A team of researchers from Vanderbilt University Medical Center, Purdue University and the University of Wisconsin-Madison have isolated potential human monoclonal antibodies potentially capable of preventing acute flaccid myelitis (AFM), a rare but devastating...
Infectious Disease
Category
Merck Announces Data from Two Phase 3 Studies Assessing its 15-valent Pneumococcal Conjugate Vaccine in Adults
Merck announced results from two Phase 3 studies, PNEU-WAY (V114-018) and PNEU-FLU (V114-021), evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. These data, in addition to...
The Race to Find a COVID-19 Vaccine: The INO-4800 Study Participation at the University of Pennsylvania
Worldwide, over 125 COVID-19 vaccines are now in development, while only a handful have progressed to human clinical trials. Of those vaccines currently undergoing clinical trials, Inovio Pharmaceuticals started recruiting patients in April 2020 to test the INO-4800...
MGB Biopharma Announces Data from Phase 2 Trial of MGB-BP-3 for the First-line Treatment of Clostridium Difficile Infection
MGB Biopharma announced positive topline results from its phase 2 trial of MGB-BP-3, an antibacterial, for the first line treatment of Clostridium difficile infections. The trial met the primary endpoints of safety, efficacy, and dose selection. The phase 2 dose...
SCYNEXIS Reports Positive Results from Phase 3 VANISH-306 Trial of Oral Ibrexafungerp for Vaginal Yeast Infection
SCYNEXIS announced positive results from the phase 3 VANISH-306 trial evaluating oral ibrexafungerp, a novel broad-spectrum antifungal, as a treatment for women with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. The trial achieved...
Data from Patients with COVID-19 Complications Treated Gilead’s Remdesivir Published in The New England Journal of Medicine
Gilead announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis have been published in The New England Journal of...
When the Taylors met Dr. Lopez de Castilla, the Possible Occurred Against COVID-19
Josie and George Taylor, 74 and 76 respectively, have been married for almost 52 years and most recently faced one of their biggest challenges in over half a century: COVID-19. After the two recovered while at EvergreenHealth medical center, they were approached by a...
Ex-GSK Infectious Disease Lead Launches Chinese Venture to Develop Monoclonal Antibodies Targeting COVID-19
Tsinghua University, Third People’s Hospital of Shenzhen (China), and Brii Biosciences (Brii Bio) announced a partnership and licensing deal to discover, develop, manufacture and commercialize fully human neutralizing monoclonal antibodies to address the...
Gilead Begins Two Phase 3 Trials to Evaluate Remdesivir in Adults Diagnosed with COVID-19 Coronavirus
Gilead announced that the U.S. FDA has rapidly reviewed and accepted Gilead’s investigational new drug (IND) filing for remdesivir for the treatment of COVID-19. Gilead has now initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in...
HIV Vaccine Trial HVTN 702 Stopped Early for Non-Efficacy
The US National Institute of Allergy and Infectious Diseases (National Institute of Allergy & Infectious Diseases (NIAID)) announced that HVTN 702, a large-scale HIV vaccine efficacy trial of a canary pox-based vaccine candidate, has been stopped following an...
Seqirus Announces FDA Approval of Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted)
Seqirus announced the U.S. FDA has approved Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) to help protect individuals six months of age and older against influenza A (H5N1). Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to...
SCYNEXIS Reports Data from Second Interim Analysis of Ongoing Phase 3 FURI Study, Oral Ibrexafungerp Effective in Treating Severe Fungal Infections in Hospital Setting
SCYNEXIS announced positive results from its second interim efficacy analysis of the ongoing Phase 3 open-label FURI study. The study is evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal...
Navigen Announces FDA Clears IND for Phase 1 Trial of HIV Entry Inhibitor, CPT31
Navigen announced that the U.S. FDA has cleared its Investigational New Drug application (IND) for the initiation of a Phase I study in healthy volunteers to test the safety, tolerability, and pharmacokinetics of its D-Peptide HIV entry inhibitor, CPT31. Results from...
ViiV Healthcare Submits NDA to FDA for Fostemsavir for use in Adults with MDR HIV-1 who are Unable to Form a Suppressive Regimen
ViiV Healthcare announced it has submitted an NDA to the U.S. FDA seeking approval of fostemsavir for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a...
Emergent BioSolutions Presents Positive Phase 2 Data Evaluating Chikungunya VLP Vaccine Candidate
Emergent BioSolutions presented updated results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate across a series of dosing regimens....
Kaiser Permanente Division of Research Real-World Study Impacts Changes to Hepatitis C Guidelines
A Kaiser Permanente Division of Research (DOR) real-world observational study has impacted new practice guidelines from the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases. Published in Clinical Gastroenterology and...
Enanta Pharmaceuticals Reports Positive Data from Phase 2A Human Challenge Study of EDP-938 for RSV
Enanta Pharmaceuticals reported new data from its Phase 2a human challenge study demonstrating EDP-938 for RSV demonstrates highly statistically significant reductions in Total Symptom Score, Mucus Weight and RSV Viral Load as Measured by RT-PCR Assay and by Plaque...
San Francisco-Based, Infectious Disease-Focused Vir Biotechnology Now Files for IPO
Vir Biotechnology fits the bill of an entrepreneurial operation—developing a pipeline based on deal making prowess, venture capital, and an alliance with the Bill & Melinda Gates Foundation. The San Francisco-based emerging biopharma venture now plans to go...
Maternal HBV Prophylaxis Doesn’t Impact BMD
Healio reports that the French National Research Institute for Sustainable Development reported results from a study that children of women who used tenofovir disoproxil fumarate (TDF), to prevent transmission of hepatitis B to their children did not have lower bone...
Aditya H. Gaur, MD, Clinical Director, Department of Infectious Diseases, St. Jude Children’s Research Hospital
Dr. Gaur was lead investigator for a Gilead clinical trial and subsequent drug approval for Biktarvy.® The study evaluated Biktarvy for efficacy and safety in virologically suppressed adolescents and children at least 6 years of age who are living with HIV. Through 48...