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Roche Holding AG (RHHBY.PK)

RHHBY.PK on OTC Markets Group

35.71USD
20 Sep 2019
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Latest Key Developments (Source: Significant Developments)

FDA Approves Roche's Cobas Babesia Blood Test
Friday, 20 Sep 2019 

Sept 20 (Reuters) - Roche Holding AG ::FDA APPROVES COBAS BABESIA, ROCHE’S FIRST WHOLE BLOOD TEST FOR DONOR SCREENING.NEW BABESIA TEST EXPANDS MENU OF TESTS AVAILABLE FOR COBAS 6800/8800 SYSTEMS FOR USE IN U.S. DONOR SCREENING LABORATORIES.  Full Article

Roche: Update On Genentech’s Breast Cancer Therapy
Friday, 13 Sep 2019 

Sept 13 (Reuters) - Roche Holding AG ::GENENTECH’S FIXED DOSE SUBCUTANEOUS COMBINATION OF PERJETA AND HERCEPTIN SHOWED NON-INFERIORITY WHEN COMPARED TO INTRAVENOUS FORMULATIONS FOR PEOPLE WITH HER2-POSITIVE BREAST CANCER.DATA WILL BE SUBMITTED TO HEALTH AUTHORITIES AROUND WORLD, INCLUDING U.S. FOOD AND DRUG ADMINISTRATION AND EUROPEAN MEDICINES AGENCY.  Full Article

Roche Holding Reports Analysis Of Ocrevus Phase IIIb Study
Friday, 13 Sep 2019 

Sept 13 (Reuters) - Roche Holding AG ::POST-HOC ANALYSIS FROM A PHASE III OPEN-LABEL EXTENSION STUDY SHOWED A 42 PERCENT REDUCTION IN RISK OF PPMS PATIENTS NEEDING A WHEELCHAIR AFTER 6.5 YEARS OF OCREVUS TREATMENT COMPARED WITH PATIENTS WHO STARTED OCREVUS AFTER DOUBLE-BLIND PERIOD.INTERIM ANALYSIS OF PHASE IIIB STUDY SHOWS 87 PERCENT OF PATIENTS WITH SUBOPTIMAL RESPONSE TO PREVIOUS TREATMENT HAD NO EVIDENCE OF DISEASE ACTIVITY ONE YEAR AFTER SWITCHING TO OCREVUS.  Full Article

Kahr Medical Announces New Clinical Collaboration With Roche
Monday, 9 Sep 2019 

Sept 9 (Reuters) - Kahr Medical: :KAHR MEDICAL ANNOUNCES CLINICAL TRIAL COLLABORATION TO EVALUATE DSP107 IN COMBINATION WITH A PD-L1 CHECKPOINT INHIBITOR IN ADVANCED LUNG CANCER PATIENTS.KAHR MEDICAL- PATIENT ENROLMENT EXPECTED TO COMMENCE IN H1 2020.KAHR MEDICAL - ANNOUNCED NEW CLINICAL COLLABORATION WITH ROCHE.KAHR MEDICAL - COLLABORATION WITH ROCHE WILL EVALUATE POTENTIAL OF DSP107 & ATEZOLIZUMAB IN NSCLC PATIENTS WHO ARE REFRACTORY TO PD1/PD-L1 INHIBITORS.KAHR MEDICAL- EXPECTS TO FILE AN IND APPLICATION WITH U.S. FDA IN H1 2020.KAHR MEDICAL - EXPECTS TO BEGIN PHASE I/II TRIAL IN H1 2020 TO EVALUATE DSP107 AS A MONOTHERAPY AND IN COMBINATION WITH ATEZOLIZUMAB.  Full Article

Chugai Pharmaceutical Says Tecentriq Approved As Lung Cancer Treatment In Japan
Thursday, 22 Aug 2019 

Aug 22 (Reuters) - Chugai Pharmaceutical Co Ltd <4519.T>::CHUGAI PHARMACEUTICAL - TECENTRIQ RECEIVES APPROVAL FOR ADDITIONAL INDICATION OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER FROM JAPAN'S MHLW.CHUGAI PHARMACEUTICAL CO LTD-BASED ON RESULTS FROM PHASE I/III IMPOWER133 STUDY, TECENTRIQ WITH CHEMOTHERAPY MET PRIMARY ENDPOINT OF OVERALL SURVIVAL.  Full Article

