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

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  · 
Biologics
Regulatory Science

Leads Biolabs secures ESMO 2026 LBA slot for EP-NEC pivotal data

Opamtistomig's Phase IIb registrational results in advanced EP-NEC will headline ESMO 2026, alongside three Proffered Paper presentations from the Nanjing biotech.
Opamtistomig's Phase IIb registrational results in advanced EP-NEC will headline ESMO 2026, alongside three Proffered Paper presentations from the Nanjing biotech.
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  · 
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  · 
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  · 
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  · 
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

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

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  · 
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
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
Cell & Gene Therapy
Diagnostics
Genomics

NCCN guidelines name clonoSEQ for myeloma MRD testing

Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Capricor to present 24-month Deramiocel DMD data at WMS 2026

Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Biogen publishes Phase 3 EMPAVELI paediatric data in CJASN

Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

SNIPR enrolls first Phase 2 patient in CRISPR phage trial

SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

1ST Bio and SK Biopharma ink $314.8m Parkinson's licence for 1ST-104

The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Novo Nordisk wins CHMP nod for denecimig in haemophilia A

The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.
The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals
Regulatory Science
Biologics

Ultragenyx wins FDA approval for FAYUVI in Sanfilippo syndrome Type A

FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Tempest Therapeutics options Senlang lentiviral in vivo CAR-T platform

Tempest secures an exclusive option on Senlang's CD7-targeted lentiviral vector platform, adding a Phase 1 multiple myeloma programme to its in vivo CAR
Tempest secures an exclusive option on Senlang's CD7-targeted lentiviral vector platform, adding a Phase 1 multiple myeloma programme to its in vivo CAR
The Biotech Times Editorial Team  · 
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