North America

The United States and Canada.
Cell & Gene Therapy

Cell therapy's second act: why Boston is still winning

Four years after the first wave of CAR-T IPOs, Massachusetts is quietly becoming the centre of gravity for the next generation of cell therapies — this time, for solid tumours.

When the FDA approved the first CAR-T therapy for leukaemia in 2017, the assumption across the industry was that the blood cancer playbook would translate quickly into solid tumours. It did not.

Mark Walker  · 
Biotech
Bioprocessing

Cannara Biotech expands credit facility to C$80m with BMO and TD

The Québec cannabis producer has upsized its syndicated debt facility by C$30m and extended its maturity to December 2029.
The Québec cannabis producer has upsized its syndicated debt facility by C$30m and extended its maturity to December 2029.
The Biotech Times Editorial Team  · 
Diagnostics
Pharmaceuticals
Digital Health

Cerenome secures $20m royalty-based facility to scale CNSide platform

The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay
The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

CooperCompanies retains CooperSurgical and lifts buyback to $3bn

CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Genelux publishes SCLC case report showing 16.7-month PFS with Olvi-Vec

A single platinum-relapsed SCLC patient achieved a deeper, longer response after Olvi-Vec-primed rechallenge than during first-line chemotherapy, Genelux reports.
A single platinum-relapsed SCLC patient achieved a deeper, longer response after Olvi-Vec-primed rechallenge than during first-line chemotherapy, Genelux reports.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Hexiris Ophthalmics to show OBi glaucoma data at five meetings

Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

Quantum BioPharma clears FDA IND for PAD2-targeting MS drug Lucid-MS

Quantum BioPharma has FDA clearance to begin a Phase 2 trial of Lucid-MS, a PAD2 inhibitor designed to target demyelination rather than suppress the
Quantum BioPharma has FDA clearance to begin a Phase 2 trial of Lucid-MS, a PAD2 inhibitor designed to target demyelination rather than suppress the
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Immutep refocuses efti on HNSCC and sarcoma after trial failure

Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
Immutep has identified a manufacturing scale difference as the likely cause of TACTI-004's failure and will restart efti trials in 2H 2027.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals
Digital Health

HOPE Therapeutics first to deploy Zeta Surgical's robotic TMS system

NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
The Biotech Times Editorial Team  · 
Diagnostics
Genomics
Regulatory Science

Bionano Labs OGM test in line for Medicare coverage under proposed LCD

MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.
MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Circle CVI positions cvi42 for TAVR volume surge after CMS ruling

CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Electra Therapeutics starts Phase 1 of SIRPγ antibody ELA822

Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Pharming wins FDA approval for Joenja in children aged 4 to 11 with APDS

The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.
The Biotech Times Editorial Team  · 
Genomics
Diagnostics
Regulatory Science

NAD recommends Nucleus Genomics modify embryo screening ad claims

The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.
The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.
The Biotech Times Editorial Team  · 
Medical Devices

Intuitive meta-analysis backs da Vinci across 13 conditions

A 14-million-procedure meta-analysis in Annals of Surgery Open found da Vinci robotic surgery improved key perioperative outcomes versus laparoscopic and open approaches.
A 14-million-procedure meta-analysis in Annals of Surgery Open found da Vinci robotic surgery improved key perioperative outcomes versus laparoscopic and open approaches.
The Biotech Times Editorial Team  · 
AgriTech
Diagnostics

Rad Source launches Sterile Insect Farms division for mosquito control

Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Medical Devices

Syncromune presents SYNC-T Phase 1 prostate data at CIRSE 2026

The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Adneuris presents Phase 3 and abuse-potential data for cebranopadol

Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
The Biotech Times Editorial Team  · 
Medical Devices

Axogen to acquire BioCircuit Technologies for $200m cash

Axogen is buying the maker of NerveTape, the first FDA-approved sutureless peripheral nerve repair device, in a deal expected to close in Q4 2026.
Axogen is buying the maker of NerveTape, the first FDA-approved sutureless peripheral nerve repair device, in a deal expected to close in Q4 2026.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

IMUNON signs NCI CRADA to expand IMNN-001 into new solid tumours

IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
The Biotech Times Editorial Team  · 
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