Archive

Category: Conditional Marketing Authorization

Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Shots: The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in […]

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients Result: in NTRK fusion+ solid tumors, […]