Keeping Track: Clarus, Agile and Sunovion Look To Bounce Back From CRLs; FDA To Review Rituximab Biosimilar
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Evofem Plans 2019 Refiling For Amphora Based On New 86% Contraception Efficacy
Evofem intends to refile the NDA for its non-hormonal contraceptive Amphora during the second quarter of 2019, after the Phase III AMPOWER study showed 86% efficacy for typical use and 98.7% efficacy when the gel was used as directed.
Deal Watch: Neos Says ‘Thanks, No Thanks’ To Repeated PDL Offer
Daiichi teams with Glycotope on an antibody-drug conjugate for cancer, while Alector will partner with AbbVie to research antibody targets for Alzheimer’s disease.
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Lipocine resubmits Tlando NDA with new study data supporting twice-daily fixed dosing regimen for the oral testosterone replacement candidate; FDA action expected by Feb. 8.