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

Scancell secures $25m BlackRock debt facility to fund iSCIB1+ Phase 3

The Oxford immuno-oncology company has agreed a structured loan facility with BlackRock to help finance its registrational melanoma trial, due to start by end
The Oxford immuno-oncology company has agreed a structured loan facility with BlackRock to help finance its registrational melanoma trial, due to start by end
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy
Pharmaceuticals

Transgene reports 100% DFS at 41 months for TG4050 HNSCC vaccine

Transgene's personalised neoantigen vaccine TG4050 maintained 100% disease-free survival at over three years in resected head and neck cancer, with Phase 2 topline
Transgene's personalised neoantigen vaccine TG4050 maintained 100% disease-free survival at over three years in resected head and neck cancer, with Phase 2 topline
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Actimed Therapeutics completes PROACT Phase 2a recruitment

The London biotech has enrolled over 100 patients in a trial testing S-pindolol benzoate to preserve lean mass during and after semaglutide therapy.
The London biotech has enrolled over 100 patients in a trial testing S-pindolol benzoate to preserve lean mass during and after semaglutide therapy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

HUTCHMED takes savolitinib-osimertinib combo to ESMO 2026

Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Roche sefaxersen hits Phase III primary endpoint in IgA nephropathy

Interim IMAgINATION trial data show sefaxersen significantly reduced proteinuria versus placebo at 37 weeks in 459 adults with IgAN.
Interim IMAgINATION trial data show sefaxersen significantly reduced proteinuria versus placebo at 37 weeks in 459 adults with IgAN.
The Biotech Times Editorial Team  · 
Biologics
Synthetic Biology
Cell & Gene Therapy

Scarlet Therapeutics wins $14m DARPA deal for smart red blood cells

The Bristol biotech will lead an international consortium to engineer red blood cells that sense and respond to physiological changes.
The Bristol biotech will lead an international consortium to engineer red blood cells that sense and respond to physiological changes.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

SOTIO wins dual FDA designations for ADC SOT106 in sarcoma

SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in
SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

Adagene wins NMPA IND clearance for masked HER2xCD3 bispecific ADG138

Adagene's double-masked T-cell engager ADG138 cleared China's NMPA for a Phase 1 solid tumour trial due to start in Q4 2026.
Adagene's double-masked T-cell engager ADG138 cleared China's NMPA for a Phase 1 solid tumour trial due to start in Q4 2026.
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing
Regulatory Science

ATCC wins $99m DOW contract to manage military medical countermeasures

ATCC will lead lifecycle management of vaccines, biologics and drugs for the US military's RAPID programme under a 10-year, $99 million contract.
ATCC will lead lifecycle management of vaccines, biologics and drugs for the US military's RAPID programme under a 10-year, $99 million contract.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Celldex barzolvolimab Phase 3 trials meet all endpoints in CSU

Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for
Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

Dialybrid raises €15m Series A and achieves first-in-human implant

The Italian medtech closed a €15m Series A and implanted its Silkothane® hybrid arteriovenous graft in its first patient in an ongoing Italian pilot trial.
The Italian medtech closed a €15m Series A and implanted its Silkothane® hybrid arteriovenous graft in its first patient in an ongoing Italian pilot trial.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Eledon tegoprubart shows 13 mL/min eGFR edge over tacrolimus

Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six
Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six
The Biotech Times Editorial Team  · 
Biologics
Bioinformatics

Envisagenics and Boehringer Ingelheim in $1bn RNA splicing deal

Envisagenics' AI-powered SpliceCore platform will supply tumour-specific targets to Boehringer across ADC, T-cell engager and multispecific antibody programmes.
Envisagenics' AI-powered SpliceCore platform will supply tumour-specific targets to Boehringer across ADC, T-cell engager and multispecific antibody programmes.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

PDS Biotech's PDS0101 combo shows 39-month survival in HNSCC trial

VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Zealand Pharma starts Phase 3 ZUPREME programme for petrelintide

The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Roche enicepatide hits both Phase II endpoints in T2D and obesity

Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
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  · 
Pharmaceuticals
Biologics

J&J wins EC approval for icotrokinra in plaque psoriasis

Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
The Biotech Times Editorial Team  · 
Biologics
Medical Devices

Roche wins EC approval for Susvimo refillable eye implant in nAMD

The European Commission has approved Roche's Susvimo, a continuous-delivery ranibizumab implant requiring as few as two treatments per year for neovascular AMD.
The European Commission has approved Roche's Susvimo, a continuous-delivery ranibizumab implant requiring as few as two treatments per year for neovascular AMD.
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  · 
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