In a recent NIH press release, the organization announced a new study published in Nature Communications analyzing the safety and immunogenicity of a new temperature-stable tuberculosis (TB) vaccine....
In a recent research letter published in JAMA Network Open, Chris A. Rees, MD, MPH, and his colleagues analyzed how pediatric clinical trial results are disseminated or made publicly available. Rees...
The Cleveland Clinic recently announced that it would begin enrolling patients for its phase 1b breast cancer vaccine study. The study will focus on cancer-free patients at risk of developing cancer,...
Despite having a high risk of failure, the clinical trial process can cost millions of dollars to complete. For clinical research organizations and sponsors, a clinical trial budget is critical in determining whether a clinical trial is...
Based on data and recommendations from an external review by the Reagan-Udall Foundation and the results of an internal study, FDA commissioner Robert M. Califf, MD, MACC, announced a new vision for...
Before the FDA Modernization Act 2.0 was passed in December 2022, the US government required that all investigational drugs be tested on animals before they could advance to human trials. Although this act does not ban animal testing, it...
Despite common misconceptions, researchers published an article in JAMA Network Open noting that buprenorphine overdose-related deaths did not increase during the COVID-19 pandemic when providers were...
Kendall Square is a round table of the largest pharmaceutical companies in the world, and Tokyo-based Takeda will soon have a seat at that table with its massive new workspace. Takeda, the largest life...
While several different approaches are used during clinical research, traditional biomedical research involving animal testing to develop new treatments and drugs may be a strategy of the past after the FDA Modernization Act 2.0 was signed...
In a systematic review and meta-regression published in The Lancet Infectious Diseases, researchers determined that hybrid protection — the combination of SARS-CoV-2 infection and vaccination...
In a recent press release, the HIV Vaccine Trials Network (HVTN) announced that the Mosaico study, an investigational HIV vaccine study, was discontinued at phase 3 after an interim review by the Data...
On December 29, 2022, President Biden signed the FDA Modernization Act 2.0 into law, allowing clinical trial leaders to use animal trial alternatives before human clinical trials. Senators Rand Paul,...
A publication in JAMA Network Open found that folate, vitamin B6, and vitamin B12 intake and serum levels are inversely related to metabolic syndrome (MetS) incidence, with higher intake levels...
Based on data from the CDC, since 1999, there have been nearly one million overdose-related deaths. In 2020, the United States reported 91,799 overdose deaths, a 31% increase from the previous year....
Over the past few weeks, the pharmaceutical industry — drug development in particular — has faced a new issue regarding drug development and the animal models typically used to model...
As the COVID pandemic has progressed, the healthcare industry has seen the virus and the state of the pandemic evolve. Equipped with the available vaccines and treatments, providers and other...
The United States Food and Drug Administration (FDA) approval process is complex and involves multiple people's input, opinions, and expertise, including the FDA advisory committees. Every time a new drug is approved, a recall is...
Clarity Pharmaceuticals recently announced its Investigational New Drug (IND) approval from the FDA to test theranostic SAR-Bombesin for prostate cancer. Prostate cancer is the fifth leading cause of...
The COVID-19 pandemic took the world by storm when it began in January 2020. Densely populated cities took a brutal hit with more significant percentages of infection, hospitalization, and death due to...
In an article published in JAMA Network Open by Gali Garmi, MD, and his colleagues state that cesarean delivery — commonly referred to as a C-section — is the most common abdominal surgery...
