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FDA revokes emergency use authorization for bamlanivimab as COVID-19 treatment
The U.S. Food and Drug Administration (FDA) revoked last week the emergency use authorization (EUA) for the sole use of the monoclonal antibody therapy bamlanivimab against COVID-19. “Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2... Read More »
INOVIO vaccine candidate maintains antibody response against COVID-19 variants
Amid rising fears that variants of COVID-19 may already be reducing the efficacy of vaccines, INOVIO provided some good news last week, with news that its vaccine candidate produced neutralizing antibodies and T cell responses against all three major variant strains. INO-4800, a DNA vaccine... Read More »
New FDA guidance stresses necessary role of remote drug facility oversight during pandemic
The U.S. Food and Drug Administration (FDA) released new guidance this week to clarify how it will request and conduct remote interactive evaluations during the ongoing COVID-19 pandemic, noting how critical such evaluations will be to operations. This was meant for any FDA-regulated facilities,... Read More »
UMBC deploys Smiths Detection’s BioFlash technology for airborne detection of SARS-CoV-2
The University of Maryland, Baltimore County (UMBC) has utilized the BioFlash Biological Identifier created by Smiths Detection to successfully identify airborne traces of SARS-CoV-2 inside its campus in real-time. BioFlash is a device that collects and analyses air samples, rapidly sifting... Read More »
Congress eyes legislation on preventing next pandemic
A panel of public health experts and U.S. senators agreed on several steps Congress should take to prevent or remediate the next pandemic, basing their proposals on lessons learned during the 14 months working to resolve the COVID-19 health crisis. Among their recommendations, aired during a... Read More »
FLIR wins DARPA contract for new Chem-Bio defense fabric
FLIR Systems, Inc. announced Monday that it had won a contract with the Defense Advanced Research Projects Agency (DARPA) to develop new fabrics embedded with catalysts and chemical agents that can fight and reduce chemical and biological threats on contact. The fabrics will be incorporated... Read More »
Updated NIH COVID-19 Treatment Guidelines recommend REGEN-COV for non-hospitalized, high risk patients
A mix of casirivimab and imdevimab, Regeneron Pharmaceuticals Inc.'s REGEN-COV, is now strongly recommended by the National Institutes of Health (NIH) for high risk COVID-19 patients that are non-hospitalized. The drug was given a strong rate based on randomized trials, which involved more than... Read More »
CDC would gain $1.6B prepare-and-respond funding boost under Biden’s FY2022 budget
The Centers for Disease Control and Prevention (CDC), the federal government’s nerve center for its COVID-19 pandemic response, would receive an additional $1.6 billion in funding over last year’s approved levels under President Joe Biden’s mammoth $1.5 trillion federal spending plan for... Read More »
COVAX reports more than 38 million COVID-19 vaccines delivered since February
The international COVAX facility has managed to deliver more than 38 million doses of various COVID-19 vaccine manufacturers to more than 100 economies within 42 days of its first international delivery to Ghana on Feb. 24, 2021. It is a positive start for a massive global undertaking meant to... Read More »
WHO labels AstraZeneca COVID-19 vaccine blood clot issues rare, but worth continued study
An assessment by the COVID-19 subcommittee of the World Health Organization (WHO) Global Advisory Committee on Vaccine Safety (GACVS) has concluded that blood clots affiliated with the AstraZeneca vaccine are concerning but rare and require further study to determine a causal relationship. All... Read More »
FDA authorizes first at home blood spot COVID-19 antibody test for emergency use
The Symbiotica COVID-19 Self-Collected Antibody Test System gained emergency use authorization from the United States Food and Drug Administration (FDA) this week, making it the first antibody test authorized for use with self-collected dried blood spot samples. The test allows those prescribed... Read More »
Senators introduce legislation to combat illegal firearms trafficking
