Roche subsidiary Genentech on Wednesday released data from the Phase III OCARINA II study, showing that its investigational subcutaneous formulation for Ocrevus (ocrelizumab) strongly reduced relapses and brain lesions in patients with relapsing or primary progressive multiple sclerosis.
Tag Archive for: multiple sclerosis
Contineum Therapeutics joined the 2024 initial public offering class on Friday with an SEC filing. The biotech will use the IPO proceeds to complete a Phase II trial for its most mature candidate targeting multiple sclerosis.
The U.S. FDA has declined to approve Viatris and Mapi Pharma’s once-a-month injection for treating relapsing forms of debilitating neurological condition multiple sclerosis (MS), the companies said on Monday.
The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.
Biogen gained exclusive ex-U.S. rights to Ampyra in 2009 and is selling the drug under the brand name Fampyra in international markets.
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.
The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.
While the patent for Biogen’s drug has expired in the United States, it had scored a win in Europe in March.
In two Phase III trials, the compound known as evobrutinib failed to beat Sanofi’s established Aubagio in reducing MS relapse rates, Merck said in a statement late on Tuesday.
The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
