Tags : Submits

Biosimilars

Vizient Submits Response to the US FDA for Draft Guidance

Shots: The company submitted report for the FDA’s guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products clarifying the clinical immunogenicity study for the approval of certain proposed biosimilars and interchangeable insulin products The guidance suggests recommendations as when and whether comparative clinical immunogenicity study will be needed for insulins to support the […]Read More

Regulatory

Celgene Files NDA for Ozanimod to the US FDA for

Shots: The NDA filing is based on P-III SUNBEAM & RADIANCE studies assessing Ozanimod vs Avonex in 1,346 & 1,320 patients with RMS across 21 countries for 12 & 24 mos. respectively In H1’19 Celegene has also filed MAA to EMA for relapsing-remitting multiple sclerosis in adults and plans to develop new therapies for RMS […]Read More