• Maryland: FDA has approved a new drug developed by Kura Oncology to treat cases of acute myeloid leukemia with a certain genetic signature. According to MedCity News, the treatment is Kura's first commercial asset and could compete against a similar drug by Syndax Pharmaceuticals, which was the first of this class of targeted cancer therapies to enter the market. The approval of Kura's drug, ziftomenib or Komzifti, was based on the results of a Phase 2 clinical trial of 112 adults. In the trial, 21.4% of patients achieved complete remission or complete remission with partial hematological recovery for a median of five months. Of these patients, 88% achieved this recovery within six months of starting treatment. Currently, Komzifti has a list price of $48,500 for a one-month supply, and Kura estimates it could generate $350 million to $400 million in annual sales. Kura will commercialize Komzifti through a partnership with Kyowa Kirin, with Kura leading manufacturing and U.S. commercialization and Kyowa Kirin leading development and commercialization overseas. (Vinluan, MedCity News, 11/13)
• New Jersey: Merck's new experimental pill enlicitide reduced LDL cholesterol by up to 60% in a late-stage clinical trial, results that were similar to those obtained by injectable monoclonal antibodies. The Phase 3 clinical trial included 2,900 participants with high levels of LDL or "bad" cholesterol who had experienced or were at risk of a major cardiovascular problem, including coronary heart disease, heart attack, and stroke. Enlicitide is a once-daily pill that inhibits a cholesterol-regulating protein called PCSK9, which often soars in patients with high LDL cholesterol. In the trial, the drug reduced LDL cholesterol by up to 60%, with two-thirds of patients cutting their cholesterol by at least 50%. According to Merck CMO Eliav Barr, the findings show that it's possible to get a significant reduction in cholesterol in primary care settings. "If you really want to impact and bend the curve on death from atherosclerotic cardiovascular disease, you have to target the patients where they are," Barr said. "And where they are for cholesterol is essentially at the family practice clinic, at the internist clinic, with a PA or a nurse practitioner who's managing their care." (Cooney, STAT+ [subscription required], 11/8)
• New York: Planned Parenthood has closed 20 clinics nationwide after a provision in the One Big Beautiful Bill Act cut funding for healthcare providers that offer abortions and receive over $800,000 in Medicaid reimbursements for basic reproductive health services each year. Other federal funding cuts have also led to the closure of two dozen other Planned Parenthood clinics. Currently, Planned Parenthood is challenging the Medicaid ban in court, but the case is still ongoing. Although lawmakers in some states have helped Planned Parenthood with funding from their state budgets, the organization still has a significant funding gap. According to Planned Parenthood president and CEO Alexis McGill Johnson, without Medicaid or another way to backfill funding, more clinics could close, which would leave many Medicaid patients without access to affordable care. In addition, clinics that are still open are "being pushed to the brink," the organization said. (Somasundaram, Washington Post, 11/12)

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