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Merck & Co Inc (MRK.N)

MRK.N on New York Stock Exchange

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18 Jan 2018
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Latest Key Developments (Source: Significant Developments)

Merck & Co Says Keytruda Phase 3 Keynote-189 Trial Met Its Dual Primary Endpoints
Tuesday, 16 Jan 2018 

Jan 16 (Reuters) - Merck & Co Inc ::MERCK'S KEYTRUDA(R) (PEMBROLIZUMAB) SIGNIFICANTLY IMPROVED OVERALL SURVIVAL AND PROGRESSION-FREE SURVIVAL AS FIRST-LINE TREATMENT IN COMBINATION WITH PEMETREXED AND PLATINUM CHEMOTHERAPY FOR PATIENTS WITH METASTATIC NONSQUAMOUS NON-SMALL CELL LUNG CANCER (KEYNOTE-189).MERCK & CO INC - PIVOTAL PHASE 3 KEYNOTE-189 TRIAL MET ITS DUAL PRIMARY ENDPOINTS.MERCK & CO INC - ‍SAFETY PROFILE OF KEYTRUDA IN COMBINATION WAS CONSISTENT WITH THAT PREVIOUSLY OBSERVED​.  Full Article

Eisai, Merck Receive Breakthrough Therapy Designation From FDA For Lenvima, Keytruda
Tuesday, 9 Jan 2018 

Jan 9 (Reuters) - Eisai Co Ltd <4523.T>::EISAI AND MERCK RECEIVE BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR LENVIMA® (LENVATINIB MESYLATE) AND KEYTRUDA® (PEMBROLIZUMAB) AS COMBINATION THERAPY FOR ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA.EISAI AND MERCK RECEIVE BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR LENVIMA® (LENVATINIB MESYLATE) AND KEYTRUDA® (PEMBROLIZUMAB) AS COMBINATION THERAPY FOR ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA.  Full Article

Merck's Keytruda Significantly Improved Recurrence-Free Survival Compared To Placebo As Adjuvant Therapy
Monday, 8 Jan 2018 

Jan 8 (Reuters) - Merck & Co Inc ::MERCK’S KEYTRUDA® (PEMBROLIZUMAB) SIGNIFICANTLY IMPROVED RECURRENCE-FREE SURVIVAL COMPARED TO PLACEBO AS ADJUVANT THERAPY IN PATIENTS WITH STAGE 3 RESECTED HIGH-RISK MELANOMA (EORTC1325/KEYNOTE-054).MERCK & CO INC - PHASE 3 EORTC1325/KEYNOTE-054 TRIAL MET PRIMARY ENDPOINT OF RECURRENCE-FREE SURVIVAL.MERCK -SAFETY PROFILE OF KEYTRUDA IN TRIAL WAS CONSISTENT WITH THAT OBSERVED IN PREVIOUSLY REPORTED STUDIES INVOLVING PATIENTS WITH ADVANCED MELANOMA.MERCK & CO INC - IN ACCORDANCE WITH TRIAL PROTOCOL, STUDY WILL CONTINUE IN ORDER TO EVALUATE OTHER KEY ENDPOINTS, INCLUDING OVERALL SURVIVAL.  Full Article

FDA Accepts New Drug Applications For Merck's Doravirine
Monday, 8 Jan 2018 

Jan 8 (Reuters) - Merck & Co Inc ::FDA ACCEPTS NEW DRUG APPLICATIONS FOR MERCK’S DORAVIRINE, THE COMPANY’S INVESTIGATIONAL NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI), FOR TREATMENT OF HIV-1 INFECTION.MERCK & CO INC - FDA HAS SET A TARGET ACTION DATE OF OCT. 23, 2018, FOR BOTH APPLICATIONS UNDER PRESCRIPTION DRUG USER FEE ACT.FDA ACCEPTS NEW DRUG APPLICATIONS FOR MERCK’S DORAVIRINE, THE COMPANY’S INVESTIGATIONAL NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI), FOR TREATMENT OF HIV-1 INFECTION.  Full Article

Lycera Corp Announces Initiation Of Phase 1b Study Of Novel Immuno-Oncology Candidate LYC-55716 In Combination With Pembrolizumab
Thursday, 4 Jan 2018 

Jan 4 (Reuters) - Merck & Co Inc ::LYCERA CORP ANNOUNCES INITIATION OF PHASE 1B STUDY OF NOVEL IMMUNO-ONCOLOGY CANDIDATE LYC-55716 IN COMBINATION WITH PEMBROLIZUMAB.  Full Article

Merck’s Keytruda Approved In Japan For Use In The Treatment Of Patients With Urothelial Carcinoma
Tuesday, 2 Jan 2018 

