May 30, 2017 News by Patricia Inacio, PhD #CMSC17 – Celgene’s Investigational Therapy Ozanimod Safe, Effective in Treating Relapsing MS, Clinical Trial Finds Long-term treatment for up to 12o weeks, with theĀ investigational drug Ozanimod (RPC-1063), found to be effective and safe in patients with relapsing multiple sclerosis (MS) who participated in the RADIANCE clinical trial. Celgene, Ozanimod’s developer, presented the study, āEfficacy and Safety of Ozanimod in the Blinded Extension (120…
May 23, 2017 News by Alice MelĆ£o, MSc Results of Phase 3 Trial for Celgene’s Ozanimod Suggest Therapeutic Benefit in RMS Patients Relapsing multiple sclerosis (RMS) patients taking the investigational drug ozanimod, also known as RPC-1063, had lowerĀ relapse rate than those on weekly Avonex (interferon Ī²-1a) therapy, according toĀ CelgeneĀ in an announcement updating results of its Phase 3 RADIANCE trial. Ozanimod is a new orally administrated drug that selectively inhibits the…
March 31, 2017 News by Patricia Silva, PhD Diplomat Pharmacy Chosen to Dispense Ocrevus to MS Patients Across US Diplomat Pharmacy, the largest independent specialty pharmacy in the U.S., has been selected to dispenseĀ Ocrevus (ocrelizumab), a limited-distribution drug,Ā to people withĀ relapsingĀ andĀ primary progressive multiple sclerosis. Ocrevus was approved by the U.S. Food and Drug Administration on March 28, becoming the first therapy approved for both RMS and…
March 28, 2017 News by Patricia Silva, PhD FDA Approves Ocrevus as 1st MS Treatment for Both Relapsing and Primary Progressive Forms At long last, and for the first time in medical history, peopleĀ with both relapsing and primary progressive forms of multiple sclerosis have reason to celebrate. The U.S. Food and Drug Administration (FDA) today approved Ocrevus (ocrelizumab)Ā as a disease-modifying therapy for both forms of MS, aĀ chronic autoimmune disease.
March 28, 2017 News by Patricia Silva, PhD Ocrevus’ Journey from Defiant Idea to Game-Changing Treatment Twenty years ago, the idea that B-cell depletion could treat multiple sclerosisĀ would have been greeted with a hearty laughĀ byĀ any well-respected neurologist or MS researcher ā or perhapsĀ a scoff. But times change and research advances. Today, a medicine that gets rid of certain B-cells may beĀ the most powerful drug yetĀ developed against…
February 28, 2017 News by Patricia Silva, PhD ‘Ocrevus Has the Potential to Change How MS Is Treated,’ Genentech’s Peter Chin Says in Interview March 28, at the latest, may be a historic date for the multiple sclerosis (MS) community ā patients, families, caregivers, researchers, and physicians alike. The U.S. Food and Drug Administration (FDA) will have its say about the marketing approval forĀ Ocrevus (ocrelizumab). The drugĀ willĀ be the first to offerĀ benefit to…
December 7, 2016 News by Patricia Silva, PhD Copaxone Use During Pregnancy by RMS Patients Now Possible in EU European users ofĀ Copaxone (glatiramer acetate injection, Teva Pharmaceutical) to treatĀ relapsing forms of multiple sclerosis (RMS) will no longer see a warning that the drug should not be used during pregnancy. A report assessing this change in the drug’sĀ marketing authorization within the European Union ā a process known as…
October 4, 2016 News by Patricia Silva, PhD NICE Planning to Reject MS Treatment, Zinbryta, in England and Wales TheĀ National Institute for Health and Care Excellence (NICE), the health authorityĀ for England and Wales,Ā has decided not to recommend Zinbryta (daclizumab)Ā be made available to multiple sclerosis (MS)Ā patients through the country’s health service. The decision came in a first stage of the drugās review process, and NICE is welcoming…
October 3, 2016 News by Patricia Silva, PhD Phase 3 Study to Test Oral Combination, Tecfidera and Ponesimod, to Treat Relapsing MS ActelionĀ announced that it will investigate the therapeutic potential of a new, oral combination therapy with ponesimod andĀ Tecfidera (dimethyl fumarate) asĀ a treatment for relapsing multiple sclerosis (RMS). The Phase 3 clinical study, being conducted underĀ a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), aims to find…
August 1, 2016 News by InĆŖs Martins, PhD Genentech Enrolling Relapsing MS Patients in Study of Mechanism of Action for Ocrevus In addition to a new study sponsored by GenentechĀ to test the experimentalĀ MS therapyĀ Ocrevus (ocrelizumab)Ā in RMS patients who have had a sub-optimal response to previous disease modifying therapies, the company is also currently recruiting patients with relapsing multiple sclerosis to understand the therapy’sĀ mechanism of action and B-cell biology…
June 29, 2016 News by InĆŖs Martins, PhD 1st Potential Therapy for Primary Progressive MS, Ocrelizumab, Under Priority Review by FDA The U.S. Food and Drug Administration (FDA) is givingĀ priority review to a request to approveĀ Ocrevus (ocrelizumab) as a treatment forĀ both forms of multiple sclerosis, the drug’s developer,Ā Genentech, announced. If the company’s Biologics License Application (BLA) is approved,Ā Ocrevus will become the first drug ableĀ to treat patients with either relapsing or…
November 11, 2015 News by Patricia Silva, PhD Roche to Pursue MS Ocrelizumab Drug Market Authorization RocheĀ recently provided an update on their late-stage pipeline products across several therapeutic areas, including ocrelizumab for the treatment of multiple sclerosis. The data was disclosed on Nov. 5 at the Roche Pharma Day 2015 event in London, U.K. Ocrelizumab was previously revealed to be the first investigational medicine…
October 9, 2015 News by Malika Ammam, PhD Gilenya’s Clinical Trial Results Presented at ECTRIMS Reinforce Long-Term Efficacy Profile in RMS Patients On October 8, 2015, data on two Phase III clinical trials called FREEDOMS and FREEDOMS II on Gilenya (fingolimod), a drug developed byĀ Novartis, were presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), currently being held in Barcelona, Spain (October 7-10).