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What We're Reading: Decision Date on COVID-19 Vaccine for Young Children; AAP Guidance Review; FDA Rebuffs 2 Cancer Therapies
The FDA sets a tentative date for a decision on authorizing a COVID-19 vaccine in children under 5 years of age; the American Academy of Pediatrics will review all of its guidance for unproven race-based recommendations contributing to health disparities; the FDA rejects 2 China-tested cancer treatments.
FDA to Decide on COVID-19 Vaccine Approval for Young Children in June
The New York Times is reporting that the FDA expects June 8 to be the earliest date for when it might authorize a COVID-19 vaccine in children under 5 years of age, who remain the last age group who are not yet eligible to be vaccinated against the disease. Data on the pediatric vaccine applications from Moderna and Pfizer/BioNTech will heard by the agency’s outside advisory committee. In addition, the FDA will present data on June 7 from Novavax regarding its protein-based vaccine in adults, which differs from the mRNA-based vaccines from Moderna and Pfizer/BioNTech.
AAP Set New Policy Aimed at Removing Unproven Race-based Guidance
The American Academy of Pediatrics (AAP) issued a new policy Monday that will assess all its guidance for the presence of flawed recommendations on race-based medicine and other factors that contribute to health disparities. As reported by the Associated Press, the lead author of the new policy noted that the move to reexamine AAP treatment recommendations came amid reports from doctors who were concerned that Black children have been undertreated and overlooked. The academy removed an unproven guideline last year indicating that Black children faced lower risks than White counterparts for urinary infections, with another guidance regarding race-based risk on newborn jaundice set to be reviewed this summer.
FDA Rejects 2 China-Tested Cancer Therapies
Reuters is reporting that the FDA issued a complete response letter (CRL) to 2 China-tested cancer treatments amid concerns that data are not representative of the US patient population. CRLs were sent to Hutchmed on its treatment surufatinib for advanced neuroendocrine tumors and Coherus BioSciences and Shangai Junshi Biosciences on their drug toripalimab to treat a type of nasopharyngeal carcinoma. The decisions were noted to raise concerns on the future of drugs tested in single-country trials, with regulators also citing issues regarding inspection of facilities for both treatments due to delayed travel during the pandemic.
New Data Update Myasthenia Gravis Outcomes for Patients in Australia
December 3rd 2023Patients living with myasthenia gravis in Australia were surveyed their demographic information, clinical features of the autoimmune disease, adverse effects from treatment, and quality of life. Outcomes were compared against 2011 data from Australia and 2019 data from the United States.
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Oncology Onward: A Conversation With Thyme Care CEO and Cofounder Robin Shah
October 2nd 2023Robin Shah, CEO of Thyme Care, which he founded in 2020 with Bobby Green, MD, president and chief medical officer, joins hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, to discuss his evolution as an entrepreneur in oncology care innovation and his goal of positively changing how patients experience the cancer system.
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Health Equity and Access Weekly Roundup: December 2, 2023
December 2nd 2023The Center on Health Equity and Access highlights the most recent updates in the realm of health equity, including news, research findings, and initiatives focused on mitigating health care disparities and enhancing overall access to quality care.
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Insufficient Data, Disparities Plague Lung Cancer Risk Factor Documentation
September 24th 2023On this episode of Managed Care Cast, we speak with the senior author of a study published in the September 2023 issue of The American Journal of Managed Care® on the importance of adequate and effective lung cancer risk factor documentation to determine a patient's eligibility for screening.
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Hospitals Report Declining Cash Reserves, Increasing Reimbursement Delays and Denials
December 1st 2023A new report highlighting the twin pressures hospitals have faced over the last 18 months shows that as reimbursement delays and denials increased and cash and investments decreased, operating expenses have risen sharply.
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