Tags : sNDA

Biotech

Pfizer Report the US FDA’s Acceptance and Priority Review of

Shots: The US FDA has accepted for Priority Review the sNDA is based on the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) CROWN is P-lll, parallel 2-arm trial in which 296 previously untreated advanced ALK-positive NSCLC were randomized in ratio 1:1 to receive LORBRENA monotherapy (n=149) […]Read More

Regulatory

Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure

Shots: The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was living with someone with an influenza infection confirmed by a rapid influenza diagnostic test Result: The proportion of household members who developed influenza (1.9% vs 13.6%); well tolerated with no […]Read More

Regulatory

GSK and Innoviva’s Trelegy Ellipta (FF/UMEC/VI) Receive the US FDA’s

Shots: The approval is based on an sNDA which includes data from CAPTAIN study assessing Trelegy (qd, 100/62.5/25, 200/62.5/25, 100/31.25/25, and 200/31.25/25 mcg) vs FF/VI (100/25 and 200/25 mcg) to patients whose asthma was inadequately controlled despite treatment with ICS/LABA Results: Trelegy (qd, easy-to-use inhaler) demonstrated improvements in lung function, presented at ERS Congress. The […]Read More