Eli Lilly has ended 2025 with strong results from its Phase III TRIUMPH-4 trial for retatrutide, a triple hormone receptor agonist aimed at weight loss. The outcome surpassed analyst expectations, prompting BMO Capital Markets to call it “a true TRIUMPH.” In related developments, Zealand Pharma signed an agreement with China’s OTR Therapeutics that could be worth up to $2.5 billion. The partnership will focus on developing next-generation drugs for obesity and other metabolic diseases. Rhythm Pharmaceuticals is awaiting a decision from the FDA on December 20 regarding Imcivree for hypothalamic obesity.
Recent reports suggested the U.S. Food and Drug Administration (FDA) was considering adding a black box warning—the agency’s strictest—on COVID-19 vaccines. However, Commissioner Marty Makary denied these claims in an interview with Bloomberg TV, stating the FDA has “no plans” to implement such a warning. This comes after an internal memo from Vinay Prasad surfaced over Thanksgiving, in which he claimed that “at least” 10 children had died “because of” COVID-19 vaccines. A subsequent internal safety review contradicted this statement, concluding that between zero and seven deaths could potentially be linked to the vaccines.
Pfizer CEO Albert Bourla expressed frustration with recent comments from the Department of Health and Human Services about vaccines, saying he hopes they are “an anomaly” that will soon be corrected. Despite falling revenue projections—Pfizer reduced its 2026 guidance to $62.5 billion—Bourla affirmed Pfizer’s commitment to continued investment in vaccine development.
The FDA recently approved new products from Amgen, Milestone Pharmaceuticals, AstraZeneca and Daiichi Sankyo. USAntibiotics received approval for Augmentin XR under the agency’s new Commissioner’s National Priority Voucher (CNPV) program. Johnson & Johnson also received a CNPV ticket without applying for it after positive Phase III data on its investigational combination of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma impressed regulators.
In clinical research highlights this week, Immunome reported success in pivotal trials for its desmoid tumor drug and Kyverna saw positive results for its CAR T therapy targeting stiff person syndrome. Conversely, Sanofi’s multiple sclerosis drug tolebrutinib and Gilead/Arcus’ TIGIT therapy domvanalimab both failed Phase III trials.
Industry analysis this week includes predictions about potential merger and acquisition targets among biotech companies as well as forecasts for M&A activity in 2026.
