Emerging Infectious Diseases
The Infectious Diseases Society of America (IDSA) issued guidance for the clinical treatment of three of the most common drug-resistant pathogens.
While antibiotics save lives, the bacteria and other microbes can evolve in ways that enable them to resist a drug’s intended effect. Misuse or... Read More »
Amid fears of political pressures to rush a vaccine for COVID-19, nine CEOs of biopharmaceutical companies working on these candidates have signed a pledge to uphold the scientific process and safety in any development.
The companies include AstraZeneca, BioNTech, GlaxoSmithKline plc, Johnson &... Read More »
Thanks to its global manufacturing consortium, biotechnology company INOVIO plans to manufacture 100 million doses of its COVID-19 vaccine candidate, INO-4800, in 2021.
The latest to join the consortium was Thermo Fisher Scientific earlier this week, which signed a letter of intent on the... Read More »
The University of Chicago Medicine is conducting a clinical trial to study the potential of an antibody treatment for COVID-19.
For the trial, called BLAZE-1, the University of Chicago is recruiting 22 participants to be treated with the LY-CoV555 antibody developed by Eli Lilly and Company in... Read More »
A new facility -- the National Bio and Agro-Defense Facility -- meant to house top-of-the-line labs for research into foreign animal diseases will soon transfer from the United States Department of Homeland Security (DHS) to the U.S. Department of Agriculture (USDA), but outstanding issues could... Read More »
Senate Democratic Whip Dick Durbin (D-IL) has forwarded correspondence to eight potential COVID-19 vaccine providers, inquiring about maintaining scientific and data-based standards in the wake of possible political pressure.
Durbin sent letters to Moderna, AstraZeneca, Sanofi and... Read More »
The U.S. Department of Defense (DoD) will host a phase three trial of the vaccine candidate AZD1222, developed by AstraZeneca, at five locations selected by Operation Warp Speed.
For the trial, the selected sites include Naval Medical Center San Diego, Joint Base San Antonio Brooke Army Medical... Read More »
Sanofi and GSK began a phase 1/2 clinical trial of their jointly developed COVID-19 vaccine candidate last week, opening enrollment for 440 participants after pre-clinical studies show promising positive safety and immunogenicity.
The vaccine is based on the recombinant protein-based technology... Read More »
The National Institutes of Health awarded $129.3 million for COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative.
The contracts went to nine companies for technologies that include portable point-of-care tests for immediate results or results within... Read More »
The intravenously administered drug Kevzara will no longer be investigated as a potential COVID-19 treatment, Sanofi confirmed this week, after it failed to meet either its primary or secondary goals during a phase 3 trial among severely and critically ill patients.
Hundreds were tested with the... Read More »
A study run by collaborators from Imperial College London and Intensive Care National Audit & Research Centre has found that the over the counter steroid hydrocortisone improves recovery changes among patients critically ill with COVID-19.
"The studies published today show that we now have more... Read More »
The virus that causes COVID-19 has mutated minimally since December 2019, according to a study by a team of scientists from the Walter Reed Army Institute of Research.
The research team arrived at this conclusion after conducting a genetic analysis of sequences from more than 27,000 individuals... Read More »
Roche announced this week plans to launch a SARS-CoV-2 Rapid Antigen Test capable of 15-minute turnarounds for markets accepting the CE Mark and file for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Meant for use in point of care settings -- which allow... Read More »
Vir Biotechnology and GlaxoSmithKline dosed the first patient last week in a phase 2/3 study with its COVID-19 treatment.
The treatment, VIR-7831, is a fully human anti-SARS-CoV-2 monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.... Read More »
U.S. Sen. Dick Durbin (D-IL) urged the Department of Defense (DoD) to adopt SHIELD T3, a system of COVID-19 testing and tracing developed by the University of Illinois.
SHIELD T3 provides rapid results in two to six hours at costs significantly below current alternatives. It could be used to... Read More »
A partnership between the Biomedical Advanced Research and Development Authority (BARDA) and NOWDiagnostics, Inc. will produce a rapid, point of care, in vitro diagnostic test for COVID-19 known as ADEXUSDx.
Based on the similarly named ADEXUSDx platform, the test proposes rapid detection of... Read More »
The United Kingdom-based biopharmaceutical company AstraZeneca launched phase 3 testing of its potential COVID-19 vaccine -- AZD1222 -- in the United States this week, with plans to enroll as many as 30,000 adult volunteers across 80 testing sites.
AZD1222 was originally developed by Oxford... Read More »
A group of lawmakers recently introduced a measure they said is designed to hold foreign nations accountable for suppressing or distorting information concerning international public health crises.
