Shots:
Moleculin received approval from Georgia’s RAMPA to initiate its global P-IIb/III (MIRACLE) study of AnnAraC (Annamycin + cytarabine) in R/R AML, and first pt dosing expected by Aug-end; CTA already approved in EU
The study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230…
Shots:
PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices
Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

