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

Amicus Therapeutics, Inc.

http://www.amicusrx.com/

Latest From Amicus Therapeutics, Inc.

EMA OKs Seven New Drugs Including First RSV Vaccine For Older Adults

GSK’s Arexvy vaccine for preventing lower respiratory tract disease caused by respiratory syncytial virus in adults aged 60 years and older is among the latest products that the European Medicines Agency said should be approved for use in the EU.

Europe Approvals

EMA Decision Time For GSK’s RSV Older Adult Vaccine & Roche’s Glofitamab For LBCL

A number of companies could soon find out whether the European Medicines Agency will back pan-EU marketing approval for their respective products.

Europe Approvals

Hemophilia B Gene Therapy Among Five Drugs On Track For EU-Wide Approval

Alongside CSL/Behring/uniQure’s Hemgenix (etranacogene dezaparvovec), the European Medicines Agency has given the green light to new drugs for liver cancer, NSCLC, Pompe disease and multiple sclerosis. But it turned down omburtamab for treating the rare cancer, neuroblastoma.  

Europe Approvals

Etranacogene Dezaparvovec, Omburtamab & Tremelimumab Await EMA Verdict

Four of the six products up for a marketing authorization opinion from the EMA’s advisory committee, the CHMP, this week are orphan drugs. One of them, omburtamab, was recently turned down by a US FDA advisory panel.

Europe Approvals
See All

Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Drug Discovery Tools
      • ADMET
      • Molecular Diversity
  • Other Names / Subsidiaries
    • Callidus Biopharma
    • Celenex
    • MiaMed, Inc.
    • Scioderm, Inc.
UsernamePublicRestriction

Register