Pharmaceutical Executive Daily: FDA Approves Orezeyful

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, an antitrust attorney weighs the legal risks of a hypothetical AstraZeneca-Bristol Myers Squibb merger, Eli Lilly beats Wall Street estimates on soaring Mounjaro and Zepbound sales and raises its full-year guidance, and the FDA approves Moderna's first mRNA-based flu vaccine for adults 50 and older.

Ron Lanton, senior partner at Lanton, Lanton & Sosa Law, tells Pharmaceutical Executive that a hypothetical AstraZeneca-Bristol Myers Squibb combination would clear the Hart-Scott-Rodino filing threshold with ease, but the real risk lies in narrower therapeutic overlaps rather than the companies' overall size. He points to direct competition between Yervoy and Imjudo in CTLA-4 treatments, Opdivo and Imfinzi in PD-(L)1, and prospective clashes in myeloma cell therapy and antibody-drug conjugate programs.

Eli Lilly posted $23 billion in second-quarter revenue, up 48 percent year over year, driven by a 60 percent jump in volume for its injectable GLP-1 drugs. Mounjaro sales climbed 91 percent to $9.94 billion and Zepbound brought in $4.93 billion, together accounting for nearly two-thirds of quarterly revenue. Injectables continue to outpace oral options, with roughly three in four new patient starts and about 80 percent of Medicare obesity pilot patients choosing injections. Lilly's new obesity pill, Foundayo, brought in $98 million, short of analyst expectations, though the company says prescriptions nearly doubled in the last week of July.

Finally, FDA has approved mFLUSIVA, Moderna's mRNA-based influenza vaccine, for adults 50 and older, marking the company's first mRNA flu shot and its fourth FDA-approved product. In a Phase III trial of more than 40,000 adults, the vaccine showed 26.6 percent relative efficacy against a standard-dose comparator, with efficacy reaching 27.4 percent in adults 65 and older; approval in that older group came via the accelerated pathway, pending a confirmatory postmarketing trial. Moderna says supply will reach select retailers ahead of the 2026-2027 respiratory virus season, with regulatory submissions also under review in the European Union, Canada, and Australia.

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