Partnerships

Diagnostics

IBA reshuffles leadership as de Romrée takes operational control

IBA has elevated Henri de Romrée to full operational leadership while founder-era CEO Olivier Legrain shifts to board vice-chairman and strategic oversight.
IBA has elevated Henri de Romrée to full operational leadership while founder-era CEO Olivier Legrain shifts to board vice-chairman and strategic oversight.
Biologics

BioCardia targets Japan PMDA submission for CardiAMP by end of 2026

BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure

FocalTherics partners with MellingMedical to bring HIFU to VA system

FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
Biologics

Memento Medicines raises $93m Series A for retinal bispecific

The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
Regulatory Science

Nicox NCX 470 clears China pre-submission review ahead of dual NDA push

Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.
Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.
Biologics

Utebzi approved as first oral carbapenem for cUTIs in the US

The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
Regulatory Science

Inventiva secures €130m debt facility to fund lanifibranor Phase 3

Claret Capital Partners and BlackRock are co-funding a €130m package backing Inventiva's MASH candidate lanifibranor ahead of a Q4 2026 trial readout.
Claret Capital Partners and BlackRock are co-funding a €130m package backing Inventiva's MASH candidate lanifibranor ahead of a Q4 2026 trial readout.
Regulatory Science

NovaBridge wins FDA Fast Track for givastomig in gastric cancer

NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
Pharmaceuticals

Menarini selinexor combo meets spleen endpoint in Phase 3 MF

Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.
Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.
Pharmaceuticals
Biotech

Parabilis Medicines raises $745m in upsized Nasdaq IPO

The Cambridge biotech priced 33.5 million shares at $20 each, with Regeneron taking a concurrent $75m private placement stake.
The Cambridge biotech priced 33.5 million shares at $20 each, with Regeneron taking a concurrent $75m private placement stake.
Diagnostics

Vivoryon touts DKD kidney data as it hunts Phase 2b partner

The Dutch biotech reported compelling eGFR data in diabetic kidney disease patients and confirmed cash runway only into Q4 2026 as partnership talks continue.
The Dutch biotech reported compelling eGFR data in diabetic kidney disease patients and confirmed cash runway only into Q4 2026 as partnership talks continue.
Bioprocessing

Neion Bio closes $23m Series A for egg-based biologics platform

The New York biotech raised an oversubscribed Series A led by Caffeinated Capital to scale its Raptor egg-based biomanufacturing platform.
The New York biotech raised an oversubscribed Series A led by Caffeinated Capital to scale its Raptor egg-based biomanufacturing platform.
Diagnostics

Roche gains FDA nod for first PTEN companion diagnostic

The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.
The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.
Diagnostics

Kura and Kyowa Kirin report 94% 12-month survival in AML combo trial

KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.
KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.
Bioinformatics

Nurix BTK degrader bexobrutideg shows 92.9% ORR in second-line CLL

Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.
Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.
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.
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.
Pharmaceuticals

Kymera Therapeutics doses first participant in IRAK4 degrader trial

KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
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.
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