News
FDA authorizes first at-home testing kit for COVID-19
Newly developed COVID-19 testing options were approved by the U.S. Food and Drug Administration (FDA) this week, with the granting of emergency use authorization (EUA) for an at-home test. It marks the first at-home iteration of tests for the disease, which has infected more than 788,000 in the... Read More »
BARDA, Tangen Biosciences partnership pursues SARS-CoV-2 diagnostic
The Biomedical Advanced Research and Development Authority (BARDA) and Tangen Biosciences, Inc. are teaming up to develop a rapid diagnostic test for SARS-CoV-2, capable of producing results within an hour. The test will be paired with the Tangen GeneSpark, a molecular diagnostic system, and... Read More »
Novartis gets FDA approval for Phase III trial of hydroxychloroquine for COVID-19
Novartis is proceeding with a Phase III clinical trial to evaluate the use of hydroxychloroquine for the treatment of patients with COVID-19 disease. The company got the go-ahead from the US Food and Drug Administration (FDA). The trial will involve approximately 440 patients and be conducted at... Read More »
Rep. Pallone seeks answers from Trump administration on COVID-19 testing plan
U.S. Rep. Frank Pallone (D-NJ) is calling on the Trump Administration to develop a comprehensive COVID-19 testing strategy as part of its efforts to reopen the economy. Pallone, chair of the House Energy and Commerce Committee, is concerned that the Trump Administration appears to be abandoning... Read More »
House bill would bring more accountability to PPE distribution
Legislation introduced in the U.S. House seeks to ensure greater accountability in the distribution of personal protective equipment (PPE) and other emergency resources under the Defense Protection Act and Stafford Act. Specifically, the bill -- the Emergency Supply Chain Transparency Act --... Read More »
Reps. Dingell, Walorski introduce bill to shore up medical supplies in SNS
U.S. Reps. Debbie Dingell (D-MI) and Jackie Walorski (R-IN) introduced a bill to shore up the medical supplies in the Strategic National Stockpile. Their bill, the Medical Supplies for Pandemics Act of 2020, would strengthen the Strategic National Stockpile by enhancing medical supply chain... Read More »
NIST tool could help hospital efforts in disinfecting N95 masks
National Institute of Standards and Technology (NIST) researchers said they have developed a tool designed to aid hospitals and medical professionals in disinfecting N95 masks. In the wake of hospitals nationwide disinfecting N95 masks by placing them in repurposed rooms or shipping containers... Read More »
Remdesivir shows promise against COVID-19 in monkeys
Animal testing of the Gilead Sciences Inc.-created antiviral Remdesivir showed promise against rhesus macaques infected with SARS-CoV-2, the virus responsible for COVID-19, National Institutes of Health (NIH) scientists said. This study was led by the NIH’s National Institute of Allergy and... Read More »
Sen. Tester, colleagues seek protective gear for firefighters, EMS
Sen. Jon Tester (D-MT) recently led a bipartisan group of colleagues in urging the Federal Emergency Management Agency (FEMA) to address fire department and emergency medical service (EMS) equipment shortages under the Coronavirus Relief, Aid and Economic Security (CARES) Act. Sen. Jon Tester... Read More »
Preclinical tests demonstrate potential vaccine’s capability to fight all four Ebola species
A universal Ebola vaccine may fight all four virus species that infect humans, according to preclinical tests of a new treatment at the Cincinnati Children’s Hospital Medical Center. Data published in the Journal of Virology shows the virus could work as a stand-alone protection, but may also... Read More »
Experts talk timetables, realities and hopes for COVID-19 vaccines
In a teleconference between experts from the Immunization Action Coalition, FasterCures and the U.S. Food and Drug Administration (FDA) on Friday, one thing was made abundantly clear: the world needs the best possible vaccines to combat COVID-19 as quickly as possible. In the opinion of Dr.... Read More »
Gov. Baker takes steps to combat mosquito-borne diseases in Massachusetts