U.S. Sens. Susan Collins (R-ME), Patrick Leahy (D-VT), and Dick Durbin (D-IL) introduced a bill Monday aimed at combating straw purchasing and illegal trafficking in firearms to keep guns out of the hands of dangerous criminals. The Stop Illegal Trafficking in Firearms Act would make it a... Read More »
BARDA, Janssen expand Phase 2a trial of COVID-19 vaccine to include adolescents
An ongoing Phase 2a trial of a Janssen Pharmaceutical Companies-developed COVID-19 vaccine candidate has been expanded to include adolescents between the ages of 12 and 17. While there are still no approved COVID-19 vaccines for children, cases of COVID-19 in children have generally been less... Read More »
Legislation to provide greater oversight of federal prisons’ COVID-19 efforts reintroduced to Congress
U.S. Rep. Nanette Diaz Barragán (D-CA) and U.S. Sens. Elizabeth Warren (D-MA) and Cory Booker (D-NJ) recently reintroduced the Federal Correctional Facilities COVID-19 Response Act to revise the prison system’s COVID-19 response. “The COVID-19 outbreaks at federal prisons across the... Read More »
CEPI offers up to $200M for SARS-CoV-2, betacoronavirus vaccine development
The Coalition for Epidemic Preparedness (CEPI) announced this week that it will invest up to $200 million into promising vaccine candidates for SARS-CoV-2 and Betacoronavirus, following a call for proposals. This funding will carry candidates through to clinical proof of concept and forms one... Read More »
Biodefense Commission warns U.S. still vulnerable to further biological threats
Even as the United States reels from a year under the thumb of COVID-19, a new analysis from the Bipartisan Commission on Biodefense, released this week, warns that without action, the nation remains dangerously vulnerable to another pandemic or biological threat. The report, Biodefense in... Read More »
Legislators introduces bill addressing doctor shortages during pandemic
U.S. Reps. Terri Sewell (D-AK), John Katko (R-NY), Tom Suozzi (D-NY), and Rodney Davis (R-IL) introduced legislation Monday designed to mitigate the nationwide physician shortages by boosting the number of Medicare-supported residency positions. The Resident Physician Shortage Act of 2021 would... Read More »
Senators urge VA to counter coronavirus vaccine misinformation spreading among veterans
A bipartisan group of senators, led by U.S. Sens. Rob Portman (R-OH) and Amy Klobuchar (D-MN), wrote to the Department of Veterans Affairs (VA) last week with concerns about and calls to action against coronavirus vaccine misinformation being sown among veterans. While misinformation has been a... Read More »
More than 300 Medical Reserve Corps units assisting U.S. COVID-19 vaccination efforts
The Medical Reserve Corps (MRC) is playing a major role in the fight against COVID-19 in the United States, deploying more than 300 units to assist vaccination efforts in 43 states, plus Puerto Rico, American Samoa, and the Northern Mariana Islands. “MRC units started training for COVID-19... Read More »
House Foreign Affairs Committee to consider SAFE Act efforts to involve United States in CEPI
A bill first introduced in the 116th Congress -- the Securing America from Epidemics (SAFE) Act (H.R. 2118) -- is making the rounds in the House of Representatives again, thanks to its reintroduction by U.S. Rep. Ami Bera (D-CA). Bera, Chairman of the House Foreign Affairs Subcommittee on Asia,... Read More »
Pfizer begins Phase 1 study of oral antiviral therapeutic for use against SARS-CoV-2
Encouraged by its success against SARS-CoV-2 and other coronaviruses in test-tube studies, Pfizer Inc. has launched a phase one study of healthy adults to determine if multiple ascending doses of an oral antiviral therapeutic could be effective against COVID-19. PF-07321332 is a protease... Read More »
Congress eyes domestic terrorism law
Lawmakers began laying the groundwork for domestic terrorism legislation that would explicitly bar certain violent and/or hate groups and acts occurring in the United States, much the way that current legislation bars international acts of terrorism and violence. “As we sit here today, we are... Read More »
CARB-X funders release plan development guide to tackle threat of antibiotic-resistant bacteria
A Stewardship and Access Plan Development Guide for countering the spread of antibiotic-resistant superbugs was developed and released this week by CARB-X, some of its leading funders and major antibacterial researchers. The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator... Read More »
