Biologics
Regulatory Science

Vaxart secures European patent for oral norovirus vaccine platform

The EPO has granted Vaxart protection for its room-temperature, needle-free norovirus pill vaccine across 13 European markets until at least 2036.
The EPO has granted Vaxart protection for its room-temperature, needle-free norovirus pill vaccine across 13 European markets until at least 2036.
Pharmaceuticals
Biologics

Novo Nordisk: semaglutide clears obesity threshold in 40% of children

Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Pharmaceuticals
Biologics

Novartis pelacarsen Phase III trial fails to cut CV events

The Lp(a)HORIZON outcomes trial in 8,323 patients met its Lp(a)-lowering goal but did not reduce the composite cardiovascular endpoint versus
The Lp(a)HORIZON outcomes trial in 8,323 patients met its Lp(a)-lowering goal but did not reduce the composite cardiovascular endpoint versus
Medical Devices
Regulatory Science

Globus Medical wins CE Mark for Excelsius3D imaging system in EU and UK

The Pennsylvania-based medtech said the CE Mark opens European commercial sales of its intraoperative 3-in-1 imaging platform, which integrates with its ExcelsiusGPS
The Pennsylvania-based medtech said the CE Mark opens European commercial sales of its intraoperative 3-in-1 imaging platform, which integrates with its ExcelsiusGPS
Medical Devices
Diagnostics
Biotech

Magrabi Health earns first global SRC Network of Excellence in

The Saudi-founded eye care group becomes the first healthcare network worldwide to receive the Surgical Review Corporation's specialist ophthalmology network
The Saudi-founded eye care group becomes the first healthcare network worldwide to receive the Surgical Review Corporation's specialist ophthalmology network
Medical Devices

ONWARD Medical starts EIGER implant study for spinal cord injury

The Eindhoven neurotechnology company has performed the first ARC-IM implant in its EIGER feasibility study, which will enrol up to 12 participants across subacute
The Eindhoven neurotechnology company has performed the first ARC-IM implant in its EIGER feasibility study, which will enrol up to 12 participants across subacute
Pharmaceuticals
Biologics

Tangram Therapeutics advances TGM-312 into MASH patient cohorts

The London RNAi biotech said its siRNA candidate cleared a safety review in healthy volunteers and now enters multiple ascending dose testing in MASH patients.
The London RNAi biotech said its siRNA candidate cleared a safety review in healthy volunteers and now enters multiple ascending dose testing in MASH patients.
Pharmaceuticals
Biologics

Newron completes ENIGMA-TRS 1 screening with 12-week data due Q1 2027

Newron Pharmaceuticals has finished screening for its 600-patient Phase 3 trial of evenamide in treatment-resistant schizophrenia, with topline results expected early
Newron Pharmaceuticals has finished screening for its 600-patient Phase 3 trial of evenamide in treatment-resistant schizophrenia, with topline results expected early
Medical Devices
Biologics

Tensive gets €20m EIB loan for bioresorbable breast implant

The Milan biotech signed a convertible loan with the EIB, covering half of its €40m plan to reach CE Mark and EU launch for REGENERA
The Milan biotech signed a convertible loan with the EIB, covering half of its €40m plan to reach CE Mark and EU launch for REGENERA
Biologics
Pharmaceuticals

HUTCHMED licenses KRAS-EGFR conjugate HMPL-A830 to GSK for $1.3bn

GSK gains worldwide rights outside Greater China to HMPL-A830, a novel antibody-targeted therapy conjugate, with $110m upfront and up to $1.295bn in
GSK gains worldwide rights outside Greater China to HMPL-A830, a novel antibody-targeted therapy conjugate, with $110m upfront and up to $1.295bn in
Biologics
Pharmaceuticals

Lecanemab subcutaneous autoinjector approved in China for early AD

China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
Medical Devices
Diagnostics

AiM Medical Robotics wins $2m NCI grant for MRI brain robot

The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
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