The FDA has withdrawn the approval of Ukoniq, which is used to treat two specific types of lymphoma.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.
Kirsten Axelsen, Richard Frank and Rachel Sachs agreed that the rapid development of the COVID-19 vaccines was a government-business success story. There was less to celebrate as the Kaiser Family Foundation panelists also unpacked the legal issues and economic consequences of drug rebates, international reference pricing, high deductible health coverage and compulsory licensing.
Findings in JAMA Health Forum show that new formulations were more likely for blockbuster drugs and drugs that received accelerated approval. Proxy measures of clinical usefulness and other elements of therapeutic value were not associated with new formulations.
Some patients aren’t getting follow-up phone calls, and others lack transportation for appointments with physicians. A new study highlights problems in post-acute care.
Those who participated in rehabilitation programs were less likely to die and had improved overall function, a recent study finds.
In COVID-19 news, FDA expanded EUA for Pfizer/BioNTech COVID-19 booster to children 5 to 11 years and cleared first at-home combo COVID-19, RSV and flu test, but declined an EUA for the antidepressant fluvoxamine to treat COVID-19. Regulators also approved Lilly’s novel diabetes drug and Dupixent eosinophilic esophagitis, modified Dsuvia REMS program and issued a CRL for bimekizumab for psoriasis.
Rates dipped in the 1990s, but the opioid epidemic and the contaminated needles associated with it have caused an increase in new acute cases.
A recent HHS Office of Inspector General's report found that Medicare Advantage (MA) plans inappropriately deny prior authorization requests. With MA enrollment growing, scrutiny of MA plans and their utilization management strategies is also likely to grow, according to Alina Czekai, M.P.H., of Cohere Health. Czekai argues that artificial intelligence and machine learning can improve utilization management and prevent inappropriate denials.
Florida Blue and Blue Shield of California are among the insurers curating and offering free access to wellness apps for their members.
A list of biosimilar competitors to Humira that may come on the market next year.
