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).

Cell & Gene Therapy
Biologics
Regulatory Science

Ocugen doses first patient in Phase 3 gene therapy trial for dry AMD

Ocugen has initiated its Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, backed by FDA RMAT designation and a BLA filing targeted for 2028.
Ocugen has initiated its Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, backed by FDA RMAT designation and a BLA filing targeted for 2028.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Ultragenyx publishes 96-week Phase 3 data for GENGLYCOS in GSDIa

Peer-reviewed results show a 61% mean reduction in daily cornstarch intake at Week 96, with glycaemic control maintained across both treatment groups.
Peer-reviewed results show a 61% mean reduction in daily cornstarch intake at Week 96, with glycaemic control maintained across both treatment groups.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Upstream Bio plans dual Phase 3 trials for verekitug in 2027

The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Alvotech wins FDA review acceptance for AVT80 vedolizumab biosimilar

Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
The Biotech Times Editorial Team  · 
Biologics

Arch Biopartners wins IRB approval to open U.S. sites in CS-AKI trial

The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.
The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Ascendis and BioMarin settle YUVIWEL dispute with royalty deal

Ascendis Pharma will pay BioMarin royalties of up to 20% on navepegritide net sales through May 2030 to resolve all litigation between the two companies.
Ascendis Pharma will pay BioMarin royalties of up to 20% on navepegritide net sales through May 2030 to resolve all litigation between the two companies.
The Biotech Times Editorial Team  · 
Biologics

Lecanemab gets positive CDA-AMC reimbursement nod in Canada

Canada's Drug Agency has backed public reimbursement of lecanemab for early Alzheimer's disease, clearing the way for pCPA pricing negotiations.
Canada's Drug Agency has backed public reimbursement of lecanemab for early Alzheimer's disease, clearing the way for pCPA pricing negotiations.
The Biotech Times Editorial Team  · 
Biologics

Disc Medicine to present first DISC-3405 clinical data at SOHO 2026

Disc Medicine will share Phase 2 safety and efficacy data for two antibody candidates targeting myeloproliferative neoplasms at SOHO in Houston this September.
Disc Medicine will share Phase 2 safety and efficacy data for two antibody candidates targeting myeloproliferative neoplasms at SOHO in Houston this September.
The Biotech Times Editorial Team  · 
Biologics

Medera SRD-002 gene therapy hits 12-month HFpEF endpoints

Twelve-month Phase 1/2a data showed 80% of patients normalised cardiac filling pressures after a single dose of the SERCA2a gene therapy.
Twelve-month Phase 1/2a data showed 80% of patients normalised cardiac filling pressures after a single dose of the SERCA2a gene therapy.
The Biotech Times Editorial Team  · 
Biologics
Diagnostics

Acoramidis shows structural cardiac reversal in 54-month ATTR-CM data

BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.
BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.
The Biotech Times Editorial Team  · 
Biologics

Coloplast reshuffles ELT with new CPO and Wound unit interim lead

Coloplast appoints Amanda Rajkumar as Chief People Officer and moves Kerecis founder Fertram Sigurjonsson into an innovation advisory role.
Coloplast appoints Amanda Rajkumar as Chief People Officer and moves Kerecis founder Fertram Sigurjonsson into an innovation advisory role.
The Biotech Times Editorial Team  · 
Biologics

Coloplast posts 6% organic growth in Q3 amid Biologics drag

The Danish medtech reported solid third-quarter trading across Chronic Care but flagged a 6% sales decline in Biologics due to reimbursement changes.
The Danish medtech reported solid third-quarter trading across Chronic Care but flagged a 6% sales decline in Biologics due to reimbursement changes.
The Biotech Times Editorial Team  · 
Biologics

HUTCHMED SANOVO trial shows PFS gain for savolitinib plus osimertinib

HUTCHMED's Phase III SANOVO trial met its primary endpoint in treatment-naïve MET-overexpressing EGFR-mutated NSCLC, with an encouraging early overall survival signal.
HUTCHMED's Phase III SANOVO trial met its primary endpoint in treatment-naïve MET-overexpressing EGFR-mutated NSCLC, with an encouraging early overall survival signal.
The Biotech Times Editorial Team  · 
Biologics

Immuron posts record A$7.7m FY26 sales as CDI asset heads to partner

The Melbourne-based polyclonal antibody company reported 6% revenue growth and a A$1.4m profit improvement while advancing IMM-529 towards a Phase 2
The Melbourne-based polyclonal antibody company reported 6% revenue growth and a A$1.4m profit improvement while advancing IMM-529 towards a Phase 2
The Biotech Times Editorial Team  · 
Biologics

Leios Therapeutics licenses 10XB-101 to CMS for China market

Leios Therapeutics has signed an exclusive licensing deal with CMS subsidiaries covering mainland China, its second major regional deal this year.
Leios Therapeutics has signed an exclusive licensing deal with CMS subsidiaries covering mainland China, its second major regional deal this year.
The Biotech Times Editorial Team  · 
Diagnostics
Biologics

Trinity Biotech faces Nasdaq delisting risk amid diagnostics overhaul

Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.
Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.
The Biotech Times Editorial Team  · 
Biologics

CLINUVEL posts tenth consecutive profit as cash hits A$252m

The Melbourne biopharmaceutical company reported FY2026 net profit of A$33.9m and plans to use its balance sheet strength to accelerate US expansion.
The Melbourne biopharmaceutical company reported FY2026 net profit of A$33.9m and plans to use its balance sheet strength to accelerate US expansion.
The Biotech Times Editorial Team  · 
Biologics

AskBio presents GenePHIT Phase 2 baseline data at ESC 2026

AskBio's umiposgene parvec heart failure gene therapy trial enrolled over 170 patients across 64 sites; efficacy data are expected in H1 2027.
AskBio's umiposgene parvec heart failure gene therapy trial enrolled over 170 patients across 64 sites; efficacy data are expected in H1 2027.
The Biotech Times Editorial Team  · 
Biologics

Insulinova partners San Raffaele to test encapsulated beta cells

Insulinova will fund OSR-led research combining stem cell-derived beta cells with Austrianova's Cell-in-a-Box encapsulation platform to pursue immunosuppression-free
Insulinova will fund OSR-led research combining stem cell-derived beta cells with Austrianova's Cell-in-a-Box encapsulation platform to pursue immunosuppression-free
The Biotech Times Editorial Team  · 
Biologics

Cytokinetics aficamten data show structural heart benefits in HCM

New analyses from ACACIA-HCM and MAPLE-HCM presented at ESC 2026 strengthen aficamten's case across both obstructive and non-obstructive HCM subtypes.
New analyses from ACACIA-HCM and MAPLE-HCM presented at ESC 2026 strengthen aficamten's case across both obstructive and non-obstructive HCM subtypes.
The Biotech Times Editorial Team  · 
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