Shots: The pivotal P-III clinical program for tapinarof in adult with PsO consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) PSOARING 3 (NCT04053387), an ongoing long-term safety study. Positive results of P-III studies were reported in Aug’2020 Tapinarof previously met the 1EP in separate P-IIb trials for PsO & AD, both studies were published […]Read More
Shots: The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries The study demonstrated that Forxiga achieved a significant reduction in the composite EP of […]Read More
Shots: The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial A voluntary pause across all global studies was triggered on Sept […]Read More
Shots: The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy Results: study met its 1EPs & 2EPs i.e. differences in median change in a weekly number of cataplexy attacks and ESS scores. Results were published at World Sleep 2019 Xywav is an oxybate product with […]Read More
Shots: The initiation of the post-exposure prophylaxis clinical trial follows Korean MFDS’ IND approval on Oct 08, 2020 The study will assess the preventive effect & safety of CT-P59 in ~1000 patients and whether CT-P59 can elicit a neutralizing Ab response to prevent the virus from infecting human cells Celltrion will continue to generate data […]Read More
Shots: The two studies of AZD7442 will enroll ~6,000 adults for the prevention of COVID-19 in and outside the US, expected to begin in next wk. with additional trials enrolling ~4,000 adults for the treatment of SARS-CoV-2 infections. The first study will evaluate the safety and efficacy of AZD7442 to prevent infection for up to […]Read More
Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results mark the first time an immune checkpoint […]Read More
Shots: The P-III HAWK (6/3mg) & HARRIER (6mg) study assessing Beovu [q12w/q8w with the majority on q12w following the loading phase) vs aflibercept (2mg) in 1,800 patients with wet AMD across 400 centers Results: first analysis ewer patients had early persistent fluid (12.5% vs 20.4%), defined as the presence of intra-retinal fluid or subretinal fluid […]Read More
Shots: In a post-hoc, sub-group analysis of the P-III BIPARK-1 study demonstrated greater reductions in overnight “off” time and time to morning “on” time compared to entacapone in patients with PD with motor fluctuations The new P-III post-hoc sub-group analysis demonstrated that long-term treatment with Ongentys when used as an add-on therapy reduced “On” time […]Read More
Shots: The P-III CheckMate -274 study involves assessing of Opdivo vs PBO in 709 patients in a ratio (1:1) with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery for up to 1yr. The study met its 1EPs of DFS in both all randomized patients and in patients whose tumor cells express […]Read More
Copyright ©2020 PharmaShots | Powered by Octavus Consulting
