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Results For "clinical-data"

188 News Found

Janssen announces novel mechanism that shows promise against dengue
Biotech | October 07, 2021

Janssen announces novel mechanism that shows promise against dengue

Early-stage research suggests the potential to prevent and treat all dengue serotypes and builds on Johnson & Johnson's work to advance science against emerging and entrenched global public health threats


Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA
Biotech | October 01, 2021

Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA

The company plans to submit the IND application by the end of 2021


Tavneos (avacopan) approved for ANCA associated vasculitis in Japan
Drug Approval | September 28, 2021

Tavneos (avacopan) approved for ANCA associated vasculitis in Japan

It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan


SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment
Biotech | September 26, 2021

SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment

Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors


Canada approves Moderna’s Covid-19 vaccine
Drug Approval | September 17, 2021

Canada approves Moderna’s Covid-19 vaccine

In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose


TCS leads in Life Sciences operations services: Everest group
Digitisation | September 08, 2021

TCS leads in Life Sciences operations services: Everest group

TCS provides clinical research services such as clinical data management, regulatory affairs, pharmacovigilance, risk-based monitoring, biostatistics and programming, medical writing, medical affairs and medico marketing, and health economics and outcomes research


HCG acquires oncology labs and divests stake in Strand Life Sciences
Healthcare | September 04, 2021

HCG acquires oncology labs and divests stake in Strand Life Sciences

The transactions resulted in a net cash inflow of Rs 183 crores for HCG in addition to the take-over of the labs and clinical research business


US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184
Biotech | August 31, 2021

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184

The drug is also intended for the treatment of glioblastoma multiforme


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


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