Protocols

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.”

→ The push to hold the line on drug prices continues to gain steam among the majors. AstraZeneca $AZN today said it would also not hike prices in the second half, taking a pledge now shared by Roche, Pfizer, Merck and Novartis. Several of those companies had already raised prices in H1, though, spurring considerable skepticism over whether pharma was giving up much as the Trump administration seeks to spotlight a win.

→ Vertex $VRTX posted some bullish numbers for Q2, highlighting a 46% increase in cystic fibrosis product revenue and forecasting that it anticipates filing an NDA on its late-stage drugs “no later than mid-2019.”


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