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Merck & Co Inc (MRK.N)

MRK.N on New York Stock Exchange

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18 Oct 2019
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Latest Key Developments (Source: Significant Developments)

WHO Welcomes EMA's Recommendation Of Conditional Marketing Authorization For Merck's V920 Ebola Zaire Vaccine
Friday, 18 Oct 2019 

Oct 18 (Reuters) - Merck & Co Inc ::WORLD HEALTH ORGANIZATION SAYS "WELCOMES" THE EMA ANNOUNCEMENT RECOMMENDING A CONDITIONAL MARKETING AUTHORIZATION FOR MERCK'S V920 EBOLA ZAIRE VACCINE.WORLD HEALTH ORGANIZATION SAYS WILL MOVE TOWARDS PREQUALIFICATION OF MERCK'S V920 EBOLA ZAIRE VACCINE.  Full Article

Merck Receives EU CHMP Positive Opinion For Investigational V920 Ebola Zaire Vaccine For Protection Against Ebola Virus Disease
Friday, 18 Oct 2019 

Oct 18 (Reuters) - Merck & Co Inc ::MERCK RECEIVES EU CHMP POSITIVE OPINION FOR INVESTIGATIONAL V920 EBOLA ZAIRE VACCINE FOR PROTECTION AGAINST EBOLA VIRUS DISEASE.MERCK & CO INC - ERVEBO IS CURRENTLY UNDER REVIEW IN UNITED STATES.MERCK - IF AFFIRMED BY EC, VACCINE TO BE INDICATED FOR ACTIVE IMMUNIZATION OF INDIVIDUALS 18 YEARS OF AGE OR OLDER.MERCK & CO INC - IF AFFIRMED BY EUROPEAN COMMISSION, V920 EBOLA ZAIRE VACCINE WILL BE AUTHORIZED UNDER BRAND NAME ERVEBO.MERCK & CO - CHMP OF EMA HAS ADOPTED POSITIVE OPINION RECOMMENDING CONDITIONAL MARKETING AUTHORIZATION FOR V920 EBOLA ZAIRE VACCINE.  Full Article

4D Pharma Collaborates With MSD To Develop Live Biotherapeutics For Vaccines
Tuesday, 8 Oct 2019 

Oct 8 (Reuters) - 4D Pharma PLC ::4D PHARMA COLLABORATES WITH MSD TO DEVELOP LIVE BIOTHERAPEUTICS FOR VACCINES.ENTERED INTO RESEARCH COLLABORATION & OPTION TO LICENSE AGREEMENT WITH MSD, TRADENAME OF MERCK & CO., INC., KENILWORTH, NJ, USA.HAS RIGHT, SUBJECT TO CERTAIN CONDITIONS, TO CAUSE MSD TO PURCHASE $5 MILLION IN ORDINARY SHARES IN 4D DURING FIRST 12 MONTHS OF COLLABORATION.BESIDES UPFRONT CASH PAYMENT, 4D WILL BE ELIGIBLE TO RECEIVE UP TO $347.5 MILLION IN OPTION EXERCISE & DEVELOPMENT AND REGULATORY MILESTONE PAYMENTS.MSD WILL BE RESPONSIBLE FOR DEVELOPMENT, MANUFACTURING, COMMERCIALISATION FOLLOWING EXERCISE OF ANY OF ITS EXCLUSIVE OPTIONS.  Full Article

Merck’s Keytruda Now Approved As Monotherapy In China
Wednesday, 2 Oct 2019 

Oct 2 (Reuters) - Merck & Co Inc ::MERCK’S KEYTRUDA® (PEMBROLIZUMAB) NOW APPROVED AS MONOTHERAPY IN CHINA FOR FIRST-LINE TREATMENT OF CERTAIN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS EXPRESS PD-L1.MERCK & CO - NEW INDICATION WAS GRANTED FULL APPROVAL BASED ON OS FINDINGS FROM PHASE 3 KEYNOTE-042 TRIAL.  Full Article

FDA Accepts 2 Applications For Merck's DIFICID (Fidaxomicin) To Treat Children Aged 6 Months To 18 Years With Clostridium Difficile Infections
Wednesday, 2 Oct 2019 

Oct 2 (Reuters) - Merck & Co Inc ::FDA ACCEPTS TWO APPLICATIONS FOR MERCK’S DIFICID® (FIDAXOMICIN) TO TREAT CHILDREN AGED SIX MONTHS UP TO 18 YEARS WITH CLOSTRIDIUM DIFFICILE INFECTIONS.FDA ACCEPTS TWO APPLICATIONS FOR MERCK’S DIFICID® (FIDAXOMICIN) TO TREAT CHILDREN AGED SIX MONTHS UP TO 18 YEARS WITH CLOSTRIDIUM DIFFICILE INFECTIONS.MERCK & CO INC - PRESCRIPTION DRUG USER FEE ACT (PDUFA), OR TARGET ACTION DATE FOR BOTH APPLICATIONS, IS SET FOR JAN. 24, 2020.  Full Article

Merck says pivotal Phase 3 RECARBRI RESTORE-IMI 2 trial met primary endpoint
Monday, 30 Sep 2019 

