Keeping Track: Clarus, Agile and Sunovion Look To Bounce Back From CRLs; FDA To Review Rituximab Biosimilar
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.
Oral Testosterone Battle Looms As Lipocine's Tlando Joins Clarus' Jatenzo In US FDA Review Queue
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.