Partnerships

Digital Health

Arab Therapy signs MOU with King Abdulaziz University on mental health

The Riyadh-based digital mental health platform will embed psychological support services, joint research, and staff training across the Jeddah campus.
The Riyadh-based digital mental health platform will embed psychological support services, joint research, and staff training across the Jeddah campus.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

IBA to install Brazil's first proton therapy centre in Rio de Janeiro

IBA has signed a contract with FUSVE to bring proton therapy to Brazil for the first time, with a focus on paediatric cancer care.
IBA has signed a contract with FUSVE to bring proton therapy to Brazil for the first time, with a focus on paediatric cancer care.
The Biotech Times Editorial Team  · 
Regulatory Science

EMBARC and Insmed to run 3,000-patient brensocatib study

The pan-European research network intends to test whether brensocatib can modify bronchiectasis disease course over three years in six countries.
The pan-European research network intends to test whether brensocatib can modify bronchiectasis disease course over three years in six countries.
The Biotech Times Editorial Team  · 
Regulatory Science

Chiesi and Arbor win EU orphan designation for ABO-101 in PH1

The European Commission has granted orphan drug designation to ABO-101, a CRISPR-based gene editing therapy for primary hyperoxaluria type 1.
The European Commission has granted orphan drug designation to ABO-101, a CRISPR-based gene editing therapy for primary hyperoxaluria type 1.
The Biotech Times Editorial Team  · 
Biologics

Boehringer opens three Phase III trials in lung and NEC cancers

Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 

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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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