Biotech | December 15, 2021
Aragen Life Sciences acquires Intox
Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune
Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week
Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021
Generalized pustular psoriasis is characterized by episodes of widespread eruptions of painful, sterile pustules
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