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Merck & Co Inc (MRK.N)

MRK.N on New York Stock Exchange

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20 Mar 2019
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Latest Key Developments (Source: Significant Developments)

EMA Adopts Positive Opinion For Merck's Keytruda For 6-Week Dosing Schedule
Monday, 4 Mar 2019 06:45am EST 

March 4 (Reuters) - Merck & Co Inc ::EUROPEAN MEDICINES AGENCY ADOPTS POSITIVE OPINION FOR MERCK’S KEYTRUDA® (PEMBROLIZUMAB) FOR SIX-WEEK DOSING SCHEDULE ACROSS ALL CURRENT MONOTHERAPY INDICATIONS.MERCK & CO INC - FINAL DECISION ON MARKETING AUTHORIZATION IS EXPECTED IN Q2 OF 2019..  Full Article

Us FDA Approves Ontruzant, Samsung Bioepis' First Oncology Medicine In The U.S.
Sunday, 20 Jan 2019 06:38pm EST 

Jan 20 (Reuters) - Samsung Bioepis Co: :US FDA APPROVES ONTRUZANT® (TRASTUZUMAB-DTTB), SAMSUNG BIOEPIS’ FIRST ONCOLOGY MEDICINE IN THE UNITED STATES.SAMSUNG BIOEPIS CO - ONTRUZANT WILL BE MARKETED AND DISTRIBUTED IN UNITED STATES BY MERCK, WHICH IS KNOWN AS MSD OUTSIDE OF US AND CANADA.  Full Article

Moderna Announces Recent Progress In Its Immuno-Oncology And Rare Disease Programs And Highlights Corporate Objectives
Tuesday, 8 Jan 2019 08:30am EST 

Jan 8 (Reuters) - Moderna Inc ::MODERNA ANNOUNCES RECENT PROGRESS IN ITS IMMUNO-ONCOLOGY AND RARE DISEASE PROGRAMS AND HIGHLIGHTS CORPORATE OBJECTIVES.MODERNA INC - IND AMENDMENT SUBMITTED TO FDA FOR A PHASE 2 COHORT OF OX40L (MRNA-2416) TO TREAT ADVANCED OVARIAN CARCINOMA.MODERNA INC - PLANNING FOR A PHASE 2 STUDY OF PERSONALIZED CANCER VACCINE (MRNA-4157) INITIATED TOGETHER WITH STRATEGIC COLLABORATOR MERCK.MODERNA INC - EXPECT OUR CASH, CASH EQUIVALENTS, AND INVESTMENTS IN MARKETABLE SECURITIES AS OF DECEMBER 31, 2018 TO BE ABOUT $1.7 BILLION.  Full Article

Amunix Announces Licensing Agreement With Merck For Protia Immune Activator Platform
Thursday, 3 Jan 2019 03:29pm EST 

Jan 3 (Reuters) - Amunix Pharmaceuticals::AMUNIX ANNOUNCES LICENSING AGREEMENT WITH MERCK FOR PROTIA IMMUNE ACTIVATOR PLATFORM.AMUNIX PHARMACEUTICALS - FINANCIAL DETAILS OF AGREEMENT WERE NOT DISCLOSED.AMUNIX PHARMACEUTICALS - UNDER TERMS OF AGREEMENT, AMUNIX WILL RECEIVE AN UPFRONT PAYMENT FROM MERCK.  Full Article

Cocrystal Pharma Announces Collaboration Agreement With Merck
Thursday, 3 Jan 2019 08:30am EST 

Jan 3 (Reuters) - Cocrystal Pharma Inc ::COCRYSTAL PHARMA ANNOUNCES EXCLUSIVE WORLDWIDE LICENSE AND COLLABORATION AGREEMENT WITH MERCK.COCRYSTAL PHARMA INC - COCRYSTAL WILL BE PAID AN UNDISCLOSED UPFRONT SUM.COCRYSTAL PHARMA INC - MERCK TO FUND RESEARCH AND DEVELOPMENT FOR PROGRAM.COCRYSTAL PHARMA INC - MERCK WILL BE RESPONSIBLE FOR WORLDWIDE COMMERCIALIZATION OF ANY PRODUCTS DERIVED FROM COLLABORATION.COCRYSTAL PHARMA - ELIGIBLE TO RECEIVE PAYMENTS RELATED TO DESIGNATED DEVELOPMENT, REGULATORY & SALES MILESTONES WITH POTENTIAL TO EARN UP TO $156 MILLION.  Full Article

