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Results For "pharmacokinetic"

76 News Found

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas
Drug Approval | January 19, 2025

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas

This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo


Iconovo and Lonza to collaborate on formulation development of an intranasal biologic
News | January 13, 2025

Iconovo and Lonza to collaborate on formulation development of an intranasal biologic

Lonza to develop spray-dried formulations for an intranasally-delivered biologic for Iconovo at its Center of Excellence for bioavailability enhancement and inhaled delivery in Bend (US)


Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies
Diagnostic Center | January 10, 2025

Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies

QUANTI clinical development program evaluated the efficacy and safety of the investigational MRI contrast agent gadoquatrane for a broad range of potential indications and in pediatric and adult patients


Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107
Diagnostic Center | January 09, 2025

Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107

The primary objective of the study is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs


FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections
Drug Approval | January 02, 2025

FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections

MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria


Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium
Diagnostic Center | December 11, 2024

Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium

Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity (clinical benefit rate


FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777
Drug Approval | October 08, 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy


Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024
Biotech | September 25, 2024

Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024

These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity


Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast
Diagnostic Center | September 11, 2024

Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast

ALS patients experience neuroinflammation and rapid neurodegeneration