Tag: FDA

Mitigating Drug Shortages via a Quality Management Rating System is Viable: New Study

sarah JonasResearch Results

A “quality management maturity” (QMM) rating system for pharmaceutical manufacturing facilities is viable toward reducing drug shortages and increasing medicine availability, according to research by risk management expert Clifford Rossi at the University of Maryland.

Four Things to Know About the Infant Formula Shortage Right Now

sarah Jonasblog

Tips from a clinical dietitian for keeping babies healthy when formula is in short supply. It’s no secret the COVID pandemic has brought with it a spate of supply chain challenges. The latest product in crisis: infant and child formula.The shortage has affected nearly all types of formulas, hitting those who require special formulas the hardest: children with milk allergies, developmental disabilities and special needs, among other conditions.

New Oral Antiviral Drug Reduces Death in Early COVID-19

sarah JonasResearch Results

Researchers note that health care providers are now able to add to their armamentarium against COVID-19 their prescription of this new antiviral drug for high-risk, newly-infected patients as soon as possible following diagnosis or within five days of the onset of symptoms.

FDA authorization of COVID-19 vaccine for kids 5 to 11: IU experts available to comment

sarah JonasExpert Pitch

Following a daylong meeting Oct. 26, the FDA authorized Pfizer’s COVID-19 vaccine for use in children ages 5 to 11. This was the first in a series of meetings to make this vaccine available to younger children. Next, the Advisory…

Rutgers Chancellor Available to Discuss COVID-19 Booster Shots, Why Frontline Workers Need Them

sarah JonasExpert Pitch

Brian L. Strom, chancellor at the Rutgers Biomedical and Health Sciences and executive vice president for Rutgers Health Affairs, is available to discuss the COVID-19 booster shot and why frontline workers need to get them. Strom agrees with the Centers…

“Read Medicine Labels” – How to Safely Use Green Chiretta Against COVID-19

sarah JonasFeature

Chula Pharmaceutical Science urges consumers to pay attention to “medicine labels” to choose and use green chiretta (Andrographis paniculata) effectively and safely. They also cautioned that the government should modify the labels, and control the price of herbal medicines that help in curbing the current pandemic.

World-first COVID vaccine booster randomized clinical trial in transplant patients proves third shot is very effective

sarah JonasResearch Results

The study enrolled 120 transplant patients between May 25th and June 3rd. None of them had COVID previously and all of them had received two doses of the Moderna vaccine. Half of the participants received a third shot of the vaccine (at the 2-month mark after their second dose) and the other half received placebo.
The primary outcome was based on antibody level greater than 100 U/ml against the spike protein of the virus. In the placebo group – after three doses (where the third dose was placebo), the response rate was only 18% whereas in the Moderna three-dose group, the response rate was 55%.

Light-Activated Dental Materials – the Latest Dental Innovation of International Standards from Chula

sarah JonasMarketplace

Chula Faculty members joined forces in dental materials science to develop easy-to-use “light-activated dental materials” that meet international standards and help shorten tooth filling time. The secret of these innovative dental materials, made by Thai people, is Acemannan polymer from Aloe Vera that can stimulate the formation of dentin and reduce tooth sensitivity in many dental health products.

UNLV Alzheimer’s Researcher and Expert Panel Present First-Use Recommendations For Aducanumab

sarah JonasResearch Alert

A group of six leading Alzheimer’s experts has convened to make the first recommendations for the appropriate use of aducanumab (Aduhelm, Biogen/Eisai), a newly approved treatment for early Alzheimer’s disease. The recommendations will help provide clinicians with greater clarity and…

Johns Hopkins Drug Commercialization Expert Looks at Controversy over Alzheimer’s Treatment

sarah JonasFeature Expert

Johns Hopkins Carey Business School Senior Lecturer Supriya Munshaw – an expert in the commercialization of early-stage technologies, especially in the life science and medical device industries – offers her insights into the FDA’s rationale for approving the Alzheimer’s drug aducanumab, the price set by Biogen, the future of FDA leadership, and other related topics, in this Q&A.