FDA Approves Genentech’S Rozlytrek For People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer And NTRK Gene Fusion-Positive Solid Tumors
Friday, 16 Aug 2019 

Aug 15 (Reuters) - Roche Holding AG ::FDA APPROVES GENENTECH’S ROZLYTREK (ENTRECTINIB) FOR PEOPLE WITH ROS1-POSITIVE, METASTATIC NON-SMALL CELL LUNG CANCER AND NTRK GENE FUSION-POSITIVE SOLID TUMORS.  Full Article

Roche's Personalized Cancer Treatment Wins FDA Approval
Friday, 16 Aug 2019 

Aug 15 (Reuters) - U.S. Food and Drug Administration::FDA APPROVES THIRD ONCOLOGY DRUG THAT TARGETS A KEY GENETIC DRIVER OF CANCER, RATHER THAN A SPECIFIC TYPE OF TUMOR.U.S. FDA - GRANTED ACCELERATED APPROVAL TO ROZLYTREK, A TREATMENT FOR PATIENTS WHOSE CANCERS HAVE SPECIFIC GENETIC DEFECT, NTRK GENE FUSION.U.S. FDA - ROZLYTREK ALSO APPROVED FOR TREATMENT OF ADULTS WITH NON-SMALL CELL LUNG CANCER WHOSE TUMORS ARE ROS1-POSITIVE AND IS METASTATIC.U.S. FDA - APPROVAL OF ROZLYTREK WAS GRANTED TO GENENTECH INC.  Full Article

Roche CEO says committed to Spark deal, portfolio "without any question"
Thursday, 25 Jul 2019 

July 25 (Reuters) - Roche Holding Ag ::CEO SAYS VERY CONFIDENT WILL CLOSE SPARK TRANSACTION BY END OF 2019, CANNOT COMMENT ON ONGOING FTC REVIEW.CEO SAYS EXPECTS MORE BIOSIMILAR IMPACT TOWARD END OF 2019.CEO SAYS CONFIDENT CAN ANSWER ALL QUESTIONS ABOUT UK, US REVIEW OF SPARK ACQUISITION, SAYS DOES NOT SEE ANY DOWNSIDE FOR TRANSACTION DESPITE DELAY IN CLOSING.CEO SAYS CANNOT COMMENT ON CONCERNS THAT SPARK ACQUISITION COULD LEAD TO SLOWDOWN OF DEVELOPMENT OF GENE THERAPY FOR HEMOPHILIA, SAYS "BOTTOM LINE" THEY ARE CONFIDENT WILL CLOSE TRANSACTION.CEO SAYS COMMITTED TO SPARK TRANSACTION, PORTFOLIO OF SPARK "WITHOUT ANY QUESTION".  Full Article

FDA Approves Ruxience (Rituximab-Pvvr), Biosimilar To Rituxan (Rituximab)
Wednesday, 24 Jul 2019 

July 23 (Reuters) - U.S Food and Drug Administration::FDA APPROVES RUXIENCE (RITUXIMAB-PVVR), BIOSIMILAR TO RITUXAN (RITUXIMAB).FDA SAYS APPROVED RUXIENCE FOR TREATING ADULT PATIENTS WITH CD20-POSITIVE B-CELL NON-HODGKIN’S LYMPHOMA USED AS SINGLE AGENT/IN COMBINATION WITH CHEMOTHERAPY.FDA SAYS APPROVED RUXIENCE FOR TREATING ADULT PATIENTS WITH CD20-POSITIVE CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH CHEMOTHERAPY.FDA SAYS RUXIENCE IS FIRST BIOSIMILAR APPROVED TO TREAT GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S GRANULOMATOSIS) AND MICROSCOPIC POLYANGITIS.FDA SAYS LIKE U.S.-LICENSED RITUXAN, LABELING FOR RUXIENCE CONTAINS BOXED WARNING TO ALERT ABOUT INCREASED RISKS OF FATAL INFUSION-RELATED REACTIONS.FDA SAYS LIKE U.S.-LICENSED RITUXAN, LABELING FOR RUXIENCE CONTAINS BOXED WARNING TO ALERT ABOUT INCREASED RISKS OF HEPATITIS B VIRUS REACTIVATION.FDA SAYS LIKE U.S.-LICENSED RITUXAN, RUXIENCE LABELING CONTAINS BOXED WARNING TO ALERT ABOUT INCREASED RISKS OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY.  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

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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.