Europe
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All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as a lower cost alternative to biosimilars and premium branded products for the condition, and higher than off-label compounds.
EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
New EU Filings
Seladelpar, CymaBay Therapeutics's investigational treatment for primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
EC Defends Data Protection Cut As EU ‘Pharma Package’ Nears Crucial Milestone
Proposals to overhaul the general pharmaceutical legislation will ensure that the EU “continues to have one of the most generous systems of incentives in the world,” the European Commission says.
EU Reaches Last-Minute Agreement On Health Data Space After Tough Negotiations
European co-legislators have reached a compromise on the text of the European Health Data Space that will see the controversial opt-out mechanism included in the framework
Vertex Resolves To Reverse English Funding Rejection For CRISPR Sickle Cell Gene Therapy
The health technology assessment institute, NICE, is not yet ready to recommend Casgevy for sickle cell disease and says it wants more data. Meanwhile, an access agreement relating to the treatment’s use for transfusion-dependent β-thalassemia is making progress in England, as are reimbursement talks for SCD in other European countries.
German HTA: Clinical Cancer Registries Could Hold Key To Better Comparative Data For Benefit Assessments
Better data linkage and data entry systems could transform Germany’s clinical cancer registries into a reliable data source for health technology assessments.
European Parliament Clears EU-Wide Compulsory Licensing Proposal
The draft regulation, which includes a ban on exports of drugs manufactured under an EU compulsory license, will be discussed with the EU member states after the June parliamentary elections.
UK MHRA Inspector Highlights Mistakes Made In Decentralized Clinical Trials
Inadequate risk assessments, participant confidentiality breaches and issues with documenting and verifying clinical trial activities have emerged as recurring themes in inspections of decentralized clinical trials by the UK medicines regulator.
NASH: Madrigal Files Resmetirom In EU While US Action Date Closes In
Resmetirom, which could become the first approved treatment for non-alcoholic steatohepatitis, is among 11 new drugs that the European Medicines Agency has started to review for potential EU approval. Meanwhile, a decision on whether to approve the drug in the US is due on 14 March.
EU’s New Variations Rules Will Cut Regulatory Burden, But Some Are Less Happy Than Others
Among the key features of the new framework are “super-grouping” of variations, a risk-based approach to classifying changes to biological products, and a more streamlined approach to updating pandemic vaccines.
European Health Data Space Talks Falter Over Opt-Out Issue
The pharmaceutical industry has warned co-legislators against any hasty compromises that could impact the competitiveness of EU research.
European Parliament Adopts Landmark AI Act
Members of the European Parliament (MEPs) have voted overwhelmingly in favor of the Artificial Intelligence Act, which will introduce strict requirements for AI systems used in high-risk settings such as health care.
UK Competition Watchdog Attacks Tribunal As Hydrocortisone Fines Overturned
UK competition watchdog the CMA says it will be appealing against a tribunal decision that has overturned nearly £100m of fines imposed over anti-competitive deals around hydrocortisone, based on what the CMA criticized as a “fundamentally misconceived procedural point” linked to the cross-examination of witnesses.
UK, US & Canada Regulators Explain Why Decentralized Trials May Get A Closer Look
Decentralized clinical trials are subject to the same regulatory requirements as traditional site-based trials, but are of special interest to regulators because they represent a new way of working.
EU’s DARWIN Project To Expand Geographical Reach With 10 New Data Partners
The EU DARWIN initiative is expected to deliver more than 70 real-world data studies this year and twice this figure from 2025 onwards to enhance European decisions on medicines.
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