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Roche Holding AG (RHHBY.PK)

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Latest Key Developments (Source: Significant Developments)

Roche: Tecentriq Reduced Risk Of Disease Worsening Compared With Chemotherapy Alone
Monday, 30 Sep 2019 

Sept 30 (Reuters) - Roche Holding AG ::IMVIGOR130 IS THE FIRST POSITIVE PHASE III STUDY OF A CANCER IMMUNOTHERAPY COMBINATION IN PEOPLE WITH PREVIOUSLY UNTREATED ADVANCED BLADDER CANCER.TECENTRIQ COMBINATION REDUCED THE RISK OF DISEASE WORSENING OR DEATH (PROGRESSION-FREE SURVIVAL) COMPARED WITH CHEMOTHERAPY ALONE.ENCOURAGING OVERALL SURVIVAL (OS) RESULTS WERE OBSERVED FOR TECENTRIQ PLUS CHEMOTHERAPY COMPARED WITH CHEMOTHERAPY ALONE IN THE INTENTION-TO-TREAT POPULATION (ITT), HOWEVER THESE DATA DID NOT REACH STATISTICAL SIGNIFICANCE AT THIS INTERIM ANALYSIS.  Full Article

FDA Approves Genentech's Rituxan (Rituximab) In Children With Two Rare Blood Vessel Disorders
Friday, 27 Sep 2019 

Sept 27 (Reuters) - Genentech::FDA APPROVES GENENTECH’S RITUXAN (RITUXIMAB) IN CHILDREN WITH TWO RARE BLOOD VESSEL DISORDERS.GENENTECH - FDA APPROVED RITUXAN COMBINED WITH GLUCOCORTICOIDS, FOR TREATMENT OF GRANULOMATOSIS WITH POLYANGIITIS & MICROSCOPIC POLYANGIITIS IN CHILDREN.  Full Article

Health Canada Approves Hoffmann-La Roche's Tecentriq In Combination With Chemotherapy For Breast Cancer
Friday, 27 Sep 2019 

Sept 27 (Reuters) - Hoffmann-La Roche Limited :HEALTH CANADA APPROVES TECENTRIQ® IN COMBINATION WITH CHEMOTHERAPY (NAB-PACLITAXEL) AS FIRST IMMUNOTHERAPY TREATMENT FOR AGGRESSIVE FORM OF BREAST CANCER(1).HOFFMANN-LA ROCHE - HEALTH CANADA APPROVED TECENTRIQ IN COMBINATION WITH CHEMOTHERAPY FOR TREATMENT OF PATIENTS WITH LOCALLY ADVANCED BREAST CANCER.  Full Article

Roche says Tecentriq helped some lung cancer patients live longer
Friday, 27 Sep 2019 

Sept 27 (Reuters) - Roche Holding AG ::GENENTECH’S TECENTRIQ (ATEZOLIZUMAB) IMPROVES OVERALL SURVIVAL AS A FIRST-LINE MONOTHERAPY IN CERTAIN PEOPLE WITH ADVANCED NON-SMALL CELL LUNG CANCER.ROCHE HOLDING AG - STUDY MET ITS PRIMARY ENDPOINT IN AN INTERIM ANALYSIS.ROCHE HOLDING AG - STUDY MET ITS PRIMARY ENDPOINT IN AN INTERIM ANALYSIS.ROCHE HOLDING AG - OS GENENTECH'S TECENTRIQ STUDY DATA DID NOT REACH STATISTICAL SIGNIFICANCE AT THIS INTERIM ANALYSIS.ROCHE HOLDING - SAFETY FOR GENENTECH'S TECENTRIQ APPEARED TO BE CONSISTENT WITH KNOWN SAFETY PROFILE.ROCHE - PHASE III STUDY SHOWS TECENTRIQ MONOTHERAPY HELPED PEOPLE WITH ADVANCED NSCLC WITH HIGH PD-L1 EXPRESSION LIVE LONGER VERSUS CHEMOTHERAPY ALONE.ROCHE HOLDING AG - NO NEW SAFETY SIGNALS WERE IDENTIFIED FOR GENENTECH'S TECENTRIQ.ROCHE - GENENTECH WILL SUBMIT DATA FROM STUDY TO FDA & EMA.ROCHE HOLDING AG - GENENTECH'S TECENTRIQ WILL CONTINUE TO FINAL ANALYSIS FOR PEOPLE WITH LOWER LEVELS OF PD-L1 EXPRESSION.  Full Article

Roche Presents New Data From Its Oncology Portfolio At European Oncology Congress
Monday, 23 Sep 2019 

Sept 23 (Reuters) - Roche Holding AG ::ROCHE TO PRESENT NEW DATA FROM ITS BROAD ONCOLOGY PORTFOLIO AT EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY 2019 CONGRESS.FIRST POSITIVE RESULTS FROM A PHASE III CANCER IMMUNOTHERAPY COMBINATION STUDY IN PEOPLE WITH PREVIOUSLY UNTREATED ADVANCED BLADDER CANCER.FIRST RESULTS FROM BFAST STUDY TESTING FOUNDATION MEDICINE'S FOUNDATIONONE® LIQUID BIOPSY ASSAY TO IDENTIFY PATIENTS WHO MAY BE ELIGIBLE FOR ALECENSA® (ALECTINIB).FIRST RESULTS FROM POSITIVE PHASE III IMPOWER110 STUDY OF TECENTRIQ® (ATEZOLIZUMAB) MONOTHERAPY AS AN INITIAL TREATMENT FOR ADVANCED LUNG CANCER.  Full Article

