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Europe

Set Alert for Europe

Netherlands Gives Funding Nod To CGRP Inhibitors For Chronic Migraines

The Dutch health technology appraisal body, ZIN, said Novartis’ Aimovig should be reimbursed for the treatment of chronic migraine after initially advising against it.

Europe Netherlands

Coronavirus Notebook: UK Rolls Out Ronapreve To Hospitalized Patients, Drug Safety Unit Reviews mRNA Vaccine Heart Inflammation Link

Pressure is growing on richer countries to share their excess vaccine doses, and the European Parliament has passed legislation intended to strengthen the EU’s health security framework and make joint vaccine procurement more transparent.

Europe International

New UK System Will Check Trial Sponsors Report Study Results

The UK has started monitoring whether clinical trial sponsors are fulfilling responsibilities to make their research open and transparent.

United Kingdom Clinical Trials

Unlocking Orphan Pricing In France

Heath technology assessments in the competitive orphan space, such as pulmonary arterial hypertension, could get tougher in France.

Europe France

BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up

A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

Europe Approvals

Roche Among EU Fast-Track Hopefuls With Lymphoma Bispecific Mosunetuzumab

Two companies are set to learn whether the European Medicines Agency will agree that their planned EU marketing applications merit an accelerated assessment.

Europe Review Pathway

Scottish Funding No For Two Orphans As SMC Tries To Catch Up After COVID-19 Backlog

Two orphan drugs, Chiesi’s Proscybi and Insmed’s Arikayce, were rejected for funding on the Scottish National Health Service.

Europe United Kingdom

One In, One Out: Mirum Seeks New EU Indication For Maralixibat, Withdraws Another

Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.

Review Pathway Drug Review

Coronavirus Notebook: Nobel Laureates Press Germany To Back Vaccine IP Waiver

The EU vaunts its vaccine donations and starts building resilience against future health threats, and the UK MHRA says Moderna can be used as a booster dose. Aviptadil has received scientific advice from the MHRA for its potential use as a treatment for COVID-19 patients.

Europe International

UK OKs Booster COVID-19 Jabs & Vaccines For 12-15 Year Olds

While the UK and other countries are implementing or considering additional vaccination campaigns, questions have been raised about the impact on lower-income countries, and COVAX has called on donors and manufactures to honor their vaccine supply commitments.

Coronavirus COVID-19 Vaccines

BeiGene’s Brukinsa Among Five Orphan Drugs Awaiting EU Approval Verdict

Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.

Drug Review Approvals

Switzerland Supports ‘Increasingly Important’ Decentralized Clinical Trials

A new position paper outlines several factors that sponsors must consider when planning to undertake decentralized clinical trials in Switzerland to ensure compliance with national legal and ethics requirements.

Clinical Trials Switzerland
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