Dermavant Sciences announced positive data from two Phase III clinical trials evaluating tapinarof cream 1% in adults with plaque psoriasis.
Sanofi announced the acquisition of Principia Biopharma in a deal valued at about $3.68 billion as the French company continues to transform its R&D division to more heavily emphasize oncology and other lucrative programs.
Roche gets U.S. approval for Enspryng, takes on Alexion’s Soliris
Adults, Approvals, Blockbusters, Central Nervous System, Cytokines, FDA, FDA/Regulatory, Japan, Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder (NMOSD), Ophthalmology, Prescription Drug Costs, Rivalries, Spinal Cord, Therapeutics, United StatesThe U.S. Food and Drug Administration approved Roche’s Enspryng for the central nervous system disorder neuromyelitis optica, putting the Swiss drugmaker head-to-head with Alexion’s Soliris in a costly treatment area.
Top 200 Medicines Annual Report: Climbing Mount Humira
Analysts, August 2020, Autoimmune Diseases, Biologics, Blockbusters, Checkpoint Inhibitors, Chemotherapy, FDA, Healthcare Physicians, Human Anti-CD38 Monoclonal Antibody, Immuno-oncology, Issue Archives, Med Ad News, Metastatic squamous cell carcinoma of the esophagus, Multiple myeloma, Oncology, PD-1/PD-L1 inhibitors, Therapeutics, Top 200 MedicinesWhile Humira remains the best-selling prescription product worldwide, Keytruda has risen to the No. 2 global rank and is on track to eventually claim the top spot.
Genentech is eliminating 474 employees, mostly based out of the company’s South San Francisco facilities, with the job cuts expected to be permanent.
The U.S. Food and Drug Administration approved MC2 Therapeutics’ Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.
The U.S. Food and Drug Administration accepted the filing of Aurinia Pharmaceuticals Inc.’s New Drug Application (NDA) for voclosporin as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
FDA Action Alert: Jazz, ANI and Ultragenyx
Approvals, Cataplexy, Excessive Daytime Sleepiness, Fatty Acids, FDA, FDA/Regulatory, Gels, Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Multiple Sclerosis, Narcolepsy, New Drug Applications, PDUFA, Refusal to File letter, Rheumatoid Arthritis, Supplemental New Drug Application (sNDA), Systemic Lupus Erythematosus (SLE), Ulcerative ColitisU.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
Eli Lilly’s experimental treatment mirikizumab for plaque psoriasis beat out Novartis’ vaunted drug Cosentyx in a Phase III comparison study.
Equillium partner Biocon reported data from a clinical trial showing that itolizumab significantly decreased mortality in hospitalized COVID-19 patients.