Mayne And Mithra Receive Australian Nextstellis Approval
Launch Expected In Mid-2022 After TGA Endorses Estetrol/Drospirenone Contraceptive
Executive Summary
Mayne Pharma and Mithra have revealed launch plans in Australia for their Nextstellis oral contraceptive that combines the novel estrogen estetrol with drospirenone, following approval by the TGA.
You may also be interested in...
Three Not A Magic Number For Mayne With Another NuvaRing CRL
Australia’s Mayne Pharma has announced another complete response letter for its proposed generic version of Organon’s NuvaRing (etonogestrel/ethinylestradiol) contraceptive device, marking a trio of setbacks for the ANDA product.
Stada Begins Work On Romanian Hub
Stada has begun work on a facility in Romania into which the German giant is investing more than €50m to bolster the European supply chain.
Humira LOE Is ‘Uncharted Territory’ As Fierce Competition Expected
Discussing the latest developments in the US biosimilars market, AmerisourceBergen’s senior director of biosimilar commercialization, Brian Biehn, talks about what we can expect from competition to Humira in 2023, how the first ophthalmology biosimilars are faring, and potential changes on the horizon at the FDA that could smooth the path to market for biosimilars sponsors.