Regulatory Science

Alterity Therapeutics wins FDA alignment on ATH434 Phase 3 MSA trial

Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.
Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.
The Biotech Times Editorial Team  · 
Biotech

Atavistik Bio wins FDA IND clearance and Fast Track tag for ATV-1601

The Cambridge biotech can now advance directly into a randomised Phase 1/2 study of its oral AKT1 inhibitor in hereditary haemorrhagic telangiectasia.
The Cambridge biotech can now advance directly into a randomised Phase 1/2 study of its oral AKT1 inhibitor in hereditary haemorrhagic telangiectasia.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Regulatory Science

Cellectis wins FDA RMAT designation for allogeneic CAR-T lasme-cel

The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic
The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

Ceribell Clarity AI links seizure burden to neurological outcomes

A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death
A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death
The Biotech Times Editorial Team  · 
Pharmaceuticals

Chiesi wins Health Canada priority review for FILSUVEZ in EB

Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.
Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.
The Biotech Times Editorial Team  · 
Regulatory Science

Disc Medicine aligns with FDA on bitopertin CRL response path

Disc Medicine said a Type A FDA meeting confirmed the Phase 3 APOLLO study could support a traditional approval for bitopertin in EPP, with data
Disc Medicine said a Type A FDA meeting confirmed the Phase 3 APOLLO study could support a traditional approval for bitopertin in EPP, with data
The Biotech Times Editorial Team  · 
Pharmaceuticals

Imviva Biotech wins FDA IND clearance for dual-target allogeneic CAR-T

CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Kymera Therapeutics doses first participant in IRAK4 degrader trial

KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Sanofi halts MOBILIZE Phase 3 trial of riliprubart in refractory CIDP

An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.
An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

TG Therapeutics launches Phase 2 MG trial after positive BRIUMVI data

Subcutaneous BRIUMVI hit MCID in 82% of myasthenia gravis patients at Week 24, prompting a potentially registration-directed Phase 2 sequential-therapy trial.
Subcutaneous BRIUMVI hit MCID in 82% of myasthenia gravis patients at Week 24, prompting a potentially registration-directed Phase 2 sequential-therapy trial.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Windward Bio doses first patients in Phase 2 COPD study of WIN378

The Basel biotech has initiated SIRIUS, a Phase 2 COPD trial of its twice-yearly anti-TSLP antibody WIN378, alongside an ongoing asthma programme.
The Basel biotech has initiated SIRIUS, a Phase 2 COPD trial of its twice-yearly anti-TSLP antibody WIN378, alongside an ongoing asthma programme.
The Biotech Times Editorial Team  · 
Genomics

Alkeus Pharmaceuticals doses first patient in Phase 3 Stargardt trial

The Cambridge biotech has initiated its pivotal NORTHSTAR study of oral gildeuretinol in Stargardt disease, with no approved treatment currently available.
The Cambridge biotech has initiated its pivotal NORTHSTAR study of oral gildeuretinol in Stargardt disease, with no approved treatment currently available.
The Biotech Times Editorial Team  · 
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