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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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VIEWPOINTS_Kari Wong1_Emma Tallantyre2_2024
VIEWPOINTS

Enhancing Multiple Sclerosis Research: Dr. Kari Wong and Dr. Emma Tallantyre in Conversation with PharmaShots

Shots:  Multiple Sclerosis affects over 2.8M people globally. Despite several tech infusions in MS research, the exact cause of the condition remains unknown  Recently, Metabolon, known for providing metabolomics solutions joined hands with the Division of Psychological Medicine and Clinical Neuroscience (DPMCN) at Cardiff University to discover new biomarkers to expedite the understanding and treatment…
June 17, 2024

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