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.
Circle 2023 on your calendar. That's when as many as 11 biosimilars to Humira are headed for the U.S. market.
Kate Sommerfeld, president of the Social Determinants of Health Institute, spoke about efforts to address social determinants of health (SDOH) gaining traction, taking an interconnected approach and using data analytics to understand the value of the efforts to address SDOH.
There’s a long history to recognizing that social factors shape people’s health. But the social determinants of health are getting more attention than ever. Will that attention turn into action and lasting change?
Across the globe, new drugs — injections, topical and oral — are being developed to help patients with atopic dermatitis.
Research suggests that COVID-19 vaccination may serve a therapeutic effect, possibly reducing the risk of developing long COVID when administered to those currently infected.
Data suggest most patients have positive serology results a month following vaccination with either the Moderna or Pfizer vaccine.
In COVID-19 news, the FDA has approved Olumiant for new COVID-19 indication, but had limited Janssen’s COVID-19 vaccine. The agency has launched a new program for rare disease drug development and approved a new oral form of ALS therapy. Regulators have also extended the review time for both a new Pompe disease therapy and the sNDA for Myfembree for endometriosis. Additionally, Eisai has completed its submission of lecanemab for Alzheimer’s disease.
The partnership will allow international manufacturers to use the technologies for the potential development of COVID-19 vaccines, treatments and diagnostics to benefit people living in low- and middle-income countries.
Pirfenidone is used to treat patients with idiopathic pulmonary fibrosis, a progressive rare disease that make it difficult to breathe.
It is not clear whether gut inflammation has a causal role in myeloproliferative neoplasms, or the other way around.
Research and discussion about the high cancer rates among Black Americans used to be dominated by genetics and the search for biological differences. Now attention has shifted to the social determinants of health.
