Moderna plans to submit to the FDA its investigational mRNA vaccine, RNA-1345, for respiratory syncytial virus (RSV) in the first half of 2023.
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Lilly expects topline results from the confirmatory phase 3 trial in the second quarter of 2023 and plans to submit for full approval.
This is the fourth indication for the Bruton’s tyrosine kinase inhibitor.
Tukysa with trastuzumab is indicated for second-line treatment of HER2-positive metastatic colorectal cancer, the first such therapy for this cancer.
There are currently no medications approved for the treatment of NASH, which can lead to cirrhosis, eventual liver failure, cancer and death. The FDA has assigned a PDUFA target action of June 22, 2023, for the therapy, obeticholic acid.
Annual savings from biosimilars could be more $100 billion by 2026, according to IQVIA’s latest Global Use of Medicines report.
Patient advocates discussed the difficulties that formulary policies and lack of transparency place on those with chronic disease at an ICER sponsored webinar.
The Inflation Reduction Act’s cap on out-of-pocket costs for insulin is likely to improve outcomes for almost half of Medicare’s insulin users.
While ICER found that overall major payer coverage policies are in line with the organization’s fair access criteria, many payers do not provide adequate transparency into clinical coverage criteria.
A new membership program, SmartRx, offers consumers savings on prescriptions, as well as office visits, eye care, vaccines and pet meds.
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Lawsuit accuses the companies of using unlawful, unfair, and deceptive practices.
Rykindo is a bi-weekly long-acting risperidone injection to treat patients with schizophrenia and bipolar 1 in adults.
Optum Rx’s Humira biosimilar strategy for 2023 was set up to allow for the most value in the first year, said CEO Heather Cianfrocco.
This update removes a previous limitation that it could not be used as the first therapy.
Newer treatments, including targeted and immunotherapies, have contributed to an increase in five-year survival rates for patients with some cancers.
CMS officials plan to engage with the public for feedback and insights as they implement the Medicare Drug Price Negotiation Program.
With this partnership, employers and their members using RxPreferred for their pharmacy benefit will have access to all medications available through Cost Plus Drugs.
Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.
Soleo Health will distribute Leqembi, the newly approved Alzheimer's therapy, to provider offices and infusion centers, as well as administer it across its own ambulatory infusions centers.
New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.
Clarivate analysts have identified the treatments they forecast could deliver annual sales of more than $1 billion within five years. These include therapies for rare diseases, as well as HIV, Parkinson’s disease, Crohn’s disease, alopecia, and cancer.
Epinephrine (L-adrenaline) is a bulk active pharmaceutical ingredient used to manufacture or compound prescription products.
The agency has assigned a Prescription Drug User Fee Act target action date of May 10, 2023, and plans to hold an advisory Committee
The supplemental BLA is based on data from a confirmatory phase 3 trial. The submission was made the same day Eisai/Biogen received accelerated approval.
Lecanemab, now with the brand name Leqembi, will launch with a wholesale acquisition cost of $26,500 a year.
Genentech’s glofitamab is a bispecific antibody being reviewed to treat adults with large B-cell lymphoma. The FDA is expected to make a decision on approval by July 1, 2023.
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