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

Applied Biologics submits CAMPX Trial abstract to SAWC Fall 2026

Updated data from the 222-patient RCT showed XWRAP nearly doubled complete wound closure rates versus standard of care alone at 12 weeks.
Updated data from the 222-patient RCT showed XWRAP nearly doubled complete wound closure rates versus standard of care alone at 12 weeks.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

INmune Bio wins MHRA PIP approval for Ebstrocel in RDEB

The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.
The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.
The Biotech Times Editorial Team  · 
Biologics

Phathom Pharmaceuticals completes enrolment in Phase 2 EoE trial

Phathom has fully enrolled 95 adults in its pHalcon-EoE-201 study of vonoprazan, with topline data expected in Q4 2026.
Phathom has fully enrolled 95 adults in its pHalcon-EoE-201 study of vonoprazan, with topline data expected in Q4 2026.
The Biotech Times Editorial Team  · 
Biologics

Lilly's $7.8bn Centessa acquisition cleared by English High Court

Eli Lilly's scheme of arrangement to acquire OX2R-focused Centessa Pharmaceuticals has been sanctioned by the High Court, with closing expected on 24 June.
Eli Lilly's scheme of arrangement to acquire OX2R-focused Centessa Pharmaceuticals has been sanctioned by the High Court, with closing expected on 24 June.
The Biotech Times Editorial Team  · 
Biologics

Sanofi's Wayrilz wins Japan approval for immune thrombocytopenia

Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero
Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero
The Biotech Times Editorial Team  · 
Biologics

Silexion secures BfArM approval for SIL204 Phase 2/3 LAPC trial

Germany's BfArM has cleared Silexion's siRNA candidate SIL204 for a Phase 2/3 trial in locally advanced pancreatic cancer, with first dosing expected
Germany's BfArM has cleared Silexion's siRNA candidate SIL204 for a Phase 2/3 trial in locally advanced pancreatic cancer, with first dosing expected
The Biotech Times Editorial Team  · 
Biologics

Boehringer opens three Phase III trials in lung and NEC cancers

Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
The Biotech Times Editorial Team  · 
Biologics

Sanofi wins EU approval for tolebrutinib in progressive MS

The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.
The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

ENA Respiratory secures two US patents for TLR2 agonist COPD programme

USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
The Biotech Times Editorial Team  · 
Biologics

Essential Pharma names Becki Morison as CEO from July 2026

The Egham-based rare disease pharma company has appointed the former LEO Pharma and Eli Lilly executive to lead its next phase of commercial growth.
The Egham-based rare disease pharma company has appointed the former LEO Pharma and Eli Lilly executive to lead its next phase of commercial growth.
The Biotech Times Editorial Team  · 
Biologics

Medicenna secures new U.S. patents across IL-2, IL-4 and IL-13 platforms

Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.
Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.
The Biotech Times Editorial Team  · 
Biologics

MoonLake's sonelokimab hits 67% HiSCR75 at one year in HS

Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
The Biotech Times Editorial Team  · 
Biologics

BioCardia targets Japan PMDA submission for CardiAMP by end of 2026

BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
The Biotech Times Editorial Team  · 
Biologics

CTD-ILD pipeline heats up as physicians seek disease modification

A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
The Biotech Times Editorial Team  · 
Biologics

Kither Biotech completes Phase 1 of inhaled peptide KIT2014 in COPD

The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
The Biotech Times Editorial Team  · 
Biologics

MAIA Biotechnology opens third US site for ateganosine Phase 2 trial

Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi wins Japan approval for Sarclisa subcutaneous formulation

Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Denali Therapeutics sells rare paediatric PRV for $195m

Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
The Biotech Times Editorial Team  · 
Biologics

IMF ASCENT trial shows 82% five-year PFS in smouldering myeloma

Phase 2 ASCENT data presented at EHA 2026 showed 97% overall response and 85% MRD negativity in high-risk smouldering myeloma patients.
Phase 2 ASCENT data presented at EHA 2026 showed 97% overall response and 85% MRD negativity in high-risk smouldering myeloma patients.
The Biotech Times Editorial Team  · 
Biologics

Memento Medicines raises $93m Series A for retinal bispecific

The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The Biotech Times Editorial Team  · 
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