Pirfenidone is used to treat patients with idiopathic pulmonary fibrosis, a progressive rare disease that make it difficult to breathe.
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Radicava ORS has the same dosing regimen as the IV form of the ALS therapy, with a treatment cycle followed drug-free periods.
The goal of the new program is to help increase the development new treatments for patients with rare diseases.
The FDA needs more time to assess information submitted by the company.
Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.
Lecanemab is monoclonal antibody that targets beta amyloid to treat mild cognitive impairment in those with early Alzheimer’s disease.
Financial hardship was more likely to be reported by older patients who don’t have insurance, take multiple medications, and have a low annual household income.
Regulators need additional time to review information on bone mineral density. The FDA has provided a new PDUFA date of Aug. 6, 2022.
The move to limit Janssen’s vaccine comes after an analysis finds there is a risk of thrombocytopenia syndrome (TTS), a rare syndrome of blood clots and low levels of blood platelets.
Drug rebates can reduce plans’ net costs but they do not reduce patients’ cost sharing.
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Some children who received GnRH agonists for precocious puberty have experienced a serious side effect known as idiopathic intracranial hypertension, which results in elevated spinal fluid pressure in the brain.
Bortezomib is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program
The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.
The production suspension will impact both the commercial and clinical trial supplies of Lutathera and Pluvicto in the United States and Canada.
Tracy Spencer, senior vice president at PSG, discusses what large, self-insured employers and plan sponsors want from their specialty drug benefit.
Centene is divesting both Magellan Rx and PANTHERx Rare and will exit the pharmacy benefit management space.
The FDA’s accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer has now converted to regular approval.
The FDA has made the labels consistent for combined hormonal contraceptives about the risk these products have to women who have or have had breast cancer.
UnitedHealthcare considers Aduhelm unproven and not medically necessary for treating Alzheimer’s disease.
The Psychopharmacologic Drugs Advisory Committee will meet on June 17, 2022; the PDUFA date is August 4, 2022.
Orphalan plans to launch Cuvrior in early 2023. It was approved to treat Wilson’s disease, which results in excess copper in the body.
The FDA would like Hutchmed to conduct a multi-regional trial that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice.
The regulatory agency has requested a quality process change for toripalimab, which is being developed to treat nasopharyngeal carcinoma.
Lenvima is approved to treat thyroid cancer, renal cell carcinoma and in combination with Keytruda for metastatic kidney cancer.
Qelbree is the first new nonstimulant to be approved in 20 years.
The complete response letter identified the need for additional chemistry, manufacturing, and controls data related the drug product and manufacturing process.
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