Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

A new pilot aims to take Brazil closer to ‘digital transformation.’

Strong concerns about the imminent joint clinical assessments remain, but there are signs that communications between the health technology assessment coordination group and stakeholders could be improving.

A new act in Germany does not go far enough to address the deeply unpopular “guardrail” link between Amnog benefit assessment ratings and price negotiations, which can deter companies from launching.

Industry shoulders some blame for growing unease about joint clinical assessments after its failure to participate in pilots.

The aim of the pilot project is to demonstrate that an electronic package leaflet has no negative effects on the proper use of medicinal products in a hospital setting, says the industry body VIG.