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

Uncertain Future For Orphazyme After Arimoclomol Snub In Europe

European Medicines Agency Likely To Advise Rejection Of Arimoclomol For Niemann-Picks Type C

Executive Summary

The EMA's medicines evaluation committee has told Orphazyme it is unlikely to recommend approval of the rare disease drug arimoclomol when it meets at the end of March, prompting the Danish firm to assess its strategic options.

You may also be interested in...



Janssen’s BCMA-Targeting CAR-T, AstraZeneca’s Evusheld Among EU Verdict Hopefuls

The EMA is poised to say whether or not six new drugs are on track for pan-EU approval, including Janssen’s first cell therapy and an antibody combination to prevent COVID-19 in people with poor immune response.

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.

Arimoclomol & Ipique Developers To Make Their Case For EU Approval

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145759

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