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Novartis Resubmits Inclisiran NDA; Provention Bio Receives CRL for Teplizumab

Here is a brief preview of this blast: Two cardiometabolic-related news items have been observed: Novartis announced the inclisiran NDA has been resubmitted to FDA and Provention Bio announced it received a CRL from FDA for the teplizumab BLA citing the need for additional data regarding PK comparability. Of note, the Provention Bio CRL did not cite any clinical deficiencies related to the efficacy and safety data packages and confirmed the acceptability of the proposed proprietary name for teplizumab, Tzield. Below, FENIX provides highlights and insights from the respective news items.

About The Author

Matthew Maryniak

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President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.