SRA's number for the day: 19
This article was originally published in SRA
Executive Summary
A total of 19 pharmaceutical companies between 2009 and 2012 failed to submit one or more annual reports on deferred measures relating to paediatric investigation plans (PIPs) for authorized medicines, as required by the EU Paediatric Regulation1.
You may also be interested in...
New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
New EU Approvals
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
ViiV Wins Fast-Track Review At EMA For HIV Therapy
A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: