Advarra

JULY 26, 2022

As such, we are seeing an uptick in research examining the therapeutic effects of cannabis and its constituents. While there isn’t a significant amount of research on cannabidiol (CBD), it’s easily accessible in the U.S. This can make research challenging, but not insurmountable. Funding Research on Cannabis.

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ProRelix Research

NOVEMBER 27, 2023

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

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Bio Pharma Dive

DECEMBER 12, 2023

Just before clearing Pfizer’s buyout of Seagen, the regulator threatened to block Sanofi’s licensing deal with Maze Therapeutics, a challenge the biotech called ‘‘unprecedented.”

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Licensing Licensing Regulation Research 291

ProRelix Research

FEBRUARY 12, 2023

Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused […] The post Clinical Trial Regulations in the United States appeared first on ProRelix Research.

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Medical Xpress

FEBRUARY 13, 2023

UT Southwestern Medical Center researchers have mapped gene control elements in specialized cardiac cells responsible for coordinating heartbeats.

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ProRelix Research

DECEMBER 14, 2023

The European Medicines Agency (EMA) coordinates the European […] The post EMA Pharmacovigilance Regulations Updates appeared first on ProRelix Research. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

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Scienmag

MAY 6, 2021

Jude Children’s Research Hospital scientists have developed a highly efficient method to address a major challenge in biology–identifying the genetic ‘switches’ that regulate gene expression. Jude Children’s Research Hospital St. Credit: St.

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BioSpace

JUNE 2, 2022

Top research stories, including gene regulation and longevity, a head-to-head comparison of COVID-19 vaccines, a newly discovered type of brain cell and more.

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Drug Discovery World

MARCH 27, 2024

Their research, published in the journal Cancer Discovery , reveals the role of epigenetics in controlling how cancer cells can become dormant – and suggests a strategy to target it before the cells wake up. They also found that in people with low expression of these enzymes, their cancer had a lower risk of coming back years later.

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Drug Discovery World

MARCH 23, 2023

These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and are designed to make the UK one of the best countries in the world to conduct clinical research. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.”

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Medical Xpress

DECEMBER 13, 2022

Researchers from the University at Buffalo School of Pharmacy and Pharmaceutical Sciences recently published in Molecular & Cellular Proteomics, describing their work in identifying key metabolic regulators involved in cancer cell resistance to gemcitabine (Gem), a standard-of-care chemotherapy for pancreatic dual adenocarcinoma (PDAC), the most lethal (..)

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Scienmag

MAY 7, 2022

A research led by Hong Kong University of Science and Technology (HKUST) has revealed a novel mechanism that regulates secretion of sonic hedgehog (Shh), a key signaling molecular that plays an important role in cancer progression, in mammals, opening the door to novel therapeutic strategies for cancer induced by the hedgehog signaling pathway.

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FDA Law Blog

MARCH 10, 2024

Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. The conference, held in Washington, D.C., April 4th and 5th, is an in-person and virtual event.

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Rethinking Clinical Trials

APRIL 24, 2024

Matthew Semler In this Friday's PCT Grand Rounds, Lauren Milner of the US Food and Drug Administration (FDA) and Jonathan Casey and Matthew Semler of Vanderbilt University will present "Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape."

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FDA Law Blog

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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Medical Xpress

MAY 9, 2023

An international group of doctors and public health experts have joined the clamor for a moratorium on AI research until the development and use of the technology are properly regulated.

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WCG Clinical

DECEMBER 13, 2023

Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. Next, let’s look at considerations for study design: Study objectives are crucial in defining the specific aim of the research and the intended use of the product.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 11, 2023

Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities.

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Medical Xpress

FEBRUARY 23, 2023

We do know that an overactive innate immune system is causing severe COVID-19 disease, but it is unclear how this is regulated. But why is this the case? Unfortunately, we do not know exactly.

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Scienmag

APRIL 22, 2021

Notch proteins are key regulators of growth and differentiation of both normal and cancer cells. Researchers in Turku, Finland, have now demonstrated that the activities of distinct Notch family members are modified differently by phosphorylation.