Jan 2 (Reuters) - Merck & Co Inc ::MERCK’S KEYTRUDA® (PEMBROLIZUMAB) APPROVED IN JAPAN FOR USE IN THE TREATMENT OF PATIENTS WITH UROTHELIAL CARCINOMA THAT IS UNRESECTABLE WITH RADICAL SURGERY WHO HAVE PROGRESSED FOLLOWING CANCER CHEMOTHERAPY.MERCK & CO INC - WILL MARKET KEYTRUDA IN JAPAN AND WILL PROMOTE IT WITH TAIHO PHARMACEUTICAL CO LTD.MERCK & CO INC - WITH THE APPROVAL, KEYTRUDA IS NOW INDICATED FOR USE IN FOUR TYPES OF CANCER IN JAPAN.  Full Article

FDA Approves SGLT2 Inhibitor Steglatro And Fixed-Dose Combination Steglujan For Adults With Type 2 Diabetes
Friday, 22 Dec 2017 

Dec 22 (Reuters) - Merck & Co Inc ::FDA APPROVES SGLT2 INHIBITOR STEGLATRO™ (ERTUGLIFLOZIN) AND FIXED-DOSE COMBINATION STEGLUJAN™ (ERTUGLIFLOZIN AND SITAGLIPTIN) FOR ADULTS WITH TYPE 2 DIABETES.MERCK & CO INC - FDA APPROVED STEGLATRO TABLETS, AN ORAL SODIUM-GLUCOSE COTRANSPORTER 2 INHIBITOR, AND FIXED-DOSE COMBINATION STEGLUJAN TABLETS.MERCK & CO INC - IN ADDITION TO STEGLATRO & STEGLUJAN, FDA ALSO APPROVED FIXED-DOSE COMBINATION SEGLUROMET.  Full Article

Merck Provides Update On Keynote-061, A Phase 3 Study Of Keytruda (Pembrolizumab)
Thursday, 14 Dec 2017 

Dec 14 (Reuters) - Merck & Co Inc ::MERCK PROVIDES UPDATE ON KEYNOTE-061, A PHASE 3 STUDY OF KEYTRUDA® (PEMBROLIZUMAB) IN PREVIOUSLY TREATED PATIENTS WITH GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA.MERCK PROVIDES UPDATE ON KEYNOTE-061, A PHASE 3 STUDY OF KEYTRUDA® (PEMBROLIZUMAB) IN PREVIOUSLY TREATED PATIENTS WITH GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA.MERCK & CO INC - PIVOTAL PHASE 3 KEYNOTE-061 TRIAL DID NOT MEET ITS PRIMARY ENDPOINT.MERCK & CO INC - CONTINUE TO EVALUATE KEYTRUDA FOR GASTRIC OR GEJ ADENOCARCINOMA THROUGH KEYNOTE-062.MERCK - CONTINUE TO EVALUATE KEYTRUDA FOR GASTRIC OR GEJ ADENOCARCINOMA THROUGH KEYNOTE-062.MERCK - ALSO CONTINUE TO EVALUATE KEYTRUDA FOR GASTRIC OR GEJ ADENOCARCINOMA WITH KEYNOTE-585.MERCK - PROGRESSION FREE SURVIVAL IN PD-L1 POSITIVE POPULATION DID NOT SHOW STATISTICAL SIGNIFICANCE IN KEYNOTE-061.MERCK & CO INC - NO NEW SAFETY SIGNALS WERE IDENTIFIED IN KEYNOTE-061.  Full Article

Merck Says Prevymis To Be Available In Canada By End Of December
Thursday, 14 Dec 2017 

Dec 14 (Reuters) - Merck & Co Inc ::MERCK & CO SAYS RECENTLY APPROVED PREVYMIS (LETERMOVIR) IS EXPECTED TO BE AVAILABLE IN CANADA BY END OF DECEMBER 2017.  Full Article

Newlink Genetics, Bps And Merck Sharp & Dohme Amended License & Collaboration Agreement
Monday, 11 Dec 2017 

Dec 11 (Reuters) - Merck & Co Inc ::NEWLINK GENETICS - ON DEC 5, BPS AND MERCK SHARP & DOHME CORP AMENDED LICENSE & COLLABORATION AGREEMENT DATED NOV 21, 2014.NEWLINK GENETICS-UNDER MERCK AMENDMENT, MODIFIED MERCK'S SUBLICENSE OF IP RIGHTS UNDER PHAC LICENSE AGREEMENT TO BE NON-EXCLUSIVE ON EBOLA SUDAN FIELD OF USE.NEWLINK GENETICS - AMENDMENT ALSO ADJUSTS EXPIRATION OF MERCK'S OBLIGATION TO PAY ROYALTIES TO BPS BASED ON ROYALTY TERM OF PHAC LICENSE AGREEMENT.  Full Article

GLOBAL MARKETS-Stocks pause after rally; bond yields climb

NEW YORK, Jan 18 A gauge of world stock markets dipped on Thursday, pausing after notching a string of record highs, as a decline in Boeing and healthcare names weighed on U.S. equities.