Biologics

Biomea Fusion completes enrolment in COVALENT-211 icovamenib trial

Biomea Fusion has fully enrolled its Phase II trial of oral menin inhibitor icovamenib in insulin-deficient type 2 diabetes, with topline data expected in
Biomea Fusion has fully enrolled its Phase II trial of oral menin inhibitor icovamenib in insulin-deficient type 2 diabetes, with topline data expected in
The Biotech Times Editorial Team  · 
Biologics

VarmX enrols first patient in Phase 3 trial of FXa reversal agent

VarmX has begun enrolling patients in EquilibriX-S, its pivotal Phase 3 study of VMX-C001 for urgent surgery in patients on Factor Xa inhibitors.
VarmX has begun enrolling patients in EquilibriX-S, its pivotal Phase 3 study of VMX-C001 for urgent surgery in patients on Factor Xa inhibitors.
The Biotech Times Editorial Team  · 
Biologics

J&J wins EC approval for teclistamab plus daratumumab in RRMM

The European Commission has approved the bispecific-antibody doublet for relapsed/refractory myeloma from second line, backed by Phase 3 survival data.
The European Commission has approved the bispecific-antibody doublet for relapsed/refractory myeloma from second line, backed by Phase 3 survival data.
The Biotech Times Editorial Team  · 
Biologics

ACTG launches alendronate trial to test HIV reservoir clearance

The global HIV trials network is testing a common osteoporosis drug as a latency-reversing agent in a 30-person randomised, placebo-controlled study.
The global HIV trials network is testing a common osteoporosis drug as a latency-reversing agent in a 30-person randomised, placebo-controlled study.
The Biotech Times Editorial Team  · 
Biologics

Vascudyne bioengineered coronary graft sustains 18-month patency

Vascudyne's acellular tissue-engineered vessel maintained full patency for 18 months in a large-animal CABG model, with anticoagulation stopped at six months.
Vascudyne's acellular tissue-engineered vessel maintained full patency for 18 months in a large-animal CABG model, with anticoagulation stopped at six months.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Humacyte V007 Phase 3 ATEV data published in Lancet Digital Health

Humacyte's peer-reviewed Phase 3 data show its bioengineered vessel outperformed standard fistulas in women and obese or diabetic men on haemodialysis.
Humacyte's peer-reviewed Phase 3 data show its bioengineered vessel outperformed standard fistulas in women and obese or diabetic men on haemodialysis.
The Biotech Times Editorial Team  · 
Digital Health
Diagnostics

AliveCor KardiaMobile 6L nearly doubles arrhythmia detection in trial

A 350-patient prospective study found the handheld 6-lead ECG device detected arrhythmias in 14.9% of patients versus 7.7% for standard ambulatory
A 350-patient prospective study found the handheld 6-lead ECG device detected arrhythmias in 14.9% of patients versus 7.7% for standard ambulatory
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science

FDA clears Vitestro's Aletta robotic blood draw device via De Novo

The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.
The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.
The Biotech Times Editorial Team  · 
Diagnostics

TearCare wins FDA label update to improve meibomian gland function

Sight Sciences says TearCare is now the first MGD treatment indicated to improve meibomian gland function in evaporative dry eye patients.
Sight Sciences says TearCare is now the first MGD treatment indicated to improve meibomian gland function in evaporative dry eye patients.
The Biotech Times Editorial Team  · 
Biologics

AC Immune NLRP3 inhibitor clears Phase 1 with CSF penetration

ACI-19764 was safe and well tolerated across dose cohorts, with brain penetration confirmed and a therapeutic dose expected at 10mg once daily.
ACI-19764 was safe and well tolerated across dose cohorts, with brain penetration confirmed and a therapeutic dose expected at 10mg once daily.
The Biotech Times Editorial Team  · 
Regulatory Science

Ambros and Werewolf merge to advance neridronate in CRPS-1

The all-stock deal, backed by a $150m oversubscribed private placement, creates a Nasdaq-listed company targeting the first FDA-approved therapy for CRPS-1.
The all-stock deal, backed by a $150m oversubscribed private placement, creates a Nasdaq-listed company targeting the first FDA-approved therapy for CRPS-1.
The Biotech Times Editorial Team  · 
Regulatory Science

Teva's ecopipam NDA gets FDA Priority Review for paediatric Tourette's

The FDA has accepted Teva's NDA for ecopipam with a PDUFA date in Q1 2027, potentially the first new Tourette's therapy in over
The FDA has accepted Teva's NDA for ecopipam with a PDUFA date in Q1 2027, potentially the first new Tourette's therapy in over
The Biotech Times Editorial Team  · 
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