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
Pharmaceuticals

First Tracks' ANB033 hits goals in coeliac gluten challenge

ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Acoramidis beats tafamidis on cardiac outcomes in real-world EHR study

A propensity-matched analysis of nearly 2,700 ATTR-CM patients found acoramidis cut composite cardiovascular risk by 18% versus tafamidis.
A propensity-matched analysis of nearly 2,700 ATTR-CM patients found acoramidis cut composite cardiovascular risk by 18% versus tafamidis.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Idorsia aprocitentan shows double-digit BP cuts in obesity and CKM

Post hoc PRECISION analyses presented at AHA 2026 show aprocitentan cut systolic BP by over 15 mmHg and reduced UACR by nearly 50% in high
Post hoc PRECISION analyses presented at AHA 2026 show aprocitentan cut systolic BP by over 15 mmHg and reduced UACR by nearly 50% in high
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Avaí Bio and Austrianova begin San Raffaele diabetes cell trial

The joint venture Insulinova has convened its first steering committee with OSR to evaluate encapsulated beta-cell replacement for insulin-dependent diabetes.
The joint venture Insulinova has convened its first steering committee with OSR to evaluate encapsulated beta-cell replacement for insulin-dependent diabetes.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Claris Bio reports positive CSB-001 data in rare corneal disease

Claris Biotherapeutics presented proof-of-concept data showing CSB-001 improved visual acuity in LSCD patients, with pivotal studies planned for 2027.
Claris Biotherapeutics presented proof-of-concept data showing CSB-001 improved visual acuity in LSCD patients, with pivotal studies planned for 2027.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

InnoCare wins China IND approval for TL1A/IL-23p19 bispecific ICP-B161

InnoCare Pharma has received NMPA clearance to trial ICP-B161, a long-acting bispecific antibody targeting two key IBD pathways, in China.
InnoCare Pharma has received NMPA clearance to trial ICP-B161, a long-acting bispecific antibody targeting two key IBD pathways, in China.
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

NurExone advances ExoPTEN optic nerve programme to rabbit study

Positive rat-model data showing statistically significant retinal recovery will support a planned larger-animal study for NurExone's exosome candidate ExoPTEN.
Positive rat-model data showing statistically significant retinal recovery will support a planned larger-animal study for NurExone's exosome candidate ExoPTEN.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

NovaBridge to present givastomig Phase 1b data at ESMO 2026

Updated safety and efficacy data for the CLDN18.2x4-1BB bispecific will be presented at ESMO Congress in Madrid on 25 October.
Updated safety and efficacy data for the CLDN18.2x4-1BB bispecific will be presented at ESMO Congress in Madrid on 25 October.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Roche vamikibart hits 52-week UME endpoints as FDA weighs BLA

Phase III MEERKAT and SANDCAT data show sustained vision gains at one year, with an FDA approval decision expected by July 2027.
Phase III MEERKAT and SANDCAT data show sustained vision gains at one year, with an FDA approval decision expected by July 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

iOnctura's roginolisib gets dual Nature Communications papers

Two peer-reviewed studies detail roginolisib's novel PI3Kδ binding mode and report a near-threefold OS improvement in metastatic uveal melanoma over historical controls.
Two peer-reviewed studies detail roginolisib's novel PI3Kδ binding mode and report a near-threefold OS improvement in metastatic uveal melanoma over historical controls.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Alumis files NDA plan for envudeucitinib after Phase 3 psoriasis data

Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Mineralys lorundrostat hits BP target in 46% of resistant HTN patients

New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.
New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Idorsia daridorexant Phase 2 paediatric data to headline Sleep Europe

Idorsia will present the first clinical data for a dual orexin receptor antagonist in children with insomnia at Sleep Europe 2026 in Maastricht.
Idorsia will present the first clinical data for a dual orexin receptor antagonist in children with insomnia at Sleep Europe 2026 in Maastricht.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Pacira grants Molteni exclusive EXPAREL rights across EU and UK

Pacira BioSciences has licensed its liposomal bupivacaine analgesic to Italian firm Molteni Farmaceutici, targeting first commercial sales in Europe by 2027.
Pacira BioSciences has licensed its liposomal bupivacaine analgesic to Italian firm Molteni Farmaceutici, targeting first commercial sales in Europe by 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Retension Pharmaceuticals raises $45m in Nasdaq IPO for RTN-001

The Virginia-based cardiovascular biotech priced 3.75 million shares at $12 each to fund its Phase 2b and planned Phase 3 trials of RTN
The Virginia-based cardiovascular biotech priced 3.75 million shares at $12 each to fund its Phase 2b and planned Phase 3 trials of RTN
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teva wins FDA approval for WELTRUZA once-monthly olanzapine

Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.
Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

Vascudyne lab-grown bypass vessel sustains flow at two-year mark

The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.
The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Cell & Gene Therapy

Cullinan Therapeutics doses first patient in pivotal CLN-049 AML study

The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.
The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics
Pharmaceuticals
Biologics

Editas Medicine clears first hurdle for EDIT-401 hyperlipidaemia trial

Editas has received ethics and regulatory approval in Australia to begin its Phase 1/2 Strive trial of in vivo gene editor EDIT-401 in
Editas has received ethics and regulatory approval in Australia to begin its Phase 1/2 Strive trial of in vivo gene editor EDIT-401 in
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Diagnostics

FDA approves Roche's Tecentriq for adjuvant stage III dMMR colon cancer

Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC
Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC
The Biotech Times Editorial Team  · 
Subscribe to Biologics