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."

Development 147

Development Research Clinical Trials Clinical Trials 147

Drug Discovery World

JUNE 29, 2023

Cancer Research UK has joined the PRIME-ROSE project, a Europe-wide effort to boost patient access to precision cancer medicine (PCM). ” The post Cancer Research UK joins precision cancer medicine consortium appeared first on Drug Discovery World (DDW).

Medicine 52

Medicine Research Trials Clinical Trials 52

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.

Gene Expression 97

Gene Expression Regulation Gene DNA 97

Drug Discovery World

MARCH 23, 2023

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.”

Clinical Trials 93

Clinical Trials Clinical Trials Regulation Trials 93

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.

Regulation 122

Regulation Production Development Sales 122

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.

Regulation 72

Regulation Trials Clinical Trials Clinical Trials 72

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.

Hormones 75

Hormones Regulation Research Protein 75

Drug Discovery World

OCTOBER 16, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. The post UK regulator cuts late-stage clinical trial approval time to two weeks appeared first on Drug Discovery World (DDW).

Clinical Trials 52

Clinical Trials Clinical Trials Regulation Trials 52

Drug Discovery World

JANUARY 23, 2024

Sano Genetics, a software company working to accelerate precision medicine research, has raised $11.4 Access and referrals for patients to join trials often depend on the hospital or location where they’re receiving treatment – which is why recruiting for clinical trials is one of the biggest challenges in research.

Medicine 52

Medicine Genetics Clinical Trials Clinical Trials 52

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,

Regulation 57

Regulation DNA Research Development 57

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. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients.

Cardiology 98

Cardiology Regulation Drugs Licensing 98

Scienmag

JANUARY 19, 2022

Seeking to better understand the key role the female hormone estrogen plays in maintaining energy balance and weight control, a group led by researchers at Baylor College of Medicine looked into estrogen interactions with specific brain regions that provide these anti-obesity benefits.

Regulation 64

Regulation Research Hormones Medicine 64

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.

Regulation 52

Regulation Clinical Trials Clinical Trials Trials 52

Drug Discovery World

SEPTEMBER 21, 2022

According to a study published in Cell Reports, the breast cancer cells regulate their own metastases by fuelling dissemination from the original tumour and determining routes to invade distant organs like the lungs. The post Breast cancer cells ‘regulate their own metastases’ appeared first on Drug Discovery World (DDW).

Regulation 52

Regulation Protein In-Vivo Scientist 52

pharmaphorum

JANUARY 13, 2022

In 2020, over half of total spending on brand medicines went to the supply chain, middlemen and other stakeholders, overtaking the amount going to drug manufacturers for the first time, according to a new study. ” The post Supply chain middlemen ‘pocket half of US branded medicine spending’ appeared first on. .

Branding 111

Branding Medicine Manufacturing Pharmacy 111

Drug Discovery World

FEBRUARY 12, 2024

The Engineering Biology Mission Award was given by UK Research and Innovation (UKRI). The top ten selling medicines worldwide and multiple vaccines, including those for Covid-19, hepatitis B and whooping cough, target membrane proteins. for drug discovery research appeared first on Drug Discovery World (DDW).

Research 105

Research Drugs Engineer Protein 105

Drug Discovery World

SEPTEMBER 20, 2023

Eurofins Genomics has adopted Olink technology to advance proteomics research and accelerate its precision medicine programmes. The collaboration is designed to bolster the company’s offerings in the fields of research, population health, and regulated clinical trials. Join now for FREE – it takes less than 2 minutes!

Genome 59

Genome Genomics Research Clinical Trials 59

XTalks

APRIL 18, 2024

In this episode of the Xtalks Food Podcast, Sydney talks about the discovery of elevated lead levels in cinnamon products, which has prompted a closer look at food safety practices and regulations. Also in this episode, Sydney talks about Kaiser Permanente’s new Food Is Medicine Center of Excellence.

Medicine 52

Medicine Contamination Packaging Packaging 52

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.

Clinical Research 52

Clinical Research Compliance Research Regulation 52

BioTech 365

NOVEMBER 30, 2020

Gain Therapeutics and University of Maryland School of Medicine Announce Research Collaboration Gain Therapeutics and University of Maryland School of Medicine Announce Research Collaboration Partnership to investigate Gain’s structurally targeted allosteric regulator candidates (STARs) in cellular models of Gaucher disease … Continue reading (..)

Medicine 40

Medicine Research Regulation 40

Scienmag

MAY 13, 2021

Credit: Martin Visser, Unsplash Humans in the 21st century spend most of their time indoors, but the air we breathe inside buildings is not regulated to the same degree as the food we eat and the water we drink. A group of 39 researchers from 14 countries, including two from the University of Colorado Boulder, […].

