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Merck and Eisai Receive Priority Review From FDA for KEYTRUDA® Plus LENVIMA® Applications for Advanced Renal Cell Carcinoma and for Advanced Endometrial Carcinoma

Applications Based on Progression-Free Survival, Overall Survival, and Objective Response Rate Data From Respective Pivotal Phase 3 Trials Merck known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration has accepted and granted priority review for applications seeking two new approvals for the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, …
Applications Based on Progression-Free Survival, Overall Survival, and Objective Response Rate Data From Respective Pivotal Phase 3 Trials
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. The first set of applications ....

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Merck Receives Priority Review From FDA for New Drug Application for HIF-2? Inhibitor Belzutifan

Merck Receives Priority Review From FDA for New Drug Application for HIF-2? Inhibitor Belzutifan
Application Based on Objective Response Rate From Phase 2 Trial Evaluating Belzutifan in Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma New Filing Further Strengthens Merck’s Expanding and Diverse Oncology Portfolio Merck known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted and granted priority review for a New Drug …
Application Based on Objective Response Rate From Phase 2 Trial Evaluating Belzutifan in Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma
New Filing Further Strengthens Merck’s Expanding and Diverse Oncology Portfolio ....

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Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)

Press release content from Business Wire. The AP news staff was not involved in its creation.
Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)
March 16, 2021 GMT
KENILWORTH, N.J. (BUSINESS WIRE) Mar 16, 2021
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan (pronounced bell-ZOO-ti-fan), a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), not requiring immediate surgery. This NDA is based on data from the Phase 2 Study-004 trial, in which belzutifan showed a confirmed overall response rate of 36.1% (n=22/61) (95% CI: 24.2-49.4) in patients with VHL dise ....

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Our Turn: Attack on unions is an attack on all workers and the environment

Our Turn: Attack on unions is an attack on all workers and the environment
Published: 2/27/2021 6:15:06 AM
Earlier this month, the New Hampshire Senate voted to pass SB 61, a bill that would make the Granite State the only “right to work” state in the Northeast.
Like so many bad bills before it with positive-sounding names to make them more palatable to the people they’re going to hurt, the devil is in the details. “Right to work” is a policy that says people cannot be required to join a workers’ union. The bill is a solution to a problem that does not exist because no one can be forced to join a union. Federal law already prohibits it. ....

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KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
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