Although there has been considerable buzz around the recent U.S. Food and Drug Administration (FDA) acceptance of Eli Lilly’s monoclonal antibody bamlanivimab (LYCoV555) for emergency use authorization (EUA) targeting COVID-19, the Infectious Diseases Society of...
Infectious Disease
Category
Gilead Reports Data from Phase 2/3 CAPELLA Trial Evaluating Long-Acting HIV-1 Capsid Inhibitor in Heavily Pre-Treated Patients with MDR HIV-1 Infection
Gilead announced topline results from the Phase 2/3 CAPELLA trial evaluating lenacapavir versus placebo in heavily treatment-experienced patients with multidrug resistant HIV-1 infection. A statistically significant greater proportion of patients receiving...
Ascension St. John’s Received $2m Gift to Expand its Infectious Disease Research Program
A generous community member, Thomas Mackey, 85, of Grosse Pointe Farms, recently gifted $2 million to Detroit’s Ascension St. John Hospital to expand the health facility’s Infectious Disease Research Program. With work already ongoing, the center should be completed...
Sanofi Spends $360m to Accelerate Cell Therapy Drugs for Oncology & Infectious Disease
French pharmaceutical giant Sanofi has made an offer to acquire Kiadis, a clinical-stage biotech company developing what they refer to as ‘off the shelf’ natural killer (NK) cell based mechanisms for the treatment of life-threatening diseases. The parties entered into...
Relief Therapeutics and NeuroRx Release Data Showing Efficacy of Aviptadil in Patients with COVID-19 and Respiratory Failure
Relief Therapeutics and NeuroRx announced topline efficacy data from patients treated with RLF-100 (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19. The topline results are from 45 patients who...
New NIH Investigator Network: NIAID Commits $82m to Form Center for Research in Emerging Diseases (CREID)
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced that it has awarded 11 grants with a total first-year value of approximately $17 million to establish the Centers for Research in Emerging...
REPRIEVE Trial Findings Informs Long-Term Health Impacts of HIV
Initial data from a large NIH-supported clinical trial offer a detailed look at the health status of people aging with HIV around the world. With 7,770 participants enrolled in 12 countries across five continents, the Randomized Trial to Prevent Vascular Events in HIV...
Amplyx Reports Top-Line Data from Phase 2 Trial of Fosmanogepix as First-Line Treatment for Invasive Fungal Infections
Amplyx Pharmaceuticals announced positive topline data following the completion of a Phase 2 clinical trial of fosmanogepix as a first-line treatment for non-neutropenic patients with invasive fungal infections caused by Candida, including suspected or confirmed...
Vanderbilt U & Purdue Translational Breakthrough Identifies Monoclonal Antibody Capable of Preventing Acute Flaccid Myelitis
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...
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...