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Results For "clinical-development"

444 News Found

Roche and KeChow to commercialise Zelboraf
News | August 23, 2021

Roche and KeChow to commercialise Zelboraf

Shanghai Roche Pharmaceuticals and Shanghai KeChow Pharma, entered into a cooperation agreement to improve market access of Zelboraf in China.


US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction
Drug Approval | August 20, 2021

US FDA approves Jardiance to treat adults living with heart failure with a reduced ejection fraction

New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US


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


EpiEndo Pharma secures  EUR 20 Million Series A funding for Macrolide
Biotech | August 18, 2021

EpiEndo Pharma secures EUR 20 Million Series A funding for Macrolide

The financing secures funds to advance the clinical development of EpiEndo’s lead compound EP395, which entered phase I clinical trials in April, through Phase IIa, targeting COPD as a primary indication


Suven Life Sciences announces Phase 3 clinical trial of Masupirdine
Biotech | August 17, 2021

Suven Life Sciences announces Phase 3 clinical trial of Masupirdine

This multi-centre study (sites in the US and Europe) comprising about 387 patients is likely to be completed in about 36 months and the topline result is expected by the end of 2024


QIAGEN and OncXerna Therapeutics sign licensing and master companion diagnostic agreements
Drug Approval | August 10, 2021

QIAGEN and OncXerna Therapeutics sign licensing and master companion diagnostic agreements

QIAGEN and OncXerna enter into a global master agreement to advance the development of the Xerna TME panel as a potential Next Generation Sequencing (NGS) companion diagnostic for OncXerna’s Navicixizumab


Novavax announces COVID-19 vaccine booster data indicating four-fold increase in neutralising antibodies
Biotech | August 09, 2021

Novavax announces COVID-19 vaccine booster data indicating four-fold increase in neutralising antibodies

Single booster dose at 6 months of NVX-CoV2373 increased wild-type neutralizing antibodies more than 4-fold versus primary vaccination series


Biocon Biologics partners Adagio to manufacture antibody for COVID-19
News | July 27, 2021

Biocon Biologics partners Adagio to manufacture antibody for COVID-19

ADG20, a novel monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses


EMA grants ODD to Saroglitazar Mg
News | July 21, 2021

EMA grants ODD to Saroglitazar Mg

Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC


Poxel and Sumitomo Dainippon gets TWYMEEG approval
News | June 25, 2021

Poxel and Sumitomo Dainippon gets TWYMEEG approval

The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies