Advanced Accelerator Applications receives FDA approval for Lutathera for treatment of gastroenteropancreatic neuroendocrine tumors. Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received U.S. Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including…
Key Growth Drivers Help Novartis Beat Fourth Quarter Estimates
Novartis reported net sales in the fourth quarter 2017 were $12.9 billion, a 5 precent (+2 percent at constant crrencies-cc) increase over the same period a year earlier, as volume growth of 7 percentage points (cc), including growth from Cosentyx and Entresto, was partly offset by the negative impacts of generic competition and pricing. Operating income…
Sandoz Enters Exclusive Collaboration With Biocon On Next-Gen Biosimilars
Sandoz is entering into a global partnership with Biocon, an India-based biopharmaceuticals company, to develop, manufacture, and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing, and global regulatory approvals for a number of products, and will have a cost and profit…
Study Data Shows Cosentyx Superior To Stelara In Clearing Psoriasis
Novartis new data reinforces superiority of Cosentyx versus Stelara in achieving skin clearance for psoriasis patients. Novartis announced today results from the head-to-head CLARITY study demonstrating the superiority of Cosentyx (secukinumab) compared to Janssen’s Stelara (ustekinumab) in delivering clear and almost clear skin in adults with moderate to severe plaque psoriasis at 12 weeks. The study results…
FDA Accepts Submission For Proposed Biosimilar To Humira
The U.S. Food and Drug Administration (FDA) has accepted the Sandoz Biologics License Application (BLA), submitted under the 351 (k) pathway, for the proposed biosimilar adalimumab to the reference medicine, Humira*. “When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health,”…
Novartis Granted Breakthrough Therapy Designation For Pediatric MS Treatment
Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS. Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for fingolimod for the treatment of children and adolescents 10 years of age or older with relapsing multiple sclerosis (MS). Fingolimod, also known as Gilenya in the…
Novartis To Evaluate Higher Dosage Of Drug For Debilitating Inflammatory Disease
Novartis initiates study evaluating impact of higher dosing of Cosentyx in patients with ankylosing spondylitis. Novartis Pharmaceuticals Corporation will initiate the ASLeap trial in patients with ankylosing spondylitis (AS), evaluating the effect of changing to a higher dose (300 mg) of Cosentyx (secukinumab) in patients who do not achieve symptom remission after treatment with Cosentyx 150 mg for 16…