Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain
Latest News
Clinical Trials
Tuba Khan
November 26, 2020
Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain
Tuba Khan
November 26, 2020
Shots: The P-IIa study involves assessing vibegron (75mg,qd) in 222 women with abdominal pain due to IBS with IBS-D (diarrhea) and IBS-M (mixed IBS) across 35 sites in the US The study did not meet
Biosimilars
Tuba Khan
November 26, 2020
Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin
Tuba Khan
November 26, 2020
Shots: The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein The submission of the
Regulatory
Tuba Khan
November 26, 2020
Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis
Tuba Khan
November 26, 2020
Shots: The approval is based on P-lll DISCOVER-1 & -2 study assessing Tremfya (100mg q4w and q8w) vs PBO in 381 & 739 patients with active PsA who had an inadequate response to SOC &
Clinical Trials
Tuba Khan
November 25, 2020
Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD
Tuba Khan
November 25, 2020
Shots: The enrollment of the first P-III study is currently underway & has reached 85% of its enrollment goal. In a P-II study of 336 patients, NOV03 met its 1EP of efficacy i.e. improvement of
Pharma
Tuba Khan
November 25, 2020
Evotec Collaborates with Rappta Therapeutics to Focus on Oncology Target
Tuba Khan
November 25, 2020
Shots: Evotec to receive research funding & is eligible for milestones. Evotec will support Rappta’s program of developing small molecule activators of the enzyme PP2A The collaboration leverages Evotec’s integrated platform for drug discovery and
Biotech
COVID-19
Tuba Khan
November 25, 2020
Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19
Tuba Khan
November 25, 2020
Shots: The ongoing P-lll study involves assessing of Sputnik V vaccine vs PBO in 40,000 patients in a ratio (1:3) with COVID-19. The efficacy of the vaccine is 91.4%, based on the second interim analysis
Biosimilars
Tuba Khan
November 25, 2020
Alvotech and Alvotech & CCHT Sign an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China
Tuba Khan
November 25, 2020
Shots: The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology Alvotech and Alvotech & CCHT will be jointly
Regulatory
Tuba Khan
November 25, 2020
Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients
Tuba Khan
November 25, 2020
Shots: The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients The ILLUMINATE-A showed that Oxlumo met its
Regulatory
Tuba Khan
November 25, 2020
BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma
Tuba Khan
November 25, 2020
Shots: The approval is based on P-lll ATTRACTION-3 study involve the assessment of Opdivo vs CT (docetaxel or paclitaxel) for patients with esophageal cancer refractory/ intolerant to 1L combination therapy with fluoropyrimidine- and Pt.-based drugs
