Shigella cause an estimated 450,000 infections in the United States each year and an estimated $93 million in direct medical costs.
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Brimonidine tartrate ophthalmic solution is used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Niraparib and abiraterone acetate plus prednisone has potential to address unmet need for patients with BRCA-positive metastatic castration-resistant prostate cancer.
If approved, ADX-2191 could be the first marketed drug specifically for patients with primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act date of June 21, 2023.
Leqembi would need a 66% to 19% discount from its wholesale acquisition cost of $26,500 a year to fall within commonly used cost-effectiveness thresholds.
The price cuts apply to Lilly’s nonbranded insulin, Humalog, Humulin and its Lantus biosimilar.
Kevzara is the first biologic to treat patients with polymyalgia rheumatica (PMR). It is also approved to treat rheumatoid arthritis.
If authorized, Pfizer’s RSV vaccine would be used to prevent respiratory disease caused by RSV in adults 60 years of age and older. An FDA decision is expected by May 2023.
The companies have also submitted an EUA for a fourth dose of the bivalent COVID-19 vaccine in children 6 months through 4 years of age.
Skyclarys will be available in the second quarter of 2023 to treat patients with Friedreich’s ataxia, an ultra-rare, inherited neurodegenerative disorder. The wholesale acquisition cost is $370,000.
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BMS is seeking an indication for Opdivo as monotherapy to treat patients with stage IIB or IIC melanoma after surgery. The FDA has assigned a Prescription Drug User Fee Act date of Oct. 13, 2023.
Investigators found an association between ICER’s value assessments and how U.S. commercial health plans cover specialty drugs.
The ads focus on how PBMs promote competition in the prescription drug marketplace and provide choice for employers.
Altuviiio is a first-in-class therapy providing factor VIII replacement to prevent bleeding in patients with hemophilia A. It is expected to be available in April 2023.
Bruce Feinberg, D.O., of Cardinal Health, said significantly changes are on the horizon for biosimilars, but physician comfort with and use of biosimilars will depend on things beyond their control, including formulary placement and utilization management efforts.
CMS said it will cover monoclonal antibodies to treat Alzheimer’s disease if they are approved through the standard review process and not through an accelerated approval.
If approved, pozelimab would be the first treatment for CHAPLE disease, which causes damage to blood and lymph vessels along the upper digestive tract. The target action date for the FDA decision is Aug. 20, 2023.
CSF-1 is a low-dose pilocarpine to treat patients with age-related blurry vision. The FDA has assigned a PDUFA goal date of Oct. 22, 2023
Alnylam is seeking approval for Onpattro’s use in cardiomyopathy related to transthyretin-mediated (ATTR) amyloidosis. The FDA set an action date of Oct. 8, 2023.
Patients who have had liver problems in the past may be at risk of liver damage from Sprycel, which is used to treat patients with chronic myeloid leukemia.
The new once-daily formulation of Austedo is used to treat adults with tardive dyskinesia and chorea associated with Huntington’s disease.
If approved, RSVpreF would be the first vaccine for administration to pregnant women to help protect against RSV disease in infants. The FDA has set an action date for August 2023.
Filspari will be available for a wholesale acquisition cost of $9,900 for a 30-day supply, and administrated through a REMS program because of the risk of liver abnormalities.
Apellis’ Syfovre will have a list price of $2,190 per vial, and Medicare is expected to be the dominant payer.
The U.S. public health emergency response to COVID-19 ends May 11, 2023, and the transition to more traditional healthcare coverage will begin later this year.
The review has been extended by three months. The new Prescription Drug User Fee Act (PDUFA) date is May 22, 2023.
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