June 2023 - August 2023
Why Recent Regulatory Changes Require a Deeper Focus on Health Equity
The 2023 EY Health Equity Outlook Report found that while there has been strong cross-sector momentum on health equity priorities across the health ecosystem, efforts remain nascent. Despite broad awareness of the challenges, health industry organizations have not universally developed strategies to address harmful social determinants of health, and many are not yet able to measure the impact of their interventions on vulnerable patient populations. In brief, the federal government strengthened its commitment to health equity advancement in its regulatory portfolio, new standards will require a transformation of organizational culture and operations, and organizations should focus on linking health equity data to actionable strategies.
HHS Invests $11 Million to Expand Medical Residencies in Rural Communities
The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded nearly $11 million to 15 awardees to strengthen the health workforce by establishing new residency programs in rural communities. Nearly 70 percent of areas designated as primary medical Health Professional Shortage Areas are in rural areas. Physician shortages, poverty, and geographic isolation contribute to lack of access to care and poorer health outcomes for rural Americans. More than half of rural U.S. counties lack hospital obstetric services. In response to the declining access to rural maternal health care, three of 15 awards will be used specifically to develop new family medicine residency programs with enhanced obstetrical training in rural communities.
Breakthrough Cures for Hepatitis C Still Fail to Reach the Vast Majority of Americans Who Need Them
A new CDC report suggests the majority of people with hepatitis C still have not been cured nearly a decade after breakthrough treatments that clear the viral infection were first approved in the United States. The findings highlight the urgent need for a proposed national program that would end much of the suffering and death from hepatitis C by eliminating the disease in the United States. It’s estimated more than 2 million people in the United States have hepatitis C, which if left untreated, often leads to serious and sometimes deadly outcomes such as liver cancer and liver failure. Despite the existence of a safe and highly effective oral cure for hepatitis C, the infection contributed to the deaths of more than 14,800 people in 2020.
FDA Approves First Oral Treatment for Postpartum Depression
The U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.The efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies. Approval of Zurzuvae was granted to Sage Therapeutics, Inc.
FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia (low blood sugar) despite intensive diabetes management and education. The primary mechanism of action of Lantidra is believed to be the secretion of insulin by the infused allogeneic islet beta cells. In some patients with type 1 diabetes, these infused cells can produce enough insulin, so the patient no longer needs to take insulin (by injections or pump) to control their blood sugar levels.
As Part of President Biden’s Unity Agenda, Cancer Moonshot Announces Launch of New ARPA-H Program to Develop Novel Technologies for More Precise and Accurate Cancer Tumor Removal
The Biden Cancer Moonshot announced a first-of-its-kind Advanced Research Projects Agency for Health (ARPA-H) program to develop novel technologies that will allow surgeons to remove cancerous tumors with more precision and accuracy, resulting in better health outcomes for Americans facing cancer. Program launch represents a major milestone for the new agency established and funded by President Biden and bipartisan members of Congress to revolutionize how we improve health outcomes for Americans facing cancer and other diseases.
Study: AI-Supported Mammogram Screening Helped Doctors Detect 20% More Breast Cancer Cases
Artificial intelligence (AI) may be able to better detect breast cancer on mammogram images than trained doctors, a new study found. New research found that AI-supported mammogram screening was 20% more likely to detect breast cancer than trained doctors. Researchers emphasized that the technology needs to be used in tandem with a radiologist, but it could make the screening process more accurate and efficient.This is particularly important as the United States is facing both a shortage of radiologists and an aging population that requires more imaging as part of their health care.
Fierce Pharma Asia - BMS, BeiGene strike settlement: Sumitomo Otsuka suffer Trial Failures: AstraZeneca CEO talks China
Bristol Myers Squibb and BeiGene have decided to terminate their China licensing deal originally signed in 2017 by Celgene around the cancer drugs Revlimid, Abraxane and Vidaza. The settlement puts an end to a feud that stemmed from a Chinese import and sale ban on Abraxane. A pair of phase 3 studies for Sumitomo Pharma and Otsuka’s schizophrenia candidate ulotaront missed their primary endpoints. In response to a question about a recent Financial Times report that AstraZeneca has crafted plans to spin out its China operations in case of rising geopolitical tensions, AstraZeneca CEO Pascal Soriot said the company studies many business scenarios.
Biden-Harris Administration Launches National Dashboard to Track Heat-Related Illness
The U.S. Department of Health and Human Services (HHS) Office of Climate Change and Health Equity (OCCHE), in partnership with the National Highway Traffic Safety Administration (NHTSA), launched a first-of-its-kind online information portal called the Heat-Related Illness EMS Activation Surveillance Dashboard (“EMS HeatTracker”), which maps emergency medical services responses to heat-related illness across the country. The tracker will help public health officials ensure that outreach and medical aid reach the people who need it most and help decision-makers prioritize community resilience investments. This tool is being published as the climate crisis makes heat waves more extreme and more frequent around the country. It is the latest step by the Biden-Harris Administration to provide communities with the support and resources they need to stay safe from the worsening effects of extreme heat.
Microplastics found in human heart tissues, both before and after surgical procedures
Everywhere scientists look for microplastics, they've found them -- food, water, air and some parts of the human body. But examinations of our innermost organs that aren't directly exposed to the environment are still limited. Now, in a pilot study of people who underwent heart surgery, researchers in ACS' Environmental Science & Technology report that they have found microplastics in many heart tissues. Research has shown that they can enter the human body through mouths, noses and other body cavities with connections to the outside world. Yet many organs and tissues are fully enclosed inside a person's body, and scientists lack information on their potential exposure to, and effects from, microplastics.