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In a letter dispatched to Congress this week, 24 stakeholder organizations urged Congressional leaders to back the $16 billion funding level for pandemic preparedness advanced by the House Energy and Commerce Committee earlier this year.
That funding was attached as part of the Build Back Better... Read More »
The U.S. Food and Drug Administration (FDA) remains without permanent leadership during the nation’s ongoing battle against the COVID-19 pandemic.
“It's of top concern that President Biden still has not nominated someone to serve as permanent FDA commissioner,” a House Energy and Commerce... Read More »
The U.S. House of Representatives passed the National Defense Authorization Act for Fiscal Year 2022 last week with a number of homeland security-related amendments, including measures that would strengthen the Cybersecurity and Infrastructure Security Agency (CISA) and Department of Homeland... Read More »
Several Senate Republican leaders recently expressed “growing concern” over the nation’s stalled progress in fighting the ongoing COVID-19 pandemic and requested details on how the Biden administration plans to move forward during the coming months.
U.S. Senate Minority Leader Mitch... Read More »
The U.S. House of Representatives passed the Fiscal Year 2022 National Defense Authorization Act (NDAA).
The NDAA addresses the nation's defense budget, Afghanistan accountability, additional defense priorities, as well as countering China and Russia.
“For 61 consecutive years, the House... Read More »
The Mexican government approved biotechnology company INOVIO to begin a Phase 3 efficacy trial of its COVID-19 DNA vaccine candidate, INO-4800, this week alongside its partner Advaccine Biopharmaceuticals Suzhou Co., Ltd.
This Mexican trial is part of a larger, worldwide Phase 2/3 trial known as... Read More »
While falling short of the full authorization Pfizer Inc. and BioNTech SE have clamored for, the United States Food and Drug Administration (FDA) has amended existing emergency use authorization (EUA) for the companies’ COVID-19 vaccine to allow a single booster dose for certain... Read More »
Tacking onto President Joe Biden’s call to make the United States an arsenal of vaccines for the world, Pfizer Inc. and BioNTech SE agreed to expand an arrangement with the U.S. government and provide another 500 million doses of their COVID-19 vaccine for low and lower-middle-income... Read More »
As the CEO of American PAPR, a Brooklyn-based company that manufactures American-made personal protective equipment, Giles Kyser has hired lobbyists to make the case that the federal government should procure medical equipment whose raw materials are sourced and assembled in the United States.... Read More »
As more vaccine developers consider the potential of COVID-19 boosters, Johnson & Johnson announced this week that the latest data shows its own booster shot provides 94 percent protection when given two months after a first dose.
That represents a major improvement, providing as much as a... Read More »
The United States Centers for Disease Control and Prevention (CDC) intends to invest $2.1 billion to improve infection prevention and control activities at the state, local and territorial levels, and better improve national capabilities to prepare for emerging infectious diseases.
These funds... Read More »
While buoyed by the House Energy and Commerce Committee’s advancement of the Build Back Better Act, and the offerings therein, the United States COVID-19 Global Vaccination Caucus chimed in last week to note that its offers for vaccine manufacturing are just a beginning.
The caucus consists of... Read More »
According to new data from clinical trials highlighted by Moderna, Inc. this week, its debut COVID-19 vaccine, mRNA-1273, continues to be highly effective against COVID-19, providing 96 percent efficacy against hospitalization and 87 percent against infection.
The data -- from a study at Kaiser... Read More »
Vaccine equity is in need of a boost globally, and in Africa in particular, and unless that changes, World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus and other health leaders said this week the COVID-19 pandemic may never end.
Cooperation is the key to ending the... Read More »
Through a contract with SIGA Technologies, Inc., the Biomedical Advanced Research and Development Authority (BARDA) has exercised a procurement option to obtain approximately $112.5 million worth of the oral TPOXX smallpox treatment this year.
TPOXX is an orally administered and IV formulation... Read More »
The Biden administration seeks an international summit on COVID-19 pandemic responses and to form a united global front for vaccination efforts, a proposal that could impact vaccine manufacturing, supply chains and even the upcoming United Nations General Assembly.
Closer to home, though, U.S.... Read More »
Novavax, Inc. began enrollment last week of the first participants for a Phase 1/2 clinical trial to assess the safety and immunogenicity of a combination vaccine formed from the company’s seasonal influenza and COVID-19 vaccines.
Each vaccine has already been tested in solo clinical trials up... Read More »
In its latest Supply Forecast, the multilateral vaccine equity program COVAX announced expectations of 1.425 billion doses of COVID-19 vaccines available this year, with 2 billion doses available for delivery in the first quarter of 2022 -- a milestone, but still a lagging figure.
