SKIA Secures FDA 510(k) Clearance for AR Surgical Platform
South Korean med‑tech firm SKIA has secured FDA 510(k) clearance for its AR surgical guidance platform, SKIA HEAD. The tablet‑based system, paired with Structure’s medical‑grade sensors, projects three‑dimensional reconstructions onto patients in real time. Clearance clears the path for a U.S. launch through a partnership with hardware provider Structure. SKIA notes prior use of its AR solutions in over 80 hernia procedures in India and multiple approvals in its home market.
Kalohexis Doses First Patients in 710GO Phase I Trial for Obesity
Kalohexis has begun dosing the first participants in a Phase I, first‑in‑human trial of 710GO, an oral dual melanocortin‑3/4 receptor agonist aimed at treating general obesity. The randomized, double‑blind, placebo‑controlled study in Australia will enroll roughly 100 obese or overweight volunteers...
Procept Secures FDA IDE for Aquablation and Completes WATER IV Study Enrolment
Procept BioRobotics secured a second FDA investigational device exemption (IDE) to launch a new randomized trial of its Aquablation water‑jet therapy, this time comparing it with active surveillance in men with low‑grade prostate cancer. The earlier WATER IV study has already...
First Participant Dosed in Jade’s Phase II JUNIPER Trial for IgAN
Jade Biosciences has dosed the first participant in its Phase II JUNIPER trial evaluating JADE101 for immunoglobulin A nephropathy (IgAN). The open‑label study will enroll 30 patients and assess safety, tolerability, and early efficacy signals such as protein‑to‑creatinine ratio, eGFR and haematuria...
SK Bioscience and VECOL Partner on Colombia Vaccine Manufacturing Initiative
SK bioscience has signed a technology‑transfer and manufacturing agreement with Colombia’s state‑owned VECOL, joining the country’s $260 million vaccine localisation initiative. The partnership will initially produce the SKYVaricella varicella vaccine locally, with VECOL handling operations and SK providing expertise. SK will also...
Pierre Fabre’s Braftovi Gains CHMP Positive Opinion for mCRC
The European Medicines Agency’s CHMP issued a positive opinion for Pierre Fabre’s Braftovi (encorafenib) combined with cetuximab and Folfox as a first‑line treatment of BRAFV600E‑mutant metastatic colorectal cancer. The Phase III BREAKWATER trial showed a 51 % reduction in death risk, extending median...
Caliway Secures FDA Clearance for CBL-514 Clinical Trial
Caliway Biopharmaceuticals received FDA clearance for its CBL‑0302 IND application, clearing the path for a pivotal global Phase III trial of CBL‑514 aimed at reducing abdominal subcutaneous fat. The double‑blind, placebo‑controlled study will enroll roughly 320 participants in the United States, Canada...
BioMarin’s ENERGY 3 Trial of BMN 401 Meets One Co-Primary Endpoint
BioMarin Pharmaceutical announced that its Phase III ENERGY 3 trial of BMN 401 met one of two co‑primary endpoints, showing a statistically significant rise in plasma inorganic pyrophosphate (PPi) levels in children with ENPP1 deficiency through week 52. The trial failed to demonstrate any...
Hospital at Home: The New Model of Modern Care
Virtual hospitals, or "virtual wards," are delivering hospital‑level care to patients at home by using wearables, AI analytics and remote clinician oversight. Early trials show reduced readmissions and the ability to free up roughly three beds per day, while an...
First Healthy Volunteers Receive TRIV-573 Doses in Triveni Bio’s Phase I Trial
Trivena Bio has dosed its first healthy volunteers in a Phase I trial of TRIV‑573, a half‑life‑extended bispecific antibody that simultaneously inhibits kallikreins 5/7 and blocks interleukin‑13. The dual‑target approach is designed to repair the skin barrier while curbing inflammation in moderate‑to‑severe...
PainTEQ Announces US Launch of SI Joint Implant
PainTEQ has begun commercial sales of TRAQ, a posterior sacroiliac (SI) joint fusion implant, in the United States. The device features triangular barbs that achieve bicortical fixation of the sacral and iliac cortices and is delivered through a 1‑inch posterior...
Massive Bio and Just Worldwide to Expand Cancer Trial Access
Massive Bio announced a strategic partnership with Just Worldwide to broaden access to oncology clinical trials. The deal combines Just Worldwide’s multicultural patient‑engagement infrastructure with Massive Bio’s SYNERGY‑AI matching engine, allowing patients to be onboarded, have records collected, and be...
Kyowa Kirin Secures FDA Approval for Crysvita Dosing Update
Kyowa Kirin has secured FDA approval for a dosing update to Crysvita (burosumab‑twza) for adults with X‑linked hypophosphataemia (XLH). The new regimen permits a 0.5 mg/kg dose every two weeks, with the option to increase to 1 mg/kg after four weeks if serum...
Hospitals Are Treating Burnout as a Wellness Problem. It Is an Operating Model Problem
Hospitals treat physician burnout as a wellness issue, but the root cause is an operating model that piles administrative load, financial risk, and decision‑making away from clinicians. Studies show wellness interventions have little impact, while physicians now spend 15‑25 hours...
Osel and Partners Launch Phase IIb FLIP-2 Trial of Lactin-V
Osel, Imperial College London and the March of Dimes have launched the Phase IIb FLIP‑2 trial to evaluate Lactin‑V, a live‑biotherapeutic containing Lactobacillus crispatus, for preventing preterm birth in high‑risk pregnancies. The study will enroll 360 women across four UK maternity...