Regulation 100

Regulation Scientist Research Engineer 100

Scienmag

JUNE 25, 2021

New study identifies possible therapeutic target to suppress cancer cell growth Credit: UCI School of Medicine Irvine, CA – June 25, 2021 – New research from the University of California, Irvine reveals how the circadian regulation of glucose production in the liver is lost during lung cancer progression, and how the resulting increase (..)

Regulation 53

Regulation Production Medicine Research 53

Drug Discovery World

SEPTEMBER 27, 2023

“Approximately two-thirds of newly-diagnosed myeloma patients are not eligible for a transplant, and now, at long last, they’ll be able to benefit from a potentially life-extending treatment that could give them precious time with their loved ones,” said Shelagh McKinlay, Director of Research and Advocacy at blood cancer charity Myeloma UK.

Regulation 52

Regulation Life Science Licensing Licensing 52

pharmaphorum

APRIL 11, 2022

Janssen’s Catherine Taylor, vice-president, EMEA medical affairs, therapy area strategy, discusses the importance of systemic innovation across the healthcare system to realise the full value of medicines. Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world.

Medicine 115

Medicine Clinical Trials Clinical Trials Development 115

pharmaphorum

OCTOBER 12, 2022

The Eureka Institute, a Syracuse, Italy-based non-profit, is focused on addressing this disparity by providing education, research, and advocacy around the field of translational medicine. Translational medicine and digital health. The group will be leading a workshop on the topic at Frontiers Health next week.

Medicine 111

Medicine Regulation Scientist Development 111

Drug Discovery World

FEBRUARY 8, 2023

The post Study shines a light on representation in clinical research appeared first on Drug Discovery World (DDW). The study confirmed that in four disease areas (asthma, COPD, HIV and influenza) census data differed from the epidemiological data. For example, US Census Bureau data indicates 13.4%

Clinical Research 97

Clinical Research Research Clinical Trials Clinical Trials 97

Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

Medicine 52

Medicine Scientist Production Regulation 52

Medical Xpress

MARCH 21, 2023

Researchers at Lund University Faculty of Medicine have determined a novel mechanism linking the metabolism of ribonucleic acids, RNA, to the development of leukemia in myelodysplastic syndrome (MDS) patients.

RNA 72

RNA Regulation Medicine Development 72

Pharmaceutical Technology

FEBRUARY 24, 2023

The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

Regulation 162

Regulation Clinical Trials Clinical Trials Medicine 162

Scienmag

OCTOBER 6, 2021

Researchers at the Centre for Genomic Regulation (CRG) and Pulmobiotics S.L have created the first ‘living medicine’ to treat antibiotic-resistant bacteria growing on the surfaces of medical implants. Credit: María Lluch/CRG Researchers at […]. Credit: María Lluch/CRG Researchers at […].

Medicine 40

Medicine Bacteria Genome Genomics 40

STAT News

JANUARY 10, 2023

That process is roughly equivalent to how regulators review new medicines. ” Specifically, the researchers looked at cases in which a newer device was cleared using a comparison to the recalled device. Continue to STAT+ to read the full story…

Research 135

Research Regulation Production Manufacturing 135

Drug Discovery World

JUNE 2, 2023

Health data generated by hospitals, healthcare providers, research organisations and clinical trials hold the potential to advance research and innovation, improve patient care and accelerate drug development. Lifebit’s Trusted Research Environment technology provides real-world data on cancer patients.

Research 52

Research Compliance Clinical Trials Clinical Trials 52

Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA). Post market research for monitoring drug safety. Why are Post- Marketing studies conducted.

Marketing 80

Marketing Research Clinical Trials Clinical Trials 80

Drug Discovery World

MARCH 19, 2024

DDW’s Diana Spencer speaks to Elaine Duncan, a PhD student on the lifETIME (Engineered Tissues for Discovery, Industry and Medicine) CDT at the University of Glasgow. ED : I’m currently a PhD researcher at the University of Glasgow. DS: What drug discovery breakthrough has been most impactful to your research?

Research 59

Research In-Vitro Drugs Engineer 59

pharmaphorum

APRIL 14, 2021

More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing international health research to thrive? . Said the authors: “Health research is crucial for all. The mechanisms by which GDPR endangers research are multiple and complex.

Research 145

Research Regulation Genome Genomics 145

Drug Discovery World

APRIL 11, 2023

US-based start-up Atomic AI is using artificial intelligence (AI) to design more intelligent RNA-targeted and RNA-based medicines. As tech experts call for improved regulation and a halt to the development of AI, we take a look at how one company, Atomic AI, is using it to develop RNA-targeting treatments for a range of diseases.

RNA 52

RNA Medicine Engineer Drugs 52

pharmaphorum

JANUARY 13, 2021

Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA said its regulatory framework remains fully functional and timelines relating to review and approval of COVID-19 medicines and vaccines are not affected.

Regulation 82

Regulation Vaccination Vaccine Medicine 82