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New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.

After mastering mass-market mRNA production during the pandemic, the industry now needs to achieve the timely delivery of individualized vaccines to thousands of patients.

The anti-TL1A antibody from Merck’s 2023 Prometheus buy delivered positive mid-stage results in a skin condition but failed in a certain type of lung disease, the Big Pharma revealed alongside second-quarter earnings.

Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.

Melanoma was slower to recur in patients receiving Merck and Moderna’s mRNA vaccine with Keytruda, supporting use of the combination in adjuvant treatment. The partners plan to take the data to the FDA.

While Merck and Gilead Sciences reported back-to-back late-stage victories for their weekly HIV pill, the partners also discontinued a Phase 3 program for their cancer combo after disappointing lung cancer survival data.

Given its intravenous route of administration, Merck’s tulisokibart will likely “need to be meaningfully improved” over Roche’s afimkibart, which can be given subcutaneously, BMO Capital Markets analysts said. Both assets are being tested for ulcerative colitis.

FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.

Merck and Kelun-Biotech’s antibody-drug conjugate significantly improved progression-free and overall survival in a pivotal endometrial cancer study, though the companies have yet to specify when they plan to file for approval.