Denise Myshko

Regulators want to discuss safety issues, as well as the phase 3 trial’s design where patients were treated based on an assessment of amyloid plaque and the inclusion of patients based on tau protein levels.

The new biosimilar, Tyenne, was approved in both an IV and a subcutaneous forms to treat inflammatory conditions such as arthritis.

Quantile Health is offering a new solution to help small health plans and self-insured employers fund gene therapy access — with a subscription model.

The FLOW trial was stopped early based on an interim analysis that found the study met the criteria for efficacy.

Women experiencing high levels of poverty and those in impoverished rural regions are less likely to get screened for breast cancer, find a new review of studies that have assessed social determinants of health.

The FLOW trial was stopped early based on an interim analysis that found the study met the criteria for efficacy.

Fran Gregory, Pharm.D., of Cardinal Health, talks about a survey of ophthalmologists and their concerns about using biosimilars for retinal conditions.

FDA has expanded the indication for Biktarvy for those with resistant HIV, granted full approval to Rybrevant and approved Simlandi, the third interchangeable Humira biosimilar. The regulatory agency has also set action dates for sxatilimab in graft-versus-host disease, tislelizumab in stomach cancer and a second indication for Epkinly.

Biktarvy can now be used to treat people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.

Biktarvy can now be used to treat people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.

High costs and prior authorization impact beneficiaries’ ability to access care. Some said they had to wait more than a month to see a doctor.

CarelonRx will provide digital coaching and wellness tools and incorporate behavioral and social health screenings for members.

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.