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Results For "pharmacokinetic"

103 News Found

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets


AL-S Pharma shows promising Phase 2 results for its therapy in ALS treatment
Biotech | December 09, 2025

AL-S Pharma shows promising Phase 2 results for its therapy in ALS treatment

Adverse events were similar to placebo, and no AP-101-induced antibody responses were detected


Bayer reports promising results for low-dose pediatric MRI contrast agent
Clinical Trials | December 07, 2025

Bayer reports promising results for low-dose pediatric MRI contrast agent

MRI is particularly valuable in pediatric care due to its non-invasive nature


Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome
Biopharma | December 04, 2025

Aelis Farma gets EMA nod for phase 2B trial of AEF0217 in down syndrome

AEF0217 is a first-in-class CB1 receptor signaling-specific inhibitor


Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt
Clinical Trials | December 03, 2025

Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt

Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data


Merck unveils first human data for Alzheimer’s candidates
Clinical Trials | December 03, 2025

Merck unveils first human data for Alzheimer’s candidates

The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration


Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi
Drug Approval | November 24, 2025

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis


Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab
News | November 24, 2025

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions


Daiichi Sankyo launches first-in-human trial of innovative cancer therapy
Clinical Trials | November 14, 2025

Daiichi Sankyo launches first-in-human trial of innovative cancer therapy

The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events