Merck & Co.
213 E Grand Ave, South San Francisco, CA
33 Avenue Louis Pasteur, Boston, MA
320 Bent St, Cambridge, MA
33 Avenue Louis Pasteur, Boston, MA
320 Bent St, Cambridge, MA
NEWS
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.
A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.
The regulator has accepted Bristol Myers Squibb’s Opdivo and the chemotherapy cisplatin for priority review in patients with unresectable metastatic urothelial carcinoma, as well as Merck and Seagen’s first-line combo.
The buy brings three small molecules in preclinical development for Parkinson’s disease, amyotrophic lateral sclerosis and lysosomal storage diseases into Merck’s pipeline.
In a 12-1 tally, the FDA’s Pulmonary-Allergy Drugs Advisory Committee determined that the data does not establish a clinically meaningful benefit in this indication.
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