Standard BioTools and Treeline Biosciences agree all-stock merger

The combined company will operate as Treeline Biosciences, with over $900m in cash and three Phase 1 oncology programmes already under way.
The combined company will operate as Treeline Biosciences, with over $900m in cash and three Phase 1 oncology programmes already under way.
Regulatory Science

Telitacicept wins NMPA approval for Sjögren's disease in China

RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI
RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI

Artiva's AlloNK wins FDA RMAT tag as EULAR data show 71% ACR50 in RA

Artiva Biotherapeutics secured RMAT designation for its allogeneic NK cell therapy after Phase 2a data showed durable responses in refractory rheumatoid arthritis.
Artiva Biotherapeutics secured RMAT designation for its allogeneic NK cell therapy after Phase 2a data showed durable responses in refractory rheumatoid arthritis.
Diagnostics

DBV Technologies presents VITESSE subgroup data at EAACI 2026

New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.
New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.
Bioprocessing
Regulatory Science

Alvotech wins FDA review acceptance for AVT16 vedolizumab biosimilar

The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis
The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis
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.
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
Regulatory Science

Agios licenses SYK inhibitor cevidoplenib from Oscotec in $1bn ITP deal

Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
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.
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.
Regulatory Science

Signati Medical wins FDA IDE approval for Separo vasectomy device trial

The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.
The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.

Cullinan Therapeutics' CLN-978 shows remissions in SLE and RA at EULAR

Phase 1 data from 29 patients show deep B cell depletion and clinical remissions in refractory lupus and rheumatoid arthritis after a single dose.
Phase 1 data from 29 patients show deep B cell depletion and clinical remissions in refractory lupus and rheumatoid arthritis after a single dose.
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