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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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.

New Rutgers Saliva Test for Coronavirus Gets FDA Approval

The FDA has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus, the first such approval granted by the federal agency. The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), will allow for broader population screening than the current method of nose and throat swabs.

FDA Approves First Plasma Therapy for Houston Methodist COVID-19 Patient

Houston Methodist received FDA approval Saturday to become the first academic medical center in the nation to transfuse donated plasma from a recovered COVID-19 patient into a critically ill patient. This treatment was fast-tracked to the bedside over the weekend as the death toll in the COVID-19 pandemic soared to more than 2,000 people across the United States, with more than 100,000 Americans sick from the virus.

AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing

AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval.

Researchers Show How Ebola Virus Hijacks Host Lipids

Robert Stahelin studies some of the world’s deadliest viruses. Filoviruses, including Ebola virus and Marburg virus, cause viral hemorrhagic fever with high fatality rates. Stahelin, professor at Purdue University, examines how these viruses take advantage of human host cells.

Expert on #FDA’s #Expanded Access program: Cost can be a barrier to critically ill patients, healthcare providers, and others seeking to try experimental treatments as a last resort. Dr. Marjorie A. Speers available to comment or participate in inter

Costs related to the expanded access procedure under which critically ill patients can  try experimental drugs, biologics, and medical devices are often overlooked. These costs, according to Clinical Research Pathways Executive Director Marjorie A. Speers, Ph.D. can become a barrier for patients,…

Expert in #expandedaccess to experimental drugs and diversity in clinical trials to speak at D.C. conf., and is available for interviews

An international expert in expanded access to experimental drugs, Marjorie A. Speers, Ph.D., will speak at the third annual Expanded Access Summit Jan. 27-29 at the National Press Club in Washington, D.C. Speers, a former CDC official, is the executive…

ANALYSIS OF FDA DOCUMENTS REVEALS INADEQUATE MONITORING OF KEY PROGRAM TO PROMOTE SAFE OPIOID USE

A risk-management program set up in 2012 by the U.S. Food and Drug Administration to curb improper prescribing of extended-release and long-acting opioids may not have been effective because of shortcomings in the program’s design and execution, according to a paper from researchers at the Johns Hopkins Bloomberg School of Public Health.

Rutgers Tobacco, Vaping Expert Available to Discuss FDA’s Finalized Enforcement Policy Targeting Flavored E-cigarettes That Appeal to Youth

Rutgers Tobacco, Vaping Expert Available to Discuss FDA’s Finalized Enforcement Policy Targeting Flavored E-cigarettes That Appeal to Youth A Rutgers University expert on tobacco and vaping is available to comment on the FDA’s enforcement policy on unauthorized flavored cartridge-or pod-based…