Pink Sheet 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

EMA Reduces Trial Requirements For Hemophilia Drugs

Executive Summary

New guidance from the EMA says that data from patient disease registries can be used instead of clinical trials of previously untreated patients during the development of new treatments for hemophilia.

You may also be interested in...



Brexit Halts Work On 119 EMA Guidelines

The European Medicines Agency chief Guido Rasi is worried that if work on guidance development and revision stutters, "the whole system may suffer."

EU & US At Odds Over Merck’s Keytruda

EU and US regulators have opposing views when it comes to Merck's applications for a new indication and new dosing schedule for the company's successful PD-1 inhibitor Keytruda.

First African Approvals For Merck’s Ebola Vaccine

Regulators have pulled out all the stops in their efforts to get the Ebola vaccine to the marketing authorization stage in Africa. 

Topics

UsernamePublicRestriction

Register

PS124353

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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