Jennifer Barrett, Associate Editor

Patients with HCC who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib are eligible for this treatment.

The pathway is intended to help patients by making more treatment options available through biosimilar and interchangeable products.

Compared with interferon beta-1a, ozanimod reduced less cortical grey matter volume in patients with relapsing forms of multiple sclerosis.

Study finds the number of patients who are eligible for and may respond to checkpoint inhibitor therapies is higher than for genome-driven therapies.

Using genetic testing for women newly diagnosed with breast cancer can decrease the high cost of chemotherapy use in the first year of care.

Although the prevalence of LEMS in children is not known, the overall prevalence is estimated to be 3 per million individuals worldwide, according to the FDA.

At the Asembia Specialty Pharmacy Summit 2019, Scott Gottlieb, MD, 23rd commissioner of the FDA discussed the agency's role in rewriting the modern rules of new regulatory paradigms for a number of recent advancements in medicine.

Co-pay accumulator programs are the latest cost management initiative resulting from the constant push and pull between payers, pharmacy benefit managers, and manufacturers to reduce drug spend.

Check back daily for our coverage of the Asembia Specialty Pharmacy Summit this week.

Etanercept-ykro (Eticovo) is the second etanercept biosimilar to be approved by the FDA, following Sandoz’s etanercept-szzs (Erelzi) in 2016

This approval marks the first generic naloxone nasal spray for use in a community setting by an individual without medical training.

Glecaprevir/pibrentasvir (G/P) plus sofosbuvir and ribavirin can potentially treat patients who experienced previous virologic failure following G/P therapy.

The expanded first-line indication makes pembrolizumab (Keytruda) monotherapy an option for more patients with non-small cell lung cancer.

Cytomegalovirus may contribute to faster cystic fibrosis progression, but further studies are warranted to confirm these findings.

Romosozumab-aqqg (Evenity, Amgen) works to decrease the risk of fracture by increasing new bone formation in women with postmenopausal osteoporosis.

Romosozumab-aqqg (Evenity, Amgen) works to decrease the risk of fracture by increasing new bone formation in women with postmenopausal osteoporosis.

With this approval, patients who have never been treated have the option of a 2-drug regimen in a single tablet, as opposed to the standard-of-care 3-drug regimen for HIV.

With this approval, patients with HIV who have never been treated have the option of a 2-drug regimen in a single tablet.

Brain stem cells of patients with primary progressive multiple sclerosis appear to age faster.

Enfortumab vedotin is being investigated for the treatment of locally advanced or metastatic urothelial cancer following both platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

For the study, the researchers assessed whether a slow-release, long-acting, implantable naltrexone could improve outcomes for patients with HIV and opioid addiction.

An implantable form of naltrexone was more effective in improving HIV outcomes in patients compared with oral naltrexone.

The daratumumab (Darzalex) combination therapy would be the first for use in the frontline setting for transplant-eligible patients with multiple myeloma.

Although lung cancer screenings are covered at no cost by most insurers, state Medicaid programs are not required to offer coverage for this service.

Gilteritinib (Xospata) was superior to standard chemotherapy in improving overall survival in patients with acute myeloid leukemia.

Cladribine (Mavenclad, EMD Serono) is the first oral multiple sclerosis drug to demonstrate 2 years of proven efficacy with a maximum of 20 days of treatment.

The combination therapy reduced the risk of squamous cell carcinoma development on the face and scalp by approximately 75% in the study.

With this approval, certolizumab pegol becomes the first FDA-approved therapy for this type of axSpA, filling an unmet clinical need for treatment options, according to the release.

Certolizumab pegol (Cimzia) is the first FDA-approved therapy for this type of axial spondyloarthritis, filling an unmet clinical need for treatment options.

An updated transmission model indicates that most new HIV infections occur due to a lack of diagnosis and treatment.