Roche’s Ocrevus treatment showed fewer patients with relapsing multiple sclerosis needed walking aids, the company said on Oct. 13
In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form.
Johnson & Johnson will launch the newly approved drug Ponvory for adults with relapsing multiple sclerosis (MS) in the United States during early April 2021 at a similar price point to rival treatments, the company’s Janssen Pharmaceutical unit said on March 19.
BioSpace reviewed the top 10 novel drug approvals of 2020, loosely based on projected earnings in the upcoming years.
The U.S. Food and Drug Administration approved a shorter two-hour infusion time for Roche Group member Genentech’s Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions.
New York-based TG Therapeutics announced positive topline results from two global Phase III clinical trials, ULTIMATE I and II, of ublituximab in relapsing forms of multiple sclerosis (RMS).
Novartis announced new post hoc data showing the efficacy and safety of Kesimpta (ofatumumab), a targeted B-cell therapy, in patients with relapsing forms of multiple sclerosis (RMS) who are newly diagnosed as well as ongoing safety study findings.
Roche aims to defend the company’s multiple sclerosis (MS) franchise from rivals Novartis and Sanofi with new studies of the Swiss drugmaker’s $4 billion-per-year Ocrevus product and advanced trials of the experimental medicine fenebrutinib.
The U.S. Food and Drug Administration approved Novartis’ Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis in adults.
The U.S. Food and Drug Administration extended by three months the regulatory agency’s review of the supplemental Biologics License Application for Arzerra (ofatumumab) as a treatment for patients with relapsing multiple sclerosis.
