Shots: The NDA & MAA submissions are based on ongoing 2 studies i.e., ACTIVATE & ACTIVATE-T evaluates safety, tolerability & efficacy of mitapivat vs PBO in patients with PKD Results: 40% of patients achieved a hemoglobin response, 33% reduction in transfusion burden @ 24wks. fixed dose period & safety profile was consistent with previously reported […]Read More
Shots: The withdrawal follows the recent discussion with the US FDA regarding the palovarotene’s NDA review that initiated in May’21 The additional analysis will be required to progress and complete the review process from Ipsen’s P- III MOVE and FOP program. Ipsen plans to resubmit to the FDA, following completion of the required data Palovarotene […]Read More
Shots: The NDA is based on P-III PSOARING 1 & 2 along with interim results from PSOARING 3 OLE study evaluating the safety & efficacy of tapinarof vs vehicle in patients with PsO In PSOARING 1 & 2 results: patients achieved a PGA score of 0 or 1 (35.4% vs 6% & 40.2% vs 6.3%) […]Read More
Shots: The NDA is based on two P-III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China. The anticipated PDUFA date is April 30, 2022 The same data from the studies will be used to file MAA to the EMA imminently, based on scientific advice from the EMA’s Committee for Medicinal Products […]Read More
Shots: The submission is based on P-II/III CAPELLA trial evaluating the safety & efficacy of lenacapavir (SC, every 6mos.) in combination with other antiretroviral agents vs PBO in 36 THE patients with multi-drug resistant HIV-1 infection The study demonstrated viral load reduction of ≥ 0.5 log10 copies/mL from baseline for 14days functional monothx. period (88% […]Read More
Shots: The application is based on two studies i.e P-III EINSTEIN-Jr & UNIVERSE. The P-III EINSTEIN-Jr study evaluates Xarelto in 500 children in a ratio (2:1) aged birth to 17yrs. with previously diagnosed VTE, following 5 days of initial parenteral anticoagulation treatment The P-III UNIVERSE study evaluates Xarelto in children aged 2-8yrs. with congenital heart […]Read More
Shots: The NDA is based on data from the BREEZE study evaluating Tyvaso DPI in 51 patients with PAH transitioning from Tyvaso inhalation solution which demonstrates the safety & tolerability of Tyvaso DPI Additionally, a separate PK study in 36 healthy volunteers demonstrates comparable treprostinil exposure b/w Tyvaso DPI & Tyvaso Inhalation Solution while FDA […]Read More
Shots: The submission is based on P-III PSOARING 1 & PSOARING 2 data as well as interim results from PSOARING 3 long-term safety study evaluating the safety and efficacy of tapinarof vs vehicle in patients with plaque psoriasis Results: Improvement in PGA scores of 0 or 1 with a minimum 2-grade improvement from baseline @12 […]Read More
Shots: The NDA submission is based on data from the ongoing P-III MOVE trial evaluating the efficacy and safety of palovarotene (chronic/flare-up dosing regimen) in patients with FOP The post hoc analyses of 1EPs from the P-III MOVE trial demonstrated a 62% reduction in mean annualized new HO volume in patients with palovarotene vs untreated […]Read More
Shots: The NDA submission is based on P-III studies (SERENITY I & II) assessing BXCL501 (120 & 180mcg doses) vs PBO for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively Results: BXCL501 met its 1EPs & 2EPs in both the studies, demonstrating rapid, and durable improvements from baseline […]Read More
Copyright ©2021 PharmaShots | Powered by Octavus Consulting
