ENDRA Life Sciences announced that its Taeus Liver device achieved high measurement consistency in a MASLD study, recording an intraclass correlation coefficient of 0.89 and a standard error of measurement of 3.3%. The trial involved 14 participants and 56 data points to assess intra‑user reproducibility and repeatability. The results position Taeus as a point‑of‑care alternative to MRI‑PDFF, offering comparable accuracy at lower cost. The device could become a standard tool for routine liver‑fat monitoring in clinics and pharmaceutical trials.
Eli Lilly disclosed Phase III ACHIEVE‑3 results showing its oral GLP‑1 agonist orforglipron outperformed oral semaglutide in lowering A1C and inducing weight loss. The 52‑week, open‑label trial enrolled 1,698 patients across six countries and compared two doses of each drug. Orforglipron also...
Mahzi Therapeutics has administered the first dose of its investigational gene therapy MZ-1866 in the Phase I/II UNITE study for Pitt‑Hopkins syndrome. The open‑label, multicentre trial will enroll roughly 12 genetically confirmed patients across sites in Spain, Israel and the...
Medical device maker Stryker has launched Synchfix EVT, a flexible syndesmotic fixation system designed to simplify ankle stabilization procedures. The all‑in‑one, single‑use device integrates suture tensioning handles and a low‑profile titanium medial implant, reducing procedural complexity for both adult and adolescent...
Vico Therapeutics has initiated patient dosing in an expanded European cohort for its Phase I/IIa VO659 trial, targeting Huntington's disease, spinocerebellar ataxia type 3 and type 1. The study employs a twice‑annual intrathecal regimen and will monitor safety, tolerability, pharmacodynamics and pharmacokinetics...
NorthX Biologics and Demeetra have formed a strategic alliance to provide an end‑to‑end solution that couples Demeetra’s CleanCut CHO cell line development platform with NorthX’s GMP manufacturing capabilities. The partnership leverages a high‑titre GS‑knockout CHO cell line that carries no...
Allurion received FDA clearance for its Gastric Balloon System featuring the Smart Capsule, a swallow‑able, endoscopy‑free obesity treatment. The capsule is placed during a 15‑minute office visit, inflates in the stomach for about four months, then exits naturally, with a...
Johnson & Johnson released long‑term QUASAR extension data for Tremfya (guselkumab) in ulcerative colitis, showing sustained efficacy through week 140. Clinical remission was achieved by 80.8% of patients, with 78.6% attaining histo‑endoscopic improvement and 53.6% reaching endoscopic remission. Approximately 89% of...
AngioDynamics announced that its NanoKnife system now holds European CE‑mark indications for soft‑tissue ablation of liver, kidney, prostate and pancreas tumours, including intermediate‑risk prostate cancer. The device uses irreversible electroporation (IRE), a non‑thermal technology that destroys cancer cells while sparing...
Serina Therapeutics has enrolled the first patient in its Phase Ib registrational trial of SER‑252 for advanced Parkinson’s disease. The study, conducted with Parkinson’s Australia and Neuroscience Trials Australia, will assess safety, pharmacokinetics, tolerability and early efficacy, with dosing slated to...
Syngene International has entered a strategic collaboration with VivaMed BioPharma to advance AI‑derived drug repurposing programmes. The partnership combines Syngene’s pre‑clinical development capabilities with VivaMed’s AI‑generated therapeutic hypotheses, creating a pathway from computational hits to translational validation. Together they will...
Merck (MSD) and Mayo Clinic have launched a research partnership that blends Mayo's Platform architecture and multimodal clinical‑genomic data with MSD's virtual‑cell technologies. The collaboration gives MSD direct access to de‑identified imaging, lab, molecular and notes data to train and...
Portal Diabetes has secured FDA breakthrough device designation for its implantable Portal Pump, an insulin delivery system that pairs an abdominal pump with continuous glucose monitoring and concentrated insulin. The company also launched a Phase I study of temperature‑stable Portal Insulin...
Janux Therapeutics has dosed the first participant in a Phase I, open‑label, dose‑escalation trial of JANX011, its inaugural candidate from the adaptive immune response modulator (ARM) platform. The bispecific antibody targets CD19‑expressing B cells to achieve a deep, lasting immune reset...
Johnson & Johnson received FDA approval for a once‑monthly subcutaneous regimen of Rybrevant Faspro combined with Lazertinib for first‑line treatment of advanced EGFR‑mutated non‑small cell lung cancer. The new schedule delivers clinical outcomes comparable to the earlier bi‑weekly dosing while preserving...
VB Spine announced it has signed a definitive agreement to acquire Augmedics' xvision Spine System, adding augmented reality navigation to its visualization portfolio. The transaction, pending regulatory approval, is expected to close in the coming weeks and follows VB Spine's...
Immunic announced an oversubscribed private placement of up to $400 million, led by BVF Partners and joined by Avidity Partners, OrbiMed, Trails Edge Capital Partners, TCGX and Vivo Capital. The funds will support Phase III ENSURE studies for its multiple sclerosis therapy...
Natus Sensory announced the acquisition of TheraB Medical, a U.S. developer of the SnugLit wearable phototherapy device for neonatal jaundice. The deal will broaden Natus Sensory’s newborn care portfolio and leverage TheraB’s FDA‑cleared technology to expand access across hospitals and...