Clinical Research Informer

Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Rethinking Clinical Trials

OCTOBER 26, 2023

Fleurence, PhD, MSc Senior Advisor National Institutes of Health Joshua M. To address this crisis, the NIH is embarking on a National Initiative on Hepatitis C. Speakers Rachael L. with the rate of reported acute Hepatitis C cases increasing 400% during 2010-2020. Rates are the highest among 20-39-year-olds.

Clinical Research

Clinical Research Clinical Trials Clinical Trials Research

Grand Rounds July 8, 2022: Results From the COVID-OUT Trial, A Phase-3 Trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jared Huling, PhD)

Rethinking Clinical Trials

AUGUST 22, 2022

Core Faculty, Program for Health Disparities Research. University of Minnesota School of Public Health. University of Minnesota School of Public Health. Some aspects were a success, particularly delivery of study medication nation-wide within 1 day of consent. University of Minnesota Medical School. Thomas Murray, PhD.

Trials

Trials Clinical Trials Clinical Trials Insulin

Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Rethinking Clinical Trials

AUGUST 23, 2022

Associate Professor, Global Health. There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. This is an issue that a number of institutions have been thinking about for some time. Michelle Kelsey, MD.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

Risk-sharing agreements are growing at a rate of 24%

Pharmaceutical Technology

FEBRUARY 10, 2023

This is not the first treatment to come with a high price tag. On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5

Gene Therapy

Gene Therapy Marketing Gene Drugs

Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

Rethinking Clinical Trials

OCTOBER 11, 2023

The Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) initiative at the National Heart, Lung, and Blood Institute (NHLBI) is their first major effort to conduct implementation research. However, in an implementation trial, these are the most interesting measures.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data

XTalks

OCTOBER 26, 2021

After initial rejection from the National Institute for Health and Care Excellence (NICE) last year, the non-departmental public body of the Department of Health in England has now given the green light to the gene silencing treatment Givlaari (givosiran) for the treatment of the rare metabolic disorder, acute intermittent porphyria (AIP).

Gene Silencing

Gene Silencing Gene Clinical Trials Clinical Trials

Oslo Medicines Initiative asks how to balance innovation incentivisation with security of access

pharmaphorum

JANUARY 21, 2022

“Access to medicines remains one of the most challenging policy areas in every country we work with through the pan-European region,” said Natasha Muscat, Director of Country Health Policies and Systems at World Health Organization (WHO) Europe. WHO is OMI? And that’s exactly what the OMI is setting out to do. About the author.

Medicine

Medicine Marketing Manufacturing Production

Novartis’ $2 Million Gene Therapy Zolgensma Shows ‘Remarkable’ Results and Offers Hope for Children with SMA

XTalks

JUNE 8, 2021

With a price tag of over $2.5 In England, five-month old baby Arthur became the country’s first SMA patient to receive the Zolgensma gene therapy last week through the National Health Service (NHS). million, Zolgensma is currently the world’s most expensive drug. Related: Is $2 Million Too Much For FDA-Approved SMA Gene Therapy?

Gene Therapy

Gene Therapy Gene Protein Trials

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

JUNE 8, 2021

That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” billion in 2027.

Drugs

Drugs Marketing FDA Approval Trials

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

FEBRUARY 27, 2024

According to the National Cancer Institute (NCI), it is estimated that approximately 8,000 people die from melanoma every year in the US. Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.” Among responders, after 18.6

FDA Approval

FDA Approval Manufacturing In-Vivo Trials

After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

pharmaphorum

DECEMBER 23, 2022

price tag of $475,000 when it was first launched in 2017 – and it becomes apparent that these may not be desirable treatment options for every patient and in every setting. Add to this the considerable cost of these medications – the first approved CAR-T, Novartis’ Kymriah (tisagenlecleucel), had a U.S. Professional reception of the findings.

Development

Development Drugs Clinical Development Antibody

Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)

Rethinking Clinical Trials

FEBRUARY 22, 2023

The study is enrolling people where they are using social media, such as Facebook ads, twitter influencers, tv ads, interviews with print/electronic news outlets, national tv (an appearance on “The Talk” to discuss the study), targeted advertising, physicians, electronic health records. There was news pushed out about general health.

Clinical Trials

Clinical Trials Clinical Trials Trials Nurses

New Rare Disease Drugs and Research Advancements

XTalks

FEBRUARY 27, 2024

Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research

Research Drugs Gene Therapy Clinical Trials

Omicron Designated as a Variant of Concern by WHO: What We Know About It So Far

XTalks

NOVEMBER 27, 2021

The World Health Organization (WHO) has declared the new variant of SARS-CoV-2 found in South Africa, first referred to as B.1.1.529, The technical advisory group on SARS-CoV-2 virus evolution (TAG-VE) met on Friday to discuss B.1.1.529, 1.1.529, two days after it was first reported to the global health agency by South Africa.

Vaccination

Vaccination Vaccine Protein Scientist

What to expect from PEGS Europe 2023: Day 2

Drug Discovery World

NOVEMBER 9, 2023

Torbjörn Gräslund, PhD, Professor, Department of Protein Science, KTH Royal Institute of Technology, on: ‘The influence of DM1, MMAE, and MMAF on biodistribution and preclinical therapeutic efficacy of affibody-based drug conjugates’.

Engineer

Engineer Antibody Protein In-Vivo

How data is crucial to the relaunch of the Cancer Moonshot

pharmaphorum

OCTOBER 4, 2022

During the first stage of the initiative, more than 2,000 research papers were published, 49 clinical trials were carried out, and more than 30 patents were filed through the support of the US National Cancer Institute (NCI). Building a bank.

Biobanking

Biobanking Clinical Trials Clinical Trials Trials

Tackling the Challenges of Limited Resources During a Pandemic

The Pharma Data

MARCH 20, 2021

Whether the scale of these labs is at the national level, processing hundreds of thousands of samples a day, through to small-scale and agile laboratories testing at an organizational level, there is a place in the workflow to accommodate automation. The Weatherall Institute of Molecular. Manager, Weatherall Institute, Oxford UK.

Reagent

Reagent RNA Bioinformatics Medicine

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% were overweight but not obese.

Drugs

Drugs Manufacturing Hormones Contract Manufacturing

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% were overweight but not obese.

Drugs

Drugs Manufacturing Hormones Contract Manufacturing

Clinical Research Informer

Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Grand Rounds July 8, 2022: Results From the COVID-OUT Trial, A Phase-3 Trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jared Huling, PhD)

Trending Sources

Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Risk-sharing agreements are growing at a rate of 24%

Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data

Oslo Medicines Initiative asks how to balance innovation incentivisation with security of access

Novartis’ $2 Million Gene Therapy Zolgensma Shows ‘Remarkable’ Results and Offers Hope for Children with SMA

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)

New Rare Disease Drugs and Research Advancements

Omicron Designated as a Variant of Concern by WHO: What We Know About It So Far

What to expect from PEGS Europe 2023: Day 2

How data is crucial to the relaunch of the Cancer Moonshot

Tackling the Challenges of Limited Resources During a Pandemic

The “Medical Bypass”: new drugs to strike obesity

The “Medical Bypass”: new drugs to strike obesity

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