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Amgen is awaiting another Phase 3 readout for the investigational Sjögren’s disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to support an FDA application.

Potential near-term commercialization through two synergistic business units: (i) a telehealth platform connecting patients with independent licensed healthcare providers and (ii) a North American network of pharmacy-based pharmaceutical 3D-printing systems for compounding medications, together forming a personalized medicine ecosystem

Bristol Myers Squibb’s $2.3 billion Houston manufacturing campus is part of the company’s larger $40 billion investment designed to bolster American innovation and manufacturing.

EloraTZP—a combination of an amylin asset and Eli Lilly’s approved obesity drug Zepbound—made a clean sweep of the primary and secondary endpoints in a mid-stage trial of adults with obesity and type 2 diabetes, setting up the launch of a Phase 3 trial before the end of the year.

With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expected later this year.

Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUSIVA.

In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor’s assertion that a Phase 3 trial met its primary outcome measures.

GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA’s recent approval for Moderna’s mRNA flu vaccine.