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Scienmag

APRIL 11, 2022

Yale scientists uncover key regulator of body weight. Yale scientists have discovered that a protein known as augmentor-alpha regulates body weight in mice, an insight that could lead to new treatments for metabolic disorders. New Haven, Conn.

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Scienmag

APRIL 25, 2022

BOSTON — Proper function of the kidney is critical for concentrating urine, regulating blood pressure, and for the tight control of electrolyte levels in the blood. The kidney achieves these important functions through many microscopic functional units, called nephrons. How these segments form during development and […].

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Scienmag

JULY 19, 2022

Differentiation of pluripotent stem cells (PSCs) is regulated through a methionine-mediated mechanism, which has now been pinpointed by Tokyo Tech researchers. They have revealed that zinc (Zn) plays a crucial role in PSC potentiation. They used these insights to design a protocol to convert PSCs into insulin-producing pancreatic ?

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Regulation Insulin Research 89

Bio Pharma Dive

JUNE 27, 2022

The biotech company revealed three new drug candidates for breast cancer, while laying out a path to regulators for its most advanced treatment.

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pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? Mental health problems are estimated to cost the UK economy at least £118 billion a year, according to research by the London School of Economics and Political Science.

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Cloudbyz

APRIL 19, 2023

Introduction: The new European Union (EU) Clinical Trial Regulation (CTR), Regulation (EU) No 536/2014, came into force in January 2022, replacing the previous EU Clinical Trials Directive (2001/20/EC). This aims to increase transparency, reduce publication bias, and promote data sharing among researchers.

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Clinical Trials Clinical Trials Regulation Trials 52

Drug Discovery World

MAY 29, 2023

Scientists are calling for tighter regulation of stem cell treatments, claiming clinics worldwide are offering unproven ‘therapies’ for conditions as varied as hair loss and Parkinson’s. They are calling on regulators to halt these products until they can be proven safe and effective in clinical trials.

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Pharma Tutor

APRIL 28, 2023

Expert Committee on Pharmacy Education, Law and Regulator admin Fri, 04/28/2023 - 15:45 ABOUT AUTHOR Dr. R. Thakur Chief Editor, Journal of Pharmaceutical Research Krupanidhi College of Pharmacy, Bengaluru, India. Email : drramsthakur@gmail.com

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STAT News

OCTOBER 12, 2022

— Biotech companies developing cutting-edge cell and gene therapies often are tripped up by how much regulations around these drugs vary from country to country. On Wednesday, regulators from the United States, the European Union, and Japan came together to discuss the scale of the problem — and possible solutions.

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pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. The rise of patient centricity. “It’s Personal approach.

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STAT News

DECEMBER 15, 2022

and European regulators on Thursday to adopt new standards for approving antibody drugs against Covid, particularly for immunocompromised and other vulnerable patients. Biotech executives and a handful of academics pleaded with U.S.

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Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., Endpoint adjudication committees (EACs), also called clinical event committees (CECs), receive potentially identifiable research data from all over the world.

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Cloudbyz

APRIL 20, 2023

The European Union (EU) Clinical Trial Regulation (CTR) No 536/2014, which came into effect in January 2022, has significantly changed the clinical trial landscape in the EU. This blog post outlines 10 key aspects of the new regulation that sponsors should be aware of when planning and conducting clinical trials in the EU.

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Clinical Trials Clinical Trials Regulation Trials 52

Scienmag

FEBRUARY 15, 2022

microRNAs (miRNA), non-coding RNA molecules, are widely known for regulating mRNA stability and translation. Given the therapeutic potential of targeting miR-10b, researchers at the Brigham sought to understand the mechanism behind the glioma dependence, often referred to as addiction, on miR-10b. […].

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Scienmag

APRIL 19, 2021

Credit: Nina Brooks Like superheroes capable of seeing through obstacles, environmental regulators may soon wield the power of all-seeing eyes that can identify violators anywhere at any time, according to a new Stanford University-led study.

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Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated products. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

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Medical Xpress

JANUARY 25, 2023

Regularly eating a high-fat/calorie diet could reduce the brain's ability to regulate calorie intake.

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