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FDA takes important steps to increase racial and ethnic diversity in clinical trials

African-Americans, American Indians, Asians, Clinical Trials, Diversity, Diversity, Diversity & Inclusion, Diversity/Equity/Inclusion, Draft Guidance, Ethnicity, FDA, FDA Oncology Center of Excellence, Hispanics, Latino, Patient Enrollment, Patient Recruitment, R&D, Racial diversity

The U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding on the agency’s previous guidances for industry to improve clinical trial diversity.

April 13, 2022/by PR Newswire

Biogen Bumps Up Diversity for Post-Marketing Aduhelm Trial

Advisory Committees, African-Americans, Alzheimer’s disease, Biogen, Business, Centers for Medicare and Medicaid Services (CMS), Clinical Trials, Diversity, Eisai, Ethnicity, FDA, Hispanics, Latino, Postmarket Studies, R&D, Therapeutics

While the Centers for Medicare & Medicaid Services undergoes the comment period on its national coverage decision for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), Biogen and its partner company Eisai released additional details about the Phase IV post-marketing study of the drug.

January 27, 2022/by BioSpace

Novavax completes enrolling 30,000 people in U.S. trial of Covid-19 vaccine

African-Americans, Biomedical Advanced Research and Development Authority (BARDA), Clinical Trials, COVID-19 Vaccines, Latino, Mexico, Novavax, R&D, Reuters, Serum Institute of India, United Kingdom, United States

Drug developer Novavax Inc. completed enrolling 30,000 volunteers in a late-stage study of the company’s Covid-19 vaccine in the United States and Mexico.

February 22, 2021/by Andrew Humphreys

Poll: 47% of Americans Hesitant to Get Covid-19 Vaccine

21st Century Cures Act, African-Americans, Caucasians, COVID-19 Vaccinations, Latino, Los Angeles Times, NPR, Online, Polls, Surveys, U.S. Centers for Disease Control and Prevention, United States, Washington

Many Americans are hesitant to be vaccinated against Covid-19, according to research from Invisibly.

January 22, 2021/by Andrew Humphreys

Abbott Becomes First Anchor Sponsor of American Diabetes Association’s Health Equity Now Initiative

African-Americans, American Diabetes Association, Asians, Business, Coronavirus Disease (COVID-19) Pandemic, Diabetes, Health Disparities, Household Income, Initiatives, Latino

Abbott became the first anchor sponsor of the American Diabetes Association’s Health Equity Now platform to address health disparities for people with diabetes.

November 18, 2020/by PR Newswire

Moderna’s Covid-19 vaccine shows similar immune response in old and young

African-Americans, Agreements, American Indians, Analysis, Business, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Vaccines, Immune Response, Immunizations, Interim Data, Latino, R&D, Shares, U.S. Centers for Disease Control and Prevention, U.S. government

Moderna Inc. said an analysis of the early-stage data of the company’s experimental Covid-19 vaccine showed mRNA-1273 induced immune responses in older adults that were similar to younger participants.

August 26, 2020/by Andrew Humphreys