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Roche Holding AG (RO.S)

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

SQZ Biotech And Roche Expand Cell Therapy Partnership
Monday, 15 Oct 2018 08:30am EDT 

Oct 15 (Reuters) - SQZ Biotechnologies::SQZ BIOTECH EXPANDS CELL THERAPY PARTNERSHIP WITH ROCHE TO DEVELOP ANTIGEN PRESENTING CELLS FOR IMMUNE-ONCOLOGY.COLLABORATION COMBINES SQZ BIOTECH'S NOVEL CELL THERAPY PLATFORM WITH ROCHE'S CANCER IMMUNOTHERAPY EXPERTISE.SQZ TO RECEIVE UP TO $125 MILLION IN UPFRONT AND NEAR-TERM MILESTONE PAYMENTS.  Full Article

Roche Says Satralizumab Added To Baseline Therapy Reduced Risk Of Relapse
Monday, 15 Oct 2018 01:47am EDT 

Oct 15 (Reuters) - Roche Holding AG ::CHUGAI PRESENTS RESULTS FROM PHASE III STUDY OF SATRALIZUMAB IN NMOSD AT ECTRIMS 2018.SATRALIZUMAB ADDED TO BASELINE THERAPY SIGNIFICANTLY REDUCED RISK OF RELAPSE.RESULTS WERE PRESENTED AT ECTRIMS CONGRESS HELD IN BERLIN FROM OCTOBER 10 TO 12.  Full Article

Go Therapeutics Enters Into Agreement With Roche For Glycotargeting Bispecific Cancer Treatment
Tuesday, 2 Oct 2018 07:00am EDT 

Oct 2 (Reuters) - Roche Holding AG ::GO THERAPEUTICS ENTERS INTO A LICENSE AGREEMENT WITH ROCHE FOR NEW GLYCOTARGETING BISPECIFIC CANCER TREATMENT.GO THERAPEUTICS SAYS ROCHE WILL PAY CO UPFRONT AND NEAR-TERM MILESTONES OF $9 MILLION.GO THERAPEUTICS-WILL BE ELIGIBLE TO RECEIVE UPTO $186 MILLION IN PAYMENTS WITH MID-SINGLE-DIGIT TO LOW DOUBLE-DIGIT ROYALTIES ON FUTURE PRODUCT SALES.  Full Article

Roche Advances Open Diabetes Management Ecosystem By Integrating Continuous Glucose Monitoring Data
Wednesday, 26 Sep 2018 08:00am EDT 

Sept 26 (Reuters) - Roche Holding AG ::ROCHE ADVANCES ITS OPEN DIABETES MANAGEMENT ECOSYSTEM BY INTEGRATING CONTINUOUS GLUCOSE MONITORING DATA TO DRIVE PERSONALISED THERAPY DECISIONS.ROCHE HOLDING AG - SIGNED A NON-EXCLUSIVE DATA INTEGRATION AGREEMENT WITH SENSEONICS INCORPORATED, EXPANDING ITS PARTNERSHIP.ROCHE - INITIAL DATA INTEGRATION IS PLANNED TO BE AVAILABLE TO USERS BEGINNING 2019.  Full Article

Roche's Genentech Presents Interim Results Of Phase III Tecentriq Trial
Monday, 24 Sep 2018 09:45am EDT 

Sept 24 (Reuters) - Roche Holding AG ::PHASE III TRIAL OF GENENTECH'S TECENTRIQ IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY SHOWED REDUCED RISK OF DISEASE WORSENING OR DEATH IN A TYPE OF PREVIOUSLY UNTREATED ADVANCED LUNG CANCER.INTERIM ANALYSIS SHOWED THAT TECENTRIQ AND CHEMOTHERAPY REDUCED RISK OF DISEASE WORSENING OR DEATH (PROGRESSION-FREE SURVIVAL, PFS) BY 40 PERCENT COMPARED WITH CHEMOTHERAPY ALONE.SAYS ON TECENTRIQ TRIAL - AT THIS INTERIM ANALYSIS STATISTICAL SIGNIFICANCE HAS NOT YET BEEN MET.  Full Article

Oncolytics Biotech Announces A Master Clinical Supply Agreement Of An Anti-PD-L1 Checkpoint Inhibitor
Thursday, 6 Sep 2018 07:00am EDT 

Sept 6 (Reuters) - Oncolytics Biotech Inc ::ONCOLYTICS BIOTECH® ANNOUNCES A MASTER CLINICAL SUPPLY AGREEMENT OF AN ANTI-PD-L1 CHECKPOINT INHIBITOR FOR USE IN THE COMPANY’S CLINICAL PROGRAM.ONCOLYTICS BIOTECH INC - ENTERED INTO AGREEMENT WITH F. HOFFMANN-LA ROCHE LTD TO SUPPLY ATEZOLIZUMAB FOR USE IN CLINICAL DEVELOPMENT PROGRAM.ONCOLYTICS BIOTECH INC - ROCHE WILL SUPPLY ATEZOLIZUMAB FOR PROPOSED CLINICAL TRIAL WITH BOTH PARTIES HAVING ACCESS TO CLINICAL DATA.  Full Article

