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Europe

Set Alert for Europe

EMA To Explain How Trial Transparency & Data Redaction Can Live Together

The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.

Europe Clinical Trials

EMA Recommends Revoking EU Approval For Novartis’s Sickle Cell Disease Drug

The results of a Phase III study did not confirm the benefits previously seen with Adakveo, the European Medicines Agency said.

Europe Approvals

EMA Backs EU Approval For Ztalmy & Pylclari; Roches Withdraws EU Filing For AMD Implant

Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.

Europe Approvals

UK In Major Move To Boost Commercial Clinical Trials & Improve Life Sciences Environment

The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.

Europe United Kingdom

UK Reveals Seven Partners Whose New Drug Approvals It Will Recognize

The UK regulator, the MHRA, says that while it will recognize drug approvals granted in the EU and a selection of other countries, it will remain a “sovereign regulator” with the ability to reject applications if they don’t meet its standards.

Europe United Kingdom

UK MHRA Says Genetic Biobank Could Transform Drug Safety Monitoring

The biobank, which the UK regulator believes puts it at the forefront of innovation in the field of drug safety monitoring, will enter a pilot in June, starting with the gout treatment allopurinol and related rare, severe skin reactions.

Europe United Kingdom

EU Pharma Revision: Legislators Prepare For Long-Haul Debate

The European Parliament and the Council of the EU are preparing their positions on the planned overhaul of the EU medicines legislation ahead of discussions that are expected to take two to three years.

Europe Legislation

EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed

As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.

Europe Legislation

EU Industry Wants ‘More Fluid’ Accelerated Assessment Procedure At EMA

EFPIA says that the European Medicines Agency’s fast-track regulatory review mechanism can be perceived by sponsors as being “hard to get and easy to lose.”

Europe Review Pathway

EMA: Marinus Filing Up For An Opinion; Amylyx, GSK & Curium Due For Oral Explanations

The European Medicines Agency’s human medicines committee, the CHMP, is meeting this week to discuss the EU marketing applications for a number of products that have reached the late stages of the regulatory review cycle.

Europe Approvals

EMA Looks For Efficiencies For Companies Ahead Of Relaunching Clinical Data Transparency Policy

Based on its learnings from proactively publishing clinical trial data on COVID-19 products, the European Medicines Agency is making procedural changes to its clinical data publication policy that is set to resume after being temporarily suspended in 2018.

Europe Clinical Trials

UK Offers Fresh Funding For New Drugs & Vaccines Against AMR

New funding from the UK’s antimicrobial resistance innovation fund is to be welcomed, but the UK pharmaceutical industry body, the ABPI, has cautioned that “multiple global solutions” bringing together governments, health care systems and the industry are needed if research efforts are to result in effective new antibiotics.

Europe United Kingdom
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