Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Mithra Pharmaceuticals SA

https://www.mithra.com/en/

Latest From Mithra Pharmaceuticals SA

Finance Watch: 3T Biosciences Emerges With $40m And Novel TCR Platform

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.

Financing Innovation

Mayne And Mithra Obtain Long-Awaited NuvaRing Nod From FDA

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.

Approvals Generic Drugs

US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

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.

Approvals Review Pathway

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, including Roche’s Enspryng for neuromyelitis optica spectrum disorder.

Europe Approvals
See All

Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Estetra SA
    • Estetra SPRL
    • Mithra IBD SA
    • Mithra RDP SA
    • Fibrocis
    • Mithra Pharmaceuticals CDMO
UsernamePublicRestriction

Register