The FDA has changed how often AcelRx Pharmaceuticals is required to audit healthcare settings that administer Dsuvia, which is a synthetic opioid.
Formulary Watch
Latest News
All News
Advertisement
Bimekizumab, now called Bimzelx, is a monoclonal antibody being reviewed as treatment for adults with moderate-to-severe plaque psoriasis.
Aetna has made available four specialty drugs that were approved early in 2022 through prior authorization. These include a biosimilar, a CAR-T immunotherapy, and therapies for macular degeneration and a rare auto-immune disease.
While regulatory flexibility is important for drugs for rare diseases, investigators are concerned the trend toward surrogate endpoints decreases confidence that new drugs can improve patient outcomes.
The booster is given at least five months after completion of a primary series.
The FDA emergency use authorization allows the nonprescription test to use at-home sample collection with testing performed in a laboratory.
FDA regulators said the data to support the EUA, which was submitted by a physician, is not sufficient to support the use of the antidepressant fluvoxamine for the treatment of patients with COVID-19.
The role of health economic and real-world evidence has become, and will continue to be, an important aspect of healthcare decision-making.
Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control.
The label for Imbruvica now includes information about the possibility of cardiac failure, which has occurred in 1% of patients. Imbruvica is used to treat B-cell blood cancers.
Advertisement
Apokyn and Kynmobi contain apomorphine hydrochloride, which can cause hemolytic anemia that requires hospitalization. The products both treat the loss of muscle movement control caused by Parkinson’s disease.
Pirfenidone is used to treat patients with idiopathic pulmonary fibrosis, a progressive rare disease that make it difficult to breathe.
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.
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.
Advertisement
Advertisement
Trending on Managed Healthcare Executive
1
Myqorzo is now available for rare heart condition at a $108,400 annual price
2
PBM reform. It has finally happened
3
Study of antibody-Keytruda combination seeds hope for overcoming immune checkpoint inhibitor resistance, use of biomarkers
4
Melanoma diagnoses projected to rise in 2026
5