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Results For "clinical-development"

548 News Found

US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction
Biotech | September 12, 2021

US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction

The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


Cipla forms JV with Kemwell Biopharma
News | August 25, 2021

Cipla forms JV with Kemwell Biopharma

The agreement is to develop, manufacture and commercialise biosimilars for the global market.


Carbogen Amcis AG signs co-investment agreement
Biotech | August 25, 2021

Carbogen Amcis AG signs co-investment agreement

The co-investment of CHF 4 million will result in capacity expansion and support the market introduction of the customer's lead compound


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