Biologics

Nurix and Roche enrol first patient in Phase 3 bexobrutideg CLL trial

The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

Eyonis and Olea Medical partner to expand AI lung cancer screening in US

Median Technologies' Eyonis will distribute its FDA-cleared eyonis LCS tool through Canon Medical subsidiary Olea Medical across the US and Europe.
Median Technologies' Eyonis will distribute its FDA-cleared eyonis LCS tool through Canon Medical subsidiary Olea Medical across the US and Europe.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi's MenQuadfi wins EU approval for infants from six weeks

The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The Biotech Times Editorial Team  · 

Beyond Air raises up to $30.1m to fund LungFit PH II launch

Beyond Air priced an at-the-market private placement to fund the commercial launch of its second-generation nitric oxide delivery system, pending FDA approval.
Beyond Air priced an at-the-market private placement to fund the commercial launch of its second-generation nitric oxide delivery system, pending FDA approval.
The Biotech Times Editorial Team  · 
Diagnostics

CorVascular launches ASUS handheld ultrasound range at SVU 2026

CorVascular has introduced the FDA-cleared ASUS LU800 handheld ultrasound to US vascular specialists at the SVU annual conference in Maryland.
CorVascular has introduced the FDA-cleared ASUS LU800 handheld ultrasound to US vascular specialists at the SVU annual conference in Maryland.
The Biotech Times Editorial Team  · 
Digital Health
Diagnostics

First Choice Healthcare to go public via Westin SPAC at $650m valuation

First Choice Healthcare Solutions will merge with Westin Acquisition Corp to list on Nasdaq as Wellgevity 360, valued at approximately $650 million.
First Choice Healthcare Solutions will merge with Westin Acquisition Corp to list on Nasdaq as Wellgevity 360, valued at approximately $650 million.
The Biotech Times Editorial Team  · 
Biologics

EPO upholds SOT201 patent for SOTIO's PD-1 immunocytokine

SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
The Biotech Times Editorial Team  · 

Integra LifeSciences Q2 revenue steady as SurgiMend relaunch nears

Integra posted $418.8m in Q2 revenue and confirmed production at its Braintree facility, setting up a fourth-quarter SurgiMend relaunch.
Integra posted $418.8m in Q2 revenue and confirmed production at its Braintree facility, setting up a fourth-quarter SurgiMend relaunch.
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

Lonza and Engitix strike ADC licence deal targeting ECM biology

Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
The Biotech Times Editorial Team  · 
Genomics

Medicus Pharma wins UAE IND nod for genomics-guided endometriosis trial

Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
The Biotech Times Editorial Team  · 
Regulatory Science

UroGen secures US patent protecting ZUSDURI to July 2044

UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
The Biotech Times Editorial Team  · 
Diagnostics

MMI wins FDA clearance to expand REMIND Alzheimer's robot surgery study

MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
The Biotech Times Editorial Team  · 
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