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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers Mathur, Mohit; Barratt, Jonathan; Suzuki, Yusuke; Engler, Frank; Pasetti, Marcela F.; Yarbrough, Jill; Sloan, Susan; Oldach, David 分享 收藏
Solithromycin versus ceftriaxone plus azithromycin for the treatment of uncomplicated genital gonorrhoea (SOLITAIRE-U): a randomised phase 3 non-inferiority trial Chen, Marcus Y.; McNulty, Anna; Avery, Ann; Whiley, David; Tabrizi, Sepehr N.; Hardy, Dwight; Das, Anita F.; Nenninger, Ashley; Fairley, Christopher K.; Hocking, Jane S.; Bradshaw, Catriona S.; Donovan, Basil; Howden, Benjamin P.; Oldach, David 分享 收藏
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Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study Hershberger, Ellie; Sloan, Susan; Narayan, Kristin; Hay, Catherine A.; Smith, Patrick; Engler, Rank; Jeeninga, Rienk; Smits, Saskia; Trevejo, Jose; Shriver, Zach; Oldach, David 分享 收藏
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A Randomized Study Evaluating Oral Fusidic Acid (CEM-102) in Combination With Oral Rifampin Compared With Standard-of-Care Antibiotics for Treatment of Prosthetic Joint Infections: A Newly Identified Drug-Drug Interaction Pushkin, Richard; Iglesias-Ussel, Maria D.; Keedy, Kara; MacLauchlin, Chris; Mould, Diane R.; Berkowitz, Richard; Kreuzer, Stephan; Darouiche, Rabih; Oldach, David; Fernandes, Prabha 分享 收藏
SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia File, Thomas M., Jr.; Rewerska, Barbara; Vucinic-Mihailovic, Violeta; Gonong, Joven Roque V.; Das, Anita F.; Keedy, Kara; Taylor, David; Sheets, Amanda; Fernandes, Prabhavathi; Oldach, David; Jamieson, Brian D. 分享 收藏
Efficacy and safety of oral solithromycin versus oral moxifloxacin for treatment of community-acquired bacterial pneumonia: a global, double-blind, multicentre, randomised, active-controlled, non-inferiority trial (SOLITAIRE-ORAL) Barrera, Carlos M.; Mykietiuk, Analia; Metev, Hristo; Nitu, Mimi Floarea; Karimjee, Najumuddin; Doreski, Pablo Alexis; Mitha, Ismail; Tanaseanu, Cristina Mihaela; Molina, Joseph McDermott; Antonovsky, Yuri; Van Rensburg, Dirkie Johanna; Rowe, Brian H.; Flores-Figueroa, Jose; Rewerska, Barbara; Clark, Kay; Keedy, Kara; Sheets, Amanda; Scott, Drusilla; Horwith, Gary; Das, Anita F.; Jamieson, Brian; Fernandes, Prabhavathi; Oldach, David 分享 收藏
LATE-BREAKING ABSTRACT: Oral solithromycin has a favorable profile versus oral moxifloxacin for treatment of adult community-acquired pneumonia (CABP) in elderly patients and those with COPD or asthma Oldach, David; Luna, Carlos; Szabo, Peter; Mitha, Ismail; Tanaseanu, Cristina; Doreski, Alexis; Barrera, Carlos; Das, Anita; Keedy, Kara; Jamieson, Brian; Fernandes, Prabhavathi 分享 收藏
Results from a Phase 3 trial in Moderate to Moderately Severe Community Acquired Bacterial Pneumonia (CABP) Treated As Outpatients With a New Oral Macrolide, Solithromycin Oldach, David; Barrera, Carlos; Rowe, Brian; Nitu, Floarea Mimi; Mykietiuk, Analia; Metev, Hristo; Laabs, Jessica; Mitha, Ismail; Tanaseanu, Cristina Mihaela; Molina, Joseph McDermott; Antonovsky, Yuri; Van Rensburg, Dirkie Johanna; Flores, Jose; Sokolowska, Barbara; Doreski, Alexis; Das, Anita; Clark, Kay; Jamieson, Brian; Sheets, Amanda; Keedy, Kara; Fernandes, Prabhavathi 分享 收藏
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Randomized, Double-Blind, Multicenter Phase 2 Study Comparing the Efficacy and Safety of Oral Solithromycin (CEM-101) to Those of Oral Levofloxacin in the Treatment of Patients with Community-Acquired Bacterial Pneumonia Oldach, David; Clark, Kay; Schranz, Jennifer; Das, Anita; Craft, J. Carl; Scott, Drusilla; Jamieson, Brian D.; Fernandes, Prabhavathi 分享 收藏
The protease inhibitor, GS-9256, and non-nucleoside polymerase inhibitor tegobuvir alone, with ribavirin, or pegylated interferon plus ribavirin in hepatitis C Zeuzem, Stefan; Buggisch, Peter; Agarwal, Kosh; Marcellin, Patrick; Sereni, Daniel; Klinker, Hartwig; Moreno, Christophe; Zarski, Jean-Pierre; Horsmans, Yves; Mo, Hongmei; Arterburn, Sarah; Knox, Steven; Oldach, David; McHutchison, John G.; Manns, Michael P.; Foster, Graham R. 分享 收藏
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A PHASE-2B TRIAL TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF A CASPASE INHIBITOR, GS-9450, IN ADULTS FAILING PEG/RBV THERAPY FOR CHRONIC HCV INFECTION Manns, M.; Palmer, M.; Flisiak, R.; DeJesus, E.; Hazan, L.; Liang, W.; Oldach, D.; McHutchison, J.; Hirsch, K. 分享 收藏
A PHASE 2B TRIAL COMPARING 24 TO 48 WEEKS TREATMENT WITH TEGOBUVIR (GS-9190)/PEG/RBV TO 48 WEEKS TREATMENT WITH PEG/RBV FOR CHRONIC GENOTYPE 1 HCV INFECTION Lawitz, E.; Jacobson, I.; Godofsky, E.; Foster, G. R.; Flisiak, R.; Bennett, M.; Ryan, M.; Hinkle, J.; Simpson, J.; McHutchison, J.; Oldach, D. 分享 收藏