Pharmaceuticals
Regulatory Science

EMA validates Biosplice's lorecivivint application for knee OA

The EMA has begun its centralised review of lorecivivint, a small-molecule CLK/DYRK inhibitor Biosplice positions as a potential first disease-modifying therapy for
The EMA has begun its centralised review of lorecivivint, a small-molecule CLK/DYRK inhibitor Biosplice positions as a potential first disease-modifying therapy for
Medical Devices
Diagnostics
Pharmaceuticals

IBA to distribute ARTMS QIS cyclotron technology for theranostics

IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
Pharmaceuticals
Biologics

Amplio Pharma Phase 1b data back NovoBioJect methotrexate booster

The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
Pharmaceuticals
Genomics

Cullinan files NDA for zipalertinib in first-line EGFR ex20ins NSCLC

Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.
Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.
Biologics
Pharmaceuticals

Leads Biolabs' opamtistomig wins Japan orphan status for EP-NEC

The PD-L1/4-1BB bispecific antibody has now secured orphan drug designation in Japan, the US, and Europe, as its China NDA enters technical
The PD-L1/4-1BB bispecific antibody has now secured orphan drug designation in Japan, the US, and Europe, as its China NDA enters technical
Biologics
Pharmaceuticals

Biogen litifilimab CLE data show durable skin clearance at 52 weeks

Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1
Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1
Pharmaceuticals
Biologics

Novo semaglutide data show liver fat normalised in 88% of obese adults

Novo Nordisk presented STEP UP sub-analysis at EASD 2026 showing Wegovy reduced mean liver fat from 8.8% to 3.1% over 72 weeks
Novo Nordisk presented STEP UP sub-analysis at EASD 2026 showing Wegovy reduced mean liver fat from 8.8% to 3.1% over 72 weeks
Cell & Gene Therapy
Biologics

Century Therapeutics' CNTY-813 hits IND-readiness milestones at EASD

Nonclinical data for the iPSC-derived islet therapy showed consistent manufacturing and durable glycaemic control, with an IND filing due in Q4 2026.
Nonclinical data for the iPSC-derived islet therapy showed consistent manufacturing and durable glycaemic control, with an IND filing due in Q4 2026.
Cell & Gene Therapy
Biologics
Pharmaceuticals

Artiva to present AlloNK autoimmune data across 34 patients at ACR 2026

Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.
Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.
Medical Devices
Digital Health
Diagnostics

ViCentra Kaleido patch pump hits TIR targets in 3,918-patient study

Real-world data from nearly 4,000 European type 1 diabetes patients shows Kaleido met consensus time-in-range targets with median hypoglycaemia of just
Real-world data from nearly 4,000 European type 1 diabetes patients shows Kaleido met consensus time-in-range targets with median hypoglycaemia of just
Biologics
Cell & Gene Therapy

ViroMissile clears first cohort in IV-dosed oncolytic virus Phase I

ViroMissile's Safety Review Committee has cleared IDOV-2 to advance to a higher dose cohort, with one patient showing confirmed stable disease at six
ViroMissile's Safety Review Committee has cleared IDOV-2 to advance to a higher dose cohort, with one patient showing confirmed stable disease at six
Pharmaceuticals
Regulatory Science

Teva ecopipam shows durable tic reduction in Tourette trial

New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing
New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing
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