Biologics
Pharmaceuticals

SAB BIO wins FDA Fast Track for SAB-142 in Stage 3 type 1 diabetes

SAB Biotherapeutics has secured Fast Track designation for its human anti-thymocyte immunoglobulin SAB-142, with trial enrolment expected to complete by end of 2026.
SAB Biotherapeutics has secured Fast Track designation for its human anti-thymocyte immunoglobulin SAB-142, with trial enrolment expected to complete by end of 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Oorja Bio screens first patient in Phase 2 IPF trial of ORJ-001

The Houston biotech, backed by a16z and Westlake BioPartners, has dosed its first patient in the ORBIT-IPF study of its AEC2-targeting peptide candidate.
The Houston biotech, backed by a16z and Westlake BioPartners, has dosed its first patient in the ORBIT-IPF study of its AEC2-targeting peptide candidate.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Digital Health

Generate Biomedicines and Zealand Pharma ink AI protein deal

Generate Biomedicines will receive $30m upfront and up to $1.2bn in milestones to design AI-engineered multispecific proteins for obesity and metabolic disease.
Generate Biomedicines will receive $30m upfront and up to $1.2bn in milestones to design AI-engineered multispecific proteins for obesity and metabolic disease.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Prelude and Lilly to trial KAT6A degrader PRT13722 in breast cancer

Prelude Therapeutics has struck a clinical supply deal with Lilly to test its oral KAT6A degrader PRT13722 alongside two approved breast cancer drugs.
Prelude Therapeutics has struck a clinical supply deal with Lilly to test its oral KAT6A degrader PRT13722 alongside two approved breast cancer drugs.
The Biotech Times Editorial Team  · 
Diagnostics
Pharmaceuticals

Royal Osteoporosis Society urges Britons to check bone health risk

New polling shows 80% of UK adults have never assessed their bone health, despite osteoporosis causing 550,000 fractures annually.
New polling shows 80% of UK adults have never assessed their bone health, despite osteoporosis causing 550,000 fractures annually.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

Gates Foundation and Wellcome Leap commit $100m to cut stillbirths

The Uzima programme targets a 50% reduction in stillbirth rates across select countries over a decade, led by AI diagnostics and biomarker tools.
The Uzima programme targets a 50% reduction in stillbirth rates across select countries over a decade, led by AI diagnostics and biomarker tools.
The Biotech Times Editorial Team  · 
Medical Devices

Iridex MicroPulse TLT shows sustained IOP cuts in two-year study

An independent Italian study found MicroPulse transscleral laser therapy reduced intraocular pressure by 37% over 24 months across early to advanced glaucoma.
An independent Italian study found MicroPulse transscleral laser therapy reduced intraocular pressure by 37% over 24 months across early to advanced glaucoma.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

First Tracks' ANB033 hits goals in coeliac gluten challenge

ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Harmony Biosciences names Anastasiou CEO as Dayno retires

Peter Anastasiou, current COO, will take the helm on 1 January 2027 as Harmony reiterates WAKIX revenue guidance of up to $1.04 billion.
Peter Anastasiou, current COO, will take the helm on 1 January 2027 as Harmony reiterates WAKIX revenue guidance of up to $1.04 billion.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

BridgeBio encaleret hits ADH1 endpoints as NDA earns Priority Review

Phase 3 CALIBRATE data show encaleret improved symptoms in all treated participants, with the FDA setting a May 2027 PDUFA date for the NDA.
Phase 3 CALIBRATE data show encaleret improved symptoms in all treated participants, with the FDA setting a May 2027 PDUFA date for the NDA.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Claris Bio reports positive CSB-001 data in rare corneal disease

Claris Biotherapeutics presented proof-of-concept data showing CSB-001 improved visual acuity in LSCD patients, with pivotal studies planned for 2027.
Claris Biotherapeutics presented proof-of-concept data showing CSB-001 improved visual acuity in LSCD patients, with pivotal studies planned for 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Milestone Pharma enrols first European patient in AFib-RVR trial

Milestone Pharmaceuticals has expanded its ReVeRA-301 Phase 3 trial to Europe, enrolling the first patient through the Dutch WCN cardiovascular network.
Milestone Pharmaceuticals has expanded its ReVeRA-301 Phase 3 trial to Europe, enrolling the first patient through the Dutch WCN cardiovascular network.
The Biotech Times Editorial Team  · 
Subscribe to