Shots:
The US FDA has approved Cosentyx(secukinumab) for the treatment of pts (≥12yrs., ≥30kg) with mod. to sev. hidradenitis suppurativa
Approval was supported by adult clinical studies, PK modeling extrapolated from adult HS & psoriasis trials, pediatric trial data from other approved indications, & dosing analyses that showed weight-based pediatric dosing achieves exposure comparable to…
Shots:
Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy
The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…
Shots:
Bio-Thera Solutions & Jamjoom Pharmaceuticals have entered into a strategic agreement to commercialize BAT2306, a biosimilar version of Novartis’ Cosentyx (secukinumab) in the Middle East & Africa (MENA)
As per the deal, Jamjoom will obtain exclusive MENA rights of BAT2306 to handle regulatory submissions, market access & commercialization, while Bio-Thera will be responsible for development…

