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Roche Holding AG (RO.S)

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23 May 2018
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Latest Key Developments (Source: Significant Developments)

Genentech's Announces results from Phase III Haven 3 study evaluating Hemlibra prophylaxis
Monday, 21 May 2018 

May 21 (Reuters) - :GENENTECH'S HEMLIBRA (EMICIZUMAB-KXWH) REDUCED TREATED BLEEDS BY 96 PERCENT COMPARED TO NO PROPHYLAXIS IN PHASE III HAVEN 3 STUDY IN HEMOPHILIA A WITHOUT FACTOR VIII INHIBITORS.GENENTECH - HEMLIBRA REDUCED TREATED BLEEDS BY 96 PERCENT COMPARED TO NO PROPHYLAXIS IN PHASE III HAVEN 3 STUDY IN HEMOPHILIA A WITHOUT FACTOR VIII INHIBITORS.GENENTECH- DATA FROM BOTH HAVEN 3 AND HAVEN 4 STUDIES ARE BEING SUBMITTED TO HEALTH AUTHORITIES AROUND WORLD FOR APPROVAL CONSIDERATION.  Full Article

FDA Issues Alert On Use Of Keytruda/Tecentriq For Patients With Urothelial Cancer, Have Low Expression Of PD-L1
Friday, 18 May 2018 

May 18 (Reuters) - FDA::U.S. FDA - ISSUES ALERT ABOUT DECREASED SURVIVAL ASSOCIATED WITH THE USE OF KEYTRUDA (PEMBROLIZUMAB) OR TECENTRIQ (ATEZOLIZUMAB).U.S. FDA SAYS THERE WAS NO CHANGE IN THE ADVERSE EVENT PROFILE OF KEYTRUDA OR TECENTRIQ.FDA - MERCK, GENENTECH HAVE STOPPED ENROLLING PATIENTS WHOSE TUMORS HAVE PD-L1 LOW STATUS TO KEYTRUDA/TECENTRIQ MONOTHERAPY ARMS PER DMCS’ RECOMMENDATIONS.U.S. FDA SAYS MONOTHERAPY ARMS REMAIN OPEN ONLY TO PATIENTS WHOSE TUMORS HAVE PD-L1 HIGH STATUS.U.S. FDA - COMBINATION ARMS AND THE CHEMOTHERAPY ARMS OF BOTH STUDIES ALSO REMAIN OPEN.FDA - ISSUED ALERT ON KEYTRUDA/TECENTRIQ AS MONOTHERAPY FOR PATIENTS WITH UROTHELIAL CANCER WHO HAVE NOT RECEIVED PRIOR THERAPY, HAVE LOW EXPRESSION OF PD-L1.  Full Article

Genentech Says In Phase 3 Impower150 Study, Survival Advantage For Tecentriq-Avastin Combo Was Seen In All Exploratory Patient Subgroups Analyzed
Wednesday, 16 May 2018 

May 16 (Reuters) - GENENTECH::PHASE III IMPOWER150 STUDY SHOWED GENENTECH’S TECENTRIQ AND AVASTIN PLUS CARBOPLATIN AND PACLITAXEL HELPED PEOPLE WITH A SPECIFIC TYPE OF METASTATIC LUNG CANCER LIVE SIGNIFICANTLY LONGER COMPARED TO AVASTIN PLUS CARBOPLATIN AND PACLITAXEL.GENENTECH - IN PHASE III IMPOWER150 STUDY, SURVIVAL ADVANTAGE FOR TECENTRIQ-AVASTIN COMBO REGIMEN WAS SEEN IN ALL EXPLORATORY PATIENT SUBGROUPS ANALYZED.  Full Article

FDA Accepts Turnstone Biologics' IND For Cancer Immunotherapy
Wednesday, 16 May 2018 

May 16 (Reuters) - Turnstone Biologics::TURNSTONE BIOLOGICS ANNOUNCES U.S. FDA ACCEPTANCE OF IND FOR IMMUNOTHERAPY TARGETING HPV POSITIVE CANCERS.TURNSTONE BIOLOGICS ANNOUNCES U.S. FDA ACCEPTANCE OF IND FOR IMMUNOTHERAPY TARGETING HPV POSITIVE CANCERS.TURNSTONE BIOLOGICS - ENTERED INTO A CLINICAL SUPPLY AGREEMENT WITH F. HOFFMANN-LA ROCHE LTD UNDER WHICH ROCHE WILL PROVIDE ATEZOLIZUMAB (TECENTRIQ).  Full Article

FDA Approves Additional Claim For Roche Cobas Zika Test
Monday, 14 May 2018 

May 14 (Reuters) - Roche Holding AG ::FDA APPROVES ADDITIONAL CLAIM FOR ROCHE COBAS ZIKA TEST.NEW CLAIM ALLOWS FOR STREAMLINED SCREENING OF POOLED BLOOD OR PLASMA DONATIONS.  Full Article

