FDA Grants Breakthrough Therapy Designation for Genentech’s Gazyva (Obinutuzumab) in Lupus Nephritis

The designation is based on the results of the Phase II NOBILITY study that showed Gazyva, in combination with standard of care, helped more people achieve a complete renal response than standard of care alone Genentech today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Gazyva® (obinutuzumab) for

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Mesenchymal stem cells in allergic diseases: Current status

Allergic diseases have become a global health problem and the most prevalent allergic disorders include allergic asthma, allergic skin diseases, allergic rhinitis, and allergic conjunctivitis. In the therapy of allergic diseases, corticosteroids, antihistamines, antileukotrienes and β2 adrenergic receptor agonists temporarily inhibit inflammation mediators and immune cells. However, long-term treatment causes various adverse effects. Drug resistance and intolerance

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FDA Approves JAK Inhibitor for Moderate to Severe Rheumatoid Arthritis

The FDA approved upadacitinib (Rinvoq, AbbVie), a 15-mg, once-daily oral Janus kinase inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. The approval is supported by data from the SELECT program, one of the largest registrational phase 3 clinical programs

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