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Europe

Set Alert for Europe

Stakeholders Must ‘Fully Engage’ If WHO’s Medicines Access Platform Is To Succeed

Delegates at the European Health Forum Gastein outlined the challenges facing an international effort to improve access to costly new medicines across the World Health Organization’s European region, insisting that the key issues had to be addressed “collectively” and without “finger pointing.”

Europe Gene Therapy

Novel Brain Penetrant For Treating X-ALD Among Raft Of New EU Filings

Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.

Europe Approvals

AB Science & Daiichi Try Their Luck Again With EU Filings

The sponsors of Alsitek and quizartinib are hoping that new data generated for the drugs will resolve the concerns raised by the European Medicines Agency when it previously rejected the products for marketing in the EU.

Drug Review Europe

Evusheld: UK Urged To Use RWD To Give Clinically Vulnerable Early Access To COVID-19 Treatment

A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection. 

United Kingdom Coronavirus COVID-19

EU To Kick Off ‘Joint Action’ On Tackling Drug Shortages

The joint action on ensuring security of medicines supply will be supported by the EU regulators’ shortages task force, which is to track efforts to coordinate member state activities on the supply and availability of medicines.

Europe Regulation

EU Drafts Recommendations On Identifying Suitable RWD Sources For Studies

EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.

Europe Guidance Documents

Clinical Trial Regulation: EU Clarifies Requirements For Patient-Facing Documents

An updated Q&A on the EU Clinical Trial Regulation distinguishes between patient-facing documents and recruitment material to clarify in which sections of the trial application these should be submitted. It also underlines the main principles to consider for transitioning studies from the Clinical Trials Directive to the CTR.

Europe Clinical Trials

Orphan Drug Companies Warned To Beware Of The Dutch Lock System

Companies selling orphan medicines in the Netherlands need to prepare for the likelihood that their products will enter the so-called lock system, which means they will come under extra scrutiny and take longer to reach patients.

Europe Netherlands

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Nulibry, BridgeBio/Sentynl's orphan drug for treating molybdenum cofactor deficiency Type A.

Europe Approvals

'Incorrect' To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA

US FDA India country director Dr Sarah McMullen provides a fact check at a recent conclave to dispel the notion that interchangeable biosimilars are safer and more effective than other approved biosimilars.

Biosimilars Drug Safety

Economic Crisis Expected To Shape UK’s Future Drug Pricing Deal

The pharmaceutical industry has warned the UK’s new government about the impact of unprecedented industry payments on medicines supply in the short term and their potential to reduce inward investment in the long term. Along with economic pressures, these considerations will be among the factors forming the backdrop to negotiations on a deal that will determine pricing and access for branded medicines access from 2024 onwards.

Europe United Kingdom

Pharma Disappointed By New Extension Of EU Signal Detection Pilot

A further extension of the EU signal detection pilot means that certain drug sponsors must keep monitoring the EudraVigilance database on a continuous basis. Industry argues there is enough evidence that this activity brings no additional value, and that current requirements should be replaced with a more proportionate approach.

Europe Drug Safety
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