Shots:The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitorsBLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…
Shots:The P-III (FRONTIER3) trial assessed Mim8 (SC) in 70 pts (1-11yrs.) with hemophilia A ± FVIII inhibitors in 2 parts: P1 involves Q1W prophylaxis therapy until 26wks. after which pts can stay on Q1W or switch to QM for further 26wks.; regulatory filings expected in 2025P1 data showed 0.53 mean & 0 median…
Shots:To create a wholesome environment for the current and the future generation, it’s totally up to life science companies and decision-makers to embrace and integrate every prospect of the underlying disease conditions and address those issues to find curesTo continue the series for disease of the month, PharmaShots brings this month a summary…

