Bioprocessing
Regulatory Science

Alvotech resubmits FDA BLAs for golimumab and aflibercept biosimilars

Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.
Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.
The Biotech Times Editorial Team  · 
Diagnostics

Boehringer's survodutide hits Phase III endpoints in obesity and MASLD

Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight
Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight
The Biotech Times Editorial Team  · 
Diagnostics

Diasome Phase 2b data shows HDV-insulin cuts hypoglycemia in T1D

OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
The Biotech Times Editorial Team  · 
Biotech

GNI Group to acquire Ayumi Pharmaceutical in ¥44.8bn deal

The Tokyo-listed biopharmaceutical group is buying Blackstone's Japanese specialty pharma asset to build a cross-Pacific commercial platform.
The Tokyo-listed biopharmaceutical group is buying Blackstone's Japanese specialty pharma asset to build a cross-Pacific commercial platform.
The Biotech Times Editorial Team  · 
Digital Health

Health Catalyst divests Vitalware to Med-Metrix for $147m

Health Catalyst will sell its mid-revenue cycle unit to fund AI investment and fully repay a $160m term loan.
Health Catalyst will sell its mid-revenue cycle unit to fund AI investment and fully repay a $160m term loan.
The Biotech Times Editorial Team  · 
Biotech

Nurix and Roche strike $2.3bn BTK degrader collaboration

Nurix Therapeutics receives $700m upfront from Roche to co-develop bexobrutideg across blood cancers, multiple sclerosis and urticaria.
Nurix Therapeutics receives $700m upfront from Roche to co-develop bexobrutideg across blood cancers, multiple sclerosis and urticaria.
The Biotech Times Editorial Team  · 
Regulatory Science

PharmAla Biotech licenses ALA-002 U.S. rights to Jupiter Neurosciences

PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Roche and Nurix strike $2.3bn BTK degrader deal for bexobrutideg

Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
The Biotech Times Editorial Team  · 
Pharmaceuticals

SERB Pharmaceuticals buys European and MENA rights to Idefirix for €115m

SERB Pharmaceuticals will acquire imlifidase's European and MENA commercialisation rights from Hansa Biopharma, targeting highly sensitised kidney transplant patients.
SERB Pharmaceuticals will acquire imlifidase's European and MENA commercialisation rights from Hansa Biopharma, targeting highly sensitised kidney transplant patients.
The Biotech Times Editorial Team  · 
Bioprocessing

Stipple Bio licenses Lonza ADC platform for precision oncology push

Stipple Bio has struck a multi-target licence with Lonza to pair its epitope-discovery platform with Lonza's GlycoConnect ADC technology, beginning with lead
Stipple Bio has struck a multi-target licence with Lonza to pair its epitope-discovery platform with Lonza's GlycoConnect ADC technology, beginning with lead
The Biotech Times Editorial Team  · 
Diagnostics

Biomea Fusion presents icovamenib diabetes data at ADA 2026

Phase II findings show durable HbA1c reductions and beta cell preservation in both type 1 and type 2 diabetes, with no immune activation signals.
Phase II findings show durable HbA1c reductions and beta cell preservation in both type 1 and type 2 diabetes, with no immune activation signals.
The Biotech Times Editorial Team  · 
Regulatory Science

Crossject closes €15m equity raise to advance ZEPIZURE EUA process

The Dijon-based emergency-medicines specialist issued new shares and warrants to fund regulatory steps for its needle-free seizure treatment and ramp production capacity.
The Dijon-based emergency-medicines specialist issued new shares and warrants to fund regulatory steps for its needle-free seizure treatment and ramp production capacity.
The Biotech Times Editorial Team  · 
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