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

FDA approves Pluvicto for hormone-sensitive prostate cancer

Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.
Novartis wins approval to use its radioligand therapy earlier in metastatic prostate cancer, nearly doubling the eligible patient population.
The Biotech Times Editorial Team  · 
Biologics

Leads Biolabs completes enrolment in Phase II BTC study of opamtistomig

The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO
The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO
The Biotech Times Editorial Team  · 
Biologics

Novo Nordisk ZEUS trial fails to cut cardiovascular events

Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
The Biotech Times Editorial Team  · 
Biologics

Royalty Pharma pays up to $425m for cliramitug royalty stake

Royalty Pharma acquires a 3-4% royalty on AstraZeneca's Phase 3 ATTR-CM antibody cliramitug, paying Neurimmune $125m upfront with more tied to milestones.
Royalty Pharma acquires a 3-4% royalty on AstraZeneca's Phase 3 ATTR-CM antibody cliramitug, paying Neurimmune $125m upfront with more tied to milestones.
The Biotech Times Editorial Team  · 
Biologics

Tiziana sees neuroinflammation fall in third MSA patient on foralumab

PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
The Biotech Times Editorial Team  · 
Biologics

Annexon secures $200m credit facility from Oxford Finance

The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor adcom setback leaves deramiocel fate with FDA

An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
The Biotech Times Editorial Team  · 
Biologics

Diakonos Oncology doses first patients in DOC1021 melanoma trial

The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
The Biotech Times Editorial Team  · 
Biologics

Disc Medicine eyes two pivotal programmes by 2027 after busy Q2

The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.
The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.
The Biotech Times Editorial Team  · 
Biologics

Keros Therapeutics earns $20m milestone as elritercept Phase 3 enrols

Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
The Biotech Times Editorial Team  · 
Biologics

Madrigal Pharmaceuticals posts $364m Q2 Rezdiffra sales, up 71%

Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
The Biotech Times Editorial Team  · 
Biologics

Celcuity gedatolisib gains NCCN Category 1 status in breast cancer

REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
The Biotech Times Editorial Team  · 
Biologics

Sanofi upgrades 2026 guidance after 17.8% Q2 sales growth

Sanofi posted Q2 net sales of €11.6 billion, lifted by Dupixent and pharma launches, and raised its full-year sales growth target to around
Sanofi posted Q2 net sales of €11.6 billion, lifted by Dupixent and pharma launches, and raised its full-year sales growth target to around
The Biotech Times Editorial Team  · 
Biologics

Allogene wins FDA RMAT and Fast Track tags for cema-cel in LBCL

Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
The Biotech Times Editorial Team  · 
Biologics

Claris Bio raises $118m Series B to fund pivotal LSCD eye-drop study

The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The Biotech Times Editorial Team  · 
Biologics

Dyne Therapeutics gains FDA Priority Review for DMD drug z-rostudirsen

Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Pfizer-BioNTech win EC nod for XFG-adapted COVID-19 vaccine

The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
The Biotech Times Editorial Team  · 
Biologics

Ipsen raises FY 2026 guidance after 23.5% CER sales growth in H1

Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
The Biotech Times Editorial Team  · 
Biologics

MiMedx to acquire Sanara MedTech in $350m regenerative medicine deal

MiMedx will pay $35 per share for Sanara MedTech in a cash-and-stock deal that nearly doubles its surgical revenue and targets combined 2027
MiMedx will pay $35 per share for Sanara MedTech in a cash-and-stock deal that nearly doubles its surgical revenue and targets combined 2027
The Biotech Times Editorial Team  · 
Biologics
Digital Health
Diagnostics

Clue data study links follicular-phase vaccination to more side effects

Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
The Biotech Times Editorial Team  · 
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