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In letters to Eli Lilly and Novo Nordisk, the FDA accused the companies of downplaying the risks of their GLP-1 weight loss drugs during a prime time special with Oprah Winfrey.

The over-representation of males and Hispanic patients in Eli Lilly’s Phase III ATTAIN-1 study could explain why orforglipron “underperformed” expectations in a previous readout, according to analysts at BMO Capital Markets.

The Boston-based AI/ML startup focuses on endocrine and cardiometabolic diseases and will use that expertise to generate new small molecule obesity medications for Lilly.

Both Novo Nordisk and Eli Lilly are eyeing regulatory advancements for their obesity blockbusters as the European Association for the Study of Diabetes’ annual conference continues this week.

This manufacturing site in Richmond, Virginia, is the first of four projects that Eli Lilly plans to reveal this year as part of a $27 billion U.S. investment announced earlier this year.

While Eli Lilly’s diabetes blockbuster was non-inferior to its older incretin therapy Trulicity in a highly anticipated Phase III cardiovascular outcomes trial, analysts had hoped for statistical significance in reducing major events such as cardiovascular death, heart attack and stroke.

Closely watched data from Eli Lilly and Viking Therapeutics this month have reignited the discussion around oral weight-loss drugs—and their ultimate place within the anti-obesity medication market.

Eli Lilly’s orforglipron cut body weight to a lesser extent than rival Novo Nordisk’s semaglutide, falling into analysts’ bear scenario for the oral med. Executives brushed off the concerns and said the drug will still have a wide advantage on the market.

Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development.