Shots: The P-III study assessing Kevzara (400mg) + BSC vs BSC in 194 patients with COVID-19 requiring mechanical ventilation did not meet it’s 1EPs & 2EPs Based on the results, the companies have stopped the US-based study that includes the second cohort of patients receiving a higher dose of Kevzara (800 mg) The IDMC is […]Read More
Shots: Following the IDMC recommendation, ongoing P-III study will be amended to enroll only critical patients. The P-III study also be amended discontinue lower-dose of Kevzara (200 mg) with all new patients to receive either Kevzara (400 mg) or placebo The ongoing portion of P-III study will enroll ~600 patients in the critical group with […]Read More
Shots: The first patient has been treated as a part of the global clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19. The P-II/III clinical program has initiated in Italy, Spain, Germany, France, Canada and Russia and is enrolling patients instantly The study outside the US will assess the safety and efficacy of […]Read More
Shots: The P-II/III study will assess the safety & efficacy Kevzara + supportive care vs PBO + supportive care in ~400 patients in a ratio (2:2:1) hospitalized with serious complications from COVID-19 The study is designed into two parts: First part will evaluate the impact of Kevzara on fever and patients’ need for supplemental oxygen […]Read More
Shots: Sanofi and Regeneron will simplify their Ab collaboration for Kevzara and Praluent by restructuring into a royalty-based agreement Under the proposed restructuring, Sanofi is expected to get WW rights for Kevzara and (Ex-US) rights for Praluent while Regeneron is expected to get US rights for Praluent. The companies will be responsible to fund development […]Read More
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