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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Quality Issues Lead to Shortages of Common Cancer Drugs
June 12th 2023More than 90% of cancer centers have experienced shortages of critical drugs. Erin R. Fox, Pharm.D., University of Utah Health, talks about why these shortages are happening and efforts that are being made to address them.
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FDA Updates for the Week of June 5, 2023
June 10th 2023The FDA has made three approvals this week: a novel drug for dry eye disease, a new indication for Prevymis to prevent CMV disease in adult kidney transplant recipients, and another prostate cancer indication for Lynparza. The agency has also set target action dates for the first CRISPR gene edited therapy and a supplement indication for Jemperli for earlier treatment of endometrial cancer. Additionally, Janssen submitted sBLA for Carvykti for early treatment of myeloma.
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Two New Therapies for Dry Eye Will Soon be on the Market
June 9th 2023The FDA has approved two novel therapies for patients with dry eye disease: Vevye (previously CyclASol) is a water-free, preservative-free solution, and Miebo, which address the excessive tear evaporation that is seen with dry eye.
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FDA Sets PDUFA Dates for First CRISPR Gene Edited Therapy
June 9th 2023Exagamglogene autotemcel is being evaluated for patients with sickle cell disease and beta thalassemia, in which a patient’s own hematopoietic stem cells are edited to produce high levels of fetal hemoglobin in red blood cells.
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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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