Researchers at Hokkaido University in Japan, in a collaboration with American scientists, may have identified neural crosstalk as the mechanism that drives widespread inflammation in inflammatory diseases, such as rheumatoid arthritis (RA), psoriasis and atherosclerosis.
UCB psoriasis drug will need to wait for US approval
Autoimmune Diseases, Biologics License Application (BLA), Complete Response Letter, FDA, Generalized Myasthenia Gravis (gMG), Humanized IgG1 monoclonal antibody, Immune-Mediated Diseases, Immunotherapeutics, Immunotherapies, Inflammatory Diseases, Lesions, Monoclonal Antibodies, Plaque Psoriasis, Plaque Psoriasis, Plaque Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis Lesions, Scalp plaque psoriasis, Scalp Psoriasis, Skin Diseases, Therapeutics, UCBThe U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
U.S. FDA Approves Second Indication for Skyrizi to Treat Adults with Active Psoriatic Arthritis
AbbVie, Active Psoriatic Arthritis (PsA), Adults, Anti-IL-23 monoclonal biologic antibodies, Approvals, Blockbusters, Clinical Trial Endpoints, COVID-19 Therapeutics, Inflammatory Diseases, Joints, New Indications, Plaque Psoriasis, Primary Endpoints, PsoriasisThe U.S. Food and Drug Administration approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts 30 percent of patients with psoriasis.
Eli Lilly announced that the company’s psoriasis drug Taltz overcame Johnson & Johnson’s Tremfya in a head-to-head study.
The Canadian province of British Columbia said its public drug plan will switch as many as 20,400 patients from three branded biologic drugs to cheap near-copies called biosimilars.
Bristol-Myers Squibb’s experimental drug BMS-986165 helped reduce the severity of the most common form of psoriasis in a mid-stage trial.
Novartis receives EU approval for biosimilar Zessly
Ankylosing Spondylitis (AS), Approvals, Biosimilars, Crohn's Disease, Dermatological Diseases, European Commission, FDA/Regulatory, Gastroenterological Diseases, Immunology, Oncology, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Rheumatological Diseases, Ulcerative ColitisNovartis’ Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.
Johnson & Johnson reported a strong first-quarter 2018 with $20 billion in sales that was fueled by significant growth in the company’s pharmaceuticals business.
Sun Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration approved Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Shares of South Korea-based Celltrion were down more than 5 percent after the company announced it received a warning letter from the U.S. Food and Drug Administration after the regulatory agency inspected a company drug manufacturing facility.