Massachusetts Gov. Charlie Baker filed a bill to help the state combat mosquito-borne diseases like Eastern Equine Encephalitis (EEE) and the West Nile Virus (WNV). The legislation -- An Act to Mitigate Arbovirus in the Commonwealth – would empower the State Reclamation and Mosquito Control... Read More »
BARDA to work with Hememics on rapid COVID-19 test
The Biomedical Advanced Research Development Authority (BARDA) is working with Hememics Biotechnologies to develop a rapid antigen and antibody test to identify the COVID-19 coronavirus in 60 seconds. The test will be designed to detect the SARS-CoV-2 antigen, which causes COVID-19, from nasal... Read More »
Collaborative effort aids COVID-19 testing initiative
The U.S. Food and Drug Administration (FDA) announced that a recent collaboration including U.S. Cotton, UnitedHealth Group, Quantigen, and the Gates Foundation has resulted in further COVID-19 testing option expansion. Officials said the determination that spun synthetic swabs, with a design... Read More »
Sen. Johnson seeks action on hydroxychloroquine use
Sen. Ron Johnson (R-WI) has forwarded correspondence to President Donald Trump, encouraging efforts to provide COVID-19 patients the right to try hydroxychloroquine (HCQ) in the course of their diagnosis. Johnson is seeking to have the president issue a directive to remove the Food and Drug... Read More »
HHS enters $336N contract with GE for 50,000 ventilators
Invoking the Defense Production Act (DPA), the Department of Health and Human Services (HHS) has entered a new, $336 million contract with General Electric (GE) that will see 50,000 ventilators supplied to the government by July 13. "The President promised on March 27 that we would have 100,000... Read More »
BARDA awards up to $483M to Moderna for mRNA SARS-CoV-2 vaccine
Moderna is working toward U.S. Food and Drug Administration (FDA) licensure on an mRNA vaccine for SARS-CoV-2 -- the virus that causes COVID-19 -- with a $483 million award from the Biomedical Advanced Research and Development Authority (BARDA). “Vaccines are a critical tool for saving lives... Read More »
Bipartisan legislation unveiled in U.S. House to ramp up nation’s emergency medical stockpile
Congressional legislators on Friday introduced two bipartisan bills in the U.S. House of Representatives to bolster the Strategic National Stockpile (SNS), the nation’s repository of antibiotics, vaccines and other critical medical supplies that has been strained by the current coronavirus... Read More »
BARDA, Red Cross to collect plasma from recovered COVID-19 patients
The Biomedical Advanced Research and Development Authority (BARDA) is partnering with the American Red Cross (ARC) to recruit blood donors who have recovered from COVID-19. BARDA and the ARC are working with the U.S. Food and Drug Administration (FDA) to collect convalescent plasma for use as a... Read More »
DHS to temporarily amend H-2A requirements for foreign agricultural workers
The U.S. Department of Homeland Security is seeking to temporarily amend H-2A requirements to help U.S. agricultural employers during the coronavirus emergency. The H-2A program allows U.S. employers to bring foreign nationals to the country to fill temporary agricultural jobs. The rule... Read More »
NIH examines efficacy of N95 respirator reuse
National Institutes of Health (NIH) scientists maintain N95 respirators can maintain functional integrity for up to three uses when decontaminated effectively. The findings stem from a study conducted in a controlled laboratory setting. The results are not yet peer-reviewed but are being shared... Read More »
Sen. Menendez, Rep. Sires seek flexibility for physician employment visas
Citing an increased need for medical staff to handle the surge in confirmed COVID-19 cases, Sen. Bob Menendez (D-NJ) and Rep. Albio Sires (D-N.J.) are encouraging the waiving of restrictions on doctors with employment-based visas. The legislators said the restrictions prevent the doctors from... Read More »
IAFC pitches survey to highlight need for personal protective equipment
Harried by an ongoing shortage of personal protective equipment for some of the emergency responders who need it most amid the COVID-19 pandemic -- firefighters and EMS workers -- the International Association of Fire Chiefs (IAFC) is pitching a survey they hope to present directly to President... Read More »