Roche Receives FDA Clearance For Cobas Pro Integrated Solutions
Monday, 16 Sep 2019 

Sept 16 (Reuters) - Roche Holding AG ::ROCHE RECEIVES FDA CLEARANCE FOR COBAS PRO INTEGRATED SOLUTIONS DESIGNED TO HELP LABS DELIVER FASTER RESULTS TO PATIENTS.ROCHE DIAGNOSTICS ANNOUNCED TODAY THAT US FOOD AND DRUG ADMINISTRATION (FDA) HAS CLEARED ITS COBAS PROⓇ INTEGRATED SOLUTIONS, A NEW GENERATION OF SERUM WORK AREA (CLINICAL CHEMISTRY AND IMMUNOCHEMISTRY) LABORATORY SOLUTION, DESIGNED TO OPTIMIZE LAB OPERATIONS.  Full Article

Halozyme Says Global Phase III FeDeriCa Study Conducted By Genentech Met Its Primary Endpoint
Friday, 13 Sep 2019 

Sept 13 (Reuters) - Halozyme Therapeutics Inc ::POSITIVE RESULTS ANNOUNCED FROM PHASE 3 TRIAL EVALUATING FIXED-DOSE SUBCUTANEOUS COMBINATION OF PERJETA® AND HERCEPTIN® USING HALOZYME'S ENHANZE® DRUG DELIVERY TECHNOLOGY.GLOBAL PHASE III FEDERICA STUDY CONDUCTED BY GENENTECH, A MEMBER OF ROCHE GROUP, MET ITS PRIMARY ENDPOINT.  Full Article

Roche Reports Positive Data From Phase III Impower110 Study Evaluating Tecentriq
Thursday, 12 Sep 2019 

Sept 12 (Reuters) - Roche Holding AG ::ROCHE’S TECENTRIQ AS A FIRST-LINE MONOTHERAPY HELPED CERTAIN PEOPLE WITH ADVANCED NON-SMALL CELL LUNG CANCER LIVE LONGER COMPARED WITH CHEMOTHERAPY.POSITIVE DATA FROM PHASE III IMPOWER110 STUDY EVALUATING TECENTRIQ® (ATEZOLIZUMAB) AS A FIRST-LINE (INITIAL) MONOTHERAPY COMPARED WITH CISPLATIN OR CARBOPLATIN AND PEMETREXED OR GEMCITABINE (CHEMOTHERAPY) IN ADVANCED NON-SQUAMOUS AND SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) WITHOUT ALK OR EGFR MUTATIONS (WILD-TYPE OR WT).STUDY MET ITS PRIMARY ENDPOINT IN AN INTERIM ANALYSIS.ROCHE WILL NOW SUBMIT THESE DATA TO GLOBAL HEALTH AUTHORITIES, INCLUDING FDA AND EMA, AND WILL DISCUSS HOW BEST TO BRING THIS OPTION TO PATIENTS AS QUICKLY AS POSSIBLE.  Full Article

Roche Presents Positive Study Results For One-Dose Xofluza In Children With Flu
Monday, 2 Sep 2019 

Sept 2 (Reuters) - Roche Holding AG ::ROCHE PRESENTS POSITIVE PHASE III STUDY RESULTS FOR ONE-DOSE XOFLUZA IN CHILDREN WITH FLU.XOFLUZA WAS ADMINISTERED AS A NEW ONE-DOSE ORAL SUSPENSION, A POTENTIALLY MORE CONVENIENT TREATMENT OPTION FOR CHILDREN.XOFLUZA WAS COMPARABLE TO OSELTAMIVIR IN RELATION TO KEY SECONDARY ENDPOINTS, INCLUDING TIME TO ALLEVIATION OF INFLUENZA SIGNS AND SYMPTOMS (MEDIAN 138.1 HOURS VERSUS. 150.0 HOURS).  Full Article

Roche Wins U.S. FDA Approval For Rozlytrek Cancer Treatment
Friday, 16 Aug 2019 

Aug 16 (Reuters) - Roche Holding AG ::FDA APPROVES ROCHE’S ROZLYTREKTM (ENTRECTINIB) FOR PEOPLE WITH ROS1-POSITIVE, METASTATIC NON-SMALL CELL LUNG CANCER AND NTRK GENE FUSION-POSITIVE SOLID TUMOURS.FIRST FDA-APPROVED TREATMENT DESIGNED TO TARGET BOTH ROS1 AND NTRK THAT ALSO SHOWS RESPONSE IN CANCER THAT HAS SPREAD TO BRAIN.ROCHE'S FIRST FDA-APPROVED TUMOUR-AGNOSTIC MEDICINE.FDA HAS ALSO GRANTED ACCELERATED APPROVAL TO ROZLYTREK FOR TREATMENT OF ADULT AND PAEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMOURS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION.APPROVALS ARE BASED ON RESULTS FROM INTEGRATED ANALYSIS OF PIVOTAL PHASE II STARTRK-2, PHASE I STARTRK-1 AND PHASE I ALKA-372-001 TRIALS, AND DATA FROM PHASE I/II STARTRK-NG STUDY.  Full Article

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Roche, Spark again extend $4.3 billion takeover offer

ZURICH Roche Holding and Spark Therapeutics announced on Tuesday another extension of the Swiss drugmaker's $4.3 billion takeover offer for the U.S. gene therapy specialist as regulatory reviews continue.