News

Due to one of the most challenging global crises in living memory and one that presented an acute challenge for the medical community, healthcare providers find themselves operating within an uncertain landscape. They are still managing the fallout of COVID-19 while also planning for the future.

The FDA has made several approvals this week, including Enhertu for HER2-low breast cancer, a steroid-free cream for plaque psoriasis and the first interchangeable biosimilar to Lucentis, as well as Stelara in children with psoriatic arthritis. The agency has issued a complete response letter for Nuplazid in Alzheimer’s psychosis. Regulators have accepted a BLA for a biosimilar of Actemra and scheduled a second advisory committee meeting for AMX0035 in ALS.

An OptumRx drug pipeline report highlights Zynteglo, a curative gene therapy treatment for beta-thalassemia, and Skysona, a gene therapy for a cerebral adrenoleukodystrophy. FDA approval decision are imminent for both. Price tags of $2 million are expected.

Public Citizen advised Amazon's acquisition of One Medical should be rejected if Amazon does not commit to robust, legally binding safeguards in a letter sent today to authorized U.S decision-makers.

Less-effective coping strategies, such as passive and palliative reaction, were associated with a significant impact on health-related quality of life in eosinophilic esophagitis (EoE).

Those living with diabetes who don't have insurance will pay $35 for a 30-day supply of Sanofi U.S. insulins.

A small study finds that an adeno-associated virus gene therapy eliminated both spontaneous bleeding and the need for factor IX prophylaxis in patients with hemophilia B.

The prescription drug launches include a therapy to treat adults with multiple myeloma and a treatment for overactive bladder. Dr. Reddy’s has also acquired several therapies from Eton Pharmaceuticals, including hypotension treatments.

There's hope for Medicare beneficiaries who believe Medicare should negotiate with drug companies to reduce costs after members of the senate announced the recent proposed legislation, Inflation Reduction Act of 2022.

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.