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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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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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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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.” They believe any regulatory oversight for laboratory developed tests (LDTs) should be mandated by Congress, rather than the Executive Branch.

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BioTech 365

DECEMBER 3, 2020

Catalyst Biosciences Hosting Research & Development Call on Systemic Complement Regulator Programs Catalyst Biosciences Hosting Research & Development Call on Systemic Complement Regulator Programs SOUTH SAN FRANCISCO, Calif., 03, 2020 (GLOBE NEWSWIRE) — Catalyst Biosciences, Inc.

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Scienmag

JANUARY 28, 2022

A protein that masterminds the way DNA is wrapped within chromosomes has a major role in the healthy functioning of blood stem cells, which produce all blood cells in the body, according to a new study from researchers at Weill Cornell Medicine. The protein, known as histone H3.3,

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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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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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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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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. How these segments form during development and […]. The kidney achieves these important functions through many microscopic functional units, called nephrons.

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Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Q32 will also receive tiered royalty payments on net sales.

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Medical Xpress

APRIL 27, 2023

Research led by Maynooth University and published today in the journal Science Signaling has found that the protein MYC is essential for MAIT cell growth, proliferation, metabolism and function. The latest findings are of critical importance to the study of MAIT cells and the development of metabolic disease such as obesity.

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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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Bio Pharma Dive

MARCH 11, 2022

On the heels of its Syndesi acquisition, the company has announced an agreement with Gedeon Richter focused on researching and developing new dopamine-regulating drugs for neuropsychiatric diseases.

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Medical Xpress

MAY 4, 2023

Scientists from Singapore have demonstrated the critical role played by a special transporter protein in regulating the brain cells that ensure nerves are protected by coverings called myelin sheaths.

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pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on.

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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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Medical Xpress

APRIL 24, 2023

Iron is important for life, and iron deficiency impairs development, but whether the iron level regulates neural differentiation remains elusive. Iron-regulatory proteins (IRPs), including IRP1 and IRP2, are the major regulators of cellular iron homeostasis.

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BioTech 365

JULY 15, 2021

… Continue reading →

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Medical Xpress

JANUARY 31, 2023

Leukemia, a type of blood cancer, affected around 2.3 million people around the world in 2015.

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pharmaphorum

DECEMBER 19, 2022

The recommendations are part of the ACT EU initiative between the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) group – launched earlier this year – intended to further develop the EU’s role as a centre for clinical research.

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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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Forte Research Systems®

AUGUST 20, 2020

Developing and negotiating a clinical trial budget that applies Medicare's rules and regulations involves many challenges. Find out strategies to assist with the process.

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XTalks

DECEMBER 4, 2023

But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy. Project Optimus is intended to reform the dose optimization and dose selection paradigm in oncology drug development,” says Dr. Confeld.

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Medical Xpress

APRIL 20, 2023

MYC proteins are important regulators of cancer cell growth, proliferation and metabolism through their ability to increase the expression of proteins involved in these processes. Numerous researchers have devoted significant efforts to try to target MYC proteins as a therapeutic approach to treat cancer.

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.

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Scienmag

SEPTEMBER 8, 2021

BORDEAUX & NARBONNE, France – The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) apply an aligned and complimentary mindset when advising the clinical development steps for live biotherapeutic products (LBPs), YSOPIA Bioscience and the Pharmabiotic Research Institute have found.

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Scienmag

JANUARY 11, 2022

Super-enhancers are clusters of enhancers that together regulate genes with important roles in cell identity. Jude Children’s Research Hospital studied the Vsx2 super-enhancer and its role in the development of the retina. Enhancers are regions of DNA that do not code for proteins, but control how genes are expressed.

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pharmaphorum

APRIL 23, 2021

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . Marketing authorisation of icosapent ethyl comes after a decade of designing and conducting evidence-based cardiovascular clinical outcomes research.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Scienmag

OCTOBER 18, 2021

Researchers have known for decades that human cells migrate by circulating cell surface adhesion receptors from one part of the cell to another. Earlier studies have also shown that cancer cells have developed particularly efficient ways to circulate these […].

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ProRelix Research

SEPTEMBER 26, 2023

Endocrine disorders result from the improper functioning of endocrine glands that secrete and regulate hormones responsible for functioning of various organs.

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BioTech 365

JANUARY 6, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Researchers use deep learning to identify gene regulation at single-cell level.Scientists at the University of California, Irvine have developed a new deep-learning framework that predicts gene regulation … Continue reading (..)

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Camargo

DECEMBER 20, 2021

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.

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Trialfacts

OCTOBER 15, 2023

More Study Details About the Research Center: Research Center: University of Texas at Austin (School of Nursing) Location: This is a nationwide virtual study. Lead Researcher: Megan C. But researchers need your help to get there. Participants will be helping to advance mental health research. Why Participate?

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Drug Discovery World

SEPTEMBER 5, 2023

In the eleventh eBook of the Hamilton series ‘Analytical Methods for Viral Vector Development and Manufacturing in Gene Therapy’, we learn about: Gene therapy: history, viral vectors and the role of CDMOs Automation of analytical assays during viral vector development and manufacturing The solutions that Hamilton offers to customers working (..)

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