Europe

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

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.

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

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

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

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

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

Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned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

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.

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.

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.

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.