Know What's Happening in Healthcare
Know What's Happening in Healthcare
Eli Lilly secures FDA nod for oral GLP‑1 weight‑loss pill as injectable trial shows 28.7% loss
The FDA approved Lilly’s oral GLP‑1 weight‑loss drug orforglipron (brand name Foundayo), which can be taken without food or water restrictions, positioning it against Novo Nordisk’s Wegovy. In parallel, Lilly’s experimental injectable triple‑hormone agonist retatrutide delivered an average 28.7% body‑weight reduction in a Phase 3 trial, outpacing competitors.
Also developing:
By the numbers: Syneron Bio raises $150M Series B
Roche announced a $480 million, five‑year investment in South Korea to build a national clinical‑trial ecosystem, fund R&D infrastructure, and train specialized personnel. The pledge also includes support for domestic biotech startups aiming for global markets. This move aligns with a wider industry shift toward offshore trial sites, with Korea prized for its expertise in antibody‑drug conjugates, cell and gene therapies. Roche’s commitment follows similar high‑value partnerships by GSK and Lilly, underscoring Korea’s growing role alongside China in biopharma collaborations.
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...
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...
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...
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...
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 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...
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,...
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...
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 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 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...
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...
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 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 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 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 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 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...
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...
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 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 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 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...
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 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 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...
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, 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...
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...
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...
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...
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...
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 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...
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...
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...
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...
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)
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,...
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...
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,...
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...
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 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,...
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...
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...
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...
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...
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
