Global biopharmaceutical company Mallinckrodt plc announced results of a retrospective, observational medical chart review subgroup analysis assessing real-world treatment outcomes among African Americans with advanced symptomatic sarcoidosis who initiated therapy with Acthar Gel (repository corticotropin injection).
The U.S. Food and Drug Administration on April 28 issued a long-awaited proposal to ban menthol cigarettes and flavored cigars, a major victory for anti-smoking advocates but one that could face stiff opposition from Big Tobacco.
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American Indians, Asians, Clinical Trials, Diversity, Diversity, Diversity & Inclusion, Diversity/Equity/Inclusion, Draft Guidance, Ethnicity, FDA, FDA Oncology Center of Excellence, Hispanics, Latino, Patient Enrollment, Patient Recruitment, R&D, Racial diversityThe U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials – expanding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.
A new research study by Klick Health and ThinkNow reveals significant cultural differences in the way Hispanics deal with their health – reinforcing the need for cross-cultural marketing programs by healthcare companies targeting this growing population segment.
Black women in the United States were nearly three times as likely to die during or shortly after pregnancy over the first year of the COVID-19 pandemic than white women, according to a government report published on February 23.
FDA’s ODAC Says Lilly & Innovent Must Run U.S. Trial
Business, Checkpoint Inhibitors, China, Clinical Trial Endpoints, Clinical Trials, Ethnicity, FDA/Regulatory, Lung Cancer, Oncologic Drugs Advisory Committee (ODAC), PD-1 Inhibitors, Primary Endpoints, Progression-Free Survival (PFS), R&D, Therapeutics, United StatesThe Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
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.
On January 17, America is celebrating the legendary life of civil rights leader Dr. Martin Luther King Jr. In 2022, the holiday comes in the wake of two years of racial tensions and protests, and the racial inequities exposed by the COVID-19 pandemic. BioSpace is marking the occasion by sharing some of its recent coverage about what the life sciences industry is doing to even those scales.
Health Technology Special Feature: Not Always Created Equal
Artificial Intelligence, August 2021, Data, Data Analysis, Ethnicity, Health Technology, Healthcare Communications Agencies, Issue Archives, Marketing & Advertising, Med Ad News, New England Journal of Medicine, Patients, Race, Special Features, TransparencyData and AI scientists must strive to eliminate bias from anything that touches patient care.
Younger adults are seeking out Covid-19 vaccines at a slower rate than older adults, and if that pace of vaccination continues through August, vaccine coverage among younger adults will not reach levels achieved with older adults, U.S. Centers for Disease Control and Prevention (CDC) reported on June 21.