Data and safety review board reports how it monitored the COVID-19 vaccine trials

sarah JonasResearch Results

Evaluation of three vaccine candidates during the COVID-19 pandemic fell to 12 experts of the federally appointed COVID-19 Vaccine Data and Safety Monitoring Board. This team has now taken the unusual step of publishing details of their review process in The Journal of Infectious Diseases.

WashU Expert: FDA menthol ban would benefit Black, younger Americans

sarah JonasExpert Pitch

The U.S. Food and Drug Administration’s proposed ban on menthol-flavored cigarettes and all flavored cigars could be particularly beneficial for Black and young people, says an expert on tobacco control at Washington University in St. Louis.“Around 80% of adult Black smokers and more than half of people age 18-34 use menthol brands,” said Todd Combs, research assistant professor at the Brown School who works on the Advancing Science & Practice in the Retail Environment (ASPiRE) project, which uses agent-based modeling to test the potential impact of retail tobacco policies.

Rutgers Experts Available to Discuss Proposed Ban on Menthol Cigarettes and Flavored Cigars

sarah JonasExpert Pitch

Rutgers health experts who study the negative effects of tobacco and advocate for stronger policies and regulations on flavored combustible tobacco products are available to discuss the new proposed ban on menthol cigarettes and flavored cigars by U.S. Food and…

Rutgers University’s Resilient, Innovative Year Confronting COVID-19

sarah JonasFeature

The last year, which has been unlike any other in Rutgers’ 254-year history, has centered on keeping the Rutgers community safe, providing top-notch health care, developing the first saliva test for the coronavirus and helping society cope with the biggest global public health crisis since the 1918 influenza pandemic.

Alzheimer’s Association again endorses Biogen drug despite mystery data analysis and financial conflict of interest, says Dr. Leslie Norins of Alzheimer’s Germ Quest

sarah JonasPolicy

Although an expert FDA panel voted ten to one to withhold approval for a Biogen anti-Alzheimer’s drug candidate, the Alzheimer’s Association endorsed the compound. Serious questions have been raised about why, including conflict of interest.

AACI Applauds Approval of COVID-19 Vaccine, Supports Widespread Vaccination Efforts

sarah JonasPolicy

The Association of American Cancer Institutes (AACI) commends the U.S. Food and Drug Administration (FDA) for its swift action to grant Emergency Use Authorization (EUA) to Pfizer’s COVID-19 vaccine.

Rutgers Vaccine Expert Available to Discuss Moderna’s FDA Submission

sarah JonasExpert Pitch

Rutgers’ principal investigator for the Moderna phase 3 coronavirus vaccine clinical trial at Rutgers New Jersey Medical School is available to discuss the drugmaker’s submission of its vaccine to the U.S. Food and Drug Administration for regulatory approval. “It is…

Remdesivir for COVID-19: FDA Approved but Still Unproven

sarah JonasResearch Results

In a review of evidence from the most reliable data from randomized trials to find likely small-to-moderate effects of remdesivir, researchers say that totality of evidence compiled before the WHO trial results justifies compassionate use of remdesivir for severely ill patients. A smaller trial in China showed significantly decreased mean recovery time but no suggestion of a mortality benefit. ACTT-1 found the same mean recovery time and a suggestion of a mortality benefit that did not achieve statistical significance.

Rapid disease pathogen identification a step closer following successful UAH startup demonstration

sarah JonasFeature

Soon it could only take an hour to find out what pathogen is making you ill, following the successful demonstration of the world’s first multi-pathogen identification using non-amplified RNA detection by GeneCapture, a company cofounded by researchers at The University of Alabama in Huntsville (UAH).

