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Roche Holding AG (RHHBY.PK)

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Latest Key Developments (Source: Significant Developments)

Ptc Therapeutics Inc Says Evrysdi Approved In Brazil By National Health Surveillance Agency For Treatment Of Spinal Muscular Atrophy
Wednesday, 21 Oct 2020 

Oct 21 (Reuters) - PTC Therapeutics Inc ::PTC THERAPEUTICS INC - EVRYSDI WAS APPROVED IN BRAZIL BY NATIONAL HEALTH SURVEILLANCE AGENCY (ANVISA) FOR TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA).PTC THERAPEUTICS INC - NDA FILED WITH JAPAN'S MHLW UNDER PRIORITY REVIEW.PTC THERAPEUTICS INC - FILING IN JAPAN BY CHUGAI PHARMACEUTICAL CO. LTD TRIGGERS A $7.5 MILLION MILESTONE PAYMENT TO PTC FROM ROCHE.  Full Article

Roche And Prothena Will Advance Prasinezumab Into Late-Stage Clinical Development Study In Parkinson’S Disease
Wednesday, 21 Oct 2020 

Oct 20 (Reuters) - Prothena Corporation PLC ::ROCHE AND PROTHENA WILL ADVANCE PRASINEZUMAB INTO LATE-STAGE CLINICAL DEVELOPMENT STUDY IN PARKINSON’S DISEASE.PROTHENA CORPORATION - TO EARN A $60 MILLION CLINICAL MILESTONE UPON FIRST PATIENT DOSED.PROTHENA - ANTI-ALPHA-SYNUCLEIN ANTIBODY TO ADVANCE INTO CONFIRMATORY LARGE STUDY IN PATIENTS WITH EARLY PARKINSON'S DISEASE; EXPECTED TO INITIATE IN 2021.  Full Article

Genentech Announces Full FDA Approval For Venclexta Combinations For Acute Myeloid Leukemia
Saturday, 17 Oct 2020 

Oct 16 (Reuters) - Roche Holding AG ::GENENTECH ANNOUNCES FULL FDA APPROVAL FOR VENCLEXTA COMBINATIONS FOR ACUTE MYELOID LEUKEMIA.GENENTECH- FDA APPROVAL SUPPORTED BY DATA FROM PHASE III CONFIRMATORY TRIALS, VIALE-A AND VIALE-C.GENENTECH - TODAY'S FDA APPROVAL CONVERTS VENCLEXTA'S ACCELERATED APPROVAL IN THIS SETTING TO A FULL APPROVAL.  Full Article

Roche Receives FDA Approval For Expanded Use Of Cintec Plus Cytology Test
Wednesday, 16 Sep 2020 

Sept 16 (Reuters) - Roche Holding AG ::ROCHE RECEIVES FDA APPROVAL FOR EXPANDED USE OF THE CINTEC PLUS CYTOLOGY TEST TO AID CLINICIANS IN PREVENTING CERVICAL CANCER.EXT-GENERATION BIOMARKER CYTOLOGY TEST SUPPORTS WORLD HEALTH ORGANIZATION'S GOAL TO ELIMINATE CERVICAL CANCER, WHICH IS NEARLY 100 PERCENT PREVENTABLE WITH PROPER SCREENING, VACCINATION AND TREATMENT.NEW INDICATION ALLOWS THIS FIRST FDA-APPROVED BIOMARKER-BASED TEST TO BE USED AS TRIAGE FOR POSITIVE COBAS HPV TESTS RUN ON COBAS 6800/8800 SYSTEMS IN PRIMARY SCREENING OR CO-TESTING PROGRAMS.MORE SENSITIVE THAN TRADITIONAL PAP CYTOLOGY, THIS TEST ALLOWS CLINICIANS TO DETERMINE WHICH HPV-POSITIVE WOMEN REQUIRE FURTHER DIAGNOSTIC PROCEDURES TO PREVENT DISEASE PROGRESSION.  Full Article

FDA Says Health Care Professionals Should Not Replace Paclitaxel Protein-Bound (Abraxane) With Paclitaxel In Clinical Practice
Tuesday, 8 Sep 2020 

Sept 8 (Reuters) - FDA::FDA ALERTS HEALTH CARE PROFESSIONALS AND ONCOLOGY CLINICAL INVESTIGATORS ABOUT EFFICACY AND POTENTIAL SAFETY CONCERNS WITH ATEZOLIZUMAB IN COMBINATION WITH PACLITAXEL FOR TREATMENT OF BREAST CANCER.FDA SAYS HEALTH CARE PROFESSIONALS SHOULD NOT REPLACE PACLITAXEL PROTEIN-BOUND (ABRAXANE) WITH PACLITAXEL IN CLINICAL PRACTICE.FDA - WILL REVIEW IMPASSION131 FINDINGS, COMMUNICATE NEW INFORMATION REGARDING IMPASSION131 RESULTS & ANY POTENTIAL CHANGES TO PRESCRIBING INFORMATION.  Full Article

