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

EMA Working On New Guidance For Infectious And Respiratory Diseases, Biosimilars

Executive Summary

Companies can expect to see a number of finalized and draft EU guidelines published throughout 2018 and into 2019, according to newly published work plans for the European Medicines Agency’s Infectious Disease Working Party, Biosimilar Medicinal Products Working Party and the Respiratory Drafting Group.

You may also be interested in...



Germany Confirms No Reimbursement Status For ‘Lifestyle’ Drug Wegovy

In Germany Novo Nordisk’s obesity drug Wegovy will remain excluded from reimbursement for obesity, unlike Rhythm’s Imcivree.

New HTA Evidence Guidelines In EU Could Spell Trouble For Advanced Therapy Companies

New guidelines that cast doubt over the use of single-arm and non-randomized studies are “discouraging” for rare disease patients and the advanced therapy sector, says ARM, the Alliance for Regenerative Medicines.

Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee

Plans to rejig two regulators’ roles and streamline the ethics committee system have drawn some criticism.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS122347

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