European regulators have for the fourth time issued a negative opinion on PTC's Translarna. Elsewhere, Amylyx read out data and Leqembi hit a roadblock in Australia.
Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.
The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.
The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.
Biosimilar competition is expected in early January for the company’s second highest-selling drug, putting greater focus on newer products' market trajectory.