Biologics
Pharmaceuticals

Knight Therapeutics signs Latin America deal for Kyowa Kirin's Poteligeo

Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.
Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Immix Biopharma NXC-201 hits 89% CR rate in AL amyloidosis trial

An interim read of 45 NEXICART-2 patients shows NXC-201 achieving an 89% complete response rate, with MRD-negativity pointing to a potential 98
An interim read of 45 NEXICART-2 patients shows NXC-201 achieving an 89% complete response rate, with MRD-negativity pointing to a potential 98
The Biotech Times Editorial Team  · 
Medical Devices

IBA to install first gantry proton therapy centre in central Italy

IBA has signed a contract with Rome's IFO to deliver a Proteus ONE proton therapy system, bringing gantry-based treatment to central and southern
IBA has signed a contract with Rome's IFO to deliver a Proteus ONE proton therapy system, bringing gantry-based treatment to central and southern
The Biotech Times Editorial Team  · 
Bioprocessing
Pharmaceuticals

Lifecore Biomedical to go private in $664m Webster Equity deal

Webster Equity Partners will acquire the CDMO for $6.28 per share in cash, plus CVRs worth up to $9.67 per share if performance
Webster Equity Partners will acquire the CDMO for $6.28 per share in cash, plus CVRs worth up to $9.67 per share if performance
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Currus Biologics wins FDA IND clearance for CUR-001 CAR-T trial

The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

CapsoVision wins FDA clearance for AI Highlights capsule endoscopy tool

CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.
CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Belite Bio to present DRAGON Phase 3 tinlarebant data at Euretina

Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Teva wins FDA approval for DEGEVMA denosumab biosimilar to Xgeva

Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

4DMT enrols first patients in 4SIGHT Phase 3 DME gene therapy trial

4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

ALX Oncology's evorpacept hits 63.6% ORR in HER2+ gastric subgroup

Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
The Biotech Times Editorial Team  · 
AgriTech
Synthetic Biology

Cibus and Crystal Crop partner to gene-edit India's mustard crop

The deal gives Crystal Crop exclusive India rights to Cibus gene-editing technology targeting higher mustard yields across 8.5 million hectares.
The deal gives Crystal Crop exclusive India rights to Cibus gene-editing technology targeting higher mustard yields across 8.5 million hectares.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

SCYNEXIS wins $214m BARDA contract to develop SCY-247 antifungal

The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
The Biotech Times Editorial Team  · 
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