Italian medicines agency chief Nicola Magrini recounts the problems AIFA faced and the lessons it learned through its work at the height of the coronavirus outbreak in Italy.
Italy’s medicines agency, AIFA, says its initial experience of dealing with the COVID-19 outbreak was difficult as opportunities to run large informative trials in the early days were missed.
Although there is now agreement on the need for large randomized clinical trials (RCTs) for generating meaningful clinical evidence, enforcing...
Casgevy, the world’s first CRISPR gene editing therapy, is the second drug to be accepted onto a managed access scheme via England’s Innovative Medicines Fund, offering a new treatment for patients with transfusion-dependent beta thalassemia.
Scotland’s health technology assessment body has agreed to reimburse Chiesi’s Elfabrio for Fabry disease, mirroring the decision from several other European countries – however, France turned down the rare disease drug, while Germany questioned its benefit.
Did Samsung Bioepis and Biogen choose early US access for their Lucentis biosimilar in exchange for postponing launch in other markets? That’s what Italy’s competition authority believes, as it investigates the biosimilar sponsors and originator companies Genentech and Novartis.
J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.
As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.