Sens. Josh Hawley (R-MO) and Tom Cotton (R-AR) joined Reps. John Curtis (R-UT), Mike Gallagher... Read More »
The U.S. Food and Drug Administration (FDA) last week expanded the emergency use authorization (EUA) for the drug Veklury (remdesivir) to allow its use on all hospitalized patients with suspected or lab-confirmed cases of COVID-19.
Its use was formerly restricted by severity, but those... Read More »
In response to reports that rising COVID-19 cases in July strained lab capacity and caused a decline in daily tests, U.S. Sens. Elizabeth Warren (D-MA) and Tina Smith (D-MN) wrote letters to several COVID-19 testing labs requesting information on the processing capacity for each.
June and July... Read More »
Seeking greater investigations into how and where viruses and other pathogens can crossover from wildlife to people, the National Institute of Allergy and Infectious Diseases (NIAID) officially created the Centers for Research in Emerging Infectious Diseases (CREID) this week through an initial 11... Read More »
The Infectious Diseases Society of America (IDSA) and the HIV Medicine Association (HIVMA) are urging the Food and Drug Administration to make sure that rigorous safety and efficacy data support the approval of a COVID-19 vaccine.
Full licensure of a vaccine is preferable to an Emergency Use... Read More »
Abbott gained emergency use authorization from the U.S. Food and Drug Administration (FDA) this week for a COVID-19 antigen test known as BinaxNOW, which proposes to test patients for $5, with a 15-minute turnaround on results.
Quick, portable, and affordable, Abbott intends for its tool to be... Read More »
AbbVie is teaming up with Harvard University on a $30 million research alliance to study and develop novel therapies against emergent viral infections.
The focus of the research, which will take place at Harvard Medical School (HMS), is on viral infections caused by coronaviruses and other... Read More »
U.S. Sen. Dick Durbin (D-IL) discussed the research and approval process for COVID-19 vaccine candidates with General Gustave Perna, chief operating officer for Operation Warp Speed, a public-private partnership designed to accelerate the development of COVID-19 vaccines and treatments,
Durbin... Read More »
Changes to the requirements for emergency use authorization (EUA) of convalescent plasma as a COVID-19 treatment by the U.S. Food and Drug Administration (FDA) has raised new barriers for hospitals, and a new line of questions from U.S. Reps. Debbie Dingell (D-MI) and Fred Upton (R-MI).
In a... Read More »
A phase 1 clinical trial for AZD7442, a combination monoclonal antibody treatment for COVID-19 licensed by AstraZeneca, began this week for 48 healthy participants in the United Kingdom.
Throughout the study, researchers will assess the safety, tolerability, and pharmacokinetics of the... Read More »
Bavarian Nordic released the results from its Phase 3 study of the freeze-dried formulation of its MVA-BN smallpox vaccine.
The FDA approved the liquid-frozen formulation of the vaccine in September 2019 under the name JYNNEOS. The prior Phase 2 study has shown bioequivalence between the... Read More »
U.S. Reps. Frank Pallone, Jr., (D-NJ), Anna G. Eshoo (D-CA) and Diana DeGette (D-CO) are calling on the Food and Drug Administration (FDA) commissioner to ensure that sound science and the protection of public health alone drive FDA’s COVID-19 vaccine approval process.
“Any political... Read More »
Cleveland, Ohio-based University Hospitals will serve as one of 120 global clinical investigational sites to test Pfizer and BioNTech's COVID-19 vaccine.
The clinical trial would be initiated at UH Cleveland Medical Center. Dr. Robert Salata, chairman of the Department of Medicine at UH... Read More »
According to the World Health Organization (WHO) and Gavi, the Vaccine Alliance, the global COVAX initiative can now count 172 national economies and nine potential COVID-19 vaccines under its banner, seven of which have entered clinical trials.
The goal of the COVAX facility is to bring the... Read More »
Thanks to the efforts of nearly 40 companies and universities in the state of Maryland, millions of dollars have been dedicated to the research and development of vaccines, therapeutics, and tests for COVID-19, Gov. Larry Hogan announced this week.
Those efforts include millions in funding... Read More »
Despite its far-reaching effects, there remains no standardized reporting of COVID-19-related data within the United States, a fact that prompted the introduction of the Health STATISTICS Act of 2020 to the House last week.
The legislation was introduced by U.S. Reps. Brian Fitzpatrick (R-PA),... Read More »
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for convalescent plasma as a treatment for COVID-19 among hospitalized patients this week, determining that its known and potential benefits outweigh any risks.
Convalescent plasma is made using the blood of... Read More »
U.S. Reps. Brett Guthrie (R-KY) and Greg Walden (R-OR) finalized a report that provides recommendations for addressing a possible second wave of the coronavirus pandemic.
The third and final installment of their report – called “Second Wave Preparedness Project” -- focuses on... Read More »
