The coronavirus pandemic has had many negative consequences. One that is now beginning to bite for biopharma companies is that the US FDA cannot carry out as many inspections as in the past.
This has led to recent cases of delayed approval decisions and outright rejections. Alkermes yesterday became the latest to suffer this fate with a complete response letter for its antipsychotic ALKS 3831. Although the company seems to have convinced investors that this was just a minor blip, other groups might not be so lucky. And a look at the numbers shows that there have already been more CRLs in 2020 than in the past few years.