Tags : Influenza

Biotech

GSK Expand its 2020 Collaboration with Vir to Advance New

Shots: Vir will receive ~$225M up front, $120M as an equity investment and $200M as regulatory milestones, ~300M as option payment and will be responsible to fund the development of VIR-2482 through the completion of the P-II trial GSK to get an exclusive option to co-develop VIR-2482 after Vir completes and reports P-II trial outcomes, […]Read More

Regulatory

Roche’s Xofluza Receives the EC’s Approval for the Treatment of

Shots: The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged≥12yrs. The approval follows the CHMP’s positive opinion for Xofluza and is based on P-III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies Xofluza is a first-in-class, single-dose oral therapy, reduces […]Read More

Biotech Regulatory

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

Regulatory

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

Biotech Regulatory

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

Clinical Trials

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

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