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’s CHMP to monitor Genzyme manufacturing improvements

This article was originally published in The Gold Sheet

Executive Summary

At its May 17-20 monthly meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use requested Genzyme to carry out a risk assessment of its manufacturing processes, and to use that assessment to develop a detailed plan for improvement. The committee wants regular progress reports on implementation, it told Genzyme officials who made a presentation about the company's management and quality assurance systems at the meeting

You may also be interested in...



Legend Biotech CEO Ying Huang On Moving Fast In the BCMA CAR-T Race

Ying Huang was named CEO as his predecessor came under investigation in China and as partner Janssen was getting closer to seeking US FDA approval for its lead CAR-T therapy.

Brazil Authorizes Oxford/AZ and Sinovac Vaccines

In addition to agreeing to emergency use of the Oxford University/Astra Zeneca and Sinovac vaccines, Brazil's medicines regulator has also published good manufacturing practices certificates for Pfizer and Janssen vaccine. It has questions about the Sputnik V authorization request.

UK Government Promise For 2021: No Halting The Advance Of Healthtech Innovation Adoption

There can be no such thing as a COVID dividend, but the renewed digital push and momentum for health system change perhaps come closest.

UsernamePublicRestriction

Register

ID004339

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