European Medicines Agency (Ema)

Regulatory agency must be proactive in fighting the surge in skepticism about the drugs and vaccines it regulates

Plus: Korenberg now CFO of Palvella and updates from Moffitt and CHMP

Plus: Autolus hires Matthias Will as CDO, and updates from HotSpot, Prilenia, Frazier, BIA and BioCentriq

The year also hit a new record for applications withdrawn during review

How one trial plus confirmatory evidence can add up to approval

Plus: a conversation with Forbion, and why Senate Democrats are holding up confirmation of a new NIH director

Having steered Europe’s regulatory agency through the pandemic, her next mark will be how she tackles the upcoming pharma legislation 

Leaked EU pharma legislation proposes to reduce regulatory protections for NMEs, orphan drugs

Leaked draft pharma legislation seeks to streamline European drug oversight, incentivize antimicrobials

Plus: Sanofi ends SHP2 deal with Revolution and updates from Novartis, Daiichi, Takeda, Autolus, C-PATH and more