Genentech had recalled the Susvimo ocular implant two years ago. The FDA has approved changes to the implant and needle.
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The prefilled syringe of Vabysmo will become available in the coming months. It treats age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion.
Company officials have said the bundled payment program could negatively impact sales of Xphozah, which was approved last year to reduce serum phosphorus in patients with kidney disease on dialysis.
Donanemab — now with the brand name of Kisunla — slows cognitive and functional decline by up to 35% and has a list price of $695.65 per vial.
Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe) will be available beginning Feb. 22, 2025 and will be marketed by Sandoz.
For the second time, the FDA is asking for additional information about chemistry manufacturing and controls.
Ohtuvayre - an inhaled bronchodilator with non-steroidal anti-inflammatory effects - is the first new mechanism in COPD approved in more than 20 years.
Epkinly is a bispecific antibody now approved to treat both relapsed or refractory follicular lymphoma and relapsed or refractory diffuse large B-cell lymphoma.
The 3Axis Advisors analysis suggests PBMs’ spread pricing practices leads to employers being charged different amounts for the same medications and to pharmacists facing reimbursement challenges.
The FDA cited issues related to a third-party manufacturer. The agency did not request any additional testing from AbbVie.
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The recalled batches have been found to have potassium chloride that does not dissolve, which can cause high potassium levels that can lead to hypertension, heart failure, or renal dysfunction.
Krazati is already available to treat patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.
Nathan Downhour, Pharm.D., discusses the Pharmacy Match program, which will engage with physicians to make sure a specialty prescription gets to the best-fit pharmacy across a network powered by Free Market Health.
Full approval was granted for the one-time gene therapy to ambulatory patients aged 4 years older. The FDA also granted accelerated approval to Elevidys for non-ambulatory patients.
Skyrizi is also available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease and has a list price of $21,017.36 for one dose.
Physicians in a new survey by the American Medical Association said prior authorization leads to delayed care and a high administration burden for physician practices.
Committee members, however, also said more data are needed on donanemab to treat patients in underrepresented patient groups, including Latin American and African American patients and special populations such as Down syndrome.
Tagrisso, which is already available to treat patients with non-small cell lung cancer and EGFR mutations, is being reviewed by the FDA for patients with this cancer and exon 19 deletions or exon 21 mutations.
The FDA is considering a monthly IV maintenance dose of Leqembi to treat people with Alzheimer’s disease. The action date is set for Jan. 25, 2025.
Included in this review will be 11 drugs that ICER assessed for cost-effectiveness in 2022. New this year is an assessment for consumer accessibility of drugs, including the burdens of prior authorization and patient cost-sharing measures.
Vanity Fair shines a light on how fake Ozempic and other semaglutide products have found their way into the U.S. supply chain.
Patients with PTSD in the clinical trials of midomafetamine were able to guess whether they received treatment or placebo. Regulators and advisory committee members said this could have impacted efficacy results. FDA’s decision is expected by Aug. 11, 2024.
mRESVIA will be available for the 2024/2025 RSV season as a pre-filled, ready to use syringe.
Zolbetuximab is first-in-class monoclonal antibody. The FDA has assigned an action date of Nov. 9, 2024.
LucyRx will begin providing pharmacy benefit services to self-insured employers, covering about half a million lives, beginning in January 2025.
FDA officials have asked for additional analyses on the efficacy of Dupixent in the two pivotal trials. The revised target action date is Sept. 27, 2024.
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