FDA Updates for the Week of Jan. 3, 2023
January 7th 2023The FDA ends the week with the approval of the Alzheimer’s medication lecanemab. Two other approvals include: Olpruva for urea cycle disorders and Wegovy for weight loss in teens. The agency has also accepted several applications, including Genentech’s second bispecific antibody, glofitamab, for blood cancer, UCB’s second application for generalized myasthenia gravis, and a therapy RSV prevention in infants. Two companies have submitted applications: Celltrion for a new formulation of infliximab and Orasis for blurry vision treatment.
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FDA Approves New Alzheimer's Drug, Leqembi. Can It Escape Aduhelm's Fate?
January 7th 2023Leqembi's starting price is almost half of what Aduhelm's was and the FDA-approved label narrows use to people with early disease. But Medicare coverage restrictions may still apply and there is concern about a side effect called ARIA (amyloid related imaging abnormalities).
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Most-Listened to Podcasts of 2022
December 31st 2022This year's most-listened to podcasts include a conversation with Jim Graham of Prime Therapeutics about a digital transformation management system in healthcare and another with Tim Ashe of WellSky on how to save Medicare home healthcare.
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Best Read Healthcare Trend Stories in 2022
December 30th 2022Among the best-read healthcare trend and PBM-related stories are ICER’s report on unsupported prices, fake drugs containing meth, an anti-tau drug that shows promise in Alzheimer’s, oncology docs say prior auth hurts patients, and satisfaction with PBMs declines.
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Most-Read Conference Coverage of 2022
December 25th 2022Conference season was a busy one this year with many stories to come out each one MHE covered. The most-read conference stories from our audience began with Atopic Dermatitis treatment at AMCP to discussion series with PBM leader Alan Lotvin of CVS Caremark.
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FDA Updates for the Week of Dec. 19, 2022
December 24th 2022In a busy week for FDA approvals, the agency cleared several first in class therapies: a treatment for HIV-1 and for follicular lymphoma. Other approvals include: Tymlos for osteoporosis in men; Vraylar for major depressive disorder; Cytalux to identify lung cancer during surgery. In COVID-19 news, the agency approved Actemra for hospitalized patients. The FDA has also accepted a sBLA for Padcev, Keytruda combo for urothelial cancer.
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To Proactively Address SDOH, the ‘Top of Funnel’ is Critical
December 20th 2022We can identify and engage the right people. But to make a real difference in any community, a managed care organization, government agency or healthcare system needs to have a robust list/dataset of its population so the tools, processes and individuals that come after can do the work to identify and engage members with the highest needs.
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FDA Updates for the Week of Dec. 12, 2022
December 17th 2022In COVID-19 news, the FDA granted fast track designation to COVID-19-flu vaccine combo. The FDA has approved the first gene therapy for bladder cancer, an 8th biosimilar referencing Humira, granted accelerated approval for KRAS-mutated lung cancer therapy, and approved Iyuzeh to reduce intraocular pressure. The agency also extended review of Lynparza/abiraterone combination for prostate cancer. In addition, two companies have submitted applications: Soligenix for a novel therapy for cutaneous T-cell lymphoma and AbbVie for Linzess in children and adolescents.
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Health Plan Executives Like Transparency Benefits, but Say Compliance is Complex
December 16th 2022Another component of the government’s Transparency in Coverage mandate and No Surprises Act legislation for health insurance plans will go into effect on January 1, 2023 for price transparency.
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The Merging Market Today in Healthcare, According to Chuck Salvo of ToneyKorf Partners
December 15th 2022In this week's episode, Briana Contreras, an editor of Managed Healthcare Executive, spoke with Chuck Salvo managing director of ToneyKorf Partners. The pair touched on topics involving mergers between healthcare organizations, the question whether CEO's are being replaced and the importance of a board in a healthcare organization.
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Differences in Patient Characteristics, Treatment of EoE by Allergists and Gastroenterologists
December 12th 2022Most (91%) of the patients were seen by gastroenterologists. Those seen by allergists were more likely to have comorbid atopic conditions, such as asthma, allergic rhinitis and atopic dermatitis.
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Biocon Biologics Completes $3 Billion Acquisition of Viatris’ Biosimilars
December 12th 2022The acquisition provides Biocon Biologics with eight commercial biosimilars, and is part of Viatris’ efforts to pay down debt related to phase 1 research and the company’s acquisition of two ophthalmology businesses.
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COVID Cases Are Less Harsh, Amid 'Certainly' Still Being in the Middle of a Pandemic
December 11th 2022Dr. Syra Madad of the NYC hospital system and an Infectious Disease Epidemiologist at Harvard's Belfer Center for Science and International Affairs responded to Dr. Anthony Fauci's, director of NIAID, statement made in late November that the U.S. is “certainly” still in the middle of a Covid-19 pandemic.
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FDA Updates for the Week of Dec. 5, 2022
December 10th 2022In COVID-19 news, the FDA has expanded the updated bivalent vaccines EUA to children. The FDA has requested athe removal of Pepaxto indication for multiple myeloma. Regulators have also accepted several applications for: Biogen’s Actemra biosimilar, Pfizer’s RSV vaccine, a resubmitted BLA for Fabry disease. Two companies — Janssen’s and Alnylam — have submitted new applications.
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