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.

In 2020, investors poured millions of dollars into biotech companies searching for new therapeutics that interact with cellular processes involving the destruction and recycling of cellular proteins. These protein degradation-targeted therapies, and molecular glues, have been attracting the attention of big pharma too.

Takeda's acquisition of Shire fueled the company into a top 10 pharma company in the latest Scrip 100 rankings, as other mega-mergers are set to shape the leaderboard in the future.