Nasal foralumab reduces brain inflammation marker in Phase 2a multiple sclerosis trial
Tiziana Life Sciences' nasal foralumab meets Phase 2a multiple sclerosis endpoints. Explore brain inflammation, fatigue and safety findings.
Pharma & Biotech
Pharma & Biotech
Huntington’s disease treatment milestone: uniQure secures priority FDA review for one-time gene therapy
uniQure's Huntington's gene therapy AMT-130 secures FDA priority review, with a May 1, 2027 decision target. Explore the clinical evidence.
Medical Devices & Diagnostics
Urologic Design raises $1.2m to advance patented male incontinence device towards first human trial
Urologic Design has secured $1.2 million in pre-seed equity financing to advance a patented urethral occlusion device for men experiencing stress urinary incontinence. The company has completed prototype development and bench testing but must still establish safety, usability and effectiveness in its planned first human study.
Medical Devices & Diagnostics
Egnite and Pathway Labs launch FDA-cleared ECG AI pilot at Stamford Health to improve structural heart disease detection
Egnite, Pathway Labs and Stamford Health are testing whether FDA-cleared ECG artificial intelligence can improve identification and follow-up of patients with possible structural heart disease. The pilot combines automated screening with longitudinal clinical records and will measure whether flagged patients actually receive further evaluation.
Medical Devices & Diagnostics
Abbott’s SonicForce recorded just 0.3% lesion failure, but can it challenge Shockwave in coronary calcium treatment?
Abbott has reported 97% procedural success and 0.3% target lesion failure at 30 days in its 335-patient TECTONIC study of SonicForce. The findings support the investigational system's regulatory development, although the single-arm trial does not establish superiority over existing coronary lithotripsy devices.
Features & Analysis
Impella registries show better survival than CHIP-BCIS3, but can Johnson & Johnson explain the conflicting evidence?
Johnson & Johnson has highlighted three observational analyses involving 1,379 Impella-supported high-risk PCI patients, reporting mortality rates below selected figures from CHIP-BCIS3. However, the original randomised study found no significant clinical advantage from routine pump use, leaving patient selection and treatment strategy important unresolved questions.
Medical Devices & Diagnostics
Reflow Medical reports zero major cardiac events at one year in nine-patient Spur Elute study
Reflow Medical has reported no major adverse cardiac events or deaths during 12 months of follow-up among nine patients treated with its investigational coronary Spur Elute system. The findings support continued development of the temporary sirolimus-delivering scaffold, but the uncontrolled pilot is too small to establish comparative effectiveness.
Medical Devices & Diagnostics
GE HealthCare unveils Allia Celeo AI-guided interventional system with European CE marking
GE HealthCare has introduced a ceiling-mounted interventional imaging platform combining AI-enabled acquisition, digital positioning and predictive service technology. The system is CE marked but awaits US clearance, leaving its clinical and commercial impact dependent on hospital adoption and measured workflow performance.
Pharma & Biotech
Altruist Biologics secures NMPA priority review for localised production of multinational client’s biologic
Altruist Biologics has supported the acceptance and priority review of a multinational client's application to manufacture an existing overseas-developed biologic in China. The milestone demonstrates the relevance of China's 2024 localisation framework, but the client's identity, the medicine and the financial terms remain undisclosed.
Pharma & Biotech
NeuroSense reported a 7.92-point ALS function gap with PrimeC, but will its Phase 3 trial confirm a real treatment benefit?
NeuroSense Therapeutics is using clinical and biomarker findings from its Phase 2b PARADIGM programme to refine the planned Phase 3 PARAGON trial of PrimeC. The published study reported encouraging long-term functional differences, but its six-month comparison was not statistically significant and the company faces substantial financing and listing pressures.