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Merck & Co Inc (MRK.N)

MRK.N on New York Stock Exchange

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16 Aug 2019
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Latest Key Developments (Source: Significant Developments)

Agilent Companion Diagnostic Gains Expanded FDA Approval
Wednesday, 31 Jul 2019 

July 31 (Reuters) - Agilent Technologies Inc ::AGILENT COMPANION DIAGNOSTIC GAINS EXPANDED FDA APPROVAL IN ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC).U.S. FOOD AND DRUG ADMINISTRATION HAS APPROVED COMPANY'S PD-L1 IHC 22C3 PHARMDX ASSAY FOR EXPANDED USE.  Full Article

FDA Approves New Monotherapy Indication For Merck’S Keytruda (Pembrolizumab)
Wednesday, 31 Jul 2019 

July 31 (Reuters) - Merck & Co Inc ::FDA APPROVES NEW MONOTHERAPY INDICATION FOR MERCK’S KEYTRUDA® (PEMBROLIZUMAB).  Full Article

Merck’s Keytruda In Combination With Chemotherapy Met Primary Endpoint Of Pathological Complete Response (pCR) In Pivotal Phase 3 Keynote-522 Trial
Monday, 29 Jul 2019 

July 29 (Reuters) - Merck & Co Inc ::MERCK’S KEYTRUDA® (PEMBROLIZUMAB) IN COMBINATION WITH CHEMOTHERAPY MET PRIMARY ENDPOINT OF PATHOLOGICAL COMPLETE RESPONSE (PCR) IN PIVOTAL PHASE 3 KEYNOTE-522 TRIAL IN PATIENTS WITH TRIPLE-NEGATIVE BREAST CANCER (TNBC).MERCK - KEYTRUDA IN COMBINATION WITH CHEMOTHERAPY DEMONSTRATED A STATISTICALLY SIGNIFICANT IMPROVEMENT IN PCR RATES COMPARED WITH CHEMOTHERAPY ALONE.MERCK & CO - SAFETY PROFILE OF KEYTRUDA IN TRIAL WAS CONSISTENT WITH PREVIOUSLY REPORTED STUDIES; NO NEW SAFETY SIGNALS WERE IDENTIFIED.  Full Article

FDA Approves Biosimilar To Humira
Tuesday, 23 Jul 2019 

July 23 (Reuters) - U.S. Food and Drug Administration: :FDA APPROVES HADLIMA (ADALIMUMAB-BWWD), BIOSIMILAR TO HUMIRA (ADALIMUMAB).  Full Article

Merck Sets Quarterly Dividend Of $0.55 Per Share
Tuesday, 23 Jul 2019 

July 23 (Reuters) - Merck & Co Inc ::SETS QUARTERLY DIVIDEND OF $0.55 PER SHARE.  Full Article

Merck And Eisai Receive Third Breakthrough Therapy Designation From FDA
Tuesday, 23 Jul 2019 

July 23 (Reuters) - Merck & Co Inc ::MERCK AND EISAI RECEIVE THIRD BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR KEYTRUDA® (PEMBROLIZUMAB) PLUS LENVIMA® (LENVATINIB) COMBINATION TREATMENT.MERCK & CO INC- EFFICACY AND SAFETY OF COMBINATION OF KEYTRUDA PLUS LENVIMA HAS NOT BEEN ESTABLISHED.  Full Article

FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections
Wednesday, 17 Jul 2019 

July 17 (Reuters) - U.S. Food and Drug Administration ::FDA - RECARBRIO SHOULD NOT BE USED IN PATIENTS TAKING GANCICLOVIR UNLESS BENEFITS OUTWEIGH RISKS AS GENERALIZED SEIZURES HAVE BEEN REPORTED.FDA - PATIENTS SHOULD AVOID USING RECARBRIO WHEN TAKING VALPROIC ACID OR DIVALPROEX SODIUM, AS REDUCTION IN VALPROIC ACID LEVEL MAY LEAD TO SEIZURES.  Full Article

Merck's treatment for urinary tract infection wins FDA approval
Wednesday, 17 Jul 2019 

July 17 (Reuters) - Merck & Co Inc ::FDA APPROVES MERCK’S RECARBRIO™ (IMIPENEM, CILASTATIN, AND RELEBACTAM) FOR THE TREATMENT OF ADULTS WITH COMPLICATED URINARY TRACT AND COMPLICATED INTRA-ABDOMINAL BACTERIAL INFECTIONS WHERE LIMITED OR NO ALTERNATIVE TREATMENT OPTIONS ARE AVAILABLE.FDA APPROVES MERCK’S RECARBRIO™ (IMIPENEM, CILASTATIN, AND RELEBACTAM) FOR THE TREATMENT OF ADULTS WITH COMPLICATED URINARY TRACT AND COMPLICATED INTRA-ABDOMINAL BACTERIAL INFECTIONS WHERE LIMITED OR NO ALTERNATIVE TREATMENT OPTIONS ARE AVAILABLE.MERCK & CO INC - APPROVAL OF THESE INDICATIONS IS BASED ON LIMITED CLINICAL SAFETY AND EFFICACY DATA FOR RECARBRIO..MERCK & CO INC - MERCK ANTICIPATES MAKING RECARBRIO AVAILABLE LATER THIS YEAR..MERCK & CO INC - FDA APPROVED RECARBRIO FOR INJECTION, 1.25 GRAMS.MERCK & CO - RECARBRIO SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY SUSCEPTIBLE BACTERIA.  Full Article

Merck & Co Plans To Initiate Phase 3 Trials Evaluating MK-8591 With Doravirine For HIV-1 Treatment
Wednesday, 10 Jul 2019 

July 10 (Reuters) - Merck & Co Inc ::MERCK HIGHLIGHTS COMMITMENT TO HIV RESEARCH WITH PRESENTATIONS FOR INVESTIGATIONAL ANTI-HIV AGENT MK-8591 AT IAS 2019.MERCK & CO INC - DATA INCLUDE WEEK 48 RESULTS FROM PHASE 2B STUDY EVALUATING MK-8591 IN COMBINATION WITH DORAVIRINE.MERCK & CO INC - CO PLANS TO INITIATE PHASE 3 TRIALS EVALUATING MK-8591 WITH DORAVIRINE FOR TREATMENT OF HIV-1.  Full Article

Peloton Therapeutics Inc Files To Withdraw IPO Plans – SEC Filing
Wednesday, 10 Jul 2019 

July 10 (Reuters) - Peloton Therapeutics Inc: :PELOTON THERAPEUTICS INC FILES TO WITHDRAW IPO PLANS – SEC FILING.PELOTON THERAPEUTICS INC - HAD FILED FOR IPO OF UP TO $115 MILLION IN APRIL, 2019.  Full Article

Burundi starts Ebola vaccines for health workers -WHO

NAIROBI, Aug 14 Burundi has started vaccinating its health workers against Ebola, beginning with those near the border with the Democratic Republic of Congo, the World Health Organization (WHO) said on Wednesday.