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Europe

Set Alert for Europe

European Parliament Signs Off Regulation To Tackle Medicine Shortages

The legislation will establish a new EU platform for monitoring and reporting medicines shortages.

Europe Coronavirus COVID-19

NICE Board Approves Landmark Changes To Increase Flexibility Of Drug Evaluation Methods And Processes In England

Big changes are in store at UK health technology assessment body NICE aimed at improving the way medicines are assessed.

United Kingdom Cost Effectiveness

EMA: Multiple COVID-19 Booster Programs ‘Not Sustainable’ In Long Term

Global regulators have been discussing how best to approach vaccination in the face of possible future coronavirus variants, and whether bivalent or multivalent vaccines could be the answer.

Europe Coronavirus COVID-19

Scottish Funding OK For Breast Cancer Drugs Tukysa And Enhertu

As well as recommending Seagen’s Tukysa and Daiichi Sankyo/AstraZeneca’s Enhertu, the Scottish Medicines Consortium has given the green light to Leo Pharma’s Adtralza and a new lung cancer indication for AZ’s Tagrisso. Meanwhile, Alexion has failed to make a submission to HTAs in both Scotland and England for a specific indication for Soliris.

Europe United Kingdom

Care Needed With Plain Language Summaries Of EU Study Results

The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.

Clinical Trials Compliance

UK Regulator Calls For More Patient Involvement In Trial Design

UK plans for a flexible and streamlined clinical trial regulatory regime are now out for consultation, covering areas such as investigational medicinal products, greater patient involvement in trial design, and lighter-touch oversight of low-intervention trials.

Europe United Kingdom

UK Kicks Off Landmark Overhaul Of Clinical Trial Framework

The UK regulatory agency, the MHRA, is planning to establish a “world-class sovereign regulatory environment” for clinical trials to support the development of new innovative medicines. In the first of two articles, we look at the MHRA’s proposals to slim down trial approval processes, lighten the safety reporting burden, and introduce greater transparency of trial registration and results.

Europe United Kingdom

New EU Clinical Trials Transformation Initiative Gets Underway

Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms. 

Clinical Trials Regulation

EU New Drug Approvals Hit Record High

Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.

Pink Sheet Perspectives Europe

The EU’s New Clinical Trial System Is Just Two Weeks Away: Are You Ready?

When the new Clinical Trial Information System goes live at the end of January, it will usher in many practical and operational considerations that sponsors need to be aware of.

Clinical Trials Compliance

First Academic Sponsor On EMA’s PRIME Pledges Cheaper CAR-Ts

An investigational CAR T-cell therapy that hospital researchers in Spain believe they could produce at a third of the price of commercially available CART19 products has been accepted onto the European Medicines Agency's priority medicines scheme.

Europe Drug Review

Use Of Real-World Data Hindered By Different Regulator Requirements

Challenges to the use of real-world data and the importance of wider international regulatory collaborations were among topics addressed by the European industry body EFPIA in a survey of its member companies.

Europe Legislation
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