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Pharma, health insurers square off about the healthcare provisions in the Inflation Reduction Act that passed the Senate yesterday. The PhRMA was sharply critical of the provisions that would empower CMS to negotiate the prices of a selected number of drugs. AHIP praised the extension of more generous ACA premium subsidies.

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.

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 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.

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.

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.