FDA Updates: Week of June 27, 2022
July 2nd 2022In COVID-19 news, the FDA has declined an EUA request for Zyesami and Pfizer has submitted NDA for Pavlovid. The regulatory agency has accepted several applications, including an sBLA for Eylea in diabetic retinopathy and the NDA for palovarotene for a rare genetic disorder. The FDA also issued a CRL for a UTI therapy and extended the review of diabetes therapy. And finally, Gilead has resubmitted its twice-year HIV therapy.
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Using Predictive and Prescriptive Insights to Close Care Gaps
July 1st 2022By using a combination of predictive and prescriptive next best action insights, providers can close the gap in care for individual patients by leveraging a combination of data sources — clinical data, patient surveys, SDOH data, and consumer and behavioral data sets — and applying artificial intelligence techniques to create those insights.
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The Association for Community Affiliated Plans has launched The ACAP Center for Social Determinants of Health Innovation. The center offers tailored resources, including policy reports, market research, and roundtable educational events, to help health plans, policymakers, and other stakeholders address social issues that impact health and wellbeing
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Adolescent Mental Health is Worsening with Varied Impacts by Race, Sex, Sexual Orientation
June 29th 2022A recent issue brief from the Kaiser Family Foundation says anxiety and depression, drug overdose deaths, self-harm and eating disorders have increased in adolescents as access and utilization of mental health care has declined.
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Making Contraception More Available
June 23rd 2022Demand for birth control obtained through telehealth or without a prescription continues to grow, and some states have loosened up their rules. Meanwhile, groups and organizations involved in contraception are bracing themselves for the effects of the U.S. Supreme Court decision today overturned Roe v. Wade and the constitutional right to abortion.
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FDA Updates for Week of June 13, 2022
June 18th 2022In COVID-19 news, the FDA expanded emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 Vaccine for children down to 6 months of age. The FDA also approved Skyrizi for Crohn’s disease, Olumiant for alopecia, as well as two rare disease therapies: Imcivree for obesity associated BBS and Amvuttra for neuropathy associated with rare disease. Additionally, FDA extended the PDUFA date Brukinsa.
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Enbrel Stays Above the Biosimilar Fray, but Humira Biosimilars May Nip at its Heels
June 15th 2022Amgen’s biologic won’t have biosimilar competition till 2029. But the possibility that up to 11 Humira biosimilars may come on the market in 2023 could exert some downward pressure on Enbrel’s price.
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The Future of Employer Sponsored Healthcare Plans Is Cost Management
June 12th 2022Adding tax-preferred savings, perhaps with an employer match, can prompt employees to accumulate assets so they are prepared to shoulder out-of-pocket costs. Using reference-based pricing can establish benchmark fees and put a ceiling on payments across a network.
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FDA Updates for the Week of June 6, 2022
June 11th 2022In COVID-19 news, an FDA advisory committee recommends EUA for Novavax’s vaccine. The FDA has also granted approvals to Dupixent for children as young as 6 month with atopic dermatitis and to the biosimilar Riabni for rheumatoid arthritis. An advisory committee has also recommended approval for two gene therapies, one for a rare neurogenerative disease and another for a blood disease.
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FTC Launches Inquiry Into PBM Industry
June 7th 2022The Federal Trade Commission says its inquiry “will shed light on” clawbacks, potentially unfair audits, rebates and other business practices of the pharmacy benefits management (PBM) industry. Today’s announcement says the commission will be requiring information from the six largest PBMs.
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