Pharmaceuticals
Diagnostics

Sagimet's denifanstat shows sustained acne efficacy at 52 weeks

Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening
Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Pacira grants Molteni exclusive EXPAREL rights across EU and UK

Pacira BioSciences has licensed its liposomal bupivacaine analgesic to Italian firm Molteni Farmaceutici, targeting first commercial sales in Europe by 2027.
Pacira BioSciences has licensed its liposomal bupivacaine analgesic to Italian firm Molteni Farmaceutici, targeting first commercial sales in Europe by 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Alumis files NDA plan for envudeucitinib after Phase 3 psoriasis data

Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Mineralys lorundrostat hits BP target in 46% of resistant HTN patients

New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.
New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Idorsia daridorexant Phase 2 paediatric data to headline Sleep Europe

Idorsia will present the first clinical data for a dual orexin receptor antagonist in children with insomnia at Sleep Europe 2026 in Maastricht.
Idorsia will present the first clinical data for a dual orexin receptor antagonist in children with insomnia at Sleep Europe 2026 in Maastricht.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teva wins FDA approval for WELTRUZA once-monthly olanzapine

Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.
Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

Spectral AI files NTAP application for DeepView burn-wound system

Spectral AI has applied to CMS for additional Medicare reimbursement for its AI-powered DeepView burn-wound imaging device, cleared by the FDA in May
Spectral AI has applied to CMS for additional Medicare reimbursement for its AI-powered DeepView burn-wound imaging device, cleared by the FDA in May
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

Vascudyne lab-grown bypass vessel sustains flow at two-year mark

The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.
The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Biotech

Al Ghurair launches Trellis Health hospital network in Dubai

The UAE conglomerate's new healthcare group opens a 50-bed multi-speciality hospital in Umm Suqeim, with two further clinics due by end of
The UAE conglomerate's new healthcare group opens a 50-bed multi-speciality hospital in Umm Suqeim, with two further clinics due by end of
The Biotech Times Editorial Team  · 
Medical Devices
Regulatory Science

Manchester-led team maps path for virtual patients in device regulation

A University of Manchester-led consortium has published a framework for using computer-simulated patients to support medical device regulatory decisions.
A University of Manchester-led consortium has published a framework for using computer-simulated patients to support medical device regulatory decisions.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics
Biologics

Myriad Genetics and SOPHiA GENETICS team up on prostate HRD biomarker

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Pharvaris HAE pill data published in The Lancet ahead of FDA review

Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due
Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due
The Biotech Times Editorial Team  · 
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