Tags : Submits

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed

Shots: The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma […]Read More

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02

Shots: The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21 The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of […]Read More

Sorrento Submits EUA to the US FDA for its COVI-TRACK

Shots: Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical […]Read More

Vizient Submits Response to the US FDA for Draft Guidance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

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