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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ICER: Monoclonal Antibodies Not Cost-Effective in Multiple Sclerosis
December 21st 2022The monoclonal antibodies that treat patients with multiple sclerosis would have to be priced more than 50% lower to meet the common standards of cost-effectiveness, according to the Institute for Clinical and Economic Review.
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ICER: Monoclonal Antibodies Not Cost-Effective in Multiple Sclerosis
December 21st 2022The monoclonal antibodies that treat patients with multiple sclerosis would have to be priced more than 50% lower to meet the common standards of cost-effectiveness, according to the Institute for Clinical and Economic Review.
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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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Beyond the Big Three and How We Got Here
December 14th 2022This isn’t the first time pharmacy benefit managers (PBMs) have been ensnared in controversy. PBMs were first created in the 1960s to help insurance companies manage and administer claims for prescription drugs. Over time, they took on the roles of claims adjudication, rebate negotiation and benefit design.
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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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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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Can Ocular Biomarkers Be Used to Diagnose Alzheimer’s Disease?
December 5th 2022In an umbrella review — a review of reviews — investigators found that so far, studies of ocular biomarkers to diagnose Alzheimer’s disease had important limitations. Longitudinal studies that use artificial intelligence could perhaps identify ocular biomarkers, the researchers suggest.
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FDA Updates for the Week of Nov. 28, 2022
December 3rd 2022This week, the FDA made two approvals, the first-ever microbiota product and a second indication for Brexafemme, and issued a CRL for a therapy for brain metastasis from neuroblastoma. The regulatory agency also granted priority review for a Duchenne gene therapy, and accepted three applications: for a cutaneous T-cell lymphoma therapy, for an antibiotic for drug-resistant infections and Evkeeza for children with rare high cholesterol. Additionally, Genentech has withdrawn Tecentriq’s indication for bladder cancer and Aldeyra has submitted an NDA for the novel dry eye therapy reproxalap.
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