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Zydus announces EPICS-IIITM phase-II(b)/III adaptive pivotal clinical trial of Saroglitazar Mg in PBC
expresspharma
December 10, 2021
Positive results from the phase-II(a) clinical trial evaluating Saroglitazar Mg in patients with NASH were published in the Journal of Hepatology.
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Gannex Announces China NMPA Approved Phase II and III Protocols of ASC42, an FXR Agonist, for Treatment of Primary Biliary Cholangitis
prnasia
November 15, 2021
Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) announces today that the protocols of Phase II and III clinical trials of ASC42 to treat patients with primary biliary cholangitis (PBC)...
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EMA grants Orphan Drug Designation to Saroglitazar Mg for treating patients with PBC
expresspharma
July 22, 2021
Zydus announced that the European Medicines Agency (EMA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).
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Due to Risk of Serious Liver Injury - FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis (PBC) Patients with Advanced Cirrhosis
americanpharmaceuticalreview
June 01, 2021
The U.S. FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm.
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US FDA grants Orphan Drug Designation to Zydus’ Saroglitazar for primary biliary cholangitis treatment
expresspharma
January 29, 2021
This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020.
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USFDA grants Zydus fast track designation for Saroglitazar to treat primary biliary cholangitis
expresspharma
December 10, 2020
Zydus announced that the United States Food and Drug Administration (USFDA) has granted ‘Fast Track Designation’ to Saroglitazar Mg for the treatment of patients with primary biliary cholangitis (PBC).
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Cadila Pharma launches Obetocad, generic obeticholic acid for liver therapy
expresspharma
September 18, 2020
Obetocad can be used as a monotherapy or along with UDCA for treatment of patients with primary biliary cholangitis who are unresponsive to UDCA therapy.
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Study reveals COVID-19 virus can cause collapse of respiratory centre in brain
expresspharma
June 19, 2020
May infect PreBötzinger complex (PBC), primary centre of the brain that controls respiratory rhythm generation.
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GENFIT, Terns Pharmaceuticals to Commercialize Elafibranor in China
contractpharma
June 28, 2019
For treatment of non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC).
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Genkyotex reports mixed efficacy Phase II data for PBC drug
pharmaceutical-technology
May 05, 2019
Genkyotex has announced that its NOX1/4 inhibitor GKT831, which is indicated for primary biliary cholangitis (PBC), has met some of its secondary endpoints in a Phase II trial.