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

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

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  · 
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

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  · 
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

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

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

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
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

Tenax Therapeutics presents Phase 3 LEVEL data at ESC 2026

TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial
TNX-103 showed a 26.3-metre walk improvement and 47% NT-proBNP reduction in lower-function PH-HFpEF patients, shaping the LEVEL-2 trial
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  · 
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

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

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
Biotech

Eascra Biotech wins $7.96m NASA contract for space-made nanomedicine

The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
The Worcester, MA startup will use microgravity manufacturing to advance its RNA-delivery nanoparticle platform toward FDA clinical trials by 2028.
The Biotech Times Editorial Team  · 
Biologics

CRISPR Therapeutics' CTX310 shows durable lipid cuts at one year

Phase 1a data published in NEJM show a single CTX310 infusion sustained 79% mean ANGPTL3 reduction and 53% LDL reduction at one year.
Phase 1a data published in NEJM show a single CTX310 infusion sustained 79% mean ANGPTL3 reduction and 53% LDL reduction at one year.
The Biotech Times Editorial Team  · 
Biologics

BioXcel Therapeutics files Chapter 11, eyes Teva asset sale

BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
BioXcel Therapeutics has entered Chapter 11 bankruptcy, naming Teva as stalking-horse bidder for IGALMI and a pending agitation sNDA.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science
Biologics

hVIVO acquires CRS Berlin to enter dermatology and women's health

hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.
hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.
The Biotech Times Editorial Team  · 
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