Myovant Sciences announced that SPIRIT 2, the first of two Phase III studies of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg, and norethindrone acetate… read more.
Sanofi’s investigational BTK (Bruton’s tyrosine kinase) inhibitor, an oral, brain-penetrant, selective small molecule achieved both the primary and secondary endpoints in a Phase IIb trial evaluating efficacy and… read more.
EASE Trial of AP 101 from Amryt Pharma Update: In recent weeks, the COVID-19 pandemic has had a material impact on clinical trials globally, including patient recruitment. Given… read more.
Amryt announced the results of an unblinded interim efficacy analysis on its pivotal Phase III EASE trial for AP 101 as a potential treatment for Epidermolysis Bullosa (“EB”).The… read more.
Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its Allplex 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2, the novel… read more.
Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced… read more.
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma announced positive topline data from Cara’s KALM-2 pivotal Phase III trial of Korsuva (CR845/difelikefalin) Injection in hemodialysis patients with… read more.
Bristol-Myers Squibb announced that CheckMate -743, a pivotal Phase III trial evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in previously untreated malignant pleural mesothelioma (MPM) met its… read more.
Alexion Pharmaceuticals, Inc.announced plans to initiate a global Phase III study to investigate Ultomiris (ravulizumab-cwvz) in a subset of adults with COVID-19 – those who are hospitalized with… read more.
Bristol Myers Squibb and Exelixis, Inc. announced that CheckMate -9ER, a pivotal Phase III trial evaluating Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) compared to sunitinib in previously… read more.
Novartis has reached an agreement with the FDA to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the… read more.
Incyte announced the initiation of RUXCOVID, a global, randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients… read more.
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