abelheira schreef op 23 augustus 2020 14:59:
FDA hands Gilead a stunning rejection for blockbuster RA candidate filgotinib, dealing CEO O’Day a major setback
John Carroll, Editor & Founder
August 18, 2020 08:40 PM EDT Updated/ Today 06:36 AM
Met dank aan Wall Street Trader.
Gilead management cited
broad concerns from the agency around the high dose, including mortality, herpes zoster infection, increased risk for malignancy, and blood-clot issues. Bottom line there is no simple fix to these complex issues, putting the entire filgotinib program (RA and beyond) at risk.
Van waar komen deze veiligheidsproblemen nu ineens? Filgotinib was toch minstens even veilig dan alle andere Jak's, zelfs in 200mg!?