D.C. News:

• President Biden has ruled out nominating Dr. Janet Woodcock to permanently lead the FDA. Woodcock, who’s served as the FDA’s acting commissioner since Biden took office and can stay in the role until November 15, has faced opposition from key lawmakers and backlash over the agency’s controversial approval of Biogen Inc.’s Alzheimer’s disease treatment earlier this year. (Article here)

 Life Sciences:

• Federal health officials are probing reports that Moderna Inc.’s COVID-19 vaccine may be tied to a higher risk of heart inflammation in younger adults than previously thought. The FDA-CDC investigation, which focuses on Canadian data, is examining U.S. data to understand whether the risk is higher in the country, though the sources stressed that the side effect is likely still uncommon. (Article here)
• House Democrats are calling on three major insulin makers to describe the steps they’ve taken to address the costliness of the diabetes treatment since early 2019, including information on list or net price increases and profits earned on their products. Chairman Frank Pallone of the House Energy and Commerce Committee and Chairwoman Diana DeGette chair of its oversight subcommittee sent letters notifying Eli Lilly & Co., Novo Nordisk A/S and Sanofi SA that they are “troubled that despite your company’s expressions of shared concern, insulin prices in the United States remain unacceptably high.” (Article here)
• AstraZeneca PLC said it will seek regulatory approval for its COVID-19 antibody treatment after a study showed it was highly effective at preventing symptomatic illness. AstraZeneca said protection could last up to a year, but that further study is needed. The development comes as drugmakers look to use antibody drugs to curb hospitalizations and serve as a potential alternative to vaccines. (Article here)

Payers:

• Nonprofit insurer Medica and nonprofit health system SSM Health announced they are launching a joint venture. Medica will invest an undisclosed sum in Dean Health Plan, a subsidiary SSM Health, to enhance operations, technology, and value-based components of the health insurance businesses. The two will retain their separate brand identities. Dean Health Plan has nearly 500,000 members across Wisconsin, Missouri, Illinois, and Oklahoma. Medica serves about 1.5 million members. The agreement is expected to be finalized during the fourth quarter pending regulatory approvals. (Press release here; Articles here and here)
• Bright Health, a Minnesota-based insurance startup, announced plans to expand its operations to 42 new markets next year across Texas, Georgia, Utah, and Virginia. The expansion will increase its total overall footprint to 17 states and 141 markets, up from 99. Bright Health also plans to broaden its product portfolio in states where it already has a presence, including in Florida, California, Colorado and North Carolina. (Press release here; Article here)
• Cigna announced that, effective September 7, all employees who are returning to its offices to be vaccinated against COVID-19. The insurer said the policy will “provide these individuals with an extra layer of safety and protection against COVID-19 while onsite.” CareFirst BlueCross BlueShield announced earlier this week that it would require all employees, boards of directors, and guests to be vaccinated by November 1. (Article here)

Public Health/Prevention:

• The U.S. administered more than one million COVID-19 vaccine doses in 24 hours for the first time in almost seven weeks. The average pace of those initiating vaccination is more than 70 percent higher than one month ago. Oklahoma and Louisiana — two states that have lagged the rest of the nation in vaccinations — are now outpacing the national average. Over the past week COVID-19 hospitalizations averaged more than 11,000 new hospital admissions. The current pace is still below pandemic highs seen in January; however, if it continues the CDC predicts the U.S. might reach a record high within a month. (Articles here, here, here, and here)