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Results For "clinical-trial"

780 News Found

Johnson & Johnson booster dose indicate impressive results
Drug Approval | August 26, 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Adjuvance announce clinical results of its next-gen saponin adjuvant
Biotech | August 26, 2021

Adjuvance announce clinical results of its next-gen saponin adjuvant

First results demonstrate favourable tolerability of TQL-1055 at all dose levels


Lonza to establish manufacturing facility in Guangzhou, China
News | August 25, 2021

Lonza to establish manufacturing facility in Guangzhou, China

The investment will establish drug product manufacturing capacity for clinical trial and commercial supply in China and offer customers combined drug substance and drug product manufacturing services


US FDA approves Medtronic’s TAVR System
Drug Approval | August 25, 2021

US FDA approves Medtronic’s TAVR System

The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment


DBT-BIRAC supported India’s first m-RNA vaccine gets nod for Phase II/III trial
Biotech | August 24, 2021

DBT-BIRAC supported India’s first m-RNA vaccine gets nod for Phase II/III trial

CDSCO gives the green signal as HGCO19 was safe, tolerable and immunogenic in the participants of the study


USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine
News | August 23, 2021

USFDA grants full approval for Pfizer-BioNTech Covid-19 vaccine

The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease


AstraZeneca-Sputnik V combination demonstrates high immunogenicity profile: RDIF
Biotech | August 20, 2021

AstraZeneca-Sputnik V combination demonstrates high immunogenicity profile: RDIF

Preliminary data from the first 20 participants in Azerbaijan show antibodies to the SARS-CoV-2 virus spike protein (S-protein) elicited in 100% of cases


Zydus Cadila receives Emergency Use Authorisation for 3-dose ZyCoV-D vaccine
Biotech | August 20, 2021

Zydus Cadila receives Emergency Use Authorisation for 3-dose ZyCoV-D vaccine

This is the world’s first Covid=19 DNA vaccine developed in partnership with DBT-BIRAC


Second-Gen mRNA COVID-19 vaccine candidate CV2CoV show positive signs in preclinical study
Biotech | August 19, 2021

Second-Gen mRNA COVID-19 vaccine candidate CV2CoV show positive signs in preclinical study

The preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone