Biologics

Xeltis passes 50% enrollment in US pivotal trial for aXess graft

The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
The Biotech Times Editorial Team  · 
Biologics

Vect-Horus and Servier tie up on CNS oligonucleotide delivery

The Marseille biotech will use its VECTrans platform to ferry Servier's oligonucleotides across the blood-brain barrier for rare neurological disorders.
The Marseille biotech will use its VECTrans platform to ferry Servier's oligonucleotides across the blood-brain barrier for rare neurological disorders.
The Biotech Times Editorial Team  · 
Biologics

Tenax Therapeutics to present LEVEL Phase 3 data at ESC 2026

Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.
Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.
The Biotech Times Editorial Team  · 
Biologics

Junshi Biosciences licenses IL-17A antibody roconkibart to Fosun Wanbang

Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
The Biotech Times Editorial Team  · 
Biotech

BellaSeno pivotal trial enrols 30 women for absorbable breast scaffold

The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
The Biotech Times Editorial Team  · 
Biologics

GNI Group completes JPY 44.8bn acquisition of Ayumi Pharmaceutical

GNI Group has acquired Ayumi Pharmaceutical from Blackstone, adding an 83% Japanese acetaminophen market share to its four-region biopharma platform.
GNI Group has acquired Ayumi Pharmaceutical from Blackstone, adding an 83% Japanese acetaminophen market share to its four-region biopharma platform.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
The Biotech Times Editorial Team  · 
Biologics

Ipsen to acquire Memo Therapeutics for up to EUR 700m

Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.
Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The Biotech Times Editorial Team  · 
Biologics
Diagnostics

Telix wins FDA alignment to open ProstACT Global Phase 3 in US

Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
The Biotech Times Editorial Team  · 
Biologics

Abivax prices upsized $800M ADS offering to fund obefazimod launch

The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Biotech Times Editorial Team  · 
Proteomics
Diagnostics

Seer wins EPO patent ruling and secures ITC probe into Nanomics

Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.
Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.
The Biotech Times Editorial Team  · 
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