August 2, 2021 News by Forest Ray PhD Botox Approved to Treat Spasticity in 8 New Arm, Hand Muscles The U.S. Food and Drug Administration (FDA) has expanded the label for Botox (onabotulinumtoxinA) in adults for the treatment of upper limb spasticity ā a common symptom of multiple sclerosis (MS) ā to include eight more muscles. The new approval will allow Botox to be used to treat…
May 24, 2019 News by Ana Pena PhD MC10, AbbVie Plan Clinical Trials to Explore Using BioStamp nPoint Device for MS Patients MC10 and AbbVieĀ are working together to launch clinical trials exploring the use of BioStamp nPoint, a system of wearable sensors that collects health data fromĀ multiple sclerosis (MS) patients, to determine if the information may serve as meaningful measures for clinical studies. MC10’s BioStamp…
May 23, 2018 News by Diogo Pinto European EMA Confirms Severe Risks Associated with MS Medicine Zinbryta A review of data concerning the multiple sclerosis (MS) medicine Zinbryta (daclizumab) confirmed its association with the risk of developing severe and potentially fatal immune reactions in the brain, liver and other organs, according to the European Medicines Agency’s (EMA)ās Pharmacovigilance Risk Assessment Committee (PRAC). Zinbryta was authorized…
March 12, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Zinbryta, Fish Oil, MS Associate Certification, Blood-brain Barrier Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta You may have heard about this already, so forgive me if it’s not new to you, but it’s important information. A dozen cases ofĀ encephalitis or meningoencephalitis have been reported in patients using Zinbryta, and…
March 6, 2018 News by Jose Marques Lopes, PhD Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta BiogenĀ and AbbVieĀ have voluntarily withdrawn global marketing authorizations for theirĀ relapsing multiple sclerosisĀ therapyĀ Zinbryta (daclizumab) because of serious side effects that include brain inflammation. The Europe Medicine Agency, which oversees medications across the European Union, also released a statement recommending a “immediate suspension” of Zinbryta’s use by patients and…
December 28, 2017 News by Patricia Inacio, PhD Zinbryta Fails to Prevent RRMS from Worsening After Patient Gets Off Tysabri, Case Study Shows Zinbryta (daclizumab) may not be the best follow-up therapy for relapsingāremitting multiple sclerosis patients who stop taking Tysabri (natalizumab) for safety reasons, a case study suggests. An article on the 25-year-old patient’s case, titled āDisease reactivation after switching from natalizumab to daclizumab,ā was published in…
October 18, 2017 News by Patricia Silva, PhD #MSParis2017 – Progressive MS Research Among ECTRIMS Highlights, National MS Society Says The 7th Joint ECTRIMS-ACTRIMS Meeting, taking place in Paris this month, is one of the largest scientific conferences focused solely on multiple sclerosis (MS), and the National Multiple Sclerosis Society will be among the many interested parties attending. To get a feeling for meeting highlights and presentations the…
December 13, 2016 News by Patricia Silva, PhD Zinbryta Approved in Canada as Once-Monthly Treatment for Relapsing MS Health CanadaĀ has approved Zinbryta (daclizumab)Ā as aĀ treatment for adults with active relapsing-remittingĀ multiple sclerosis (RRMS), BiogenĀ and AbbVieĀ announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies. “ZINBRYTAā¢ is the first once-monthly, self-administered treatment…
October 5, 2016 News by Patricia Silva, PhD MS Trust to Oppose NICE Plan to Reject Zinbryta as MS Therapy in Health System for England, Wales The Multiple Sclerosis (MS) Trust isĀ expressing its disappointment at the recent committee decision ofĀ theĀ National Institute for Health and Care ExcellenceĀ (NICE)Ā to not recommendĀ Zinbryta (daclizumab) be made available as a therapy to MSĀ patients using the public health system in England and Wales. NICE’sĀ preliminary recommendationĀ was based on a review of…
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…
September 19, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – Biogen and AbbVie Present New Positive Data on Zinbryta to Treat Relapsing MS BiogenĀ andĀ AbbVieĀ presented positive new post-hoc analysis from the pivotal DECIDE clinical trial, whichĀ showed that a significantly larger number of relapsing multiple sclerosis (RMS) patients treated with Zinbryta (daclizumab) hadĀ no evidence of disease activity (NEDA)Ā compared to thoseĀ treated with Avonex (interferon beta-1a).Ā The data wereĀ given at the recentĀ 32nd Congress of the European…
July 7, 2016 News by Patricia Inacio, PhD Zinbryta (Daclizumab) Approved in Europe to Treat Relapsing MS Biogen and AbbVieĀ announced that the drug ZinbrytaĀ (daclizumab) has received marketing authorization by the European Commission, and is an approved treatment across most ofĀ Europe forĀ adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a self-administered, once monthly subcutaneous injection. āClinical data showed Zinbryta significantly reduced relapses, 24-week…
May 4, 2016 News by Patricia Silva, PhD CHMP Favors European Approval of Zinbryta (Daclizumab) to Treat Relapsing MS The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently recommended marketing authorization to Zinbryta (daclizumab) for the treatment of patients with relapsing multiple sclerosis (RMS). Zinbryta (daclizumabĀ HYP) is a humanized monoclonal antibody that is injected every four weeks, and being developed by…
April 22, 2016 News by Patricia Silva, PhD Biogen and AbbVie Present New Data Showing Zinbryta, an RRMS Drug Candidate, Aids Cognition Without Immune Depletion New data presented byĀ BiogenĀ andĀ AbbVieĀ at the recent 68th annual meeting of theĀ American Academy of Neurology (AAN) showed that ZinbrytaĀ (daclizumab high-yield process) improved cognitive outcome measures in patients with relapsing forms of multiple sclerosis (RMS). Additional results ā from post-hoc analyses of clinicalĀ trials ā also offer a better…
October 9, 2015 News by Margarida Azevedo, MSc Promising Data on ZINBRYTA (Daclizumab High-Yield Process) Compared to Interferon Beta-1a in RRMS, ECTRIMS 2015 Lead scientists representing Biogen and AbbVie presented new data on clinical results from the Phase 3 study DECIDE on the compound ZINBRYTA TM at the 31st Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Barcelona, Spain. The full results of the 2 to 3-year long…
May 6, 2015 News by Patricia Silva, PhD FDA Evaluates ZINBRYTA For MS Treatment The U.S. Food and Drug Administration (FDA) has announced it willĀ considerĀ marketing approval ofĀ ZINBRYTA (daclizumab high-yield process), a potential treatment for relapsing forms of multiple sclerosis (MS). Biogen and AbbVie, who are jointly developing the therapy, have filed aĀ Biologics License Application…
September 22, 2014 News by Maureen Newman New MS Therapy From Biogen Idec, AbbVie Reveals Positive Phase 3 Results in RRMS Patients Phase 3 clinical trial results from Biogen Idec and AbbVie presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRMIS) suggest that relapsing-remitting multiple sclerosis patients experience…
June 18, 2014 News by Maureen Newman Biogen Idec, AbbVie Show Superiority of Daclizumab High Yield Process in RRMS Biogen Idec, who recently presented over 60 company-sponsored presentations at the Consortium of Multiple Sclerosis Centers and the Sixth Cooperative Meeting with Americas Committee for Treatment and…