Menacing Assaults on Science Causing Alarming and Avoidable Deaths in the U.S.

sarah JonasFeature

In early 2016, the U.S. was judged to have been best prepared for the existential threat of a pandemic, but turned out to be the least prepared for the actual threat. In a commentary, researchers say that “pandemic politics” is causing assaults on science, the FDA and CDC. They say that politicization of the FDA and CDC is creating continued losses of trust by the U.S. public and continued harm to their longstanding reputations of respect and admiration worldwide.

Lack of Key Considerations in FDA Food Chemical Safety Process Leaves Consumers at Risk of Chronic Diseases

sarah JonasPolicy

Today, a group of health, environmental, and consumer organizations challenged the Food and Drug Administration’s (FDA) practice of not accounting for the cumulative health effect of chemicals in the diet when allowing new chemicals in food. Over 60 years ago, Congress passed a law requiring that FDA and industry do just that. Unfortunately, an Environmental Defense Fund investigation of nearly 900 safety determinations found that only one considered the requirement in a meaningful way.

FDA Guidance Fails to Ensure Security of 3D-Printed Masks and PPE

sarah JonasExpert Pitch

New Brunswick, N.J. (Sept. 16, 2020) – FDA guidelines for making 3D-printed masks, face shields and other personal protective equipment (PPE) in the COVID-19 era fail to defend against cyberattacks, according to Rutgers and Georgia Tech engineers. Due to the…

Rutgers Expert Available to Discuss Drug Companies’ Safety Pledge on COVID-19 Vaccine Quest

sarah JonasExpert Pitch

Michael Gusmano, a Rutgers bioethicist and health policy expert, is available to discuss the pledge by drug manufacturers to uphold ethical standards and scientific principles in the global quest for a COVID-19 vaccine. “The safety pledge indicates the pharmaceutical industry…

ATS Statement on Latest COVID-19 Policy Actions: Convalescent Plasma and Testing of Asymptomatic Patients

sarah JonasPolicy

The American Thoracic Society is alarmed by two federal agency policy actions that may significantly impact our nation’s COVID-19 response. This week, the FDA issued an emergency use authorization (EUA) for the use of convalescent plasma to treat COVID-19 disease. This action was taken despite a lack of adequate evidence demonstrating a clear benefit for most patients. As pulmonary and critical care clinicians and researchers who treat individuals with COVID-19, we are concerned that an EUA for convalescent plasma has the potential to put patients at risk.

AMP Commends Department of Health and Human Services on Decision to Lessen Regulatory Burden on Laboratory Professionals

sarah JonasPolicy

The Association for Molecular Pathology (AMP), the premier global, molecular diagnostics professional society, commends the decision by the U.S. Department of Health and Human Services (HHS) to rescind the requirement for premarket review of laboratory developed testing procedures (LDPs) by the Food and Drug Administration (FDA).

Seafood Products Made From Cells Should be Labeled Cell-Based

sarah JonasResearch Results

Companies seeking to commercialize seafood products made from the cells of fish or shellfish should use the term “cell-based” on product labels, according to a Rutgers study – the first of its kind – in the Journal of Food Science. Both the U.S. Food and Drug Administration and U.S. Department of Agriculture require food products to have a “common or usual name” on their labels so consumers can make informed choices about what they’re purchasing.

KIDNEY HEALTH INITIATIVE URGES INVESTIGATORS TO INCLUDE PEOPLE WITH KIDNEY DISEASES IN CLINICAL TRIALS FOR CORONAVIRUS 2019 (COVID-19) THERAPIES

sarah JonasPolicy

People with kidney diseases are often excluded from clinical trials because of the complexity and high morbidity of kidney disease.

COVID-19 puts people with kidney diseases at a two to sixteen-fold increased risk of severe symptoms.

All investigators should include people with kidney diseases when developing vaccines, preventative therapies or treatments related to COVID-19.

FDA Approves First At-Home Saliva Collection Test for Coronavirus

sarah JonasFeature

Rutgers’ RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results. The decision follows the FDA’s recent emergency approval to RUCDR Infinite Biologics for the first saliva-based test, which involves health care workers collecting saliva from individuals at testing sites.