US Biomedical Advanced Research and Development Authority (BARDA) has partnered with Ireland-based ICON to conduct clinical trials of Covid-19 vaccine candidates selected as part of “Project NextGen”. A part of the US Government’s Strategic Preparedness and Response division, BARDA has launched Project NextGen to develop Covid-19 vaccines and therapies for current and future strains. To achieve this, BARDA plans to leverage its public-private partnerships. The government has plans to invest more than $5bn in the Project NextGen programme. In June, the European Medicines Agency (EMA) identified the need to update the Covid-19 vaccines to include the XBB Omicron variant. The US Government seconded that sentiment, and last month, BARDA partnered with Regeneron to develop a Covid-19 monoclonal antibody vaccine candidate. ICON’s government and public health solutions team will conduct a Phase IIb active comparator clinical trial to evaluate the efficacy of the next-generation Covid-19 vaccine, selected by BARDA, compared to ...
More than 1,300 oncology drugs are in the development pipeline, waiting to potentially embark on the long journey toward their commercial debut. This journey is usually an arduous one, made even more difficult by the mere 6% participation rate in clinical trials among adult cancer patients in the U.S. To help tackle this issue, OneOncology — a cancer center network that TPG and AmerisourceBergen bought for $2.1 billion in June — recently announced that it is deploying Verily’s clinical trial management software platform across 11 of its community oncology clinics. Verily’s platform, called SignalPath, was designed with the intention of making providers’ complex clinical research ecosystems more manageable. It does this by converting trial protocols from PDFs to automated workflows, enabling centralized site and study management, and facilitating communication across site stakeholders. SignalPath also produces real-time metrics on performance and finances that users can turn into actionable insights. “As a ...
Drugdu.com expert’s response: Based on the years of experience from Drugdu.com, the number and cases of clinical trials conducted in India are related to the current clinical situation and whether the original research drug is marketed locally. Specific issues require case-by-case analysis. In general, for drug registration in India, if it is a chemical drug or a formulation, and the original research drug is already marketed in India, it can be registered as a generic drug in India, and clinical trials can be waived. Some orphan drugs, especially those that face recruitment challenges in clinical trials and are already marketed in the regulatory markets of Europe and the US, can also apply for exemption from local clinical trials. However, for biologics such as vaccines, monoclonal antibodies, and blood products, conducting phase III (bridging) clinical trials locally is mandatory for registration in India. Taking phase III clinical trials as an example, ...
The Scleroderma Research Foundation (SRF) has announced the launch of a new clinical trial platform aimed at advancing treatments for the rare autoimmune disease of the skin and organs. Using a model created over a decade ago to accelerate oncology drug development but not previously used for autoimmune disorders, the CONQUEST platform is designed to identify agents that are ready to progress from phase 2b to phase 3 clinical trials. The initiative, conceived and led by the SRF, will initially focus on interstitial lung disease secondary to scleroderma but will be expanded in the future to address other manifestations of the disease. The first iteration, which is expected to begin in the fourth quarter of this year, will include approximately 400 patients and will test two drugs, including one from Sanofi. The trial will measure forced vital capacity, the total volume of air that can be exhaled during a maximal ...
Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
A major clinical trial has found a simple change to world practice for kidney transplants could deliver real benefits for recipients and reduce their need for dialysis by 25%. The BEST-Fluids trial was conducted by the Australasian Kidney Trials Network (AKTN) in collaboration with researchers from The University of Queensland, The University of Adelaide, and The University of Sydney. The research was published in The Lancet. ATKN chair and UQ Professor David Johnson said the trial assessed the use of an intravenous fluid containing sodium, potassium, magnesium and chloride in proportions similar to human blood—instead of the usual practice of using normal saline (sodium chloride and water). “Of those study participants who received intravenous Plasma-Lyte 148, 30% needed dialysis after their transplants, compared to 40% for those given normal saline,” Professor Johnson said. “This is a significant improvement in outcomes for those undergoing kidney transplant surgery.” Royal Adelaide Hospital Nephrologist ...
The first drug fully generated by artificial intelligence entered clinical trials with human patients this week. Insilico Medicine, a Hong Kong-based biotech startup with more than $400 million in funding, created the drug, INS018_055, as a treatment for idiopathic pulmonary fibrosis, a chronic disease that causes scarring in the lungs. The condition, which has increased in prevalence in recent decades, currently affects about 100,000 people in the U.S. and can lead to death within two to five years if untreated, according to the National Institutes of Health. “It is the first fully generative AI drug to reach human clinical trials, and specifically Phase II trials with patients,” Alex Zhavoronkov, founder and CEO of Insilico Medicine, told CNBC. “While there are other AI-designed drugs in trials, ours is the first drug with both a novel AI-discovered target and a novel AI-generated design.” The discovery process for the new drug began in ...
New analysis of official records from the National Institute of Health (NIH) have revealed that just 365,000 people took part in a clinical trial for Type 2 Diabetes in 2021, despite 37.3 million people in the US living with the condition – or more than 11% of the population. By taking part in a clinical trial, people affected by conditions like diabetes can access innovative new treatments and drugs and help bring the medicines to market much faster, benefiting millions of others. The new findings were uncovered by Lindus Health, a clinical trials start-up, who analyzed the official clinical trial records across multiple diseases and found that diabetes was clearly being under-represented – with the equivalent of fewer than 1% of people affected by the disease being involved in a trial. Despite the number of people affected by diabetes, the condition is frequently overlooked in clinical trials. This is despite ...
Beth Snyder Bulik Senior Editor The American Lung Association is doubling down on efforts to encourage more Black Americans to join lung cancer clinical trials. The new pharma-sponsored “Awareness, Trust and Action” initiative aims to put those three words into action with a national campaign that includes digital posts and social media. The first posts are slated to go up on Saturday, which is Clinical Trials Awareness Day. Daiichi Sankyo, Genentech, Merck, Novartis and Novocure provided financial support for the project. Cedric “Jamie” Rutland “We have to do a better job of recruiting Black Americans into clinical trials and letting them know why,” said pulmonologist Cedric “Jamie” Rutland, a national volunteer medical spokesperson for the American Lung Association. “And not only that, but teaching Black Americans what lung cancer is, what the risk factors are, why they have risk factors living in heavily polluted areas … We have to ...
May 12, 2023 By Sean Whooley Leave a Comment Abbott (NYSE:ABT) announced a new series of programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care in under-represented populations. The additions to Abbott’s “Diversity in Clinical Trials” initiative build on partnerships, scholarships and the focus on diversified patients. Abbott applied these to its own clinical trials throughout the initiative’s first year. Within that first year, the company established a Diversity in Clinical Trials Medical Advisory Board. Through $5 million in grants, it also sponsored more than 300 scholarships at four historically black colleges and university (HBCU) medical schools, plus the National Black Nurses Association and National Association of Hispanic Nurses. Within this program expansion, Abbott launched a new initiative with the Norton Healthcare Foundation. It aims to build and implement new models of sustainable clinical research alongside the Institute for Health Equity in Louisville, Kentucky. ...
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