Latest From Bowman Cox
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.
FDA historically has based 100% of drug adulteration warning letters on inspections but COVID-19-related travel restrictions began changing that in FY 2020, when 2% of drug GMP warning letters were based on testing import samples. The change became even more pronounced in the first two months of FY 2021, with 59% of actions related to sample testing and 41% to inspections.
Government offers help securing supplies in return for another 100 million doses by Q2. That would mean abandoning Pfizer’s preferred arms-length relationship.
Look for alternative approaches like sample testing, remote records review and reliance on trusted host nation authorities to fill many inspection gaps – except for OAI re-inspections. Meanwhile, post-emergency planning begins.
Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.