FDA Update for Week of April 22, 2024: Second Gene Therapy for Hemophilia B
April 27th 2024This week, the FDA has approved several products, including Beqvez, the second gene therapy hemophilia B; Ojemda for children with brain tumors; an additional indication for Lutathera for adolescents with neuroendocrine tumors; and a bladder cancer immunotherapy. The agency has also issued a complete response letter for pz-cel to treat epidermolysis bullosa.
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Personal Health Information was Released in Change Healthcare Hack
April 23rd 2024UnitedHealth has found 22 screenshots, allegedly from Change Healthcare files, that were posted for about a week on the dark web. Some of these contained personal health information. The extent of data release is not yet known.
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Potential Generics Could Lower Prices for Oncology, Cardiovascular Drugs | AMCP 2024
April 18th 2024Up to 50 generics could be approved this year, including Victoza to treat patients with diabetes. If generics of Victoza become available, this would the first GLP-1 to face generic competition.
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Are Value-Based Contracts the Answer to Ultra-High-Priced Gene Therapies? | AMCP 2024
April 17th 2024Innovative contracts are becoming more common for gene therapies. They aim to balance a therapy’s cost-effectiveness and affordability, as well as address the uncertainty of long-term benefit.
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Providing Access to Rezdiffra for NASH and the Therapies to Come | AMCP 2024
April 16th 2024The pipeline for NASH treatments is robust, with six therapies in phase 3 development. Speakers at the annual AMCP meeting discuss Rezdiffra, the first drug approved specifically for NASH, and how to think about coverage issues.
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Prime Study Finds Lower Adherence, Higher Costs for Weight Loss Drugs | AMCP 2024
April 15th 2024Use of GLP-1 drugs and weight-loss care management programs need to focus on adherence and persistency for better health outcomes, suggests Prime Therapeutics/MagellanRx Management poster at AMCP 2024.
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Payers Recognize the Benefits, but Still See Weight Loss Drugs through a Cost Lens
April 12th 2024Jeffrey Casberg, M.S., R.Ph., a senior vice president of clinical pharmacy at IPD Analytics LLC, a drug intelligence firm that advises payers and pharmaceutical companies, talks about how payers are thinking about weight-loss drugs.
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Drugs to Watch: Mental Health Conditions
April 11th 2024The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
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Humira Biosimilars Have a Slow Uptake, Finds Samsung Bioepis Report
April 8th 2024Caps on Medicare Part D cost sharing as a result of the Inflation Reduction Act, could reduce members’ financial incentive for switching to a biosimilar, suggests the newest Samsung Bioepis Quarterly Biosimilar Market Report.
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FDA Updates for Week of April 1, 2024: Approvals for Blood Disorder and Bacterial Infections
April 6th 2024The FDA has approved several new therapies this week, including Voydeya as an add-on therapy for blood disorder PNH; Zevtera for serious bacterial infections; Fanapt for bipolar 1; and the CAR-T therapy Abecma for earlier treatment in multiple myeloma. The agency has also accepted a supplemental BLA for Bimzelx in hidradenitis suppurativa and set a review date for datopotamab deruxtecan in breast cancer.
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FDA Accepts Supplemental BLA for Bimzelx in Hidradenitis Suppurativa
April 4th 2024The FDA is also considering a separate BLA for a 2 mL syringe. Bimzelx is already available to treat plaque psoriasis as a 1 ml syringe; a dose is two subcutaneous injections with a cost of $7,200 per syringe.
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