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


EU Paediatric Regulation Report ‘Positive,’ But More Investigation Needed, Legal Expert Claims

Executive Summary

The new EU report on how the Paediatric Regulation is working after 10 years is a “positive step forward,” says a legal expert, who also wants the commission to use its postponement of any future legislative changes as an opportunity to further examine – and discuss with all stakeholders – how to improve the procedure concerning pediatric investigation plans. The expert also raises concerns about some of the figures cited in the report.

You may also be interested in...

EU Approval In Sight For New ATMP, Products For XLH And Diabetes, And 2nd Biosimilar Herceptin

A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a potential multiple myeloma therapy derived from sea squirts.

Codeine/Ibuprofen Combo Safety Concerns Prompt EMA Call For Prescription-Only Status

Drugs combining codeine and ibuprofen were among the latest products for which the European Medicines Agency has recommended new risk minimization measures –Imbruvica and terlipressin-containing medicines were the others.

New EU Filings

Santhera Pharmaceuticals’ vamorolone for treating Duchenne muscular dystrophy is among the latest medicines that have been submitted for review for potential pan-EU approval.


Latest News
See All



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