Mayne Pharma and partner Mithra have announced the launch of their Haloette generic version of NuvaRing in the US, adding further competition to a field that already includes Amneal and Teva as well as Prasco’s authorized generic.

Private Company Edition: Westlake Village BioPartners’ latest launch 3T Biosciences also licensed a second TCR platform from Stanford University. In other recent financings, Senda raised a $123m series C round, Orna revealed a $221m series B and CPRIT funded several cancer drug developers.

Following a trio of complete response letters received since late 2018, Mayne Pharma and partner Mithra Pharmaceuticals have finally obtained US FDA approval for a generic version of Organon’s NuvaRing vaginal hormonal contraceptive ring.

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.