Clinical Trials

Biologics
Pharmaceuticals

AnaptysBio reports Jemperli royalties up 34% as FDA decision looms

AnaptysBio posted $644m in Jemperli global net sales for H1 2026 and expects an FDA ruling on a rectal cancer indication by February 2027.
AnaptysBio posted $644m in Jemperli global net sales for H1 2026 and expects an FDA ruling on a rectal cancer indication by February 2027.
Pharmaceuticals
Diagnostics

Avalyn publishes Phase 1 data showing AP02's lung-targeted delivery

Peer-reviewed Phase 1 results confirm nebulised nintedanib achieved 26-fold higher lung exposure than the oral dose, with no serious adverse events.
Peer-reviewed Phase 1 results confirm nebulised nintedanib achieved 26-fold higher lung exposure than the oral dose, with no serious adverse events.
Pharmaceuticals
Regulatory Science

HMNC Brain Health names Doebler CEO ahead of Phase 3 push

The Munich neuroscience company promotes its Chief Business Officer to lead Ketabon and Nelivabon into late-stage development following a $50m Series B close.
The Munich neuroscience company promotes its Chief Business Officer to lead Ketabon and Nelivabon into late-stage development following a $50m Series B close.
Pharmaceuticals
Biologics

J&J wins EC approval for icotrokinra in plaque psoriasis

Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Biologics
Medical Devices

Roche wins EC approval for Susvimo refillable eye implant in nAMD

The European Commission has approved Roche's Susvimo, a continuous-delivery ranibizumab implant requiring as few as two treatments per year for neovascular AMD.
The European Commission has approved Roche's Susvimo, a continuous-delivery ranibizumab implant requiring as few as two treatments per year for neovascular AMD.
Biologics
Regulatory Science

Leads Biolabs secures ESMO 2026 LBA slot for EP-NEC pivotal data

Opamtistomig's Phase IIb registrational results in advanced EP-NEC will headline ESMO 2026, alongside three Proffered Paper presentations from the Nanjing biotech.
Opamtistomig's Phase IIb registrational results in advanced EP-NEC will headline ESMO 2026, alongside three Proffered Paper presentations from the Nanjing biotech.
Pharmaceuticals
Biologics

NewAmsterdam and Menarini win EC approval for obicetrapib

The European Commission has approved obicetrapib as both a monotherapy and fixed-dose combination, marking the CETP inhibitor's first regulatory clearance worldwide.
The European Commission has approved obicetrapib as both a monotherapy and fixed-dose combination, marking the CETP inhibitor's first regulatory clearance worldwide.
Pharmaceuticals
Biologics

Novo Nordisk CagriSema beats tirzepatide on weight loss in Phase 3

CagriSema at 1.0 mg/1.0 mg achieved 12.4% weight loss versus 9.1% for tirzepatide 5 mg in adults with type 2
CagriSema at 1.0 mg/1.0 mg achieved 12.4% weight loss versus 9.1% for tirzepatide 5 mg in adults with type 2
Cell & Gene Therapy
Biologics
Pharmaceuticals

Vironexis VNX-101 achieves MRD-negative responses in R/R ALL

All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
Medical Devices

Z Optics presents six-month IOL data at ESCRS 2026

Z Optics reported zero halos and strong visual acuity across lighting conditions for its Z+ Virtual Aperture IOL in a 43-patient single-centre study.
Z Optics reported zero halos and strong visual acuity across lighting conditions for its Z+ Virtual Aperture IOL in a 43-patient single-centre study.
Cell & Gene Therapy
Bioprocessing
Biologics

Avaí Bio clears cell bank safety testing for Klotho therapy

Avaí Bio and Austrianova confirmed their Master Cell Bank is free of more than 30 viruses, unlocking the next development stage for an α-Klotho
Avaí Bio and Austrianova confirmed their Master Cell Bank is free of more than 30 viruses, unlocking the next development stage for an α-Klotho
Biologics
Pharmaceuticals

Cue Biopharma: CUE-221 beats placebo and omalizumab in CSU trial

CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12
CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12
Cell & Gene Therapy
Pharmaceuticals

Longeveron HLHS stem cell trial misses primary endpoint

ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
Pharmaceuticals
Regulatory Science

Teva study shows HCPs favour AUSTEDO attributes for older TD patients

A discrete choice experiment involving 489 clinicians found somnolence risk and symptom improvement are the top priorities when selecting a VMAT2 inhibitor for tardive
A discrete choice experiment involving 489 clinicians found somnolence risk and symptom improvement are the top priorities when selecting a VMAT2 inhibitor for tardive
Diagnostics
Digital Health
Medical Devices

Spectral AI showcases DeepView burn diagnostic at SRBC

Spectral AI displayed its FDA-cleared DeepView multispectral imaging system at the Southern Regional Burn Conference, with two KOL presentations backing its clinical
Spectral AI displayed its FDA-cleared DeepView multispectral imaging system at the Southern Regional Burn Conference, with two KOL presentations backing its clinical
Pharmaceuticals
Genomics

Telomir Pharmaceuticals publishes preclinical AMD data for Telomir-Zn

A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
Pharmaceuticals
Biologics

Teva's UZEDY shows lower ER visits and cost savings in real-world data

New observational data presented at Psych Congress show UZEDY outperformed rival long-acting injectables on treatment continuity and cut monthly healthcare costs by over
New observational data presented at Psych Congress show UZEDY outperformed rival long-acting injectables on treatment continuity and cut monthly healthcare costs by over
Pharmaceuticals

Cardiff Oncology and NMS settle dispute and expand onvansertib deal

Cardiff Oncology and Nerviano Medical Sciences have resolved litigation and expanded their 2017 licence agreement, clearing the path for a global Phase 3 trial of
Cardiff Oncology and Nerviano Medical Sciences have resolved litigation and expanded their 2017 licence agreement, clearing the path for a global Phase 3 trial of
Biologics
Pharmaceuticals

GOA Therapeutics exits stealth with $15.5m alcohol antidote

GOA26, a dual-action engineered enzyme and acetaldehyde scavenger, cut blood alcohol by 61% in porcine studies; an IND filing is planned for Q4 2026.
GOA26, a dual-action engineered enzyme and acetaldehyde scavenger, cut blood alcohol by 61% in porcine studies; an IND filing is planned for Q4 2026.
Pharmaceuticals
Diagnostics

Jack Ady Cancer Centre launches Alberta's first rural cancer trial

Lethbridge's Jack Ady Cancer Centre is trialling a two-session prostate radiotherapy protocol, the first researcher-led cancer trial outside Alberta's major cities.
Lethbridge's Jack Ady Cancer Centre is trialling a two-session prostate radiotherapy protocol, the first researcher-led cancer trial outside Alberta's major cities.
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