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).

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  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Telix to acquire ITM in $1.65bn radiopharmaceutical deal

Telix Pharmaceuticals will merge with ITM Isotope Technologies Munich in a deal worth up to $2.35bn including milestones, creating a vertically integrated
Telix Pharmaceuticals will merge with ITM Isotope Technologies Munich in a deal worth up to $2.35bn including milestones, creating a vertically integrated
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teva's UZEDY shows lower ER visits and cost savings in real-world data

New observational data presented at Psych Congress show UZEDY outperformed rival long-acting injectables on treatment continuity and cut monthly healthcare costs by over
New observational data presented at Psych Congress show UZEDY outperformed rival long-acting injectables on treatment continuity and cut monthly healthcare costs by over
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

GOA Therapeutics exits stealth with $15.5m alcohol antidote

GOA26, a dual-action engineered enzyme and acetaldehyde scavenger, cut blood alcohol by 61% in porcine studies; an IND filing is planned for Q4 2026.
GOA26, a dual-action engineered enzyme and acetaldehyde scavenger, cut blood alcohol by 61% in porcine studies; an IND filing is planned for Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Rezera launches REVEAL-PAD study to map inflammation in PAD

The Boston biotech plans a prospective, multi-centre observational study to characterise PAD patients ahead of its Phase 3 ruvonoflast trial in 2027.
The Boston biotech plans a prospective, multi-centre observational study to characterise PAD patients ahead of its Phase 3 ruvonoflast trial in 2027.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Tiziana Life Sciences signs KAIMRC MOU for RRMS combination trial

Tiziana will collaborate with Saudi Arabia's KAIMRC on a clinical trial combining intranasal foralumab with anti-CD20 therapy in poorly responding RRMS patients.
Tiziana will collaborate with Saudi Arabia's KAIMRC on a clinical trial combining intranasal foralumab with anti-CD20 therapy in poorly responding RRMS patients.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Diagnostics

VivoSim Labs presents NAMkind toxicity data at EUROTOX 2026

VivoSim's 3D liver and intestinal platforms showed predictive superiority for DILI and GI toxicity across small molecules and antibody-drug conjugates.
VivoSim's 3D liver and intestinal platforms showed predictive superiority for DILI and GI toxicity across small molecules and antibody-drug conjugates.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

J&J's teclistamab wins CHMP backing for second-line myeloma use

The EMA's medicines committee has recommended expanding teclistamab's label to relapsed/refractory myeloma patients after just one prior therapy.
The EMA's medicines committee has recommended expanding teclistamab's label to relapsed/refractory myeloma patients after just one prior therapy.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Roche's Ocrevus gets CHMP backing for paediatric MS

The EMA's medicines committee has recommended ocrelizumab for children aged 10 and over with relapsing MS, following Phase III superiority data over fingolimod.
The EMA's medicines committee has recommended ocrelizumab for children aged 10 and over with relapsing MS, following Phase III superiority data over fingolimod.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Electra Therapeutics prices upsized $350m IPO on Nasdaq

The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Novartis secukinumab gets positive CHMP opinion for PMR

The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Regulatory Science

Novo Nordisk's Sogroya wins CHMP backing for idiopathic short stature

A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.
A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Bavarian Nordic appoints Tarja Stenvall as CEO from October

The Danish vaccine company has named Sanofi and AstraZeneca veteran Tarja Stenvall as its new chief executive, effective 15 October 2026.
The Danish vaccine company has named Sanofi and AstraZeneca veteran Tarja Stenvall as its new chief executive, effective 15 October 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teva presents Phase 3 data on once-monthly olanzapine LAI TEV-'749

Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Regulatory Science

Zealand Pharma gets CHMP nod for glepaglutide in short bowel syndrome

The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.
The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.
The Biotech Times Editorial Team  · 
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