FDA Updates for Week of June 26, 2023
July 1st 2023Approvals this week include: a $2.9 million gene therapy for hemophilia A; a pediatric growth hormone; the first cell therapy for type 1 diabetes; a new alopecia drug; a therapy for generalized myasthenia gravis; and full approval for Blincyto in B-cell ALL. The agency also rejected a higher dose of Eylea and set an action for hemophilia B gene therapy.
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Stroke Patients in Post-Acute Stage Had Improved Quality of Life While in Hospital-Based Rehab
July 1st 2023Stroke patients treated in home-based and hospital-based rehabilitation had mean scores of QOL assessment improved significantly after intervention. Though, the hospital-based group had better improvement than the home-based group in mobility, self-care, pain/ discomfort and depression/anxiety.
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UnitedHealthcare Removes Out-of-Pocket Costs for Eligible Members Using 24/7 Virtual Visits
June 29th 2023Removing out-of-pocket expenses for the accessible virtual visits may help improve health equity by reducing medical costs for consumers and encourage earlier interventions. In turn, interventions may reduce the risk of complications and avoid visits to more expensive settings like the emergency room.
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Marijuana Use During Different Times of Pregnancy Can Affect Growth of a Newborn
June 29th 2023Data from a survey conducted by Central Michigan University College of Medicine found that newborn weight can be reduced somewhat by marijuana exposure even if it only occurs early in the pregnancy, while reduced head circumference was caused by exposure continued through the second trimester.
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Pearson Stepping Down as Head of ICER, Emond Taking Over
June 28th 2023Sarah K. Emond, M.P.P., will take over as president and CEO of the Institute for Clinical and Economic Review (ICER) next year. Steve Pearson, M.D.,M.Sc., founded the organization, which has become the leading cost-effectiveness assessment organization of pharmaceuticals in the U.S.
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U.S. Latino Patients Cut Down Binge Drinking After Receiving AB-CASI
June 28th 2023Researchers of a study compared the effectiveness of an automated bilingual computerized alcohol screening and intervention (AB-CASI) digital health tool with standard care for the reduction of alcohol consumption among U.S. adult Latino emergency department patients with unhealthy drinking.
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FDA Updates for the Week of June 19, 2023
June 24th 2023The FDA’s approvals this week include: a $3.2 million gene therapy, the first anti-inflammatory drug for cardiovascular disease, a subcutaneous version of Vyvgart for myasthenia gravis and Jardiance and Synjardy for kids with type 2 diabetes. Three rejections by the agency include: a therapy for NASH, for retinal cancer, and for rare fungal infections. In addition, Geron has submitted an NDA for first-in-class therapy for MDS.
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The Protect Patient Access to Pharmacies Act is the Latest Effort Combatting High Pharmacy DIR Fees
June 23rd 2023Recently introduced to the U.S. Senate, the Protect Patient Access to Pharmacies Act (S. 2052) will help to secure Medicare patients’, typically seniors, freedom to receive medications and care from the pharmacy of their choice choice through improvements to the “any willing pharmacy” law.
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The Healthcare Market is Expected to Skyrocket in the Next Decade After a Decline Following the PHE
June 21st 2023According to a report conducted by the Centers for Medicare and Medicaid Services (CMS) Office of the Actuary (OACT), researchers project healthcare spending growth to pick back up and reach $7.2 trillion by 2031.
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FDA Updates for the Week of June 12, 2023
June 17th 2023The FDA has approved a second bispecific antibody to treat patients with diffuse large B-cell lymphoma, as well as Linzess to treat children with constipation. Additionally, an FDA advisory committee recommends approval of Sanofi/AstraZeneca’s RSV vaccine for infants.
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Pre-pandemic Sleep Disorders Associated With Risk of Long COVID, Study Finds
June 15th 2023Some effects of poor sleep (fatigue, daytime dysfunction) resemble some symptoms of long COVID. As it turns out, infected women who were healthy sleepers before and early in the pandemic were less likely to report long COVID symptoms.
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