Zealand And Roche Diabetes Care Enter Phase 3 Study Collaboration For Treatment Of Congenital Hyperinsulinism With Dasiglucagon
Wednesday, 11 Apr 2018 

April 11 (Reuters) - Zealand Pharma A/S - Co Is Responsible For Conducting Phase 3 Trials, While Roche Diabetes Care Provides Its Accu ::ZEALAND AND ROCHE DIABETES CARE ENTER PHASE 3 STUDY COLLABORATION FOR TREATMENT OF CONGENITAL HYPERINSULINISM WITH DASIGLUCAGON.SURGICAL TREATMENT FOR CHILDREN WITH CHI.PHASE 3 TRIALS OF DASIGLUCAGON ARE SET TO START IN SECOND HALF OF 2018.CHEK COMBO PUMP SYSTEM FOR STUDY.  Full Article

Inception Neuroscience Program Acquired By Roche
Wednesday, 4 Apr 2018 

April 4 (Reuters) - Roche Holdings Inc [RIC:RIC:ROGUS.UL]::INCEPTION NEUROSCIENCE PROGRAM ACQUIRED BY ROCHE.‍VERSANT VENTURES SAYS FINANCIAL TERMS ARE NOT DISCLOSED​.  Full Article

Roche Says Completes Acquisition Of Flatiron Health
Thursday, 15 Feb 2018 

April 6 (Reuters) - Roche Holding AG ::SAYS COMPLETES ACQUISITION OF FLATIRON HEALTH.  Full Article

Abcam Says Entered Into License Agreement With Roche​
Monday, 22 Jan 2018 

Jan 22 (Reuters) - Abcam Plc ::‍HAS ENTERED INTO A DEFINITIVE LICENSE AGREEMENT WITH ROCHE​.‍WILL OBTAIN EXCLUSIVE RIGHTS TO PRODUCT PORTFOLIO OF SPRING BIOSCIENCE CORPORATION IN RESEARCH USE ONLY (RUO) FIELD OF USE.ROCHE TO RETAIN ANTIBODY DEVELOPMENT CAPABILITIES, RIGHTS TO SPRING PORTFOLIO FOR INTERNAL RESEARCH, COMPANION DIAGNOSTIC, IVD USES​​.ALL PRODUCTS TO BE SOLD UNDER ABCAM BRAND, INCLUSIVE OF SP BRANDING, ARE EXPECTED TO BE AVAILABLE THROUGH ABCAM.COM FROM 21 FEBRUARY 2018​.GRANTED EXCLUSIVE RUO RIGHTS FOR FUTURE PRODUCTS DEVELOPED BY SPRING THAT ROCHE REQUESTS TO BE COMMERCIALISED IN RUO FIELD OF USE FOR INITIAL PERIOD OF 10 YEARS.‍FINANCIAL TERMS OF AGREEMENT HAVE NOT BEEN DISCLOSED​.  Full Article

Abcam Says Signed Exclusive License Agreement with Roche
Monday, 22 Jan 2018 

Jan 22 (Reuters) - Abcam Plc ::‍HAS ENTERED INTO A DEFINITIVE LICENSE AGREEMENT WITH ROCHE​.‍WILL OBTAIN EXCLUSIVE RIGHTS TO PRODUCT PORTFOLIO OF SPRING BIOSCIENCE CORPORATION ("SPRING") IN RESEARCH USE ONLY (RUO) FIELD OF USE​.‍WILL RETAIN ANTIBODY DEVELOPMENT CAPABILITIES AND RIGHTS PERTAINING TO SPRING PORTFOLIO FOR INTERNAL RESEARCH, COMPANION DIAGNOSTIC AND IVD USES​.‍ALL PRODUCTS WILL BE SOLD UNDER ABCAM BRAND, INCLUSIVE OF SP BRANDING, AND ARE EXPECTED TO BE AVAILABLE THROUGH ABCAM.COM FROM 21 FEBRUARY 2018​.‍HAS ALSO BEEN GRANTED EXCLUSIVE RUO RIGHTS FOR ALL FUTURE PRODUCTS DEVELOPED BY SPRING THAT ROCHE REQUESTS TO BE COMMERCIALISED IN RUO FIELD OF USE FOR AN INITIAL PERIOD OF 10 YEARS.‍FINANCIAL TERMS OF AGREEMENT HAVE NOT BEEN DISCLOSED​.  Full Article

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AstraZeneca cancer drug hits second goal by extending survival

LONDON AstraZeneca's immunotherapy drug Imfinzi has hit a second important goal by improving overall survival in lung cancer patients, boosting prospects for a medicine that has already got off to a promising commercial launch.