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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…
4 days ago

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Roche
NEWS

Roche Reports P-III (FENhance 1) Trial Data on Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Shots: Roche has reported P-III (FENhance 1) trial results in RMS pts, randomized to either fenebrutinib (PO, BID) with PBO-matched to teriflunomide or teriflunomide (PO, QD) with PBO matched to fenebrutinib Trial met its 1EP, reducing ARR by 51% over ≥96wks., consistent with the P-III (FENhance 2) study showing 59% reduction, while 2EPs showed significant…
March 3, 2026

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NEWS

Genentech Presents the P-III (FENtrepid) Trial Data on Fenebrutinib for Primary Progressive Multiple Sclerosis (PPMS) at ACTRIMS Forum 2026

Shots: Genentech has reported the P-III (FENtrepid) trial data assessing fenebrutinib (QD, PO) with IV Ocrevus-matching PBO vs Ocrevus & oral fenebrutinib-matching PBO in 985 adults with PPMS Trial met its 1EP, showing a 12% reduction in disability progression (cCDP12) with curves separating by wk. 24 & consistent benefit across subgroups & duration. The strongest effect was…
February 9, 2026

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NEWS

Zenas BioPharma Enters ~$2B Deal with InnoCare Pharma for Three Autoimmune Product Candidates

Shots: InnoCare granted Zenas exclusive global rights to develop, manufacture, & commercialize orelabrutinib for MS & non-oncology indications (excl. Greater China & Southeast Asia), plus rights to an IL-17AA/AF inhibitor outside those regions & a brain-penetrant TYK2 inhibitor globally As per the deal, InnoCare will receive $100M in upfront & near-term milestones, incl. 2026 milestones,…
October 8, 2025

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NEWS

Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

Shots: Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…
September 2, 2025

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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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NEWS

Tiziana Life Sciences Identifies New Immune Biomarkers in Multiple Sclerosis Patients Treated with Foralumab

Shots: Tiziana identified new immune biomarkers in na-SPMS patients treated with nasal foralumab, using single-cell RNA sequencing of peripheral blood samples taken before treatment & at 3 as well as 6mos. post-administration Study showed that after dosing in ongoing ISPPEA (expanded access program; n=10), gene expression changed starting 3mos. incl. modulation of FoxP3 Tregs,…
January 23, 2025

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Roche
NEWS

Roche Reports the US FDA’s Approval of Ocrevus Zunovo for Treating Relapse and Progressive Multiple Sclerosis 

Shots:     The US FDA has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq), a twice-a-year, 10-minute SC injection, to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)  The approval was supported by the pivotal P-III (OCARINA) study assessing the PK, safety, clinical & radiological efficacy of the Ocrevus SC vs IV in patients (n=236)…
September 13, 2024

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