News

In COVID-19 news, an FDA advisory committee recommends EUA for Novavax’s vaccine. The FDA has also granted approvals to Dupixent for children as young as 6 month with atopic dermatitis and to the biosimilar Riabni for rheumatoid arthritis. An advisory committee has also recommended approval for two gene therapies, one for a rare neurogenerative disease and another for a blood disease.

Dupixent was already approved for patients 6 years and older. The new approval makes the drug available to children 6 months to 5 years whose atopic dermatitis is inadequately controlled.

Improving customer experience strategies is a top priority to keep pace in the modern market.

Findings reported in JAMA Network Open today show that Black and Hispanic Medicare beneficiaries with dementia were less likely to use hospice services than White beneficiaries and were more likely to have emergency department visits and hospitalizations.

The commission will review PBM business practices, including the impact of rebates on formulary design, the costs of prescription drugs to patients, and methods to determine pharmacy reimbursement.

The Federal Trade Commission says its inquiry “will shed light on” clawbacks, potentially unfair audits, rebates and other business practices of the pharmacy benefits management (PBM) industry. Today’s announcement says the commission will be requiring information from the six largest PBMs.

Approved in March, Tlando is an oral testosterone that doesn’t require dose titration.

A more accurate number of rare diseases is more than 10,000, and just 500 of these disorders have treatment options available for patients, according to RARE-X.

To thrive organizations must figure out how to build and maintain a strong culture in an increasingly remote workplace, and implement effective recruitment and retention strategies in an economy where there are fewer workers.

The FDA has withdrawn the approval of Ukoniq, which is used to treat two specific types of lymphoma. In approvals, the regulatory agency has approved a new indication for Kymriah, two addition Opdivo regimens, and extended the use of Evrysdi in newborns with SMA. The agency also accepted for review Dupixent to treat skin lesions but extended the review of a new ALS therapy, refused to file an application for a rare metabolic disorder, and put a hold on the trial for Cialis OTC.

New launches this week include: new strength of Alimta, a generic of Esbriet, a generic of Toradol, and a generic of Florinef.

Healthcare organizations must encourage anyone in need to explore the mental health and wellness resources available at their institution.

Byooviz, the first FDA approved ophthalmology biosimilar for macular degeneration, will be priced 40% lower than the reference product. It will be commercially available on July 1, 2022.

The rebate total is high relative to many past years but is half of the $2 billion in rebates in 2021 and less than half of the $2.5 billion paid in 2020.

A 52-week open-label extension study supported the long-term use of Dupixent to treat adolescents with moderate-to-severe atopic dermatitis.

The guide is designed to help spread best practices and help healthcare decision-makers understand the benefits of digital therapeutics.

If approved, Orasis’ low-dose pilocarpine would be the second product that improves presbyopia, which is the age-related loss of clear up-close vision. The company plans to submit an NDA in the second half of the year.

The bill would allow the Federal Trade Commission to impose penalties on PBMs of up to $1 million for unfair and deceptive practices.

One in 4 COVID-19 patients in the 18-64 age group experienced at least one of the 26 conditions that may be associated with COVID-19, according to CDC researchers. However, the study did not differentiate the risk by vaccination status or SARS-CoV-2 strain, both of which may affect the risk of post-acute conditions and symptoms.

Pharmacy benefit managers can help health plans understand when to best leverage and align to biosimilars and other cost-effective treatments, argues Prime Therapeutics' Kelly McGrail-Pokuta.

The FDA has approved the first non-steroid cream for psoriasis, as well as another biosimilar of Neulasta, Tibsovo combination for older patients with leukemia and a new formulation of Tyvaso. The agency has issued a second CRL for poxvirus treatment and also accepted applications for several therapies, including a nasal spray for migraine, mirvetuximab for ovarian cancer, and a treatment for the rare disease Friedreich’s ataxia.

The Access to Oncology Medicines Coalition brings together pharma companies and other organizations to help countries develop the capacity and access to essential cancer medicines.

Two studies published this week documented the billions that Medicare and Medicaid spend on drugs that have been granted accelerated approval by the FDA based on surrogate end points. A study reported today in JAMA Health Forum found that only 6 of the 22 confirmatory trials used clinical outcomes.

Although climate change affects the entire global population, historically marginalized and under-resourced communities will be disproportionately affected.

Surgeon General Vivek Murthy’s sweeping report on health worker burn out listed five steps that insurers and payers could take to reduce the burden of burn out.

Data gathered from electronic medical records found that the results in a real-world patient population with atopic dermatitis were consistent with those found in clinical trials.

University of Pennsylvania researcher conducted 36 interviews of Black veterans with chronic kidney disease to find out how they experienced racism in their lives and especially as patients at the VA.

New survey from American Medical Association identifies the continued burden of prior authorizations on physicians.

While the trend toward value-based care is promising, research shows it can take a long time for healthcare payers to effectively implement the model. Value-based programs require an infrastructure that enables the many-to-many relationships between value-based care stakeholders and their counterparts.

Traditional Medicare has been an important proving ground for U.S. healthcare for decades, and Medicare reimbursement has been used to support rural healthcare and medical education. In an opinion piece published by JAMA, Gretchen Jacobson and David Blumenthal of The Commonwealth Fund discuss some of the pitfalls of shrinking enrollment in traditional Medicare as the proportion of beneficiaries in Medicare Advantage plans grows.