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.

Stada and Alvotech have heralded the start of biosimilar competition to Stelara in Europe with the launch of their partnered Uzpruvo version.

At a high-profile panel closing out Medicines for Europe’s 30th annual conference in Dublin, six industry leaders set out their views on key topics including pricing, regulation, sustainability, and stakeholder communication.

Public Company Edition: Several special purpose acquisition corporations have emerged, including various health care- and life science-focused SPACs. Also, Alvotech entered into a $965m refinancing agreement and Avidity grossed $461m in a follow-on offering, among other updates.