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Multiply Labs is revolutionizing cell therapy production with ai

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins.

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins, cutting costs by up to 70%, increasing throughput, and reducing contamination ri

The Biotech Times Editorial Team  · 
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
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  · 
Cell & Gene Therapy
Pharmaceuticals

Longeveron HLHS stem cell trial misses primary endpoint

ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Telomir Pharmaceuticals publishes preclinical AMD data for Telomir-Zn

A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
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

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

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

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

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  · 
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  · 
Pharmaceuticals
Regulatory Science

MIRA Pharmaceuticals submits Ketamir-2 Phase 2a protocol for CIPN

MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.
MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.
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  · 
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  · 
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  · 
Pharmaceuticals
Regulatory Science

Aquestive resubmits Anaphylm NDA after human factors and PK studies

Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
The Biotech Times Editorial Team  · 
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