The FDA approved a supplemental BLA for use of Krystexxa with methotrexate for the treatment of uncontrolled gout.
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This is the second batch to be recalled because of the potential of missing labels.
NOV03 (perfluorohexyloctane) is a first-in-class eye drop with a novel mechanism of action. If approved it will be the first to address signs and symptoms of dry eye disease.
Under the national vaccine strategy, the U.S. Department of Health and Human Services is expanding access to the monkeypox vaccine, Jynneos, in areas with the highest transmission and need.
Under a new add-on program, plan members will have access to an expanded list of FDA-approved specialty generic medications with no copays.
If approved, mosunetuzumab could be the first T-cell engaging bispecific antibody for the treatment of any type of non-Hodgkin’s lymphoma. The FDA has assigned a PDUFA date of Dec. 29, 2022.
Lecanemab is monoclonal antibody that targets beta amyloid to treat mild cognitive impairment. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of Jan. 6, 2023.
The Peripheral and Central Nervous System Drugs Advisory Committee will meet for a second time in September 2022 to discuss new analysis of the data for AMX0035 for the treatment of patients with amyotrophic lateral sclerosis.
The United States has acquired adult and pediatric doses of the COVID-19 vaccine for delivery in early fall in a contract worth $3.2 billion, as well as an additional 150,000 doses of bebtelovimab for about $275 million.
Qsymia is only available through a Risk Evaluation and Mitigation Strategy (REMS) program because of the increased risk for birth defects.
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The removal of prior authorizations for buprenorphine for use in opioid use disorder was associated with a statistically significant increase in the number of prescriptions filled among Medicaid populations in Illinois but not in California, which had already been seeing an increase in use of such therapies.
Effective July 1, 2022, CVS Caremark has removed 16 drugs and added 14 to its Standard Control Formulary.
The new PDUFA date is Nov. 17, 2022. If approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes.
NRx Pharmaceuticals had been seeking emergency use for Zyesami for COVID-19 respiratory failure. The company will now focus on clinical research for its therapy for patients with bipolar disorder.
Final results from a phase 3 study found that Copiktra was associated with a higher risk of serious side effects, dose modifications, and deaths compared with Kesimpta.
The submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated people at high risk for progression to severe illness from COVID-19.
Zelnorm is used to treat adult women less than 65 years of age with irritable bowel syndrome with constipation.
Palovarotene is being reviewed as a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of Dec. 29, 2022.
The FDA is accepting comments on the proposed rule through Oct. 26, 2022.
Sanofi has lowered the out-of-pocket cost for those without insurance of its insulins to $35 for a 30-day supply through the company’s savings program.
Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.
Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.
If approved, lenacapavir would be the first HIV-1 treatment administered twice-yearly.
The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.
Diacomit was approved in 2018 for seizures associated with Dravet syndrome, a rare pediatric disorder.
Labels now warn that buprenorphine products that dissolve in the mouth can cause dental problems. Buprenorphine is used to treat opioid use disorder and pain.
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