The investigational agent, zipalertinib, received the breakthrough designation from the FDA in January 2022

In an opinion article, investigators argue that gene therapies may not achieve their full potential if the innate inflammation in Duchenne muscular dystrophy is not effectively managed.

According to Regeneron, the drug is a bispecific antibody that binds to B-cell maturation antigen (BCMA) on cancerous plasma cells and CD3 on T cells, directing the immune system to attack and destroy multiple myeloma cells.

In a conversation with Managed Healthcare Executive, Michael Abrams, M.A., managing partner at Numerof & Associates, painted a picture of what’s at stake.

FDA officials have determined that information regarding the risks for six CAR T-cell therapies can be communicated through product labeling, which includes a boxed warning for the risks of cytokine release syndrome and neurological toxicities.

After a one-year follow-up, 10 of 12 patients given the islet cell therapy zimislecel no longer required insulin. Vertex officials said regulatory submissions are expected in 2026

Physician ownership of facilities and joint ventures with major chains also increased substantially from 2005 to 2019.

A new study found that patients with hemophilia A could safely switch directly from emicizumab to Mim8 without a washout period, meaning they did not need to stop treatment before starting the new medication and could maintain continuous protection against bleeding.

Health insurers and others decry the steep cuts in Medicaid spending that are projected to total approximately $1 trillion over the next 10 years.

Care gaps in women’s health are closing, thanks to increased cultural awareness of gendered healthcare disparities, according to Susan Cantrell, CEO of the Academy of Managed Care Pharmacy.

Climate change and air pollution are growing threats to public health, and new research suggests they may also worsen atopic dermatitis (AD), the most common chronic inflammatory skin condition, affecting up to 15% of people worldwide.

Absent a federal committee’s recommendation, Duchenne muscular dystrophy advocates are trying to get states to adopt screening programs.

Proponents say direct-to-consumer sales by drugmakers cut out intermediaries that add needlessly to prices. Detractors see ethical issues and prices that are still too high for many patients.

Employers, some lawmakers and others have criticized pharmacy benefit managers (PBMs), especially the "big three," for having complicated, sometimes hidden practices. The PBMs say they have responded with programs and policies that add transparency to what they do.

Datroway (datopotamab deruxtecan) is the first TROP2-directed therapy approved for advanced lung cancer in the U.S.

For payers, claims for rare disease treatments used to be uncommon. Not anymore, thanks to an increasing number of new, high-priced drugs for rare diseases.

According to the latest edition of The Cancer Atlas, lower-income nations are experiencing a rise in lung, colorectal and breast cancer incidence due to increasing adoption of behaviors associated with economic development—such as tobacco use, poor nutrition and physical inactivity.

Optum Rx officials said they now have eliminated reauthorization requirements for more than 140 chronic disease medications.

To prepare for CMS’ new risk adjustment data validation (RADV) strategy, Medicare Advantage plans must take a coordinated, organization-wide approach.

Patients addicted to opioids receive less mental health care if they are only covered by public insurance, compared with patients receiving care through alternate funding, according to a recent study published in Addiction Science & Clinical Practice.

Health plans must embrace real-time member awareness, timely clinical context and actionable insights to realize the benefits of care management.