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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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USFDA Grants Orphan Drug Designation To Zydus Cadila's Saroglitazar Mg

USFDA grants orphan drug designation to Zydus Cadila s Saroglitazar Mg
Zydus Cadila, which is a part of Cadila Group, said 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 USFDA approval.
PTI
January 28, 2021 / 11:25 AM IST
Zydus Cadila on Thursday said the US health regulator has granted orphan drug designation (ODD) to its Saroglitazar Mg used for the treatment of patients with Primary Biliary Cholangitis (PBC), a liver disease.
The United States Food and Drug Administration (USFDA) has granted ODD to Saroglitazar Mg, Cadila Healthcare said in a regulatory filing. ....

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January 13, 2021 Extraordinary Shareholders Meeting: Wide support for the resolutions submitted to the shareholders' vote but quorum not met on first convening Paris Stock Exchange:GNFT

January 13, 2021 Extraordinary Shareholders Meeting: Wide support for the resolutions submitted to the shareholders’ vote but quorum not met on first convening
January 12, 2021 14:15 ET
| Source:
GENFIT S.A.
GENFIT S.A.
Loos, FRANCE
French
Partial buyback and amendment of the bond terms approved by approx. 98% of voting shareholders at this time
Insufficient quorum of 20.63% on first convening, but greater than the 20% quorum required on second convening
Extraordinary Shareholders Meeting will be reconvened on January 25, 2021 with the same agenda
Votes cast on the first convening remain valid for the second convening
Shareholder engagement remains important to ensure the success of this transaction, which aims to decrease the bond debt by nearly half and extend its maturity by 3 years. ....

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GENFIT Informs its Shareholders of Certain Procedures for the Extraordinary General Meeting of January 13, 2021

Lille, France; Cambridge, MA; January 8, 2021 -
GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases (the
“Company”), today informs its shareholders of certain changes in certain of the participation and organization procedures for the extraordinary general meeting of January 13, 2021 (the
“Extraordinary General Meeting”), following the publication of decree n° 2020-1614 of December 18, 2020 extending and modifying decree n° 2020-418 of April 10, 2020 specifying the procedures for holding meetings behind closed doors (the
“Decree”). Consequently, the procedures for participation in the Extraordinary General Meeting indicated in this press release (proxy representation, written questions, composition of the Committee and broadcast details) supplement those set out in the notice ( ....

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