pharmaphorum

SEPTEMBER 27, 2021

As the vaccines were developed and rolled out, the disparity in their take up among different sections of the community highlighted how excluded some minority communities felt from areas of healthcare. In 2020, 53 novel medicines were approved by the FDA and of the patients who took part in trials, just 8% were black and 6% were Asian.

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Clinical Trials Clinical Trials Trials Vaccination 122

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmacovigilance refers to the practice of collecting, detecting, assessing, monitoring and preventing adverse effects (AEs) caused by new drug substances. RWS’ resource management team also had to develop new methods to ensure the availability of linguistic resources and ‘any language, anytime’ capabilities.

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Engineer Production Medicine Trials 130

pharmaphorum

AUGUST 4, 2020

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. Rates of approval.

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Drugs Manufacturing Marketing Regulation 122

Delveinsight

AUGUST 13, 2021

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. Why the Need?

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Clinical Trials Clinical Trials Trials Drugs 98

pharmaphorum

DECEMBER 1, 2022

According to the FDA’s 2020 Drug Trials Snapshot Report , only 8% of clinical trial participants are Black or African American, as compared to nearly 14% of the US population. The fact is, many minorities never learn about vital clinical trials in play, or that they’re eligible to participate.

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Clinical Trials Clinical Trials Trials Clinical Research 111

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. FDA Expedited Programs.

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Clinical Trials Clinical Trials FDA Approval Drugs 52

Advarra

JUNE 27, 2023

This article explores how the clinical research phases protect study volunteers from harm and ensure new drugs and therapies are developed effectively. The Importance of Clinical Research in Medical Advancements Researchers use clinical trials to test a drug’s or other medical treatment’s safety and efficacy.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 10, 2020

Biomarkers will be critical to developing precision medicine for Alzheimer’s disease. Therefore, Eli Lilly is developing an assay that measures P-tau 217 in blood. We wanted a tau antibody that would bind to the expressed forms of tau, so we developed a very specific assay,” Dage said. Michael Vi/Shutterstock.

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Clinical Trials Clinical Trials Trials Antibody 52

XTalks

FEBRUARY 25, 2022

They are also at a high risk of developing heart disease and stroke. times greater risk of developing kidney disease and are 2.3 times greater risk of developing kidney disease and are 2.3 They are also more likely to develop hypertension earlier in life than white individuals. Race-Based Medicine.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

FDA Law Blog

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). National Library of Medicine.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Placebo Control

DECEMBER 4, 2013

Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished. 1001566.

Trials 40

Trials Clinical Trials Clinical Trials Containment 40

FDA Law Blog

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). National Library of Medicine.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Regulation 40

XTalks

AUGUST 4, 2022

This started back in 1993 when the FDA established guidelines to increase diversity by gender and race/ethnicity of participants in clinical trials that were contributing to new drug approvals. In January 2015, the FDA implemented its Drug Trials Snapshots program to make clinical trial demographic data more transparent and available.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022. billion by 2028.

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