In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

AOP Orphan Pharmaceuticals AG

www.aoporphan.com

Latest From AOP Orphan Pharmaceuticals AG

Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations

Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP.  Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn an application for another.

Europe Regulation

CHMP Delays Review of Portola's Ondexxya; Who Will Pass Muster?

With its final meeting of the year under way, the EMA's medicines evaluation committee, the CHMP, will bring seasonal cheer for some companies if it decides their products merit EU approval. New treatments from Shionogi and Medac are up for an opinion. A planned appearance by Portola before the panel to answers questions relating to its marketing application for Ondexxya/AndexXa has been cancelled and the review period for the marketing authorization application for the product extended.
Europe BioPharmaceutical

Moment Of Truth For Pacritinib And Other EU Approval Hopefuls

CTI BioPharma has had a bumpy ride with pacrotinib, its investigational treatment for patients with myelofibrosis who have thrombocytopenia. But it has persevered and should learn this week whether the European Medicines Agency will recommend that the product be approved for the sale across the EU. Pacritinib, J&J's apalutamide, and AEterna Zentaris's macimorelin are among a handful of products reaching the end of the approval process.

Europe Approvals

Pipeline Watch: Phase III Progress With Anacetrapib, ALKS 3831 And LentiGlobin

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals
See All

Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Cancer
  • Cardiovascular
  • Neurology, Nervous System
  • Respiratory, Pulmonary
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • Austria
  • Parent & Subsidiaries
  • AOP Orphan Pharmaceuticals AG
  • Senior Management
  • Rudolf S Widmann, CEO
    Andreas Steiner, CFO
    Georg Fischer, Dir., Bus. Dev.
    Christoph Klade, Dir., R&D
  • Contact Info
  • AOP Orphan Pharmaceuticals AG
    Phone: (43) 5037244-10
    Wilhelminenstrasse 91
    Vienna, A-1160
    Austria
Advertisement
Advertisement
UsernamePublicRestriction

Register