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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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 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 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 »
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 »
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 »
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 »
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 »
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 »
A molecular test for COVID-19 can now be used at home without a prescription, following the U.S. Food and Drug Administration’s (FDA) granting of emergency use authorization (EUA) to the Cue COVID-19 Test for Home and Over the Counter (OTC) Use.
A molecular nucleic acid amplification test... Read More »
New research from the Washington University School of Medicine in St. Louis seemingly confirms scientists' and health experts' worst fear that all three of the prominent, fast-spreading variants of COVID-19 can resist vaccines and antibodies currently effective against their forebear.
Published... Read More »
The Biomedical Advanced Research and Development Authority (BARDA) and Hologic, Inc. are working together to develop the Panther Fusion SARS-CoV-2/Flu/RSV assay, intended to be able to simultaneously detect and differentiate a variety of viruses from a single sample.
While SARS-CoV-2 is a major... Read More »
A team, including GE Research, the Broad Institute, DNA Script, MEDInstill, Molecular Assemblies, and the University of Washington, has been awarded a five-year, up to $41 million contract from the Defense Advanced Research Projects Agency (DARPA) to create a new, quicker vaccine production... Read More »
The Biden administration helped forge a deal between Merck and Johnson & Johnson (J&J) to expand production of J&J’s COVID-19 vaccine, which is expected to help the company deliver 100 million doses by the end of May instead of its previous June goal.
The collaboration between the... Read More »
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) awarded up to $18 million to GSK Biologicals and its affiliate GSK Vaccines Institute for Global Health (GVGH) to develop new vaccines for two different illnesses.
One is a vaccine for Group A streptococcus... Read More »
The U.S. Food and Drug Administration (FDA) announced this week that undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine will now be allowed to be transported and stored at conventional pharmaceutical freezer temperatures for up to two weeks.
While the preferred storage for this... Read More »
