Inpefa, a New Heart Failure Drug, Surpasses Cost-Effectiveness Threshold
June 6th 2023Inpefa (sotagliflozin) added 0.39 quality of life years at an incremental lifetime cost of $29,449 for an incremental cost-effectiveness ratio of $75,510 per quality-of-life year gained, according to the study that was sponsored by the drug's maker, Lexicon Pharmaceuticals.
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FDA Updates for the Week of March 20, 2023
March 25th 2023FDA approvals this week include: novel treatment for invasive candidiasis, an accelerated approval to Zynyz for Merkel cell carcinoma, the high-concentration Humira biosimilar Hyrimoz, and extension of Evkeeza’s indication to include young children. The agency also issued two complete responses this week: for Incyte’s extended-release Jakafi and for AbbVie’s Parkinson’s therapy.
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University of Virginia Researchers Discover New Target to Prevent Vision Loss
March 24th 2023The discovery of a protein that determines levels of vascular endothelial growth factor-A (VEGF) could lead to new therapies for macular degeneration, diabetic retinopathy and other common causes of vision loss.
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Clinical Trial Addresses the Lack of Diversity in Dermatology Research
March 19th 2023VISIBLE is focused on answering data gaps in people of color with psoriasis. Lead investigator Andrew F. Alexis, M.D., hopes the study will generate data to help address care gaps and inform future best practices in diversity research in dermatology.
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Cancer Treatment's Checkpoint Inhibitors Are Causing Skin-Related Side Effects
March 18th 2023Checkpoint inhibitors, such as Keytruda (pembrolizumab) and Opdivo (nivolumab), are playing a major role in cancer treatment. But they also produce side effects that affect the skin. Steven Chen, M.D., M.P.H., M.H.P. Ed., said dermatologists need to work with oncologists to manage the side effects so patients can stay on checkpoint inhibitors.
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Treatment of Atopic Dermatitis and Psoriasis in People Who Are Pregnant: It’s Complicated
March 18th 2023Women who are pregnant don’t have to stop all of their treatments during pregnancy. Some can be safely treated for their psoriasis or eczema, according to a presentation today at the annual meeting of the American Academy of Dermatology.
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Contact Dermatitis Can Be a Complication of Metal Implants
March 17th 2023Although not a common complication of hip, knee and other metal implants, the number of allergic reactions is growing, partly the number of joint replacements is growing, according to a presentation at the annual meeting of the American Academy of Dermatology. Nickel is the most common contact allergen.
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FDA updates for Week of March 6, 2023
March 11th 2023The FDA has approved a novel nasal spray for migraine and a generic leukemia treatment. The agency has granted priority review to Leqembi for traditional approval but extended the review of hemophilia A gene therapy. Regulators have also assigned target dates for Voxzogo in young children with dwarfism, a skin infection gel, a nerve disorder drug and for Jardiance in children 10 to 17 with diabetes.
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FDA Updates for Week of Feb. 27, 2023
March 4th 2023The FDA has approved Kevzara for an inflammatory rheumatic disease and Skyclarys, the first therapy for rare neuromuscular disease. The agency set an action date for Opdivo for melanoma indication. An advisory committee has supported Pfizer’s RSV vaccine, and Janssen has submitted an NDA for combo tablet for metastatic prostate cancer.
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FDA Updates for Week of Feb. 20, 2023
February 25th 2023The FDA approved several new therapies this week, including a weekly hemophilia A treatment, an extended-release version of Austedo, and the first drug for geographic atrophy due to AMD, as well as an accelerated approval to Filspari for rare kidney disease. The agency also indicated it will hold an advisory committee meeting on Onpattro for heart failure indication, granted priority review for Pfizer’s RSV vaccine and for a life-threatening hereditary immune disease, and also set goal date for blurry vision therapy.
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Formulary Placement and Outcomes to Drive Physician Use of Humira Biosimilars
February 24th 2023Bruce Feinberg, D.O., of Cardinal Health, said significantly changes are on the horizon for biosimilars, but physician comfort with and use of biosimilars will depend on things beyond their control, including formulary placement and utilization management efforts.
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