Pharmaceuticals
Biologics

Zealand Pharma starts Phase 3 ZUPREME programme for petrelintide

The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
The Biotech Times Editorial Team  · 
Medical Devices

Traferox X°Port Heart wins FDA 510(k) clearance for transplant use

Traferox Technologies has secured FDA 510(k) clearance for its X°Port Heart Preservation System, targeting improved donor heart outcomes via 10°C static cold
Traferox Technologies has secured FDA 510(k) clearance for its X°Port Heart Preservation System, targeting improved donor heart outcomes via 10°C static cold
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Quoin Pharma wins FDA Fast Track for QRX003 in Peeling Skin Syndrome

Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

PDS Biotech's PDS0101 combo shows 39-month survival in HNSCC trial

VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Ophirex BRAVIO trial misses endpoints but signals krait benefit

Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.
Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.
The Biotech Times Editorial Team  · 
Biotech

Patient safety checklist marks 25 years with reform agenda unfinished

Dr Peter Pronovost's ICU infection checklist turns 25, but patient harm rates in US hospitals have barely shifted in a generation.
Dr Peter Pronovost's ICU infection checklist turns 25, but patient harm rates in US hospitals have barely shifted in a generation.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Fakih IVF marks UAE 15th anniversary with free IVF initiative

The Dubai fertility group will provide 15 complimentary IVF cycles to families facing financial barriers, timed to the UAE's Year of the Family.
The Dubai fertility group will provide 15 complimentary IVF cycles to families facing financial barriers, timed to the UAE's Year of the Family.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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