Sept 30 (Reuters) - Merck & Co Inc ::PIVOTAL RESTORE-IMI 2 PHASE 3 STUDY OF MERCK’S RECARBRIO™ (IMIPENEM, CILASTATIN, AND RELEBACTAM) IN HOSPITAL-ACQUIRED AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) MET PRIMARY ENDPOINT.MERCK & CO INC - TO PRESENT FULL DATA FROM TRIAL AT A SCIENTIFIC CONGRESS IN 2020.MERCK & CO INC - PLANS TO PRESENT FULL DATA FROM TRIAL AT A SCIENTIFIC CONGRESS IN 2020..MERCK & CO INC - RELEBACTAM HAS RECEIVED U.S. FDA QUALIFIED INFECTIOUS DISEASE PRODUCT (QIDP) DESIGNATION & FAST TRACK STATUS.  Full Article

AstraZeneca, Merck Says Cancer Treatment Achieves Improvement In Progression-Free Survival
Monday, 30 Sep 2019 

Sept 30 (Reuters) - AstraZeneca PLC ::ASTRAZENECA PLC - LYNPARZA IMPROVED THE TIME WOMEN LIVED WITHOUT.ASTRAZENECA PLC - ANNOUNCED DETAILED POSITIVE RESULTS FROM PHASE III PAOLA-1 TRIAL.ASTRAZENECA - RESULTS SHOW LYNPARZA (OLAPARIB) DEMONSTRATED STATISTICALLY SIGNIFICANT IN PROGRESSION-FREE SURVIVAL IN WOMEN WITH NEWLY-DIAGNOSED ADVANCED OVARIAN CANCER.ASTRAZENECA PLC - SAFETY AND TOLERABILITY PROFILE OF LYNPARZA AND BEVACIZUMAB WERE CONSISTENT WITH THOSE KNOWN FROM PREVIOUS TRIALS FOR EACH MEDICINE.  Full Article

Merck’s PIFELTRO And DELSTRIGO Receive US FDA Approval For Use In Appropriate Adults Living With HIV-1 Who Are Virologically Suppressed
Friday, 20 Sep 2019 

Sept 20 (Reuters) - Merck & Co Inc ::MERCK’S PIFELTRO™ (DORAVIRINE) AND DELSTRIGO™ (DORAVIRINE/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE) RECEIVE US FDA APPROVAL FOR USE IN APPROPRIATE ADULTS LIVING WITH HIV-1 WHO ARE VIROLOGICALLY SUPPRESSED.MERCK & CO INC - APPROVALS BASED ON FINDINGS FROM PHASE 3 DRIVE-SHIFT TRIAL EVALUATING A SWITCH TO DELSTRIGO.MERCK & CO INC - DELSTRIGO CONTAINS A BOXED WARNING REGARDING POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B VIRUS (HBV) INFECTION.  Full Article

U.S. FDA Says Announcing Project Orbis, An Initiative Of The FDA Oncology Center Of Excellence
Tuesday, 17 Sep 2019 

Sept 17 (Reuters) - U.S. Food and Drug Administration::U.S. FDA SAYS ANNOUNCING PROJECT ORBIS, AN INITIATIVE OF THE FDA ONCOLOGY CENTER OF EXCELLENCE.FDA SAYS UNDER PROJECT, FDA, AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION & HEALTH CANADA REVIEWED APPLICATIONS FOR 2 ONCOLOGY DRUGS.FDA - UNDER PROJECT, FDA GRANTED ACCELERATED APPROVAL TO LENVIMA IN COMBINATION WITH KEYTRUDA FOR TREATMENT OF PATIENTS WITH ADVANCED ENDOMETRIAL CARCINOMA.  Full Article

FDA Warns Patients, Health Care Professionals About Rare Instances Of Serious Liver Injury In Some Patients With Advanced Liver Disease
Thursday, 29 Aug 2019 

Aug 28 (Reuters) - Abbvie Inc ::FDA IN BRIEF: FDA WARNS PATIENTS AND HEALTH CARE PROFESSIONALS ABOUT RARE INSTANCES OF SERIOUS LIVER INJURY OR FAILURE WITH CERTAIN HEPATITIS C TREATMENTS IN SOME PATIENTS WITH ADVANCED LIVER DISEASE.FDA - GOT REPORTS THAT USE OF MAVYRET, ZEPATIER, VOSEVI FOR CHRONIC HEPATITIS C RESULTED IN RARE CASES OF WORSENING LIVER FUNCTION, LIVER FAILURE.FDA - HEALTH CARE PROFESSIONALS SHOULD CONTINUE TO PRESCRIBE MAVYRET, ZEPATIER OR VOSEVI AS INDICATED.FDA - HEALTH CARE PROFESSIONALS SHOULD DISCONTINUE USE OF MAVYRET, ZEPATIER OR VOSEVI IN PATIENTS WITH SIGNS AND SYMPTOMS OF WORSENING LIVER FUNCTION.  Full Article

CORRECTED-BRIEF-WHO Welcomes EMA Recommendation Of Conditional Marketing Authorization For Merck's V920 Ebola Zaire Vaccine

* WORLD HEALTH ORGANIZATION SAYS "WELCOMES" THE EMA ANNOUNCEMENT RECOMMENDING A CONDITIONAL MARKETING AUTHORIZATION FOR MERCK'S V920 EBOLA ZAIRE VACCINE