Tags : Influenza

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for

Shots: The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals Xofluza […]Read More

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval

Shots: The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and […]Read More

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to

Shots: The EMA’s CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged ≥12yrs. Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged ≥12yrs. The CHMP recommendation is based on the results of the P-III CAPSTONE-1, CAPSTONE-2 and […]Read More

Sanofi’s Supemtek Receives CHMP’s Positive Opinion for Approval to Prevent

Shots: The CHMP’s recommendation is based on two P-III studies demonstrating the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000+ patients aged ≥18yrs. The company expects EC’s decision in Q4’20 Supemtek is the first and only influenza vaccine to rely on recombinant manufacturing technology and is available in the US since 2017 […]Read More

Janssen Halts the Development of Pimodivir for Influenza

Shots: The discontinuation is based on pre-planned interim analyses of P-III studies assessing Pimodivir + SOC vs SOC as monothx. in hospitalized & non-hospitalized patients with influenza A The therapy is unlikely to add benefits in hospitalized patients with influenza A. The company will halt both the studies, after consulting with BARDA In 2014, Janssen […]Read More

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

Pfizer partners with BioNTech to develop vaccine for Influenza for

Shots:  Pfizer is planning to pay $120M upfront along with $305M milestone payment  BioNTech will also receive double-digit royalties post sales whereas, Pfizer acquires small stakes in BioNTech as part of upfront payment  Pfizer plans to do further trials and commercialization of vaccines post completion of the first clinical study by BioNTech Click here to […]Read More