Diagnostics
Biotech

ACTG launches Phase 2 trial of dasatinib to shrink HIV reservoir

The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Alpha Tau and Tolmar partner to commercialise Alpha DaRT in U.S.

Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
The Biotech Times Editorial Team  · 
Regulatory Science

Attralus wins FDA orphan drug status for AL amyloidosis candidate AT-02

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
The Biotech Times Editorial Team  · 
Genomics

Biogen's salanersen wins FDA Breakthrough Therapy tag for SMA

The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

GH Research publishes Phase 2a PPD data for inhaled GH001

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
The Biotech Times Editorial Team  · 
Regulatory Science

Gilead and Lakefront close Ouro Medicines deal for $1.675bn

The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The Biotech Times Editorial Team  · 
Regulatory Science

Novartis ALIGN data show Vanrafia slows IgAN kidney decline by 34%

Final 2.5-year Phase III results, published in The Lancet, back a traditional approval filing for atrasentan in IgA nephropathy later this year.
Final 2.5-year Phase III results, published in The Lancet, back a traditional approval filing for atrasentan in IgA nephropathy later this year.
The Biotech Times Editorial Team  · 
Biotech

Ona Therapeutics raises $86.6m Series B to bring ADCs into clinic

The Barcelona biotech closed an oversubscribed round to advance its lead ADC, ONA-255, toward clinical proof of concept in breast cancer.
The Barcelona biotech closed an oversubscribed round to advance its lead ADC, ONA-255, toward clinical proof of concept in breast cancer.
The Biotech Times Editorial Team  · 
Diagnostics

Spectral Medical PMX shows sustained mortality benefit at 12 months

Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
The Biotech Times Editorial Team  · 
Regulatory Science

Iovance wins TGA approval for lifileucel in advanced melanoma

Amtagvi becomes the first T cell therapy approved for a solid tumour in Australia, the country with the world's highest melanoma incidence.
Amtagvi becomes the first T cell therapy approved for a solid tumour in Australia, the country with the world's highest melanoma incidence.
The Biotech Times Editorial Team  · 
Regulatory Science

Novartis Cosentyx Phase III PMR data published in NEJM

Phase III REPLENISH trial showed secukinumab achieved sustained remission in twice as many PMR patients as placebo at 52 weeks, with significant steroid sparing.
Phase III REPLENISH trial showed secukinumab achieved sustained remission in twice as many PMR patients as placebo at 52 weeks, with significant steroid sparing.
The Biotech Times Editorial Team  · 
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