Chinese regulators green light Merck's Keytruda in record time; AstraZeneca takes the price-freeze pledge
→ China’s drug regulators have approved Merck’s Keytruda for advanced melanoma in record time. The pharma giant said that the China National Drug Administration offered the OK on a Phase Ib study after providing priority review status, “creating an industry leading approval turnaround time for imported cancer medicine in China.”
Merck’s $MRK Roy Baynes thanked the Chinese regulators for the speedy work, saying: “The approval of Keytruda in China, for this first indication, was made possible through extensive collaborative effort with the Chinese patients and investigators who participated in KEYNOTE-151, as well as the regulatory and government authorities who prioritized this filing.”
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