Pink Sheet 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

Arimoclomol & Ipique Developers To Make Their Case For EU Approval

Orphazyme & Rotterdam Biologics Are Scheduled To Present Before The EMA This Week

Executive Summary

The sponsors of two investigational drugs that have previously experienced key regulatory setbacks are set to give oral explanations to the European Medicines Agency about why they believe their products should be approved in the EU.

You may also be interested in...



Orphazyme Teeters On The Brink As Arimoclomol EU Filing Is Pulled

Danish biotech Orphazyme has withdrawn the EU marketing application for its Niemann-Pick disease type C therapy arimoclomol and all hopes for the drug’s survival now rest on a meeting with the US Food and Drug Administration.

Orphazyme Teeters On The Brink As Arimoclomol File Is Pulled

All hopes for survival rest on a meeting with the US FDA about arimoclomol now that the Danish biotech has withdrawn its submission for the Niemann-Pick disease type C therapy with the European Medicines Agency.

EMA Thumbs Up For Idorsia’s Insomnia Drug And Immunocore’s Uveal Melanoma Treatment

An insomnia drug to improve daytime functioning, a treatment for a rare type of eye cancer, and an oral migraine drug for both acute and preventive treatment are among 13 new products recommended for pan-EU approval.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145736

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel