New approvals this week include a $4.25 million gene therapy, a drug that treats hypertension in a new way, a nonsteroidal drug for Duchenne, and an oral drug for aggressive leukemia. The agency has set an action date for resubmitted Lymphir in rare skin cancer, and Celltrion has launched Zymfentra, a subcutaneous form of infliximab.
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Payers Question CMS’ Ability to Get Discounts Though Drug Price Negotiation
March 19th 2024In a recent survey, payers said the Inflation Reduction Act will help lower patients’ out-of-pocket costs, but they were concerned about Medicare’s drug price negotiation and the IRA’s impact on formulary management.
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FDA Updates for Week of March 11: First CAR-T for CLL/SLL and First NASH Treatment
March 16th 2024The FDA this week approved a few firsts: the first treatment for NASH and the first CAR-T cell therapy for CLL/SLL. Other approvals include Tevimbra for esophageal cancer; Livmarli for second liver disease indication; and Praluent for children with genetic form of high cholesterol. The FDA also issued a CRL for monthly MS drug. Additionally, Celltrion submitted an application for an interchangeable Xolair biosimilar.
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Michigan is First Medicaid Program to Offer Lyfgenia for Sickle Cell
March 11th 2024Michigan’s state Medicaid agency has signed an outcomes-based agreement for Lyfgenia patients with sickle cell disease. The agreement provides payers with risk sharing tied to vaso-occlusive events-related hospitalizations
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Oral Drug for Hidradenitis Suppurativa Shows Promise in Small Study | AAD 2024
March 9th 2024A phase 2 study demonstrated positive results for remibrutinib, a BTK inhibitor, as a treatment for patients with the rare skin condition, hidradenitis suppurativa, finds a study presented at the American Academy of Dermatology Association.
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FDA Updates for Week of March 4, 2024: Wegovy Gets New Indication
March 9th 2024The FDA has approved Wegovy for reducing cardiovascular risks in people who are obese or overweights. The agency approved new biosimilars that reference Actema, Prolia and Xgeva. Additionally, the FDA plans to hold advisory committee meeting for donanemab in Alzheimer’s disease.
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Opzelura Provides Benefit in Atopic Dermatitis in Real-World Studies | AAD 2024
March 8th 2024Physicians switch to Opzelura (ruxolitinib) when other therapies fail to help patients with atopic dermatitis, according to a new analysis presented at the annual meeting of the American Academy of Dermatology.
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