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Roche Holding AG (RO.S)

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7 Dec 2018
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Latest Key Developments (Source: Significant Developments)

FDA approves Genentech’S tecentriq in combination with avastin and chemotherapy
Friday, 7 Dec 2018 

Dec 6 (Reuters) - Roche Holding AG ::FDA APPROVES GENENTECH’S TECENTRIQ IN COMBINATION WITH AVASTIN AND CHEMOTHERAPY FOR THE INITIAL TREATMENT OF PEOPLE WITH A SPECIFIC TYPE OF METASTATIC LUNG CANCER.GENENTECH SAYS APPROVAL IS BASED ON RESULTS FROM PHASE III IMPOWER150 STUDY.  Full Article

Genentech Acquires Jecure Therapeutics
Tuesday, 27 Nov 2018 

Nov 27 (Reuters) - Jecure Therapeutics Inc::GENENTECH ACQUIRES JECURE THERAPEUTICS.JECURE THERAPEUTICS INC SAYS GENENTECH WILL OBTAIN FULL RIGHTS TO CO'S ENTIRE PRECLINICAL PORTFOLIO OF NLRP3 INHIBITORS.  Full Article

Daiichi Sankyo Co, Roche To Collaborate On New HER2 Low Companion Diagnostic Test
Tuesday, 27 Nov 2018 

Nov 27 (Reuters) - Daiichi Sankyo Co Ltd <4568.T>::DAIICHI SANKYO AND ROCHE TO COLLABORATE ON NEW HER2 LOW COMPANION DIAGNOSTIC TEST.DAIICHI SANKYO- UNDER AGREEMENT, ROCHE WILL SEEK TO DEVELOP, MANUFACTURE & COMMERCIALIZE WORLDWIDE AN IMMUNOHISTOCHEMISTRY COMPANION DIAGNOSTIC TEST.DAIICHI SANKYO CO - SPECIFIC FINANCIAL TERMS OF AGREEMENT HAVE NOT BEEN DISCLOSED.  Full Article

Roche Launches Assay To Be Used Across Multiple Tumor Types
Tuesday, 27 Nov 2018 

Nov 27 (Reuters) - Roche Holding AG ::ROCHE LAUNCHES FIRST IVD PAN-TRK IMMUNOHISTOCHEMISTRY ASSAY.VENTANA PAN-TRK (EPR17341) ASSAY1 IS FIRST ASSAY OF ITS TYPE TO DETECT TROPOMYOSIN RECEPTOR KINASE (TRK) WITH ANTICIPATED USE ACROSS MULTIPLE SOLID TUMOR TYPES.ASSAY IS EXPECTED TO PROVIDE IMPROVED DATA ON PREVALENCE OF TRK PROTEINS IN TUMOR TISSUE STUDIES.SIGNIFICANCE OF TRK FUSION PROTEINS IS CURRENTLY BEING INVESTIGATED IN VARIOUS CANCER INDICATIONS.  Full Article

Genentech Says FDA Approves Venclexta in Newly-Diagnosed AML
Wednesday, 21 Nov 2018 

Nov 21 (Reuters) - Genentech::GENENTECH - FDA GRANTED ACCELERATED APPROVAL TO VENCLEXTA, IN COMBINATION WITH A HYPOMETHYLATING AGENT, OR LOW-DOSE CYTARABINE IN NEWLY-DIAGNOSED AML.  Full Article

FDA Warns Patients And Doctors About Risk Of Inaccurate Results From Home-Use Device To Monitor Blood Thinner Warfarin
Friday, 2 Nov 2018 

Nov 1 (Reuters) - Roche Holding AG ::FDA WARNS PATIENTS AND DOCTORS ABOUT RISK OF INACCURATE RESULTS FROM HOME-USE DEVICE TO MONITOR BLOOD THINNER WARFARIN.U.S. FDA - ANNOUNCED ROCHE DIAGNOSTICS' VOLUNTARY RECALL OF CERTAIN TEST STRIP LOTS USED WITH ITS COAGUCHEK TEST METER DEVICES, AS A CLASS I RECALL.  Full Article

Roche Holding AG - Randomized Phase III CLL14 Study Met Its Primary Endpoint
Thursday, 1 Nov 2018 

Oct 31 (Reuters) - Roche Holding AG ::PHASE III DATA SHOWED THAT VENCLEXTA PLUS GAZYVA REDUCED THE RISK OF DISEASE WORSENING OR DEATH IN PEOPLE WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH CO-MORBIDITIES.ROCHE HOLDING AG - DATA WILL BE SUBMITTED TO HEALTH AUTHORITIES AND PRESENTED AT AN UPCOMING MEDICAL MEETING.ROCHE HOLDING AG - RANDOMIZED PHASE III CLL14 STUDY SHOWED A STATISTICALLY SIGNIFICANT REDUCTION IN RISK OF DISEASE WORSENING OR DEATH.ROCHE HOLDING AG - RANDOMIZED PHASE III CLL14 STUDY MET ITS PRIMARY ENDPOINT.  Full Article

Roche Announces FDA Approval Of Xofluza (Baloxavir Marboxil) For Influenza
Wednesday, 24 Oct 2018 

Oct 24 (Reuters) - Roche Holding AG ::ROCHE ANNOUNCES FDA APPROVAL OF XOFLUZA (BALOXAVIR MARBOXIL) FOR INFLUENZA.  Full Article

Principia Biopharma Appoints Dolca Thomas As Chief Medical Officer
Wednesday, 24 Oct 2018 

Oct 24 (Reuters) - Principia Biopharma Inc ::PRINCIPIA BIOPHARMA APPOINTS DOLCA THOMAS, M.D. AS CHIEF MEDICAL OFFICER.PRINCIPIA BIOPHARMA APPOINTS DOLCA THOMAS, M.D. AS CHIEF MEDICAL OFFICER.PRINCIPIA BIOPHARMA APPOINTS DOLCA THOMAS, M.D. AS CHIEF MEDICAL OFFICER.PRINCIPIA BIOPHARMA INC - THOMAS JOINS PRINCIPIA FROM ROCHE.  Full Article

Roche Says Phase III Study On Alecensa Meets Primary Endpoint
Monday, 22 Oct 2018 

Oct 22 (Reuters) - Roche Holding AG ::SAYS WILL TO ANNOUNCE RESULTS FROM THE PHASE III ALESIA STUDY, SHOWING THAT ALECENSA® (ALECTINIB) MET ITS PRIMARY ENDPOINT OF INVESTIGATOR-ASSESSED (INV) PROGRESSION-FREE SURVIVAL (PFS).ALECENSA (ALECTINIB) SIGNIFICANTLY REDUCED RISK OF DISEASE WORSENING OR DEATH AS FIRST-LINE TREATMENT IN ASIAN PATIENTS WITH ALK-POSITIVE ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER.  Full Article

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Roche's lung cancer combo treatment wins FDA approval

Swiss drugmaker Roche Holding AG said on Thursday that its Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer.