医療ニュースと研究

A federal initiative has launched two proof-of-concept oncology trials plus an RFI for a summer pilot, aiming to reduce phase-to-phase delays by enabling FDA review of validated trial signals as data accrue.

Approval of tebipenem pivoxil is supported by a global randomized double-blind noninferiority trial in 1,690 hospitalized adults showing comparable composite clinical and microbiologic response to IV imipenem-cilastatin for 7 to 10 days.

Network meta-analysis of 716 double-blind RCTs with 159,362 participants found fewer AE-driven discontinuations with ARB-containing regimens, while CCBs, ACE inhibitor plus CCB, and beta-blocker plus thiazide increased withdrawals vs placebo.

Phase 1 dose-escalation data for ZW191 reported cORR 78.6% in FRα-high and 47.4% in FRα-low/negative PROC, with median DoR not reached and grade 3 or higher TEAEs in 55%.