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Roche Holding AG (RHHBY.PK)

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Latest Key Developments (Source: Significant Developments)

UK competition watchdog launches Roche-Spark inquiry
Tuesday, 22 Oct 2019 

Oct 22 (Reuters) - Spark Therapeutics Inc ::UK'S CMA - CONSIDERING WHETHER ROCHE-SPARK DEAL MAY RESULT IN LESSENING OF COMPETITION WITHIN ANY MARKET OR MARKETS IN UK FOR GOODS OR SERVICES.UK'S COMPETITION AND MARKETS AUTHORITY SAYS CONSIDERING WHETHER IT IS OR MAY BE CASE THAT MERGER OF ROCHE HOLDING AND SPARK THERAPEUTICS WILL RESULT IN CREATION OF A RELEVANT MERGER SITUATION UNDER MERGER PROVISIONS OF ENTERPRISE ACT 2002.UK'S COMPETITION AND MARKETS AUTHORITY ANNOUNCES LAUNCH OF ITS MERGER INQUIRY BY NOTICE TO PARTIES ON 21 OCTOBER 2019 AND HAS A DEADLINE OF 16 DECEMBER 2019 FOR ITS PHASE 1 DECISION..  Full Article

Roche Holding: FDA Approval For Xofluza
Friday, 18 Oct 2019 

Oct 18 (Reuters) - Roche Holding Ag ::ROCHE ANNOUNCES FDA APPROVAL OF XOFLUZA (BALOXAVIR MARBOXIL) FOR PEOPLE AT HIGH RISK OF DEVELOPING INFLUENZA-RELATED COMPLICATIONS.XOFLUZA IS THE FIRST AND ONLY ANTIVIRAL MEDICINE INDICATED SPECIFICALLY FOR PATIENTS AT HIGH RISK OF DEVELOPING SERIOUS COMPLICATIONS FROM INFLUENZA.  Full Article

Roche CEO does not expect U.S. to slap tariffs on European drugs
Wednesday, 16 Oct 2019 

Oct 16 (Reuters) - Roche Holding AG ::CEO SAYS BELIEVES CONCERNS, REPORTS ABOUT U.S. TARIFFS IMPACT ON SWISS DRUGMAKERS 'BASED ON WRONG FACTS'.DRUGS DIVISION HEAD SAYS CHINA SALES HAVE GROWN MORE THAN 50% THIS YEAR, BELIEVES THIS YEAR "HIGH WATER MARK" FOR GROWT RATE.CEO SAYS BIOSIMILARS IMPACT IS "IN LINE" WITH EXPECTATIONS.DRUGS DIVISION HEAD SAYS CHINESE GROWTH COMES AS MABTHERA, HERCEPTIN EXPANDED GEOGRAPHICALLY INTO RURAL AREAS, BUT THAT "GREATER THAN 50%" GROWTH IS HARD TO ACHIEVE.DRUGS DIVISION CHIEF EXPECTS SIGNIFICANT UPTAKE OF BIOSIMILARS IN UNITED STATES, BUT HAS NOT HAPPENED YET.DRUGS DIVISION HEAD SAYS OPTIMISTIC ABOUT EUROPEAN GROWTH PROSPECTS FOLLOWING BIOSIMILARS IMPACT, "THE OUTLOOK IS VERY STRONG FOR EUROPE".CEO SAYS HAS NO EXPECTATION THAT UNITED STATES WILL IMPOSE TARIFFS ON PHARMACEUTICAL PRODUCTS FROM EUROPE.  Full Article

Roche Says Phase 3 Study Shows Mabthera/Rituxan Superior To Mycophenolate Mofetil In Patients With Pemphigus Vulgaris
Monday, 14 Oct 2019 

Oct 14 (Reuters) - Roche Holding AG ::PHASE III PEMPHIX STUDY SHOWS ROCHE’S MABTHERA/RITUXAN (RITUXIMAB) SUPERIOR TO MYCOPHENOLATE MOFETIL IN PATIENTS WITH PEMPHIGUS VULGARIS.40% OF PATIENTS WITH PEMPHIGUS VULGARIS (PV) ACHIEVED SUSTAINED COMPLETE REMISSION, WITHOUT USE OF STEROIDS FOR 16 WEEKS OR MORE, WHEN TREATED WITH MABTHERA/RITUXAN COMPARED TO 9.5% OF PATIENTS ON MYCOPHENOLATE MOFETIL.STUDY REINFORCES EFFICACY AND SAFETY OF MABTHERA/RITUXAN FOR TREATMENT OF PV, A RARE AUTOIMMUNE CONDITION CHARACTERISED BY BLISTERING OF SKIN AND MUCOUS MEMBRANES.FULL DATA OF 52-WEEK TREATMENT PERIOD PRESENTED AT 28TH CONGRESS OF EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY (EADV) IN MADRID.  Full Article

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

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AstraZeneca breast cancer treatment gets FDA priority review

AstraZeneca Plc said on Thursday that the U.S. drug regulator will give a speedy review to its experimental breast cancer treatment, which could put the British drugmaker in direct competition with bigger rival Roche Holding AG.