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Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide . Results from the Phase III TRIUMPH-4 trial exceeded analyst expectations, leading BMO Capital markets to cleverly dub it “a true TRIUMPH.” Also in the weight loss arena, Zealand Pharma inked a deal with China’s OTR Therapeutics worth up to $2.5 billion to collaborate on next-gen drugs for obesity and other metabolic diseases, and Rhythm Pharmaceuticals awaits a Dec. 20 FDA verdict for Imcivree in hypothalamic obesity. Turning to the FDA, reports broke late last week that the agency was considering slapping a black box label—its strictest warning—on COVID-19 vaccines. Commissioner Marty Makary denied those reports on Monday, stating on Bloomberg TV that the FDA has “no plans” to make such a move. This follows an internal memo from Vinay Prasad leaked over Thanksgiving in which the CBER director claimed that “at least” 10 children have died “because of” COVID-19 vaccines. An internal safety review published last week refuted this conclusion, instead concluding that between zero and seven deaths could be linked to the shots. Pfizer CEO Albert Bourla , for one, is tired of the recent rhetoric from HHS on vaccines and hopes they are “an anomaly” that will be corrected soon. With strong words about the administration’s sentiment on vaccines, Bourla prominsed Pfizer’s continued investment in vaccines despite declining revenue. Pfizer this week lowered its 2026 guidance to $62.5 billion in revenue, missing analyst consensus. Clinical research 5 of 2025’s Defining Clinical Wins In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal parts. Here are some of this year’s most glorious clinical trial victories. December 15, 2025 · 9 min read · Tristan Manalac The FDA has also granted several approvals in the past week, to Amgen , Milestone Pharmaceuticals and AstraZeneca and Daiichi Sankyo . USAntibiotics also snagged a greenlight, for Augmentin XR , the first approval to be given under the agency’s new Commissioner’s National Priority Voucher (CNPV) program. Also this week, Johnson & Johnson scored a CNPV ticket—without even having to apply—for its investigational combo of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma after the FDA was impressed by Phase III data. In ClinicaSpace this week, we highlighted 5 of 2025’s Defining Clinical Wins and The 5 Most Painful Clinical Trial Failures of 2025 . This past week provided a few more on each front. In the winner’s circle, Immunome’s desmoid tumor drug and and Kyverna’s CAR T for stiff person syndrome both aced pivotal trials, while Sanofi’s MS drug tolebrutinib and Gilead and Arcus’ TIGIT therapy domvanalimab each failed Phase III tests. And in BioPharm Executive, we highlight 6 Biotechs That Could Be Big Pharma’s Next M&A Target , and more M&A predictions for 2026.

Courtesy of Johnson & Johnson Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a Phase III study testing Tecvayli plus Darzalex in patients with relapsed or refractory multiple myeloma. Johnson & Johnson has secured a Commissioner’s National Priority Voucher from the FDA—without even having to apply for it. The ticket covers J&J’s investigational combination of Tecvayli plus Darzalex for the treatment of relapsed or refractory multiple myeloma. The voucher award was prompted by findings from the Phase III MajesTEC-3 study, which the pharma presented at the annual meeting of the American Society of Hematology earlier this month. Results showed an 83% improvement in progression-free survival in patients treated with the combination at a median of 34.5 months, compared to controls receiving standard therapies. Overall survival likewise leaned strongly in favor of Tecvayli plus Darzalex, hitting 83.3% at 36 months versus 65% in controls. “Within hours of the trial results being published, FDA leaders read the study, consulted with internal experts, and the following day contacted the company to discuss a national priority voucher,” FDA Commissioner Marty Makary said in a prepared statement on Monday. This proactive award, he added, is part of the agency’s mission to accelerate promising therapies. “When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly,” Makary said. J&J is the 16th company to be awarded the national priority voucher since the program was announced in June . The vouchers are granted to companies whose products align with certain federal priorities, including addressing key medical needs, boosting domestic manufacturing and lowering drug prices in line with President Donald Trump’s Most Favored Nation scheme. Companies can use the priority voucher to drastically shorten drug review times from the usual 10–12 months to 1–2 months. The first batch of vouchers were handed out in October and included Sanofi’s type 1 diabetes drug Tzield, Regeneron’s investigational gene therapy DB-OTO for hereditary deafness and Revolution Medicines’ oral cancer drug RMC-6236 for pancreatic cancer. One awardee from this group, USAntibiotics’ amoxicillin formulation Augmentin XR, won the first CNPV approval earlier this month, “strengthening the U.S. drug supply chain through enhanced domestic manufacturing,” according to the regulator. The second batch of CNPVs , awarded in November, included Novo Nordisk’s weight-loss blockbuster Wegovy and Eli Lilly’s oral obesity candidate orforglipron. Vertex Pharmaceuticals and CRISPR Therapeutics’ gene therapy Casgevy for sickle cell disease has also been given a voucher.