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Sanofi

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 reviewSubmission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data…

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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,…

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Roche

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)…

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VIEWPOINTS_Kari Wong1_Emma Tallantyre2_2024

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…

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PharmShots Interview In Conversation with Biogen’s Vice President, Monica Mann, Where she Shares Insights on The Publication of Data from the NOVA Study to Treat Multiple Sclerosis

PharmShots Interview: In Conversation with Biogen’s Vice President, Monica Mann, Where she Shares Insights on The Publication of Data from the NOVA Study to Treat Multiple Sclerosis

Shots:Monica spoke about the data from the NOVA P-IIIb study evaluating the efficacy of its lead candidate in Multiple Sclerosis(MS)Monica also talked about the clinical trial results and formulation of the advanced product in MSThe interview gives a view of Biogen’s developing molecules in the pipeline for MSSmriti: Can you share with…

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PharmaShots Interview Biogen’s Monica Mann Shares Insights on the New Real-World Data on Tysabri & Vumerity for the Treatment of Multiple Sclerosis

PharmaShots Interview: Biogen’s Monica Mann Shares Insights on the New Real-World Data on Tysabri & Vumerity for the Treatment of Multiple Sclerosis

In an interview with PharmaShots, Monica Mann, Vice President, Medical Affairs for Global MS and Pipeline at Biogen shared her views on the data of Tysabri, Vumerity & highlights of new digital health research to predict multiple sclerosis disease progressionShots:Monica spoke about detailed results of the new real-world & clinical data on the long-term use of Tysabri & real-world analyses…

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Viewpoints_Dr. Allitia DiBernardo

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…

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