Pharmaceuticals
Regulatory Science
Biologics

60 Degrees Pharma to report babesiosis trial data in January 2027

The NASDAQ-listed biotech will unblind its tafenoquine babesiosis trial early and seek a pre-sNDA FDA meeting, targeting an accelerated approval pathway.
The NASDAQ-listed biotech will unblind its tafenoquine babesiosis trial early and seek a pre-sNDA FDA meeting, targeting an accelerated approval pathway.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

APIIC launches National Fragility Index for US drug supply chains

The API Innovation Center's new benchmark found over 550 million prescriptions in 2023 were filled for medicines rated High or Severe fragility.
The API Innovation Center's new benchmark found over 550 million prescriptions in 2023 were filled for medicines rated High or Severe fragility.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

ArriVent firmonertinib misses Phase 3 PFS endpoint in NSCLC

The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.
The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.
The Biotech Times Editorial Team  · 
Digital Health
Diagnostics
Bioinformatics

Digbi Health preprint shows IBS relief in 16,000-member study

A real-world preprint from Digbi Health found 54% of symptomatic IBS members improved meaningfully after 12 weeks on its microbiome-personalised programme.
A real-world preprint from Digbi Health found 54% of symptomatic IBS members improved meaningfully after 12 weeks on its microbiome-personalised programme.
The Biotech Times Editorial Team  · 
Medical Devices

Zenflow raises $52m Series D and signs Cook Medical distribution deal

Zenflow closes an oversubscribed Series D to commercialise its FDA-approved BPH Spring System, with Cook Medical as exclusive US distributor.
Zenflow closes an oversubscribed Series D to commercialise its FDA-approved BPH Spring System, with Cook Medical as exclusive US distributor.
The Biotech Times Editorial Team  · 
Bioprocessing
Cell & Gene Therapy
Biologics

Repligen completes BioLife Solutions acquisition for cell therapy push

Repligen has closed its acquisition of BioLife Solutions, adding biopreservation media that underpins 18 commercially approved cell therapies.
Repligen has closed its acquisition of BioLife Solutions, adding biopreservation media that underpins 18 commercially approved cell therapies.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Gate Bioscience expands Lilly deal to target hard-to-drug proteins

The Brisbane biotech adds at least one new target to its Lilly collaboration, with total milestone-contingent deal value potentially exceeding $870 million.
The Brisbane biotech adds at least one new target to its Lilly collaboration, with total milestone-contingent deal value potentially exceeding $870 million.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

BridgeBio to present CALIBRATE Phase 3 encaleret data at ASBMR 2026

BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.
BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.
The Biotech Times Editorial Team  · 
Genomics
Biologics
Pharmaceuticals

Korro Bio doses first cohort in ANCHOR Phase 1/2 UCD trial

Korro Bio has begun dosing healthy volunteers with KRRO-121, its RNA-editing candidate for urea cycle disorders, with UCD patients expected to follow in
Korro Bio has begun dosing healthy volunteers with KRRO-121, its RNA-editing candidate for urea cycle disorders, with UCD patients expected to follow in
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  · 
Pharmaceuticals
Biologics

Jupiter Neurosciences doses first patient in Phase 2a Parkinson's trial

Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.
Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Revolution Medicines starts Phase 3 RAS G12D PDAC doublet trial

Revolution Medicines has dosed first patients in RASolute 309, a Phase 3 study pitting its RAS inhibitor doublet against standard chemotherapy in metastatic pancreatic
Revolution Medicines has dosed first patients in RASolute 309, a Phase 3 study pitting its RAS inhibitor doublet against standard chemotherapy in metastatic pancreatic
The Biotech Times Editorial Team  · 
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