But researchers found that only a small percentage of plans use available real-world evidence studies and economic evaluations in their coverage policies.
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Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.
The companies have also initiated a phase 1/2/3 study to evaluate different doses and dosing regimens of the BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.
While some patients with relapsed or refractory multiple myeloma saw a benefit in a confirmatory trial, the main issue concerning the committee members was a high rate of death in the study.
RBX2660 — now with the brand name Rebyota — is a potential first-in-class microbiota-based live biotherapeutic that aims to reduce recurrent C. difficile infection.
An Avalere review finds that the proportion of generic drugs covered on lower tiers (with generally lower out-of-pocket costs for patients) in Part D plans have decreased.
Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.
This is the first RET Inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of tumor type.
Elucirem requires half the gadolinium dose of existing gadolinium-based contrast agents, addressing practitioners’ concerns about gadolinium exposure during MRIs. It will be available in bottle and pre-filled syringe form.
World Health Organization said there is a lack of evidence of clinical effectiveness of the monoclonal antibodies Xevudy and Regen-Cov against the COVID-19 variants that are currently circulating.
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Commercial shipments are already under way of Cosette’s gel formulation of tazarotene to treat patients with acne and facial wrinkles.
Veru is seeking an emergency use authorization for sabizabulin, a first-in-class treatment for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The advisory committee meeting is now Nov. 9, 2022.
Hospitalization, disability, having private high-deductible, Medicare Advantage, or no coverage were risk factors associated with medical debt.
There are currently no FDA-approved therapies that specifically target HER2 in colorectal cancer. The agency has set a target action date of Jan. 19, 2023.
Skysona, with a wholesale acquisition cost of $3 million, is the first FDA approved therapy to slow progression of neurologic dysfunction in boys with this neurodegenerative disease.
Aponvie is the same formulation as Cinvanti, which is an injectable emulsion for prevention of chemotherapy-induced nausea and vomiting.
Approved in May 2022, Tibsovo is the first therapy targeting cancer metabolism for older patients with newly diagnosed IDH1-mutated acute myeloid leukemia.
The applications are based on progression-free survival data even though the FDA has recommended that the company wait for more mature overall survival data.
Terlivaz is the first approved therapy to treat hepatorenal syndrome, a rare form of kidney disfunction related to advanced liver disease.
The additions include apps to help people better manage their sleep issues, anxiety, alcohol and opioid use disorders, and inflammatory conditions.
Aripiprazole, currently available as a once-monthly injection under the brand name Abilify Maintena, is being reviewed as a two-month therapy. The FDA target date for completion of the review is April 27, 2023.
The FDA has granted priority review of velmanase alfa, an enzyme replacement, to treat patients with alpha-mannosidosis, a rare genetic disease. The FDA has assigned an action date in the first half of 2023.
Jeffrey A. Shaman, Ph.D., chief science officer at Coriell Life Sciences, talked about how pharmacogenomics can inform medication management.
If approved, Perrigo’s Opill could be the first-ever over-the-counter birth control pill. The advisory committee meeting is scheduled for Nov. 18, 2022.
If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare, genetic neurological disorder mostly in girls. The FDA action date is March 12, 2023.
Kali Panagos, Pharm.D., at ARMSRx, discusses the growing trend of copay assistance programs and alternative funding solutions that can help provide access to expensive specialty therapies.
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