GBT Signs Licensing Agreement For Inclacumab To Treat Vaso-Occlusive Crisis
Thursday, 23 Aug 2018 08:00am EDT 

Aug 23 (Reuters) - Global Blood Therapeutics Inc ::GBT EXPANDS SICKLE CELL DISEASE PIPELINE WITH WORLDWIDE LICENSING AGREEMENT FOR INCLACUMAB FOR THE TREATMENT OF VASO-OCCLUSIVE CRISIS.GLOBAL BLOOD THERAPEUTICS INC - ENTERED INTO AN EXCLUSIVE WORLDWIDE LICENSING AGREEMENT WITH F. HOFFMANN-LA ROCHE LTD.GLOBAL BLOOD THERAPEUTICS INC - AGREEMENT FOR DEVELOPMENT AND COMMERCIALIZATION OF INCLACUMAB.GLOBAL BLOOD THERAPEUTICS INC - GBT WILL BE RESPONSIBLE FOR ALL DEVELOPMENT, MANUFACTURING, AND COMMERCIALIZATION OF INCLACUMAB WORLDWIDE.GLOBAL BLOOD THERAPEUTICS INC - ROCHE WILL RECEIVE AN UPFRONT PAYMENT OF $2.0 MILLION FROM GBT.GLOBAL BLOOD THERAPEUTICS INC - ROCHE IS ELIGIBLE TO RECEIVE UP TO ABOUT $125 MILLION IN MILESTONE PAYMENTS FOR SICKLE CELL DISEASE INDICATION.GLOBAL BLOOD THERAPEUTICS INC - GBT HAS ALREADY BEGUN PROCESS OF TECHNOLOGY TRANSFER FROM ROCHE TO A CONTRACT MANUFACTURING ORGANIZATION.GLOBAL BLOOD THERAPEUTICS - EXPECTS SUBMITTING IND APPLICATION TO U.S. FDA FOR INCLACUMAB IN 2021.GLOBAL BLOOD THERAPEUTICS - ADDITIONALLY, ROCHE IS ELIGIBLE TO RECEIVE TIERED ROYALTIES BASED ON NET REVENUES FOR INCLACUMAB.  Full Article

Roche Receives FDA Approval For Cobas EGFR Mutation Test v2 As Companion Diagnostic With IRESSA
Thursday, 23 Aug 2018 07:00am EDT 

Aug 23 (Reuters) - Roche Holding AG ::ROCHE RECEIVES FDA APPROVAL FOR COBAS EGFR MUTATION TEST V2 AS COMPANION DIAGNOSTIC WITH IRESSA (GEFITINIB) IN FIRST-LINE TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC).ROCHE HOLDING AG - APPROVAL FOR USE OF EITHER TUMOUR TISSUE OR PLASMA BIOPSY PROVIDES PATIENTS AND CLINICIANS A NON-INVASIVE SAMPLE COLLECTION OPTION.  Full Article

U.S. FDA Updates Prescribing Information For Keytruda & Tecentriq
Thursday, 16 Aug 2018 06:31pm EDT 

Aug 16 (Reuters) - U.S. Food and Drug Administration::FDA - UPDATES PRESCRIBING INFORMATION FOR KEYTRUDA (PEMBROLIZUMAB) & TECENTRIQ (ATEZOLIZUMAB) TO REQUIRE USE OF FDA-APPROVED COMPANION DIAGNOSTIC TEST.FDA SAYS TWO COMPANION DIAGNOSTIC TESTS APPROVED; ONE FOR USE WITH KEYTRUDA & ONE FOR TECENTRIQ.FDA - SECOND-LINE INDICATIONS IN UROTHELIAL CARCINOMA FOR KEYTRUDA (PEMBROLIZUMAB) & TECENTRIQ (ATEZOLIZUMAB) REMAIN UNCHANGED.FDA - UPDATED PRESCRIBING INFORMATION FOR KEYTRUDA & TECENTRIQ TO REQUIRE USE OF APPROVED TEST FOR SELECTION OF PATIENTS WHO ARE CISPLATIN-INELIGIBLE.  Full Article

Roche Says Plans To Launch Coaguchek Vantus System
Monday, 11 Jun 2018 07:00am EDT 

June 11 (Reuters) - Roche Holding AG ::ROCHE - PLANS TO LAUNCH COAGUCHEK VANTUS SYSTEM, EXPECTED TO BE COMMERCIALLY AVAILABLE IN U.S. IN SUMMER OF 2018.  Full Article

BRIEF-Roche CEO Says 'Confidence Rising' in Sales Growth in 2019, Beyond

* CEO SAYS HIS CONFIDENCE RISING QUARTER-BY-QUARTER THAT DRUGMAKER WILL CONTINUE SALES GROWTH IN 2019, BASED ON TRIAL RESULTS; "WE ARE SURE WE CAN OUTGROW THE IMPACT OF BIOSIMILARS"