News

In COVID-19 news, the FDA granted fast track designation to COVID-19-flu vaccine combo. The FDA has approved the first gene therapy for bladder cancer, an 8th biosimilar referencing Humira, granted accelerated approval for KRAS-mutated lung cancer therapy, and approved Iyuzeh to reduce intraocular pressure. The agency also extended review of Lynparza/abiraterone combination for prostate cancer. In addition, two companies have submitted applications: Soligenix for a novel therapy for cutaneous T-cell lymphoma and AbbVie for Linzess in children and adolescents.

In COVID-19 news, the FDA has expanded the updated bivalent vaccines EUA to children. The FDA has requested athe removal of Pepaxto indication for multiple myeloma. Regulators have also accepted several applications for: Biogen’s Actemra biosimilar, Pfizer’s RSV vaccine, a resubmitted BLA for Fabry disease. Two companies — Janssen’s and Alnylam — have submitted new applications.

This week, the FDA made two approvals, the first-ever microbiota product and a second indication for Brexafemme, and issued a CRL for a therapy for brain metastasis from neuroblastoma. The regulatory agency also granted priority review for a Duchenne gene therapy, and accepted three applications: for a cutaneous T-cell lymphoma therapy, for an antibiotic for drug-resistant infections and Evkeeza for children with rare high cholesterol. Additionally, Genentech has withdrawn Tecentriq’s indication for bladder cancer and Aldeyra has submitted an NDA for the novel dry eye therapy reproxalap.

Short-term manufacturing problems are happening as the demand for Adderall and other stimulant medications for ADHD have increased. Data from Arrive Health show a marked increase in ADHD medication prescriptions for people in their 30s.

What does it take for a healthcare organization to effectively expedite and achieve a digital transformation? Start with the fundamentals, like having an integrated transformation strategy with clear goals across the enterprise, highly visible and vocal top-down leadership, and exceptional tactical talent for implementation.

To truly transform healthcare, we must create a connected care journey: delivering care that meets patients where they are, when they need it, and continues to be personalized for them through their entire health journey, wherever that may lead next.

The FDA has approved a $3.5 million hemophilia B gene therapy and warned about Prolia in patients with kidney disease. The agency accepted for priority review two BLAs: for a dengue vaccine and for epcoritamab for large B-cell lymphoma. Additionally, GSK has pulled Blenrep from the U.S. market at the request of the FDA.

In this final video of a three-part video series, Oncologist and Vice President of Medical Affairs at Quest Diagnostics, Dr. Yuri Fesko, shares a key takeaway from Quest's recent Health Trends Survey. Results reveal how cancer diagnosis numbers are still lagging to pre-pandemic levels of 11%. Fesko adds that bringing cancer screenings to the community can increase diagnosis numbers, leading to care sooner.

AMCP CEO Susan A. Cantrell spoke with Managed Healthcare Executive® about Preapproval Information Exchange (PIE) Act of 2022, which would allow drug manufacturers to share information about a drug with payers before the drug is approved. Cantrell says passage of the PIE Act would speed up patient access to new medications.

In this week's episode, Editor of Managed Healthcare Executive, Briana Contreras, had the pleasure of speaking with Chief Clinical Officer of WellSky, Tim Ashe, about the issue of Centers for Medicare and Medicaid Services cutting rates for Medicare home health. Tim addressed the solutions that are either underway or those that can potentially preserve access to these services.

Oncologist and Vice President of Medical Affairs at Quest Diagnostics, Dr. Yuri Fesko, talks about why shortening this gap is critical to ensuring better patient outcomes and shared steps hospitals, health systems and physicians can take now to reduce testing delays, improve outcomes and lower costs of care. This is the first part of a three-part video series.