Merck & Co.
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The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
The competition between Merck’s pneumococcal vaccine and Pfizer’s Prevnar series of vaccines is intensifying after the regulator granted priority review to the former’s BLA for V116.
Merck’s HIF-2α inhibitor Welireg has been approved by the FDA to treat advanced renal cell carcinoma after treatment with PD-1 or PD-L1 and VEGF-TKI-based therapies.
The combination of Keytruda and an mRNA vaccine reduced the risk of death or relapse in patients with the most deadly form of skin cancer after three years in a Phase IIb study.
The year may be coming to a close, but there’s no holiday break for the FDA, which will release five regulatory verdicts over the next two weeks.
For the second time in as many days, Merck has reported a Phase III failure for its blockbuster PD-1 inhibitor Keytruda, this time as a first-line treatment with Eisai’s Lenvima for cancer in the uterus lining.
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