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Roche Holding AG (RHHBY.PK)

RHHBY.PK on OTC Markets Group

35.64USD
19 Sep 2019
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Latest Key Developments (Source: Significant Developments)

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

Convelo Therapeutics To Acquire Genentech To Discover Novel Remyelinating Therapies
Tuesday, 16 Jul 2019 

July 16 (Reuters) - Roche Holding AG ::CONVELO THERAPEUTICS ENTERS INTO COLLABORATION AND OPTION TO ACQUIRE AGREEMENT WITH GENENTECH TO DISCOVER NOVEL REMYELINATING THERAPIES.CONVELO THERAPEUTICS - CONVELO WILL RECEIVE AN UNDISCLOSED UPFRONT PAYMENT AND RESEARCH SUPPORT FROM GENENTECH..CONVELO THERAPEUTICS - CONVELO AND GENENTECH WILL COLLABORATE TO DISCOVER NOVEL REMYELINATION THERAPIES FOR MS AND OTHER MYELIN DISORDERS.CONVELO - GENENTECH RETAINS EXCLUSIVE OPTION TO ACQUIRE OUTSTANDING STOCK OF CONVELO FOR ADDITIONAL UNDISCLOSED PAYMENT & DOWNSTREAM MILESTONES..  Full Article

Skyhawk Therapeutics Signs Agreement With Genentech To Develop Small Molecule RNA Splicing Modifiers For Oncology And Neurodegenerative Diseases
Tuesday, 16 Jul 2019 

July 16 (Reuters) - Roche Holding AG ::SKYHAWK THERAPEUTICS ANNOUNCES AGREEMENT WITH GENENTECH TO DISCOVER AND DEVELOP SMALL MOLECULE RNA SPLICING MODIFIERS FOR ONCOLOGY AND NEURODEGENERATIVE DISEASES.SKYHAWK THERAPEUTICS - SKYHAWK WILL RECEIVE AN UPFRONT PAYMENT AND MAY BE ELIGIBLE FOR MORE THAN $2 BILLION OVER TIME.SKYHAWK THERAPEUTICS - WILL USE SKYSTAR PLATFORM TO DEVELOP DRUG CANDIDATES DIRECTED TO MULTIPLE TARGETS FOR ONCOLOGY AND NEURODEGENERATIVE DISEASES.SKYHAWK THERAPEUTICS - AGREEMENT GRANTS GENENTECH AN EXCLUSIVE WORLDWIDE LICENSE TO DEVELOP AND COMMERCIALIZE POTENTIAL THERAPEUTICS.SKYHAWK THERAPEUTICS - GENENTECH WILL BE RESPONSIBLE FOR CLINICAL DEVELOPMENT AND COMMERCIALIZATION..SKYHAWK - DEAL ALSO INCLUDES ROYALTIES ON SALES OF COMMERCIALIZED MEDICINES.  Full Article

ImaginAb Inc Says It Entered Non-Exclusive License And Collaboration Agreement With Roche
Tuesday, 9 Jul 2019 

July 9 (Reuters) - :IMAGINAB INC SAYS IT ENTERED INTO NON-EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT WITH ROCH; FINANCIAL TERMS OF AGREEMENT WERE NOT DISCLOSED..IMAGINAB INC SAYS ROCHE WILL USE IMAGINAB'S NOVEL MINIBODY CD8 T CELL IMAGING AGENT IN IMMUNO-ONCOLOGY CLINICAL TRIALS FOR MULTIPLE TYPES OF CANCERS.  Full Article

Roche Presents Data For Hemlibra At ISTH 2019 Congress
Tuesday, 9 Jul 2019 

July 9 (Reuters) - Roche Holding AG ::NEW ANALYSES FROM PHASE III HAVEN STUDIES SUPPORT HEMLIBRA'S SUSTAINED EFFICACY, SAFETY AND QUALITY OF LIFE BENEFIT IN PEOPLE WITH HAEMOPHILIA A, WITH AND WITHOUT FACTOR VIII INHIBITORS.FIRST DATA OF PHASE IIIB STASEY STUDY REINFORCES SAFETY PROFILE OF HEMLIBRA SEEN IN PIVOTAL HAVEN 1 CLINICAL TRIAL.NEW ANALYSIS OF PIVOTAL DATA SUGGESTS ADDITIONAL FACTOR TREATMENT MAY NOT BE NEEDED FOR PEOPLE ON HEMLIBRA UNDERGOING CERTAIN MINOR SURGERY.  Full Article

Roche: Rituximab Phase III Study Met Primary Endpoint
Thursday, 13 Jun 2019 

June 13 (Reuters) - Roche Holding AG ::PHASE III PEMPHIX STUDY SHOWED THAT MABTHERA/RITUXAN (RITUXIMAB) IS SUPERIOR TO STANDARD OF CARE IN ACHIEVING SUSTAINED REMISSION IN PATIENTS WITH PEMPHIGUS VULGARIS.MABTHERA/RITUXAN MET THE PRIMARY AND SECONDARY ENDPOINTS IN THE PHASE III PEMPHIX STUDY.LATEST PHASE IIISTUDY MET THE PRIMARY ENDPOINT, AND DEMONSTRATED THAT MABTHERA IS SUPERIOR TO MMF IN ACHIEVING SUSTAINED COMPLETE REMISSION.  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.