Teva’s Quartette data support US filing
This article was originally published in Scrip
Executive Summary
Teva Women’s Health has reported Phase III clinical data for its novel, dose-ascending extended-regimen oral contraceptive Quartette. The new product, which contains levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets, is currently under review at the US FDA after being accepted for review in August, and is the first dose-ascending oral contraceptive.
You may also be interested in...
Agile's Phase III Data For Twirla Patch Fall Flat, Raise Doubts On Approval
Twirla low-dose birth control patch doesn't work as well in heavier women in Phase III SECURE study, but Agile believes that this is a class effect and an artifact of the stringent, real-world study design requested by FDA.
The Shifting Sands Of Biopharma R&D
A year is a long time in biopharma. Pharmaprojects’ annual pipeline review finds changes in the therapeutic spread of drug candidates and a reordering of the top R&D companies, as Chinese firms made their presence felt all the more over the past 12 months.
Nine Pivotal Studies To Look Out For In 2024
While not expected to be quite so busy as previous years, 2024 will still see many pivotal clinical trial readouts that should create a splash. Here are nine (plus a few extras) that have caught attention for one reason or another, e.g., for being the first readout for a novel drug class, having the potential to take a product in a new lucrative direction, for maybe being able to succeed where a rival has already failed or even for having been a long time coming.