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
Regulatory Science

Bavarian Nordic wins EC approval of mpox vaccine for young children

IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.
IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.
The Biotech Times Editorial Team  · 
Biologics

NewAmsterdam wins CHMP backing for obicetrapib ahead of PREVAIL

NewAmsterdam Pharma secured a positive CHMP opinion for obicetrapib in Europe as its 9,500-patient PREVAIL outcomes trial heads toward an interim readout.
NewAmsterdam Pharma secured a positive CHMP opinion for obicetrapib in Europe as its 9,500-patient PREVAIL outcomes trial heads toward an interim readout.
The Biotech Times Editorial Team  · 
Biologics

Adneuris licenses cebranopadol to Maruishi for Japan and South Korea

Adneuris Therapeutics receives $35m upfront as it grants Maruishi Pharmaceutical exclusive rights to develop its dual-receptor pain candidate in two Asian markets.
Adneuris Therapeutics receives $35m upfront as it grants Maruishi Pharmaceutical exclusive rights to develop its dual-receptor pain candidate in two Asian markets.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Oblenio Bio doses first patients in LBL-051 autoimmune Phase 1a trial

The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi's MenQuadfi wins EU approval for infants from six weeks

The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The Biotech Times Editorial Team  · 
Biologics

Nurix and Roche enrol first patient in Phase 3 bexobrutideg CLL trial

The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Leads Biolabs wins IND approval for Opamtistomig in metastatic CRC

China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
The Biotech Times Editorial Team  · 
Biologics

EPO upholds SOT201 patent for SOTIO's PD-1 immunocytokine

SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

Lonza and Engitix strike ADC licence deal targeting ECM biology

Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
The Biotech Times Editorial Team  · 
Biologics

DBV Technologies raises $50m via ATM programme with RA Capital

The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The Biotech Times Editorial Team  · 
Biologics

Amplia Therapeutics publishes narmafotinib pancreatic cancer preprint

A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
A Garvan Institute preprint shows Amplia's FAK inhibitor reduced tumour fibrosis, chemotherapy resistance and metastatic spread in preclinical pancreatic cancer models.
The Biotech Times Editorial Team  · 
Biologics

Anika Therapeutics raises 2026 guidance after record Q2 revenue

The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.
The Bedford, Massachusetts orthopaedics biotech posted record commercial channel revenue of $13.9m in Q2 2026 and lifted its full-year adjusted EBITDA margin outlook.
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

Atavistik Bio joins Cure HHT network as Harmony-HHT trial opens

Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
Atavistik Bio has partnered with Cure HHT and activated its first clinical site at Massachusetts General Hospital for its Phase 1/2 ATV-1601 trial.
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

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

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

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
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  · 
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