BRIEF-Merck Says FDA PDUFA Date For Subcutaneous Pembrolizumab Set For Sept 23

Reuters03-27

March 27 (Reuters) - Merck & Co Inc MRK.N:

  • MERCK: INVESTIGATIONAL SUBCUTANEOUS PEMBROLIZUMAB WITH BERAHYALURONIDASE ALFA SHOWS NONINFERIOR PHARMACOKINETICS VERSUS IV KEYTRUDA IN 3475A-D77 TRIAL

  • MERCK: APPLICATIONS FOR SUBCUTANEOUS PEMBROLIZUMAB ARE UNDER REVIEW IN U.S. & EUROPE

  • MERCK: FDA HAS SET PDUFA DATE OF SEPT 23

  • MERCK EXEC SAYS WILL LAUNCH SUBCUTANEOUS KEYTRUDA AT RISK IF HALOZYME PATENT DISPUTE NOT RESOLVED YET - INTERVIEW

  • MERCK EXEC SAYS HOPES TO LAUNCH SUBCUTANEOUS KEYTRUDA ON OCT 1, SEES PEAK ADOPTION ABOUT 18-24 MONTHS AFTER APPROVAL - INTERVIEW

Further company coverage: MRK.N

((Reuters.Briefs@thomsonreuters.com;))

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