The RNA drug’s accelerated approval brings Sarepta’s exon-skipping market share to nearly 30%.

In what could be a blow to some aspiring developers eyeing the nascent but growing biosimilars market in China, new rules lay out when extrapolation of approved indications of reference biologics will be allowed, meaning this will not be automatic.

CanSino's adenovirus-based COVID-19 vaccine, along with another one from state-owned Sinopharm grab promot approvals in China as  Beijing shipping millions of doses around the world.

Novartis and Takeda’s R&D efforts saw an impact from the COVID-19 pandemic, but both Lutz Hegemann and Andrew Plump believe that when the next pandemic hits, the industry and regulators will be better prepared for it.