HbA1c provides more context. If it's low with low insulin this is potentially good news Also check liver enzymes, to...
GLP‑1 Drugs Cut Substance‑abuse Risk in Veterans
Best evidence yet that GLP-1 drugs reduce the risk of substance abuse, from >600,00 US Veterans across alcohol, nicotine, opioid, cocaine, cannabis @bmj_latest @zalaly @Miao_Cai_SLU https://t.co/rcqUt0kY77
64K SF Boulder Lab Leased To Pharma Company: The Denver Deal Sheet
CordenPharma Colorado has signed a 15‑year lease for a 64,000 SF purpose‑built lab in Boulder’s Flatiron Park, expanding its peptide development capabilities adjacent to an existing manufacturing plant. The speculative building, completed in 2024, features adaptable lab grids, advanced utilities and specialized...