Biologics

Manufactured-protein therapeutics: monoclonal antibodies (mAbs); bispecifics & fusion proteins; therapeutic proteins & enzymes; vaccines; and blood & plasma products. Distinct from Cell & Gene Therapy (living cells / genetic material) and from chemically-synthesised small molecules (which stay under Pharmaceuticals).

Biologics
Regulatory Science

Vaxcyte hires CMO and CLO as VAX-31 readout moves to October

Vaxcyte has appointed two senior executives and narrowed its OPUS-1 Phase 3 topline data window to end of October 2026.
Vaxcyte has appointed two senior executives and narrowed its OPUS-1 Phase 3 topline data window to end of October 2026.
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

Tensive gets €20m EIB loan for bioresorbable breast implant

The Milan biotech signed a convertible loan with the EIB, covering half of its €40m plan to reach CE Mark and EU launch for REGENERA
The Milan biotech signed a convertible loan with the EIB, covering half of its €40m plan to reach CE Mark and EU launch for REGENERA
The Biotech Times Editorial Team  · 
Pharmaceuticals
Bioprocessing
Biologics

WuXi TIDES maps the path for oligonucleotides beyond the liver

WuXi AppTec argues that extrahepatic oligonucleotide delivery requires tissue-specific strategies, not a single universal technology.
WuXi AppTec argues that extrahepatic oligonucleotide delivery requires tissue-specific strategies, not a single universal technology.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Newron completes ENIGMA-TRS 1 screening with 12-week data due Q1 2027

Newron Pharmaceuticals has finished screening for its 600-patient Phase 3 trial of evenamide in treatment-resistant schizophrenia, with topline results expected early
Newron Pharmaceuticals has finished screening for its 600-patient Phase 3 trial of evenamide in treatment-resistant schizophrenia, with topline results expected early
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Attovia Therapeutics raises $332m IPO as itch drug shows Phase 1b signal

The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Teva's TEV-408 meets primary endpoint in celiac Phase 2a

Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Lecanemab subcutaneous autoinjector approved in China for early AD

China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

HUTCHMED licenses KRAS-EGFR conjugate HMPL-A830 to GSK for $1.3bn

GSK gains worldwide rights outside Greater China to HMPL-A830, a novel antibody-targeted therapy conjugate, with $110m upfront and up to $1.295bn in
GSK gains worldwide rights outside Greater China to HMPL-A830, a novel antibody-targeted therapy conjugate, with $110m upfront and up to $1.295bn in
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Genomics

Scribe Therapeutics IPO raises $155m as STX-1150 enters clinic

The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside
The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Opus Genetics to unveil OPGx-BEST1 Phase 1/2 data on 9 September

The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

Transgene TG4050 sustains 100% disease-free survival at three years

All 16 TG4050-treated HNSCC patients remained relapse-free at 41 months' median follow-up, with full Phase 1 data now published in Nature Communications.
All 16 TG4050-treated HNSCC patients remained relapse-free at 41 months' median follow-up, with full Phase 1 data now published in Nature Communications.
The Biotech Times Editorial Team  · 
Diagnostics
Pharmaceuticals
Biologics

Juniper's JBS-003 wins FDA Breakthrough Therapy Designation

The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Ocugen doses first patient in Phase 3 gene therapy trial for dry AMD

Ocugen has initiated its Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, backed by FDA RMAT designation and a BLA filing targeted for 2028.
Ocugen has initiated its Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, backed by FDA RMAT designation and a BLA filing targeted for 2028.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novartis remibrutinib meets Phase III endpoints in relapsing MS

The REMODEL-1/-2 trials showed remibrutinib significantly reduced relapse rates versus teriflunomide, with disability progression benefits and no liver safety signal.
The REMODEL-1/-2 trials showed remibrutinib significantly reduced relapse rates versus teriflunomide, with disability progression benefits and no liver safety signal.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Kyntra Bio cuts royalty obligation by $60m in balance sheet overhaul

Kyntra Bio has amended its royalty financing deal to reduce maximum aggregate payments from $125m to $65m, extending its cash runway into Q4 2027.
Kyntra Bio has amended its royalty financing deal to reduce maximum aggregate payments from $125m to $65m, extending its cash runway into Q4 2027.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Ultragenyx publishes 96-week Phase 3 data for GENGLYCOS in GSDIa

Peer-reviewed results show a 61% mean reduction in daily cornstarch intake at Week 96, with glycaemic control maintained across both treatment groups.
Peer-reviewed results show a 61% mean reduction in daily cornstarch intake at Week 96, with glycaemic control maintained across both treatment groups.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Upstream Bio plans dual Phase 3 trials for verekitug in 2027

The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Boehringer Ingelheim launches SCOVELLA for equine laminitis in GB

Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.
Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.
The Biotech Times Editorial Team  · 
Biologics

Arch Biopartners wins IRB approval to open U.S. sites in CS-AKI trial

The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.
The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.
The Biotech Times Editorial Team  · 
Biologics

Lecanemab gets positive CDA-AMC reimbursement nod in Canada

Canada's Drug Agency has backed public reimbursement of lecanemab for early Alzheimer's disease, clearing the way for pCPA pricing negotiations.
Canada's Drug Agency has backed public reimbursement of lecanemab for early Alzheimer's disease, clearing the way for pCPA pricing negotiations.
The Biotech Times Editorial Team  · 
Subscribe to Biologics