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Multiply Labs is revolutionizing cell therapy production with ai

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins.

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins, cutting costs by up to 70%, increasing throughput, and reducing contamination ri

The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Cartesian licenses mRNA payload to WestGene for in vivo CAR-T

Cartesian Therapeutics and WestGene Biopharma will combine mRNA CAR-T payloads with targeted LNPs to run a Phase 1 MG trial from late 2026.
Cartesian Therapeutics and WestGene Biopharma will combine mRNA CAR-T payloads with targeted LNPs to run a Phase 1 MG trial from late 2026.
The Biotech Times Editorial Team  · 
Regulatory Science

Tris Pharma wins FDA Orphan Drug Designation for TRN-257 in IH

The New Jersey biotech's once-nightly, low-sodium oxybate candidate secured ODD based on its potential to eliminate the disruptive mid-night second dose.
The New Jersey biotech's once-nightly, low-sodium oxybate candidate secured ODD based on its potential to eliminate the disruptive mid-night second dose.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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  · 
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  · 
Biotech

Hengrui and Kailera report ribupatide Phase 2 oral data at ADA 2026

Oral ribupatide delivered up to 12.1% mean weight loss at 26 weeks in a China Phase 2 trial, with no observed plateau and a
Oral ribupatide delivered up to 12.1% mean weight loss at 26 weeks in a China Phase 2 trial, with no observed plateau and a
The Biotech Times Editorial Team  · 
Biotech

Zealand Pharma petrelintide hits 10.7% weight loss at 42 weeks

Phase 2 ZUPREME-1 data show the amylin analogue achieved double-digit weight reduction with near-placebo tolerability, ahead of planned Phase 3 initiation.
Phase 2 ZUPREME-1 data show the amylin analogue achieved double-digit weight reduction with near-placebo tolerability, ahead of planned Phase 3 initiation.
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  · 
Digital Health

ApolloMD passes $1.5bn in patient medical debt relief since 2018

The physician-led practice manager has abolished over $1.5bn in patient debt via Cascade365 and non-profit Undue Medical Debt, targeting low-income patients.
The physician-led practice manager has abolished over $1.5bn in patient debt via Cascade365 and non-profit Undue Medical Debt, targeting low-income patients.
The Biotech Times Editorial Team  · 
Regulatory Science
Biotech

BridgeBio wins ANVISA approval for acoramidis in ATTR-CM

BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.
BEYONTTRA becomes the first near-complete TTR stabiliser approved in Brazil, backed by Phase 3 data showing a 42% cut in cardiovascular mortality and hospitalisation.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Tonix Pharmaceuticals gains GPO coverage for TONMYA across 35m lives

The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
The Biotech Times Editorial Team  · 
Bioprocessing
Cell & Gene Therapy

Cabaletta Bio signs 10-year cell therapy supply deal with Cellares

The agreement covers commercial-scale automated manufacture of rese-cel for autoimmune disease, with a BLA submission in myositis planned for 2027.
The agreement covers commercial-scale automated manufacture of rese-cel for autoimmune disease, with a BLA submission in myositis planned for 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Crescent Biopharma posts Q1 2026 results with $189m cash runway

The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
The Biotech Times Editorial Team  · 
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