AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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Rethinking Clinical Trials

MARCH 28, 2024

Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. View the Equitable Language Cheat Sheet.

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Bio Pharma Dive

OCTOBER 14, 2024

Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.

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Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 5, 2024

India has taken centre-stage in clinical trials for HIV/AIDS drug as there are several ongoing clinical trials in India focused on advancing HIV treatment. These trials are investigating new drug candidates, therapies, and approaches to manage HIV more effectively and potentially cure it.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 19, 2024

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

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Pharma Mirror

DECEMBER 23, 2024

Clinical trials are the foundation of medical innovation, paving the way for groundbreaking therapies. Yet for many, the idea of joining a trial can feel intimidating or unclear. Have you ever wondered how life-saving treatments for cancer, Alzheimers, or chronic diseases come to life?

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 6, 2024

This according to multinational majors like Amgen, GSK, Eli Lily, Bayer, Mylan, AstraZeneca among others indicated that it underscores India’s importance in R&D and clinical trials. These GCCs in the lifesciences and healthcare segment are driving digital tech assignments, key business and corporate […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

Researchers analyzed the electronic health records of more than 18,000 US patients between May 2022 and September 2023 to compare outcomes among those receiving the two injected medicines, and published the […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human studies.

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Rethinking Clinical Trials

AUGUST 8, 2024

Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities. It is imperative to get a learning health system in progress,” she said.

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Pharmaceutical Technology

AUGUST 10, 2022

The Reliance Clinical Research Program underway is analysing REL-1017’s potential as a quick-acting, oral, once-a-day antidepressant therapy. A registrational Phase III trial, Reliance III, is analysing REL-1017 as a single agent. Presently, the therapy is being analysed in late-stage studies.

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Worldwide Clinical Trials

AUGUST 10, 2023

The Psychedelic Community Casts a Wide Net Along with a robust community of scientific researchers and medical practitioners, Psychedelic Science included artists, educators, religious and cultural leaders, philanthropists, patient and policy advocates, and many more.

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Clinical Trials Clinical Trials Trials Clinical Research 246

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 9, 2024

The convergence of gene therapies and clinical research is pushing the boundaries of what’s possible in ophthalmic care, offering hope for more effective treatments and potential cures for a range of vision-threatening conditions.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success. Twisted and tangled proteins are found in the brains of many of those who die with Alzheimer’s disease. A promising new medicine has now […]

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Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 8, 2023

Trials have shown that the R21/Matrix vaccine, developed by Oxford University together with the Serum Institute of India, reduces malaria by up to 75 […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 30, 2023

Four patients with severe chemical burns to one eye have shown early positive results in a phase 1 clinical trial of a therapy based on their own stem cells.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 3, 2023

An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.

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Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

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Rethinking Clinical Trials

JANUARY 15, 2025

Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke Clinical Research Institute, and director of biostatistics and bioinformatics at the Duke Clinical and Translational Science Instituteall at Duke University. Join the online meeting.

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Worldwide Clinical Trials

AUGUST 15, 2023

We prioritize cost-effectiveness, providing essential services for your trial’s success at competitive rates. Discover the difference we can make for your trial. Contact us today–> The post 9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey appeared first on Worldwide Clinical Trials.

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Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Pharmaceutical Technology

FEBRUARY 26, 2023

Finch Therapeutics’s Phase III PRISM4 trial for recurrent Clostridioides difficile infection (CDI) and MaaT Pharma’s Phase III trial in steroid-resistant acute graft-versus-host disease were both put on hold. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. with placebo.

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FDA Law Blog

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. Below, we explore some of the key themes seen in the changes.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 20, 2024

(VioletaStoimenova/Getty Images) To better treat and prevent depression, we need to understand more about the brains and bodies in which it occurs. Curiously, a handful of studies have identified links between depressive symptoms and body temperature, yet their small sample sizes have left too much room for doubt.

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Clinical Trials Clinical Trials Clinical Research Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 15, 2024

A team of researchers led by Johns Hopkins Bloomberg School of Public Health epidemiologist Jason Smith has found improvements to common vision problems could potentially prevent as many as […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 9, 2024

Yet researchers have suspected there could be more to the story. In the US, roughly two out of every three people with Alzheimer’s is a woman, a statistic that could be partially explained by the fact women typically live longer than men. Now two new studies raise the possibility of complex interactions between hormones and […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 18, 2024

(Bloomberg Creative/Getty Images) Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s.

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Clinical Trials Clinical Trials Clinical Research Trials 246

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 26, 2024

Researchers at Ningxia Medical University in China have found that some coffee or tea drinkers are lowering their risk of dementia. (juanma hache/Getty Images) A new study has investigated whether drinking coffee or tea can reduce the risk of developing dementia, and the findings help explain some murky past results.

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