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

NewAmsterdam Pharma to present obicetrapib Alzheimer's data at AAIC 2026

NewAmsterdam Pharma will share four BROADWAY-derived analyses at AAIC 2026, including biomarker data suggesting obicetrapib may slow Alzheimer's pathology.
NewAmsterdam Pharma will share four BROADWAY-derived analyses at AAIC 2026, including biomarker data suggesting obicetrapib may slow Alzheimer's pathology.
The Biotech Times Editorial Team  · 
Biologics

Anaveon promotes Laetitia Pouzol to Chief Scientific Officer

The Basel biotech has elevated its Head of Immunology to CSO, as ANV200 advances through IND-enabling studies toward clinical testing.
The Basel biotech has elevated its Head of Immunology to CSO, as ANV200 advances through IND-enabling studies toward clinical testing.
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

Pluristyx secures Japan patent for synthetic mRNA iPSC reprogramming

The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.
The Seattle biotech's licensed mRNA technology cuts iPSC line generation to under 30 days, addressing a key bottleneck for commercial cell therapy manufacturing.
The Biotech Times Editorial Team  · 
Biologics
Bioprocessing

VERAXA Biotech taps ATUM to develop cell lines for BiTAC-TCE programme

VERAXA has engaged ATUM's Leap-In Transposase technology to generate stable clonal cell lines for its lead conditional T-cell engager candidate ahead of
VERAXA has engaged ATUM's Leap-In Transposase technology to generate stable clonal cell lines for its lead conditional T-cell engager candidate ahead of
The Biotech Times Editorial Team  · 
Bioinformatics
Biologics

Corten Capital and Ampersand acquire Beacon Intelligence in PE buyout

The deal separates Beacon from the Hanson Wade Group, giving the R&D intelligence platform independent status backed by Corten's €680m second fund.
The deal separates Beacon from the Hanson Wade Group, giving the R&D intelligence platform independent status backed by Corten's €680m second fund.
The Biotech Times Editorial Team  · 
Biologics

Kyowa Kirin mogamulizumab data show survival gains in rare CTCL

Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.
Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.
The Biotech Times Editorial Team  · 
Biologics

Revolution Medicines: zoldonrasib combos active in RAS G12D PDAC

Phase 1/2 data presented at ESMO GI show response rates above 60% for zoldonrasib combinations, supporting two planned Phase 3 trials in pancreatic cancer.
Phase 1/2 data presented at ESMO GI show response rates above 60% for zoldonrasib combinations, supporting two planned Phase 3 trials in pancreatic cancer.
The Biotech Times Editorial Team  · 
Biologics

Xeltis passes 50% enrollment in US pivotal trial for aXess graft

The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
The Biotech Times Editorial Team  · 
Biologics

Junshi Biosciences licenses IL-17A antibody roconkibart to Fosun Wanbang

Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
The Biotech Times Editorial Team  · 
Biologics

Vect-Horus and Servier tie up on CNS oligonucleotide delivery

The Marseille biotech will use its VECTrans platform to ferry Servier's oligonucleotides across the blood-brain barrier for rare neurological disorders.
The Marseille biotech will use its VECTrans platform to ferry Servier's oligonucleotides across the blood-brain barrier for rare neurological disorders.
The Biotech Times Editorial Team  · 
Biologics

GNI Group completes JPY 44.8bn acquisition of Ayumi Pharmaceutical

GNI Group has acquired Ayumi Pharmaceutical from Blackstone, adding an 83% Japanese acetaminophen market share to its four-region biopharma platform.
GNI Group has acquired Ayumi Pharmaceutical from Blackstone, adding an 83% Japanese acetaminophen market share to its four-region biopharma platform.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The Biotech Times Editorial Team  · 
Biologics

Nicox partner Kowa files NDA for NCX 470 glaucoma eye drop

Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
The Biotech Times Editorial Team  · 
Biologics

Ipsen to acquire Memo Therapeutics for up to EUR 700m

Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.
Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.
The Biotech Times Editorial Team  · 
Biologics
Diagnostics

Telix wins FDA alignment to open ProstACT Global Phase 3 in US

Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
The Biotech Times Editorial Team  · 
Biologics

Truveta study finds 16% of adalimumab biosimilar switchers revert

Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.
Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.
The Biotech Times Editorial Team  · 
Biologics

Abivax prices upsized $800M ADS offering to fund obefazimod launch

The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Biotech Times Editorial Team  · 
Biologics

Candel Therapeutics opens Phase 3 AURORA trial for CAN-2409 in NSCLC

Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.
Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi's Nexviazyme hits all endpoints in infantile Pompe phase 3

Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
The Biotech Times Editorial Team  · 
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