Iyuzeh can be stored at room temperature. It has a list price of $299 for a month’s supply.
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The FDA has assigned a target action date of Jan. 31, 2024, for Dupixent to treat children 1 to 11 years of age with the inflammatory condition eosinophilic esophagitis.
In patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.
ICER adds a more formal process to evaluate the diversity of clinical trials and an assessment of a product’s impact on patient and caregiver productivity. ICER also plans to evaluate how newer methods — which would consider the change of a drug’s price over time and disease severity — can be applied to its value assessment.
The FDA is conducting an ongoing inspection of a third-party filler.
Jardiance is currently available to treat patients with type 2 diabetes, end stage renal disease and heart failure. It has a list price of $570.48 for a month supply.
Developing novel drugs to treat cancer remains a strong focus for drug developers. Several first-in-class therapies have become available over the last few months.
Non-White patients who used copay cards were significantly more likely to encounter copay adjustment programs, such copay accumulators and maximizers, compared with their White counterparts.
Laurie Sobel, associate director for women’s health policy at KFF, moderated a panel discussion about the challenges associated with providing insurance coverage for the first FDA-approved oral contraceptive, Opill.
An analysis from 3 Axis has found that PBMs control how much pharmacies are reimbursed. This can vary significantly depending on the PBM contracts with insurers, creating a system with large inconsistencies in the prices that consumers pay for both generics and branded products.
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The FDA has requested an additional study. ARS Pharmaceuticals plans to appeal the decision.
Atidarsagene autotemcel is a one-time gene therapy to treat patients with the rare and fatal disease metachromatic leukodystrophy (MLD). The agency has set a review date of March 18, 2024.
Earlier this year, RedHill Biopharma began a warranty program for patients taking Talicia, with a commitment to reimburse patient out-of-pocket costs if Talicia does not work.
Momelotinib — now with the brand name Ojjaara — is the first treatment for myelofibrosis patients with anemia. It has a list price of $26,900 for a bottle of 30 tablets.
Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
The date has been extended by three months to Feb. 24, 2024, because of resource constraints at the regulatory agency.
CMS has included an additional 34 drugs on the list on products subject to rebates if their price increases are higher than inflation.
This simulation study also showed that semaglutide was the most effective for weight loss, and researchers said, long-term, savings associated with potential lifelong health improvements may shift the balance of cost-effectiveness.
The FDA has granted priority review and assigned a review date of March 14, 2024, for resmetirom treat adult patients with nonalcoholic steatohepatitis (NASH) who have liver fibrosis.
Cell and gene therapies can be used for patients with cancer and serious diseases who have limited or no treatment options — but at a cost.
Addressing drug affordability and accessibility will involve tackling the interrelated problems of high prices and problematic pharmacy benefit manager practices, says Benjamin N. Rome, M.D., with Brigham and Women’s Hospital in Boston.
Miebo, approved in May, addresses tear evaporation in dry eye disease. It will have a wholesale acquisition cost of $771 for a one-month supply.
In clinical trials, Aphexda plus filgrastim enabled a majority of patients to achieve the collection goal to enable stem cell transplantation for patients with multiple myeloma. It will have a list price 5,900 per vial, with most patients needing two vials for treatment.
In total, Medicare beneficiaries paid $21 billion for 100 drugs that receive the most rebates, while health plans paid $5.3 billion after rebates.
Libervant is film version of diazepam that is placed inside the cheek to treat children between two and five years of age who have refractory epilepsy. The PDUFA target goal date is April 28, 2024.
Crystal formation could lead under- or over-dosing of Sandimmune oral solution, which is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.
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