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).

Diagnostics
Genomics
Biologics

Myriad Genetics and SOPHiA GENETICS team up on prostate HRD biomarker

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

X4 Pharmaceuticals secures $150m debt facility with K2 HealthVentures

The Boston rare-haematology biotech refinanced its existing loan and gains fresh capital to support mavorixafor's Phase 3 trial and potential commercial launch.
The Boston rare-haematology biotech refinanced its existing loan and gains fresh capital to support mavorixafor's Phase 3 trial and potential commercial launch.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

argenx Phase 2 data back FB102 as first drug for celiac disease

argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now
argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

argenx halts Phase 3 UNITY trial of efgartigimod in Sjögren's disease

An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Novartis wins FDA approval for Rhapsido in symptomatic dermographism

Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Medical Devices

GenSight optogenetic therapy safe and restores object detection

A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Rezera: ruvonoflast cuts inflammation added to semaglutide

Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

TISSIUM begins US enrolment in UNITE hernia fixation trial

TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.
TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Vaxcyte raises ~$1bn via equity and convertible notes to fund VAX-31

Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.
Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

vTv Therapeutics wins FDA Orphan Drug tag for HPPD in sickle cell

The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin
The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Zealand Pharma's petrelintide hits Phase 2 weight and glycaemic goals

Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.
Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

ArriVent firmonertinib misses Phase 3 PFS endpoint in NSCLC

The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.
The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Gate Bioscience expands Lilly deal to target hard-to-drug proteins

The Brisbane biotech adds at least one new target to its Lilly collaboration, with total milestone-contingent deal value potentially exceeding $870 million.
The Brisbane biotech adds at least one new target to its Lilly collaboration, with total milestone-contingent deal value potentially exceeding $870 million.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Jupiter Neurosciences doses first patient in Phase 2a Parkinson's trial

Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.
Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

RougeTx launches with $58m Series A to target HHT bleeding disorder

The Leiden spin-out is advancing RTX-001, a once-daily oral pericyte-targeting candidate, toward first-in-human trials in a condition with no
The Leiden spin-out is advancing RTX-001, a once-daily oral pericyte-targeting candidate, toward first-in-human trials in a condition with no
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Epcoritamab plus R-CHOP cuts DLBCL progression risk by 51% in Phase 3

Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large
Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

CAR-T safety events dent rheumatologist confidence, Spherix finds

A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Bioprocessing

Avaí Bio and Austrianova confirm Klotho secretion in encapsulated cells

Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.
Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

Cuprina to acquire seven-clinic Singapore healthcare group for S$4m

Nasdaq-listed Cuprina is buying East Coast Podiatry and Orchard Clinic to integrate clinical delivery with its wound-care and collagen technologies.
Nasdaq-listed Cuprina is buying East Coast Podiatry and Orchard Clinic to integrate clinical delivery with its wound-care and collagen technologies.
The Biotech Times Editorial Team  · 
Biologics
Synthetic Biology
Bioprocessing

NorthStrive Biosciences engages Charles River for probiotic CRO work

NorthStrive Biosciences has signed a statement of work with Charles River Laboratories to characterise plasmid copy numbers in its EL-22 and EL-32 engineered
NorthStrive Biosciences has signed a statement of work with Charles River Laboratories to characterise plasmid copy numbers in its EL-22 and EL-32 engineered
The Biotech Times Editorial Team  · 
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