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Sanofi
NEWS

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Shots: The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…
5 days ago

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Sanofi
NEWS

Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Shots: The US FDA has accepted NDA & granted priority review to tolebrutinib for nrSPMS & slowing disability progression independent of relapse (PDUFA: Sep 28, 2025); MAA is under EMA review Submission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data…
March 25, 2025

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Viewpoints_Dr. Allitia DiBernardo
VIEWPOINTS

PharmaShots Interview: Janssen’s Dr. Allitia DiBernardo Shares Insights on the Availability of Ponvory in the US

In an interview with PharmaShots, Dr. Allitia DiBernardo, Global Head of Medical Affairs for Neurology at the Janssen share her views on the availability of Ponvory in the US for MS patients. Shots: Ponvory offers patients superior efficacy in reducing annualized relapses and brain lesions over established oral therapy teriflunomide (Aubagio), with a safe and generally well-tolerated profile…
May 24, 2021

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