The FDA has approved lupus therapy for children and allows importation of contrast medium. The agency has accepted applications for several therapies, including for a Tysabri biosimilar, a therapy for a genetic form of ALS, and an immunotherapy for bladder cancer, as well as for Enhertu in low HER2 breast cancer. Additionally, AbbVie seeks additional indication for Rinvoq.
The House of Representatives recently passed a bill this week that continues telehealth use under Medicare through 2024 that was initially authorized during the the height of the COVID-19 pandemic.
The healthcare sector has always been one of constant change, regularly experiencing technological, policy, and practice transformation. But the level of uncertainty and complexity since the pandemic hit has put understanding how the business of healthcare has changed on life support.
The average person checks their phone 58 times a day, so there is a good chance that a text message will be read.
Third annual report from Optavise demonstrates why ongoing health benefits education is critical.
The donation supports youth mental health in California in honor of Black, Indigenous, People of Color (BIPOC) Mental Health Month celebrated in July.
Automation not only eases the financial pressure these organizations are often under but requires less manpower, which helps overcome challenges associated with worker shortages, all while supporting a positive vendor relationship.
Social determinants of health largely influence the health status of patients and their health choices. Included are tips for health providers on how to add social determinants collection to healthcare software.
Pharmacogenomics looks at how genetic influences affect an individual’s response to therapeutic medications.
FDA approves Xalkori for rare tumor, as well as Opzelura for skin conditions. The agency has accepted applications for a supplemental indication for the biosimilar Hyrimoz and pegcetacoplan for advanced macular degeneration. Additionally, Acadia submits NDA for trofinetide.
The program started before specialty drugs became such a large expense for Medicare and its beneficiaries. Congress is considering legislation that would cap beneficiary out-of-pocket costs and require price discounts from manufacturers.
The organization claims that direct and indirect remuneration fees and other clawback programs amount to a breach of contract.
Novo Nordisk’s Saxenda (liraglutide) and Wegovy (semaglutide) are leading the way for a new crop of drugs that reduce appetite. But their cost-effectiveness is in question, and many payers are saying no to coverage — for now.
Some experts want to see more funding for hospice care in the home. Others say the advantages of hospice in a hospital or nursing home have been underrated.
As the clinician shortage continues, leaning on technology to streamline inefficiencies is essential.
MHE spoke with Matt Parker, vice president of Products at Kyruus and HealthSparq, about the recent price transparency rules that went into effect, who they apply to and compliance improvement by insurers.
Sharing technologies like blockchain could help healthcare institutions establish a consistent, accurate, and trustworthy approach to data collection and dissemination.
In COVID-19 news, the FDA grants EUA for Novavax’s COVID-19 vaccine. The agency approved a novel diagnostic dye and another indication for Xalkori, but delayed a decision on a therapy for esophageal cancer. FDA has also accepted a BLA for advanced HER2 breast cancer therapy. Finally, Can-Fite BioPharma plans submission for psoriasis therapy.
A novel therapy in early development aims to permanently turn off the PCSK9 gene in the liver and lower cholesterol with a one-time treatment. It is being developed for a genetic form of high cholesterol.
Although the Oncology Care Model produced some positive results, the value-based care model cost Medicare money. Now attention is turning to its successor, the Enhancing Oncology Model.
The Big Three all set up group purchasing organizations recently, but some industry observers question the timing of the move and who will benefit.
As Congress considers legislation that would cap out-of-pocket costs for insulin, Walmart and Civica Rx are taking steps that could make less expensive versions of the diabetes medication more available.
The FDA expands label for Krystexxa. Agency has granted priority review for two therapies: lecanemab for Alzheimer’s disease and a novel immunotherapy for follicular lymphoma. The FDA will convene a second advisory committee for ALS therapy. Additionally, Bausch + Lomb submits NDA for dry eye disease therapy.
Bispecific antibody therapies are also in development.
One trend to keep an eye on is the establishment of “care traffic control” centers to remotely monitor patients and use home-based insights to identify risks and inform care plans.
The increases had no impact on the efficacy of the drug and were rarely associated with symptoms or sequelae.
Under the national vaccine strategy, the U.S. Department of Health and Human Services is expanding access to the monkeypox vaccine, Jynneos, in areas with the highest transmission and need.
The United States has acquired adult and pediatric doses of the COVID-19 vaccine for delivery in early fall in a contract worth $3.2 billion, as well as an additional 150,000 doses of bebtelovimab for about $275 million.
In COVID-19 news, the FDA has declined an EUA request for Zyesami and Pfizer has submitted NDA for Pavlovid. The regulatory agency has accepted several applications, including an sBLA for Eylea in diabetic retinopathy and the NDA for palovarotene for a rare genetic disorder. The FDA also issued a CRL for a UTI therapy and extended the review of diabetes therapy. And finally, Gilead has resubmitted its twice-year HIV therapy.
