EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency. 

A high profile panel including the WHO's chief scientist and ministers of Norway and South Africa discussed critical dimensions pertaining to coronavirus vaccines and risks of a “pandemic within a pandemic” with the emergence of  SARS-CoV-2 variants. Funding gaps at the ACT Accelerator and extending the shelf life of vaccines were also deliberated.

The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.

New drug development is an increasingly communal enterprise. In Vivo examines how one major US academic institution – the University of California at Los Angeles (UCLA) – is expanding its range of research contacts to open new areas of therapy and shorten the transition from bench to the bedside.  Its commercial impact is considerable: over the past two decades, private-sector VC’s have invested more than $2bn in UCLA-backed innovations, with 26 start-ups launched through the university in 2019 alone. Amir Naiberg, UCLA’s point man on technology transfer, explains the factors that have made the university a successful advocate for partnerships that produce results for patients.