Tags : (baloxavir marboxil)

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

Pharma

Genentech Reports Results of Xofluza (baloxavir marboxil) in P-III MINISTONE-2

Shots: The P-III MINISTONE-2 (NCT03629184) study involves assessing of Xofluza vs Oseltamivir in children with an influenza infection aged b\w 1 to ≤12yrs. confirmed by rapid influenza diagnostic test/ influenza symptoms The P-III MINISTONE-2 study resulted in meeting its 1EPs demonstrating reduction in duration of flu symptoms including fever and is well tolerated in children […]Read More