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.
Eli Lilly released the company’s first-quarter 2021 financial report and is abandoning plans to submit mirikizumab to health regulators for psoriasis.
Swiss drugmakers Roche and Novartis each won European approval for drugs on March 30 in a sign that the rival Basel-based companies are increasingly competing for the same patients.
BrainStorm Cell Therapeutics, one of the leading developers of adult stem cell therapies that mainly focuses on adult neurodegenerative diseases, reported that the company’s 28-week-long Phase II clinical trial for progressive multiple sclerosis (MS) came to a close.
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.
The U.S. Food and Drug Administration approved AbbVie’s biologic therapy Humira (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.
Shares of Pandion Therapeutics soared more than 131 percent in trading after pharma giant Merck announced the acquisition of the autoimmune-focused company for up to $1.85 billion.
The U.S. Food and Drug Administration approved Biogen Inc.’s new intramuscular injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis.
GlaxoSmithKline discontinued a Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody aimed at treating ulcerative colitis licensed from Australia-based Immutep Limited following an interim assessment of an Independent Data Monitoring Committee.
Amgen is partnering with Ann Arbor, Michigan-based EVOQ Therapeutics for a license and collaboration deal to discover and develop drugs for autoimmune disorders.