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.
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
Biologics

Roche enicepatide hits both Phase II endpoints in T2D and obesity

Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
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
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
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
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.
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
Pharmaceuticals
Biologics

CDT Equity and QIMA to test tapinarof combos in psoriasis

CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
Medical Devices

Milestone Scientific adds Pain and Spine to CompuFlo Programme

Milestone Scientific named Pain and Spine Specialists and Dr Sudhir Rao as development partners to advance its CompuFlo epidural confirmation technology.
Milestone Scientific named Pain and Spine Specialists and Dr Sudhir Rao as development partners to advance its CompuFlo epidural confirmation technology.
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.
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
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