BARDA, Sanofi focus on non-clinical studies, Phase 1 clinicals for COVID-19 vaccine
Efforts begun on a SARS-CoV-2 vaccine in February are moving closer to fruition for the Biomedical Advanced Research and Development Authority (BARDA) and Sanofi Pasteur, with the announcement of pending non-clinical studies and a Phase 1 clinical trial. These trials will determine the initial... Read More »
Repurposed technology to help sterilize millions of N95 respirators for health care workers
Millions of N95 respirators used by U.S. health care workers in hospital settings can now be sterilized for reuse, helping to combat the spread of COVID-19. The U.S. Food and Drug Administration issued an emergency use authorization (EUA) on April 11 for one such technology that has the... Read More »
University of Illinois working with Carle Health to develop COVID-19 face shields
Researchers and engineers from the University of Illinois at Urbana-Champaign and Carle Health launched an effort to produce face shields for health professionals responding to the COVID-19 pandemic. It stems from a personal protective equipment (PPE) design initiative led by The Grainger... Read More »
BARDA to work with Vela on rapid test for COVID-19
The Biomedical Advanced Research and Development Authority (BARDA) is working with Vela Diagnostics USA to develop a rapid diagnostic test for the COVID-19 pandemic. The rapid diagnostic test would be for use on two instrument platforms, which is needed to test as many people as possible and... Read More »
Effort expands, expedites Ohio COVID-19 testing
Ohio State University researchers have received Food and Drug Administration (FDA) approval for a process designed to expand and accelerate COVID-19 testing statewide. In response to shortages of test kit components, including swabs and vials filled with a liquid called viral transport media... Read More »
Bill broadens public safety officer protections amid COVID-19 pandemic
A group of lawmakers recently introduced a measure designed to expand assurances for public safety officers contracting COVID-19 in the line of duty. Rep. Bill Pascrell, Jr. (D-NJ), co-chair of the Congressional Law Enforcement Caucus and Fire Services Caucus, House Judiciary Committee Chairman... Read More »HHS collaborates with non-government organizations to further COVID-19 immunotherapies
The push for convalescent plasma and hyperimmune globulin immunotherapies to use against COVID-19 continues at the federal level, with the U.S. Department of Health and Human Services (HHS) touting collaboration with non-governmental entities to see it done. These immunotherapies could... Read More »
Criticism mounts over Trump decision to halt WHO funding amid pandemic
President Donald Trump’s pledge to halt funding to the World Health Organization (WHO) while the White House reviews its handling of the COVID-19 outbreak has drawn immediate criticism from the health community. “We must all be allies against this threat; this is not the time to stand... Read More »
Maryland School of Medicine initiates expanded COVID-19 testing initiative
University of Maryland School of Medicine (UMSOM) officials said a new $2.5 million State of Maryland funding allotment would aid in initiating a broader COVID-19 testing initiative expanding testing capability. "The state is in dire need of increased coronavirus testing, and the School of... Read More »
Rutgers gains emergency use authorization for new saliva test to detect SARS-CoV-2
Rutgers University gained emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) this week for a new test utilizing saliva to detect SARS-CoV-2, the virus that causes COVID-19. The test comes from Rutgers’ RUCDR Infinite Biologics, the world's largest... Read More »
BARDA, DiaSorin enter public-private partnership to create fully automated serology test for SARS-CoV-2
The Biomedical Advanced Research and Development Authority (BARDA) will pump approximately $180,000 into a new partnership with DiaSorin, Inc. to create a clinical lab test capable of identifying people infected with and recovered from the SARS-CoV-2 virus. SARS-CoV-2 is the virus that causes... Read More »