Updated guidance on France’s experimental fast-track procedure for approving clinical trials shows that the pathway has entered a new phase.
The French regulatory agency, ANSM, has now opened up its experimental fast-track pathway for approving clinical trials to sponsors developing advanced therapy medicinal products (ATMPs), according to an updated guide on how to use the rapid authorization process.
The voluntary pathway, which ANSM began testing last year for other types of medicinal products, may be used by ATMP...
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.
England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.
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.
The Haute Autorité de Santé says that the risk of granting early access may only be justifiable if uncertainties over the clinical benefit of a drug can be addressed within a “reasonable” timeframe.
<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.
