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Roche Holding AG (RHHBY.PK)

RHHBY.PK on OTC Markets Group

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1 Dec 2020
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Latest Key Developments (Source: Significant Developments)

Genentech Announces FDA Approval Of Xofluza For The Prevention Of Influenza Following Contact With An Infected Person
Tuesday, 24 Nov 2020 

Nov 23 (Reuters) - Genentech::GENENTECH ANNOUNCES FDA APPROVAL OF XOFLUZA FOR THE PREVENTION OF INFLUENZA FOLLOWING CONTACT WITH AN INFECTED PERSON.DETERMINING PATH FORWARD WITH FDA FOR POTENTIAL INDICATION FOR XOFLUZA AS TREATMENT FOR ACUTE UNCOMPLICATED INFLUENZA IN PEDIATRIC SETTING.  Full Article

FDA Expands Approval Of Influenza Treatment To Post-Exposure Prevention
Monday, 23 Nov 2020 

Nov 23 (Reuters) - FDA:FDA EXPANDS APPROVAL OF INFLUENZA TREATMENT TO POST-EXPOSURE PREVENTION.GRANTED APPROVAL OF XOFLUZA TO GENENTECH USA, INC.  Full Article

SAP, Roche And Tenthpin To Create New Standard For Clinical Trial Supplies Operation
Thursday, 29 Oct 2020 

Oct 29 (Reuters) - SAP SE ::SAP, ROCHE AND TENTHPIN PARTNER TO CREATE NEW STANDARD FOR CLINICAL TRIAL SUPPLIES OPERATION.  Full Article

Roche Announces Chinese Approval For Tecentriq In Combination With Avastin
Thursday, 29 Oct 2020 

Oct 29 (Reuters) - Roche Holding AG ::ROCHE'S TECENTRIQ IN COMBINATION WITH AVASTIN APPROVED IN CHINA FOR PEOPLE WITH MOST COMMON FORM OF LIVER CANCER.TECENTRIQ IN COMBINATION WITH AVASTIN IS FIRST AND ONLY CANCER IMMUNOTHERAPY REGIMEN APPROVED FOR TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC), MOST COMMON FORM OF LIVER CANCER.TECENTRIQ COMBINATION IMPROVED OVERALL SURVIVAL AND PROGRESSION-FREE SURVIVAL COMPARED WITH SORAFENIB IN PEOPLE WITH UNRESECTABLE HCC.APPROVAL BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION BRINGS A NEW TREATMENT OPTION TO HCC PATIENTS IN CHINA, WHERE ALMOST HALF OF ALL CASES WORLDWIDE ARE FOUND.  Full Article

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

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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.