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Merck & Co Inc (MRK.N)

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Latest Key Developments (Source: Significant Developments)

FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections
Wednesday, 17 Jul 2019 09:50am EDT 

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 06:45am EDT 

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 06:45am EDT 

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 06:26am EDT 

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

Merck CEO Frazier:less appetite for big deals than mid or small-sized deals
Thursday, 20 Jun 2019 11:44am EDT 

June 20 (Reuters) - Merck & Co Inc ::CEO Frazier says the company has less appetite for big deals than mid or small-sized deals-investor day.CEO Frazier says most big pharma deals have not created the value they said they were going to create.  Full Article

Merck Prepares For CEO's Departure With Internal Successor Hunt - Bloomberg
Wednesday, 19 Jun 2019 12:38pm EDT 

June 19 (Reuters) - :MERCK PREPARES FOR CEO'S DEPARTURE WITH INTERNAL SUCCESSOR HUNT - BLOOMBERG.  Full Article

Astrazeneca And Merck's Lynparza Approved In Japan
Wednesday, 19 Jun 2019 06:45am EDT 

June 19 (Reuters) - Merck & Co Inc ::ASTRAZENECA AND MERCK’S LYNPARZA® (OLAPARIB) APPROVED IN JAPAN AS FIRST-LINE MAINTENANCE THERAPY IN PATIENTS WITH BRCA-MUTATED ADVANCED OVARIAN CANCER.MERCK & CO - JAPAN'S PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA) HAS APPROVED LYNPARZA AS A MAINTENANCE TREATMENT AFTER FIRST-LINE CHEMOTHERAPY.MERCK & CO INC - LYNPARZA APPROVAL IN JAPAN WAS BASED ON DATA FROM RANDOMIZED, DOUBLE-BLINDED PHASE 3 SOLO-1 TRIAL.  Full Article

FDA Approves Merck's Keytruda As Monotherapy For Patients With Metastatic Small Cell Lung Cancer
Tuesday, 18 Jun 2019 06:45am EDT 

June 18 (Reuters) - Merck & Co Inc ::FDA APPROVES MERCK’S KEYTRUDA® (PEMBROLIZUMAB) AS MONOTHERAPY FOR PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY AND AT LEAST ONE OTHER PRIOR LINE OF THERAPY.MERCK & CO INC - CONTINUED APPROVAL FOR INDICATION MAY BE CONTINGENT UPON VERIFICATION AND DESCRIPTION OF CLINICAL BENEFIT IN CONFIRMATORY TRIALS..MERCK & CO INC - DECISION MARKS FIRST INDICATION FOR KEYTRUDA IN SCLC..  Full Article

IBM, KPMG, Merck And Walmart in blockchain collaboration with FDA
Thursday, 13 Jun 2019 08:05am EDT 

June 13 (Reuters) - Walmart Inc ::IBM, KPMG, MERCK AND WALMART TO COLLABORATE AS PART OF FDA'S PROGRAM TO EVALUATE THE USE OF BLOCKCHAIN TO PROTECT PHARMACEUTICAL PRODUCT INTEGRITY.IBM - PILOT PROJECT IS SCHEDULED TO BE COMPLETED IN Q4 OF 2019.IBM - BLOCKCHAIN MAY BE INTEGRATED WITH EXISTING SUPPLY CHAIN AND TRACEABILITY SYSTEMS.IBM - PROGRAM IS TO ASSIST DRUG SUPPLY CHAIN STAKEHOLDERS IN DEVELOPING A SYSTEM THAT WILL IDENTIFY, TRACE CERTAIN PRESCRIPTION DRUGS DISTRIBUTED IN U.S..  Full Article

Merck Says Keytruda Showed Improved Overall Survival In Head & Neck Cancer Trial
Friday, 31 May 2019 06:45am EDT 

May 31 (Reuters) - Merck & Co Inc ::MERCK’S KEYTRUDA® (PEMBROLIZUMAB) DEMONSTRATES IMPROVED OVERALL SURVIVAL AS FIRST-LINE TREATMENT OF RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA AT FINAL ANALYSIS OF PIVOTAL PHASE 3 KEYNOTE-048 TRIAL.MERCK & CO - FOR DUAL PRIMARY ENDPOINT OF PROGRESSION-FREE SURVIVAL, STATISTICAL SIGNIFICANCE NOT ACHIEVED FOR KEYTRUDA IN COMBINATION WITH CHEMOTHERAPY IN CPS≥20 POPULATION VERSUS EXTREME REGIMEN.MERCK & CO - FOR CPS ≥1 POPULATION KEYTRUDA WITH CHEMOTHERAPY REDUCED RISK OF DEATH BY 35% IN THESE PATIENTS, WITH SIGNIFICANTLY LONGER OS VERSUS EXTREME REGIMEN.MERCK & CO - KEYTRUDA WITH CHEMOTHERAPY REDUCED RISK OF DEATH BY 40% IN PATIENTS WHOSE TUMORS EXPRESSED PD-L1 WITH CPS≥20, SHOWING SIGNIFICANTLY LONGER OS VERSUS EXTREME REGIMEN.  Full Article

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Merck's treatment for urinary, abdominal infections gets FDA approval

The U.S. Food and Drug Administration has approved Merck & Co Inc's combination treatment for complicated forms of urinary tract and abdominal infections, the drugmaker said on Wednesday.