Tecvayli targets BCMA and CD3 to activate the body’s immune system. It was approved for heavily pretreated patients with relapsed or refractory multiple myeloma.
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If approved, SER-109 would be the first oral microbiome therapeutic available. The Prescription Drug User Fee Act action date is April 26, 2023.
One of the drivers of a lowered payer satisfaction is the public perception of PBMs, said Morgan Lee, Ph.D., of PSG.
Quizartinib, which is under review to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3-ITD positive, has a Prescription Drug User Fee Act date (PDUFA) of April 24, 2023.
Regulators have approved Imjudo, a monoclonal antibody that targets the activity CTLA-4, to be used in combination with Imfinzi, a PD-L1 inhibitor.
Novaliq’s CyclASol uses the EyeSol technology that allows for improved bioavailability and better efficacy. The PDUFA target action date set by the FDA is June 8, 2023.
The FDA has assigned a PDUFA goal date of June 16, 2023, for an expanded indication to reduce the need for septal reduction therapy (SRT), which is a procedure to treat hypertrophic cardiomyopathy.
Eylea is being reviewed as a treatment for retinopathy in premature infants.
The arrangement allows Vivio customers to stop overpaying for drugs, the company said.
Two reports show that drug-related deaths are skyrocketing among people 65 years and older.
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Novavax’ protein-based vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
Escalating costs are hitting patients hard. CMS price negotiation and the $2,000 cap on Part D out-of-pocket expenses should benefit many patients with Medicare coverage.
Most of the brands that have been removed fall into the categories of hormonal therapies, pain and inflammatory conditions or skin conditions or high blood pressure/heart medications.
Arash Sadeghi, Pharm.D., discusses three drugs in development, which treat a rare kidney disease, hemophilia B, and an advanced form of age-related macular degeneration.
If approved, tofersen will be the first treatment that targets a genetic cause of ALS. The updated PDUFA date is April 25, 2023.
The lack of competition and the vertical integration of PBMs and insurers can have a negative impact on patients’ access to and cost of prescription drugs, AMA said.
A real-world study by the PBM shows major benefits from the new cystic fibrosis drug when it comes to hospitalizations and pulmonary exacerbations. But total cost of care of patients tripled because the drug is expensive.
The Amgen Biosimilars Trend Report found that competition is lowering prices of biosimilars but the largest PBMs are inconsistent in their management of these products.
Exela has received five reports of flying glass injuring skin, eye and/or other parts. The recall includes both Exela and Civica brands.
Until supply is restored, the FDA suggests the use of alternatives such as the extended-release version of amphetamine mixed salts.
Regence implemented a preferred infliximab biosimilar strategy and was able to achieve more than 90% adoption.
If approved, valoctocogene roxaparvovec would be the first gene therapy in the U.S. for the treatment of severe hemophilia A. A PDUFA action date has been set for March 31, 2023.
The bivalent booster vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 along with a component of omicron BA.1.
In total, CVS Caremark has removed 26 products and added 31 products effective Jan. 1, 2023.
The FDA has assigned a target action date of Feb. 11, 2023.
The submission is expected to be complete by the end of the year, and if approved, could be available in early 2024.
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