Browsing items tagged “Novartis | EVERSANA”

FDA Sets September Review Date for Novartis’ Multiple Sclerosis Targeted B-Cell Therapy, Ofatumumab

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #actionadate #b-celltherapy #fda #multiplesclerosis #novartis #ofatumumab #sbla PRICENTRIC BRIEF: The U.S. Food and Drug Administration (FDA) issued a notice to Swiss-based Novartis explaining that the agency has extended its review of the supplemental Biologics License Application (sBLA) for ofatumumab, a targeted B-cell therapy for relapsing multiple sclerosis (MS) The FDA is now expected to make a decision […]

Deciphera’s Qinlock Approved for Fourth-Line GIST Treatment by FDA

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #deciphera #fda #projectorbis #qinlock #realtimeoncologyreview PRICENTRIC BRIEF: The Food and Drug Administration (FDA) approved Deciphera’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (branded as “Gleevec” by Novartis in the U.S.) The New Drug Application (NDA) […]

Zolgensma Proposed to Cost 167 Million Yen in Japan

Country: JAPAN | Region: ASIA & SOUTH PACIFIC | Type: Pricing & Reimbursement | Keywords: #chuikyo #genetherapy #listing #mhlw #nhi #novartis #pediatrics PRICENTRIC BRIEF: Japanese media have reported that the price of Novartis’ spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec) is expected to be 167 million yen under the National Health Insurance (NHI) scheme In the case of Zolgensma, health official insiders from the MHLW suggested that the […]

Czech Republic Allows Pre-Authorized Use of Zolgensma

Country: CZECH REPUBLIC | Region: EUROPE | Type: Regulation | Keywords: #avexis #chmp #earlyaccess #ema #genetherapy #novartis #pediatrics PRICENTRIC BRIEF: The Ministry of Health is allowing the implementation of a specific treatment program for pre-authorized use of spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec) by AveXis, a Novartis company Zolgensma will be allowed to treat pediatric patients under the age of two with SMA with a survival motor […]