Pfizer CEO Albert Bourla on Tuesday said FDA could authorize the drugmaker's updated COVID-19 booster shots by the end of the month, in today's bite-sized hospital and health industry news from the District of Columbia, Maryland, and New York.
- District of Columbia: FDA on Monday announced it has approved the immune checkpoint inhibitor, called dostarlimab and marketed as Jemperli, plus chemotherapy as a frontline option for treating certain patients with advanced or recurrent endometrial cancer. According to drugmaker GlaxoSmithKline, FDA's approval marks "the first new frontline treatment option in decades" for patients with endometrial cancer. The approval was based on a phase III trial that showed adding dostarlimab to frontline chemotherapy cut risk of disease progression by 71% compared to chemotherapy alone. (Bassett, MedPage Today, 7/31)
- Maryland: CMS last week announced that over 700,000 people lost Medicaid coverage in April, nearly 80% of whom lost coverage because of procedural reasons, meaning the patients were still eligible for Medicaid but had incomplete or missing paperwork. According to the Washington Post, at least 3.8 million people have lost Medicaid coverage since the end of a pandemic-era promise that those with Medicaid could keep it without demonstrating each year that they qualified for the coverage. Daniel Tsai, CMS' Medicaid director, said the agency has ordered six states to stop the removal of people from Medicaid for paperwork reasons and to reinstate those whose coverage was denied. According to Tsai, some states aren't following the federal requirement to rely on electronic data, including a person's wage records from food stamps or other benefit programs, whenever possible to automatically check a person's eligibility for Medicaid. "Make no mistake, where we have found problems or violations of federal requirements, we are taking action to ensure that states correct the issue immediately," said CMS Administrator Chiquita Brooks-LaSure. (Messerly/King, PoliticoPRO [subscription required], 7/28; Goldstein, Washington Post, 7/28; Goldstein, Washington Post, 4/1)
- New York: Pfizer CEO Albert Bourla on Tuesday during an investor call said that FDA could authorize the drugmaker's updated COVID-19 booster shots targeting the XBB.1.5 subvariant by the end of the month. This news comes as the company says it's eyeing potential cost-cutting measures as demand for COVID-19 vaccines slows. Bourla said Pfizer believes COVID-19 cases and hospitalizations will continue to rise heading into the fall. "We expect a new COVID wave to start in the U.S. this fall," he said. During the call, Pfizer also reported its second-quarter earnings fell short of projections, with COVID-19 vaccine revenue down 64% compared to last year and revenue related to the company's Paxlovid antiviral therapy down 58%. Bourla said vaccination rates over the next few months are expected to be a "reliable predictor of trends in subsequent years." (Lovelace Jr., NBC News, 8/1; Reed, Axios, 8/2; Hopkins, Wall Street Journal, 8/1)