Pharmaceuticals, Biotechnology and Life Sciences
Novartis announced Monday positive top-line results from the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study (NCT04578834) at 9 months.
Novartis today announced new overall survival (OS) and quality of life (QoL) analyses which evaluated Kisqali® (ribociclib) plus endocrine therapy for patients with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) advanced or metastatic breast cancer. These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, Novartis said.
Novartis has announced positive topline results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 expression.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Novartis’s Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Novartis-s Vijoice (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.
Novartis has announced new long-term data from the Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension that demonstrated long-term efficacy and safety of Kesimpta (ofatumumab), with continued reduced risk of disability worsening, for people living with relapsing multiple sclerosis following up to four years of treatment.
The U.S. Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’s Durham, N.C. site, a multi-product gene therapy manufacturing facility.
Novartis has announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade.
The US Food and Drug Administration (FDA) has approved Novartis’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer
Novartis has announced new data that reinforce the transformational benefit of Zolgensma (onasemnogene abeparvovec), an essential one-time treatment for spinal muscular atrophy (SMA).