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Results For "European-Commission"

136 News Found

Alvotech and STADA pave way to launching Hukyndra
Biotech | April 06, 2022

Alvotech and STADA pave way to launching Hukyndra

All intellectual-property disputes related to the market entry of Alvotech’s AVT02 (adalimumab) in the U.S. and Europe are now resolved


Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Biotech | April 01, 2022

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product


Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors
Drug Approval | March 30, 2022

Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding


EU approves Evusheld to prevent Covid-19
Drug Approval | March 28, 2022

EU approves Evusheld to prevent Covid-19

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months


Evusheld recommended for market authorisation in EU
Biotech | March 25, 2022

Evusheld recommended for market authorisation in EU

Recommendation based on Phase III PROVENT trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months


CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma
News | March 25, 2022

CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma

Recommendation is based on pivotal data from the phase III POLARIX study


Study shows green Mediterranean diet modifies bacterial population in gut
Biotech | March 23, 2022

Study shows green Mediterranean diet modifies bacterial population in gut

The study was published recently in Genome Medicine, a leading international journal focused on translational, genomic-based medicine


Jardiance is first and only treatment approved in Europe for chronic heart failure
Drug Approval | March 07, 2022

Jardiance is first and only treatment approved in Europe for chronic heart failure

The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe


VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod
Biotech | February 27, 2022

VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod

If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.


Novavax ships first consignment of Covid-19 vaccine to European countries
News | February 24, 2022

Novavax ships first consignment of Covid-19 vaccine to European countries

The first wave of shipments includes several countries, such as Germany, France and Austria