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New research has helped unravel the role of a key molecule in cholestatic liver disease

Researchers from the Quadram Institute, University of East Anglia and Technische Universität Braunschweig found that, in mice, a key metabolic regulator triggers cells in the immune system to attack liver cells, progressing the disease. ....

Stuart Rushworth , Stuarta Rushworth , Technische Universita , Anna Isaacs , Karsten Hiller , Tobias Ludwig , Federico Bernuzzi , Naiara Beraza , Charlotte Hellmich , Andre Martens , Mar Moreno Gonzalez , Quadram Institute , Norwich Research Park , University Of East Anglia , Sciences Research Council , Norwich Medical School , Research Council , Doctoral Training Partnership , East Anglia , Norwich Research , Medical School , Prof Dr Karsten Hiller , Molecular Gastroenterology , Biological Sciences Research Council , Medical Research Council , Anna Isaacs Ten ,

Cadila Healthcare rises after USFDA grants orphan drug designation for Saroglitazar Mg

Read more about Cadila Healthcare rises after USFDA grants orphan drug designation for Saroglitazar Mg on Business Standard. Cadila Healthcare rose 0.69% to Rs 465.40 after the company was granted orphan drug designation by the US drug regulator for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC). ....

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Zydus receives USFDA 'Orphan Drug Designation' for Saroglitazar Mg

Zydus announced that United States Food and Drug Administration (USFDA) has granted Orphan Drug Designation (ODD) to
Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).
Orphan drug
designation provides eligibility for certain development incentives, including tax credits for qualified
clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon
FDA approval.
This follows the grant of Fast Track Designation by the USFDA to Saroglitazar Mg
for PBC in December 2020.
Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma
dual agonist. Results of PHASE 2, prospective multicentre randomized double-blind, placebo
controlled study to evaluate the safety, tolerability and efficacy of Saroglitazar Mg in patients with ....

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