Latest From Francesca Bruce
Brazilian Regulator Extends COVID-19 Measures
Brazil’s medicines regulator is extending COVID-19 era resolutions designed to speed up its evaluation of clinical research in Brazil.
Canada Publishes Real World Evidence Guidance For HTA And Regulatory Decision Making
The new guidance was drawn up through extensive engagement with national and international experts in RWD and RWE, as well as stakeholders in Canada.
EU Pharma Revision Of Hospital Exemptions For ATMPs 'Is Unsatisfactory'
The EU legislative overhaul falls short on dealing with the issue of hospital exemptions for advanced therapies, says the Alliance For Regenerative Medicine.
European Countries Flags Four Medicines For Joint HTA Evaluation
Drugs for treating Duchenne muscular dystrophy and amyotrophic lateral sclerosis are among the products that the European cross-country coalition BeNeLuxA thinks would be suitable for a joint health technology evaluation.
Mexico, Colombia and Cuba Formalize Talks On New Latin American Regulator
Medicines regulators from Mexico, Colombia and Cuba have pledged to create a new agency for medicines and medical devices of Latin America and the Caribbean.
Oncopeptides’ Melflufen: Same Data, Different Conclusions From EMA, US FDA
The two regulators were an OCEAN apart on their interpretation of the overall survival and progression-fee survival data from the Phase III confirmatory trial. European regulators saw fit to recommend Pepaxti’s approval, even after the drug was voluntarily discontinued in the US market due to FDA concerns.