The FDA has removed the approval of Pepaxto in multiple myeloma. The agency approved Amtagvi, the first TIL therapy for a solid tumor, as well a new biweekly dosing of Tecvayli for multiple myeloma. The agency has set actions for several products, including a first-in-class lung cancer therapy, a bispecific antibody for advanced multiple myeloma, and another for Dupixent for COPD
Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.
Avalere’s Kolton Gustafson talks about CMS’ new model for negotiating outcomes-based agreements for sickle cell gene therapies for patients in state Medicaid programs.
Payers now covering Hadlima include United Healthcare, Prime Therapeutics and associated Blues plans, and some managed Medicare organizations.
A small trial that combined the anticancer drug Zolinza with an immunotherapy had a modest impact on antiviral activity in patients with HIV. Researchers are hoping better approaches can be found to coax HIV out of hiding.
The FDA approves Eohilia for eosinophilic esophagitis and Onivyde for metastatic pancreatic cancer but extends review of gene therapy for rare immune disorder. The agency also set goal dates for three products: full approval for Elevidys, Augtyro for solid tumors with NTRK gene fusions and seladelpar as for rare liver disease.
The FDA has set a PDUFA date of June 21, 2024, to convert the accelerated approval to full approval and expand the labeling of the gene therapy Elevidys beyond the current use in children aged 4 and 5 with Duchenne muscular dystrophy.
The Inflation Reduction Act has helped to close some of the gaps in insurance coverage for vaccines, including some of the newly approved ones.
The Inflation Reduction Act has helped to close some of the gaps in insurance coverage for vaccines, including some of the newly approved ones.
Compared with gastric sleeve, more patients who underwent a gastric bypass surgery remained in remission from type 2 diabetes even if weight is regained.
Voquezna is a potassium-competitive acid blocker, which has a mechanism similar to proton pump inhibitors but with a more rapid action. It has a list price of $650 for a 30-count bottle.
The FDA has set PDUFA dates for several products: Arexvy to prevent RSV in 50 to the 59 population, for acoramidis in heart failure indication, and for an engineered tissue for vascular replacement. The agency has also scheduled an advisory committee meeting for Abecma in supplemental multiple myeloma indication. Additionally, Amneal has resubmitted its application for novel Parkinson’s therapy.
Glaucoma is a leading cause of blindness, and African Americans and other minorities have a higher risk for the disease.
CVS’s Health Services segment — which includes its PBM CVS Caremark — now accounts for more than half of CVS’s total revenue.
Although HHS is no longer managing the distribution of COVID-19 drugs, Secretary Xavier Becerra has been closely monitoring distribution of the antivirals Paxlovid and Lagevrio.
The bulk of Cigna’s $195.3 billion 2023 revenue comes from Evernorth. And Cigna is positioning itself to grow Evernorth even more.
The bulk of Cigna’s revenue comes from Evernorth, which includes the PBM Express Scripts. The company is positioning itself to grow Evernorth even more.
New research finds that in 2022, U.S. prices across all drugs were almost three times higher than in other countries.
New research finds that in 2022, U.S. prices across all drugs were almost three times higher than in other countries.
Biogen has stopped its confirmatory trial of Aduhelm and will direct resources toward Leqembi and the research of other treatments for Alzheimer’s disease.
Biogen will focus its resources on Leqembi and research of other treatments for Alzheimer’s disease.
CVS Caremark, however, will continue to manage specialty drug benefits for Tyson Foods.
CVS Caremark will continue to manage specialty drug benefits for Tyson Foods.
Joseph M. Shields talks about the formation of Transparency-Rx and its goals of achieving PBM reform that focuses on “corrective steps to address the misalignment in the marketplace to ensure that there’s competition and choice.”
Coverage of contraceptives and contraceptive care without cost-sharing is required under the Affordable Care Act.
Current treatments for urea cycle disorders, which causes ammonia to build up in the blood, have a bitter taste and smell. Pheburane was developed with a special coating that masks the taste of sodium phenylbutyrate. It has a list price of $4,375 per bottle.
Peter Rubin of No Patient Left Behind worries that patients may not see benefits, either in lowered costs or continued investment in new therapies, from drug price negotiations required under the Inflation Reduction Act.
Last year saw the approval of several firsts, including the first vaccines to prevent respiratory syncytial virus in older adults and infants and a first vaccine to prevent the mosquito-borne virus chikungunya.
A 2020 rule stands in which copay assistance from pharmaceutical companies counts toward deductibles for brand name drugs without a generic competition.
The digital prescription therapeutic AspyreRx, when added to prescription diabetes therapies, can help reduce the costs of managing the disease.
