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.
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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.
Medicare beneficiaries without subsidies were 35% to 50% less likely to fill their prescriptions for drugs used to treat cancers, immune system disorders, and high cholesterol.
Illuccix is approved to detect prostate cancer when using PET scan. It is available through Cardinal Health, PharmaLogic, and United Pharmacy Partners.
A phase 3 trial is expected to begin by the end of the second quarter.
The agency has extended the review period to address pending inspection classification at third-party secondary packaging and labeling facility. The new PDUFA date is July 14, 2022.
Genentech also announced progress in meeting the supply challenges associated with Actemra, which is currently available under an emergency use authorization.
Camcevi is the first ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required.
The FDA has asked Merck to provide to additional data from studies. The new PDUFA date is July 1, 2022.
The FDA’s final decision on AMX0035 is expected by June 29, 2022
The FDA cited safety concerns related to vadadustat, which is under review for the treatment of anemia due to chronic kidney disease.
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