Personal Genome Diagnostics collaborates with Merck on global clinical trial evaluating response to dual biomarker directed precision oncology combination therapy
Thursday, 3 Jan 2019 08:00am EST 

Jan 3 (Reuters) - Merck & Co Inc ::PERSONAL GENOME DIAGNOSTICS COLLABORATES WITH MERCK ON GLOBAL CLINICAL TRIAL EVALUATING RESPONSE TO DUAL BIOMARKER DIRECTED PRECISION ONCOLOGY COMBINATION THERAPY.PERSONAL GENOME DIAGNOSTICS-REPORTED ITS 500+ GENE PAN-CANCER TUMOR PROFILING TISSUE ASSAY BEING USED IN MERCK'S PHASE 2 PRECISION ONCOLOGY KEYIMPACT STUDY.  Full Article

Ra Pharmaceuticals Receives Development Milestone Payment Under Agreement With Merck
Thursday, 6 Dec 2018 07:30am EST 

Dec 6 (Reuters) - Ra Pharmaceuticals Inc ::RA PHARMACEUTICALS RECEIVES DEVELOPMENT MILESTONE PAYMENT UNDER AGREEMENT WITH MERCK.RA PHARMACEUTICALS INC - RECEIVED A DEVELOPMENT MILESTONE PAYMENT UNDER ITS COLLABORATION AGREEMENT WITH MERCK, KNOWN AS MSD OUTSIDE US AND CANADA.RA PHARMACEUTICALS INC - CO ELIGIBLE TO EARN UP TO $59 MILLION IN ADDITIONAL MILESTONE PAYMENTS FROM MERCK.RA PHARMACEUTICALS - ALSO ELIGIBLE TO RECEIVE LOW-TO-MID SINGLE DIGIT PERCENTAGE ROYALTIES ON FUTURE SALES OF COMPOUNDS RESULTING FROM COLLABORATION.  Full Article

NewLink Genetics Says Merck Has Begun Rolling Submission Of Licensure Application For Ebola Vaccine V920
Thursday, 15 Nov 2018 09:03am EST 

Nov 15 (Reuters) - NewLink Genetics Corp ::NEWLINK GENETICS ANNOUNCES MERCK HAS BEGUN ROLLING SUBMISSION OF LICENSURE APPLICATION FOR EBOLA VACCINE V920 (RVSV∆G-ZEBOV-GP) TO U.S. FOOD AND DRUG ADMINISTRATION.NEWLINK GENETICS - ROLLING SUBMISSION IS MADE PURSUANT TO FDA'S BREAKTHROUGH THERAPY DESIGNATION FOR V920.  Full Article

Merck Begins Rolling Submission Of Licensure Application For V920 To U.S. FDA
Tuesday, 13 Nov 2018 04:35pm EST 

Nov 13 (Reuters) - Merck & Co Inc ::MERCK BEGINS ROLLING SUBMISSION OF LICENSURE APPLICATION FOR V920 (RVSV∆G-ZEBOV-GP) TO U.S. FOOD AND DRUG ADMINISTRATION.MERCK & CO INC - CURRENTLY, MERCK EXPECTS ROLLING SUBMISSION OF BLA TO BE COMPLETED IN 2019.  Full Article

BioXcel Therapeutics Announces FDA Acceptance Of IND For Lead Cancer Drug
Monday, 5 Nov 2018 04:00am EST 

Nov 5 (Reuters) - BioXcel Therapeutics Inc ::BIOXCEL THERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF IND FOR LEAD IMMUNO-ONCOLOGY CANDIDATE, BXCL701, IN TREATMENT EMERGENT NEUROENDOCRINE PROSTATE CANCER.BIOXCEL THERAPEUTICS INC - FIRST-IN-HUMAN PHASE 1B / 2 COMBINATION TRIAL OF BXCL701 AND PEMBROLIZUMAB (KEYTRUDA®) EXPECTED TO INITIATE IN 4Q 2018.BIOXCEL THERAPEUTICS INC - EFFICACY STUDY WITH OBJECTIVE RESPONSE RATE ENDPOINT TO ENROLL UP TO 40 PATIENTS AT MULTIPLE CLINICAL SITES.  Full Article

U.S. FDA approves Roche's small cell lung cancer treatment

March 18 Swiss drugmaker Roche Holding AG's U.S. unit Genentech said on Monday its immunotherapy Tecentriq won approval for a tough-to-treat type of lung cancer, the latest win for the drug whose sales trail medicines from Merck & Co and Bristol-Myers Squibb.