The PDUFA date for Enhertu in the lung cancer indication is in the third quarter of 2022.
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Dr. Caroline Carney of Magellan Healthcare discusses the psychedelics in the pipeline for treating mental health conditions.
A Parkinson’s therapy, a treatment for seizures, a drug used in the treatment of heart failure, and a therapy for a rare disease have been removed from Prime’s Medicare formularies.
Zosyn’s label was updated to warn about the risk of a severe immune response called hemophagocytic lymphohistiocytosis.
Generic launches include equivalents of Combigan, Abraxane, Cytotec, Solu-Medrol, and Tobradex.
The InspectIR Systems Breathalyzer test can provide results in three minutes.
Capital Rx uses the NADAC model, which was developed by CMS for Medicare and Medicaid drug pricing.
Vonjo is the first therapy that specifically addresses the needs of patients with cytopenic myelofibrosis, a bone marrow cancer.
Amneal's Alymsys is approved to treat several cancers.
The FDA needs to review additional data from a trial that assessed REGEN-COV for the prevention of COVID-19. The new PDUFA date is July 13, 2022.
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The label of Triumeq now includes additional information about use in patients who have both HIV and hepatitis B.
Some vials have been found to be missing a label.
Increased use of biosimilars could reduce Medicare Part D spending by 18% and beneficiaries’ out-of-pocket costs by 12%.
The generic cysteine could be available after a ruling in a patent dispute, which is expected in the third quarter of 2022.
If approved, pegzilarginase would be the first treatment for ARG1 deficiency, a rare progressive disease.
A literature review found an association between increased cost-sharing and lower patient adherence, which in turn could be associated with increased hospitalizations.
The FDA had previously issued a CRL due to manufacturing issues for the therapy, which is seeking an indication for preventing infections after chemotherapy for breast cancer. The agency has set a new PDUFA date of September 9, 2022.
CMS’s final decision is that monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized controlled trial conducted under an investigational new drug application.
Two new subsections have been added to the warning and precautious section of Zepzelca’s label to address serious adverse events that were identified during post-market monitoring.
Drew Mihalyo of Delta Care Rx discusses the company’s pass-through pharmacy pricing model.
Treatment with Zegalogue for severe hypoglycemia has the potential to save costs and reduce emergency department visits and hospitalizations.
Igalmi is the first and only film that dissolves under the tongue that treats adults with agitation associated with schizophrenia or bipolar. BioXcel expects to launch the therapy in the second quarter of 2022.
A proof-of-concept study showed that patients can be successfully switched from Cosentyx to Taltz with similar outcomes and lower costs.
Novartis’ Vijoice is the first approved treatment for PIK3CA-related overgrowth spectrum, a group of rare disorders.
Karthik Ganesh, CEO of EmpiRx Health, discusses how its technology and clinical focus provide strategies for patient management that results in lower costs for clients.
The PBM has removed 20 products and added a half dozen new therapies, including several generics. The changes are effective April 1, 2022.
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