Bristol Myers Squibb’s Zeposia (ozanimod) won approval from the U.S. Food and Drug Administration as a new treatment for a type of multiple sclerosis.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
France-based MedDay Pharmaceuticals announced the company’s MED1003 failed to meet the primary and secondary endpoints in the second pivotal Phase III trial for progressive multiple sclerosis (MS).
Multiple Sclerosis Update: Biogen, Sanofi, Active, Adamas and Novartis
Blockbusters, Bruton's Tyrosine Kinase (BTK) Inhibitors, Business, Clinical Trial Endpoints, Clinical Trials, CNS damage, MS with walking impairment, Multiple Sclerosis, Neurology, Patent Challenges, R&D, Secondary Endpoints, Shares, U.S. Patent Trial and Appeal Board (PTAB)Biogen successfully fended off a patent challenge from generic company Mylan over the multiple sclerosis (MS) drug Tecfidera.
A new business direction was approved by the board of directors for Lund, Sweden-based Active Biotech.
The European Commission approved Novartis’ Mayzent for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.
Adamas Pharmaceuticals Inc.’s product Gocovri to treat walking impairment in patients with multiple sclerosis did not show the clinical benefit the drugmaker was hoping for in a late-stage trial, sending shares of the company down 45 percent.
Researchers Working to Understand Why Some Patients with Autoimmune Diseases Develop Diabetes Instead of Arthritis
Arthritis, Autoimmune Diseases, Autoimmune inflammation, Beta cells, Diabetes, Genes, Immune Cells, Inflammatory Bowel Disease, Insulin, Multiple Sclerosis, National Institutes of Health, Nature Genetics, Pancreatic beta cells, Pluripotential cells, Researchers, Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Type 1 DiabetesRecently published research in the journal Nature Genetics found significant insight into this question: Why does a patient with an autoimmune disease become a type 1 diabetic rather than have rheumatoid arthritis?
Mallinckrodt receives SEC subpoena over Acthar gel lawsuit
Addictions, Business, Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), Gels, Generics, Infantile Spasms, Lawsuits, Manufacturing, Multiple Sclerosis, Opioid Litigation, Opioids, Shares, U.S. Securities and Exchange Commission (SEC)Mallinckrodt Plc received a subpoena from the U.S. Securities and Exchange Commission for documents related to the drugmaker’s lawsuit against the U.S. Department of Health and Human Services (HHS).
The U.S. Food and Drug Administration approved Vumerity (diroximel fumarate) – a novel oral fumarate with a distinct chemical structure – for the treatment of relapsing forms of multiple sclerosis.