Biotech
Bioinformatics

Bexorg wins up to $28.3m ARPA-H award to extend human brain perfusion

The New Haven CNS platform company will use the 36-month grant to push its BrainEx system from 24-hour to two-week intact human
The New Haven CNS platform company will use the 36-month grant to push its BrainEx system from 24-hour to two-week intact human
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Rezera: ruvonoflast cuts inflammation added to semaglutide

Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Regulatory Science

SeaStar Medical wins seventh Breakthrough Device tag for SCD in sepsis

The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

TISSIUM begins US enrolment in UNITE hernia fixation trial

TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.
TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

vTv Therapeutics wins FDA Orphan Drug tag for HPPD in sickle cell

The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin
The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Medical Devices

GenSight optogenetic therapy safe and restores object detection

A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Zealand Pharma's petrelintide hits Phase 2 weight and glycaemic goals

Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.
Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Vaxcyte raises ~$1bn via equity and convertible notes to fund VAX-31

Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.
Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

argenx Phase 2 data back FB102 as first drug for celiac disease

argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now
argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

argenx halts Phase 3 UNITY trial of efgartigimod in Sjögren's disease

An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novartis wins FDA approval for Rhapsido in symptomatic dermographism

Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

OKYO Pharma enrols first patients in Phase 3 urcosimod NCP trial

OKYO Pharma has initiated its NEPTUNE pivotal study of urcosimod for neuropathic corneal pain, a condition with no approved treatments.
OKYO Pharma has initiated its NEPTUNE pivotal study of urcosimod for neuropathic corneal pain, a condition with no approved treatments.
The Biotech Times Editorial Team  · 
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