FDA Updates for the Week of Aug. 14, 2023
August 19th 2023It was a busy week for the FDA. Regulators approved several new therapies, including the first for a rare bone disorder, a combination product for metastatic prostate cancer and a long-acting botulinum toxin for cervical dystonia, as well as an accelerated approved for multiple myeloma. The agency also set review dates for three products, including for full approval of Tarpeyo for a rare kidney disease, an additional indication for Tibsovo for myelodysplastic syndromes and a combination antibiotic for complicated UTIs.
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Blue Shield of California to Save $500 Million with New Pharmacy Program
August 17th 2023Blue Shield is replacing CVS Caremark with Prime Therapeutics as the company that will negotiate with drug manufacturers beginning in January 2025. The insurer is also teaming up with Mark Cuban Cost Plus Drug Company and Amazon Pharmacy.
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FDA Updates for the Week of July 31, 2023
August 5th 2023FDA Approves new indications for two cancer drugs: Lonsurf combination for metastatic colorectal cancer and Jemperli as frontline treatment for advanced endometrial cancer. The agency has also rejected the BLA for therapy to treat rare skin cancer.
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Geographic Atrophy Presents Significant Burden to Patients and Caregivers | ASRS 2023
July 29th 2023Patients with geographic atrophy and their caregivers would benefit from support and accommodations related to managing daily life activities and social activities, as well as their mental health, Sophie J. Bakri, M.D., said during her presentation
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FDA Update for the Week of July 24, 2023
July 29th 2023FDA approvals this week include the second nonprescription naloxone nasal spray for opioid overdose, the first drug for a skin infection from pox virus and a drug to treat an eye infection caused by mites. In addition, the FDA has accepted a supplemental application for Ofev in children with rare lung disease.
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FDA Updates for the Week of July 17, 2023
July 22nd 2023The FDA has cleared several new products this week, including the first monoclonal antibody for RSV in infants, a novel therapy for newly diagnosed patients with AML and a postexposure anthrax vaccine. Additionally, an FDA decision on donanemab for Alzheimer’s is expected by the end of this year.
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FDA Updates for the Week of July 10, 2023
July 15th 2023Approvals this week include Opill, the first nonprescription oral contraceptive, the use of Veklury for COVID-19 in patients with severe renal impairment, and the earlier use of Leqvio for in heart disease. In addition, Takeda pulled its application for a dengue vaccine.
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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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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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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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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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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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