At issue is an ongoing review of inspection results from a third-party filling company. No issues were cited in the FDA’s complete response letter about clinical efficacy or safety.
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It will be commercially available in the third quarter of 2023 and have a list price of $6,050 per vial.
Pfizer’s biologics license application (BLA) for the gene therapy fidanacogene elaparvovec has been assigned a PDUFA date in the second quarter of 2024.
Blincyto is immuno-oncology therapy that targets CD19 surface antigens on B cells to treat patients with acute lymphoblastic leukemia. Its current wholesale acquisition cost price is $4,900.15 per vial.
Now with the name Litfulo, ritlecitinib is the first oral treatment for adolescents with alopecia. It has an annual list price of $49,000.
Elevidys is a one-time therapy that delivers to muscle a gene that codes for a shortened, functional form of dystrophin, which is mutated in Duchenne muscular dystrophy.
Optum Rx will include the three biosimilars on its standard formulary at parity with Humira.
The company plans to discontinue further research of obeticholic acid to treat nonalcoholic steatohepatitis (NASH) after the FDA asked for long-term outcomes data.
Regulators indicated there was a lack of evidence of effectiveness and lack of clinical trials done to support the application.
Vyvgart Hytrulo’s under-the-skin administration means it can be given in 30 to 90 seconds, compared with one hour for the intravenous product. It will be priced at parity to Vyvgart, which has a net price of $225,000 annually.
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Jardiance and Synjardy are the first SGLT2 inhibitors approved for children with type 2 diabetes.
Employers and plans need to prioritize clinical efficacy over drug price, look for price reductions — and not rebates — on biosimilars, and advocate for a public option to cover gene therapies. These are just a few of ideas that consultant Alex Jung put forward at a meeting of the Midwest Business Group on Health.
Imetelstat targets telomerase to inhibit uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies.
Lodoco targets the inflammation that is an underlying cause of atherosclerotic cardiovascular disease. It will be available in the second half of 2023.
The FDA is requesting additional data and analysis for olorofim. F2G plans to resubmit revised NDA with complete data set from phase 2 study.
About a quarter of those surveyed said their insurance didn’t cover a needed prescription drug or charged a very high copay.
Columvi will cost about $350,000 for a fixed duration therapy with 12 treatments over eight and a half months.
The supply interruption is the result of a combination of factors, including significant increases in demand, an increase in syphilis infection rates, as well as competitive shortages.
If passed, PBMs would not be able to charge fees that are connected to the price of a drug, discounts, or rebates.
Ziprasidone is used to treat patients with schizophrenia and bipolar disorder. Taking dronabinol instead may lead to worsening of mental illness symptoms.
Ozempic, Wegovy and other GLP-1 drugs present a challenge to payers in terms of costs and outcomes, finds PSG’s new Drug Benefit Design Report.
SmithRx will offer Yusimry through Mark Cuban’s online pharmacy for $569.27, and members will be able to apply their insurance benefits.
Linzess is first FDA-approved prescription therapy for functional constipation in children 6 to 17 years of age.
If approved, nirsevimab would be the first immunization specifically to protect infants through their first RSV season. The Prescription Drug User Fee Act date is in the third quarter of 2023.
More than 90% of cancer centers have experienced shortages of critical drugs. Erin R. Fox, Pharm.D., University of Utah Health, talks about why these shortages are happening and efforts that are being made to address them.
Exagamglogene autotemcel is being evaluated for patients with sickle cell disease and beta thalassemia, in which a patient’s own hematopoietic stem cells are edited to produce high levels of fetal hemoglobin in red blood cells.
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