Roche wins FDA blessing for BK virus test for transplant patients
Tuesday, 8 Sep 2020 

Sept 8 (Reuters) - Roche Holding AG ::ROCHE RECEIVES FDA CLEARANCE FOR BK VIRUS QUANTITATIVE TEST ON COBAS 6800/8800 SYSTEMS TO SUPPORT BETTER CARE FOR TRANSPLANT PATIENTS.ROCHE RECEIVES FDA CLEARANCE FOR BK VIRUS QUANTITATIVE TEST ON COBAS 6800/8800 SYSTEMS TO SUPPORT BETTER CARE FOR TRANSPLANT PATIENTS.IMMUNOCOMPROMISED TRANSPLANT PATIENTS ARE AT RISK OF MAJOR COMPLICATIONS WHEN INFECTED WITH BK VIRUS.COBAS BKV TEST ADDRESSES CRITICAL NEED FOR HOSPITALS AND LABORATORIES.DEVICE TEST EXPANDS ROCHE MOLECULAR TEST MENU FOR TRANSPLANT PATIENTS.  Full Article

Blueprint Medicines Announces FDA Approval Of Gavreto For Treatment Of Adults With Metastatic Ret Fusion-Positive Non-Small Cell Lung Cancer
Saturday, 5 Sep 2020 

Sept 4 (Reuters) - Blueprint Medicines Corp ::BLUEPRINT MEDICINES ANNOUNCES FDA APPROVAL OF GAVRETO™ (PRALSETINIB) FOR THE TREATMENT OF ADULTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER.BLUEPRINT MEDICINES - GAVRETO, ONLY ONCE-DAILY RET-TARGETED THERAPY, DEMONSTRATED DURABLE EFFICACY, WITH COMPLETE RESPONSES IN A SUBSET OF PATIENTS.NDA ACCEPTED BY FDA FOR PRALSETINIB FOR RET-MUTANT MEDULLARY THYROID CANCER AND RET FUSION-POSITIVE THYROID CANCER.BLUEPRINT MEDICINES AND GENENTECH PLAN TO MAKE GAVRETO AVAILABLE IN U.S. WITHIN ONE WEEK.  Full Article

Genentech Announces FDA Approval Of Gavreto For Treatment Of Adults With Metastatic Ret Fusion-Positive Non-Small Cell Lung Cancer
Saturday, 5 Sep 2020 

Sept 4 (Reuters) - Genentech::GENENTECH ANNOUNCES FDA APPROVAL OF GAVRETO (PRALSETINIB) FOR THE TREATMENT OF ADULTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER.GENENTECH - GAVRETO IS A ONCE-DAILY, ORAL PRECISION THERAPY THAT SELECTIVELY INHIBITS RET-ALTERED CANCERS.GENENTECH - GENENTECH AND BLUEPRINT MEDICINES WILL CO-COMMERCIALIZE GAVRETO IN THE UNITED STATES.GENENTECH -FDA ALSO GRANTED PRIORITY REVIEW TO GAVRETO FOR PEOPLE WITH ADVANCED, METASTATIC RET-MUTANT MTC, RET FUSION-POSITIVE THYROID CANCER.  Full Article

Roche To Launch SARS-CoV-2 Rapid Antigen Test In Countries Accepting CE Mark
Wednesday, 2 Sep 2020 

Sept 1 (Reuters) - Roche Holding AG ::ROCHE TO LAUNCH SARS-COV-2 RAPID ANTIGEN TEST IN COUNTRIES ACCEPTING CE MARK, ALLOWING FAST TRIAGE DECISIONS AT POINT OF CARE.ROCHE HOLDING AG - INTENDS TO FILE FOR EUA TO U.S. FDA FOR SARS-COV-2 RAPID ANTIGEN TEST.  Full Article

Roche Says To Launch SARS-CoV-2 Rapid Antigen Test In Countries Accepting CE Mark
Wednesday, 2 Sep 2020 

Sept 1 (Reuters) - Roche Holding AG ::ROCHE TO LAUNCH SARS-COV-2 RAPID ANTIGEN TEST IN COUNTRIES ACCEPTING CE MARK, ALLOWING FAST TRIAGE DECISIONS AT POINT OF CARE.ANTIGEN TEST RELIABLY AND QUICKLY TRIAGES PEOPLE SUSPECTED OF SARS-COV-2, WITH RESULTS READY IN 15 MINUTES.INTENDS TO FILE FOR EUA TO U.S. FDA FOR SARS-COV-2 RAPID ANTIGEN TEST.  Full Article

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Roche, Atea team up on potential COVID-19 pill

ZURICH Roche Holding and Atea Pharmaceuticals have joined forces to develop an antiviral oral treatment called AT-527, now in phase 2 clinical trials, as a potential treatment for COVID-19 patients, the companies said on Thursday.

No consensus analysis data available.