Independent board questions AstraZeneca COVID-19 vaccine data
AstraZeneca, already racked with setbacks in the European Union, faced another crisis in its COVID-19 vaccine efforts on Tuesday when the U.S. Data and Safety Monitoring Board (DSMB) expressed concerns that recent trial data released by the company is outdated. The focus of concern is AZD1222,... Read More »
Sens. Smith, Young introduce One Health legislation to combat disease outbreaks
U.S. Sens. Tina Smith (D-MN) and Todd Young (R-IN) introduced a bill that would improve coordination among government agencies when studying animal and human health to prevent disease outbreaks. Specifically, the Advancing Emergency Preparedness Through One Health Act would require the... Read More »
IDSA, health partners call on House leaders to increase federal investments for antimicrobial resistance fight
Warning that antibiotic resistance is one of the greatest public health threats of the age, the Infectious Diseases Society of America (IDSA) and several partner organizations wrote to House leaders last week urging them to create a comprehensive One Health approach to counter the rising... Read More »
FDA grants first marketing authorization for a COVID-19 diagnostic test beyond current emergency
The U.S. Food and Drug Administration (FDA) granted this week marketing authorization of the BioFire Respiratory Panel 2.1, allowing it to become the first SARS-CoV-2 diagnostic able to be marketed past the ongoing COVID-19 pandemic. BioFire Respiratory Panel 2.1 is a test by BioFire Diagnostics... Read More »
AstraZeneca reaches agreement with U.S. government to supply up to 500,000 additional COVID-19 antibody treatment doses
AstraZeneca announced plans this week to supply up to 500,000 additional doses of AZD7442, an under-development, long-acting antibody combination meant for use against COVID-19, modifying an existing agreement with the U.S. government. Specifically, the agreement was reached with the Departments... Read More »
Sanofi, Translate Bio begin Phase 1/2 trial of mRNA COVID-19 vaccine paralleling preclinical efforts
Sanofi Pasteur and Translate Bio launched a Phase 1/2 clinical trial last week for an mRNA COVID-19 vaccine candidate known as MRT5500, hoping for interim results in the third quarter of 2021. The united efforts of the vaccine and mRNA therapeutics companies include parallel preclinical studies... Read More »
AstraZeneca defends safety of COVID-19 vaccine after countries suspend use
Drugmaker AstraZeneca defended the safety of its COVID-19 vaccine after three more European countries said they would suspend the use of the vaccine. Over the weekend, Germany, Ireland, and The Netherlands announced they would stop using the vaccine temporarily over concerns about the vaccine's... Read More »
House Energy and Commerce Committee’s LIFT America Act includes $37B to build up healthcare infrastructure
Democrats on the House Energy and Commerce (E&C) Committee unveiled a sweeping, $312 billion bill known as the LIFT America Act last week that, among other things, would invest in America’s health infrastructure. “As our nation combats COVID-19 and a severe economic downturn, the LIFT... Read More »
CEPI proposes joint, global $3.5B plan to invest in pandemic preparedness
Building on its efforts during the ongoing COVID-19 pandemic, the Coalition for Epidemic Preparedness Innovations (CEPI) has proposed a $3.5 billion plan to reduce or eliminate future pandemic and epidemic risk through preparedness investment over the next five years. The organization has sought... Read More »
Plans unveiled to improve BioWatch Program’s bioterrorism efforts
The BioWatch Program, established by Congress in 2003, transferred to the U.S. Department of Homeland Security’s Countering Weapons of Mass Destruction (CWMD) office in 2018 with a whopping budget averaging $76 million per fiscal year from 2018 to 2020. According to BioWatch officials, the... Read More »
CDC says antibiotic resistance from six pathogens costs US more than $4.6B annually
According to a new report from the U.S. Centers for Disease Control and Prevention (CDC) and the University of Utah, the costs of antibiotic resistance among diseases are growing, leading to billions of dollars in health care costs and increasing rates of infections. According to “National... Read More »