Resulting from... Read More »
Homeland Security Secretary Alejandro Mayorkas assured Thursday the growing effort to combat domestic terrorism and the mass influx of Afghan refugees will not distract the agency from its ongoing efforts to guard against attacks from international terrorism.
Speaking at the National Press Club... Read More »
A group of lawmakers have forwarded correspondence to Secretary of State Antony Blinken and Homeland Security Secretary Alejandro Mayorkas, seeking guidance regarding the evacuation of Americans and others from Afghanistan.
Representatives Ami Bera (D-CA), Zoe Lofgen (D-CA), and Jerry Nadler... Read More »
A new report from Trust for America’s Health (TFAH) has found that 20 years after the September 11 attacks on the World Trade Center and Pentagon, America is not fully prepared for public health emergencies.
The report, 2021 Ready or Not: Protecting the Public’s Health from Diseases,... Read More »
The Bipartisan Commission on Biodefense last week applauded the Biden Administration’s work on a new $65.3 billion American Pandemic Preparedness Plan for investments to combat the next biological threat, though it argues that greater funding is necessary to make sufficient plans.
The White... Read More »
In a national first, the House Armed Services Committee voted last week in favor of a bill that would grant the mayor of the District of Columbia authority over the D.C. National Guard, adding that provision to the 2022 National Defense Authorization Act.
Since its inception, the D.C. National... Read More »
Thanks to collaborations with commercial and academic research partners alike, the Argonne National Laboratory has published new research showing the capabilities of artificial intelligence and simulation workflows to provide insight to the SARS-CoV-2 viral genome and potentially fuel drug... Read More »
A new House bill introduced by United States Reps. Mike Turner (R-OH), Jason Crow (D-CO), and Brad Wenstrup (R-OH) -- the Havana Syndrome Service Member Support Act -- seeks to provide aid for those with Havana Syndrome-induced brain injuries and initiate federal efforts to address related... Read More »
A group of lawmakers are encouraging the Department of Justice to prioritize investigating hate group networks supporting extremist ideology.
Sens. Jeff Merkley (D-OR) and Ron Wyden (D-OR) recently joined Reps. Earl Blumenauer (D-OR) and Suzanne Bonamici (D-OR) in forwarding correspondence to... Read More »
Thinking up ways to better address future public health emergencies, the Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research, Innovation and Ventures (DRIVe) has expanded a partner program focused on technology development to include digital health tools and... Read More »
Although a United States Food and Drug Administration (FDA)-approved prescription medication, the Centers for Disease Control and Prevention (CDC) issued a warning last week that the drug ivermectin is not meant to be used for prevention or treatment of COVID-19.
Failing to heed that warning... Read More »
A new policy brief released this month by the advocacy group Pandemic Action Network (PAN) calls on world leaders to create a 100-day action plan toward creating a new financing mechanism at the United Nations General Assembly capable of bolstering pandemic preparedness by at least $10 billion... Read More »
New voices were added to the United States Department of Health and Human Services’ (HHS) Tick-Borne Disease Working Group this week, filling positions left vacant by public members looking to workshop ideas on how best to counter rising cases of tick-borne illnesses.
In all, seven new members... Read More »
New data released by Johnson & Johnson this week showed that using its single-shot COVID-19 vaccine as a booster for the previously vaccinated could provide as much as a nine-fold increase in antibodies for patients at least 18 years old.
The news follows interim reports from July, published in... Read More »
With data from its Phase 3 COVE study showing a COVID-19 vaccine with 93 percent effectiveness, Moderna, Inc. has officially filed for a biologics license application (BLA) to the United States Food and Drug Administration (FDA) that would lead to full licensure.
It’s an important step, which... Read More »
A 210-person Phase 2 clinical trial for the COVID-19 vaccine candidate, ABNCoV2, began this week to determine its potential as a booster vaccine for those who have either caught the disease previously or been otherwise vaccinated.
Licensed by Bavarian Nordic A/S and developed by AdaptVac, the... Read More »
Results of a Phase 3 clinical trial have shown that AstraZeneca’s antibody combination for COVID-19, AZD7442, cuts the risk of symptomatic COVID-19 cases by 77 percent for at least three months.
That is dependent on the treatment being taken prior to infection. However, the antibodies used in... Read More »
The United States Food and Drug Administration (FDA) on Monday granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for use among patients 16 years and older, making it the first of the disease’s vaccines to cross beyond conditional use.
Since Dec. 11, 2020, the mRNA-based vaccine had... Read More »