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

Europe

Set Alert for Europe

EU Legislators Firm Up Commission’s Plans To Overhaul Pharma Rules

Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.

Europe Legislation

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.

European Performance Tracker Review Pathway

Comirnaty mRNA Vaccine First To Get EU Clearance For Under-12s

The EMA is going all out to maximize coverage of the EU population with both vaccines and treatments for COVID-19.

Europe Coronavirus COVID-19

EMA Moves To Ensure ‘Smooth’ Evaluation Of Drug Approval Dossiers

Drug sponsors seeking centralized EU marketing authorizations now have the opportunity to have simpler pre-submission “interactions” with the European Medicines Agency six months before the submission to help avoid complications down the line. Full meetings may still be appropriate for complex issues such as requests for accelerated assessment or conditional approval.

Europe Drug Review

Accelerated Assessment Success In EU For CSL Behring And Roche

There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted. 

Review Pathway Gene Therapy

Seventeen And Counting – Bumper Crop Of New EU Filings

Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.

Europe Drug Review

Coronavirus Notebook: Molnupiravir EU Approval Likely By Year End, Special CHMP Session Due On Comirnaty in 5 to 11-year-olds

The EMA is assessing the Janssen vaccine as a booster, and Switzerland is evaluating the use of the Pfizer/BioNTech and Moderna COVID-19 vaccines in younger age groups. The WHO has announced the first voluntary global license on a COVID-19 antibody detection technology.

Europe Switzerland

EMA To Consider How To Deliver Drug Risks Information Via Digital Formats

European Medicines Agency plans to finalize changes to its guideline on additional risk minimization measures and then establish a new drafting group on digitalization of education materials.

Safety Drug Safety

GSK/Vir’s Xevudy Begins EU Review For COVID-19

Things are happening very quickly on the COVID-19 front, with sotrovimab, molnupiravir, Paxlovid and Novaxovid all under EU review for marketing authorization or emergency use, and EMA decisions expected on boosters and the use of vaccines in younger age groups.

Europe Coronavirus COVID-19

ViiV & Janssen Win English Funding First For HIV Therapy

Around 13,000 people are now expected to be eligible for treatment with the long-acting, injectable Vocabria/Rekambys combination therapy in England.

Health Technology Assessment Infectious Diseases

Aducanumab: Biogen Is The Latest Firm To Preempt A Negative EU Opinion On Approval

The EU marketing application for aducanumab is heading for a rejection for Alzheimer’s disease, according to a “negative trend vote” at the CHMP disclosed by the drug’s sponsors.

Europe Drug Review

Sanofi ‘Strongly Disagrees’ With EMA Rejection Of NAS Status For Nexviadyme

Sanofi argues that the European Medicines Agency applies a narrow interpretation of its new active substance principles which is not appropriate for biological therapies, and that the regulator fails to consider the challenges of conducting clinical research in rare diseases.

Europe Innovation
See All
UsernamePublicRestriction

Register