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Roche Holding AG (ROG.S)

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Latest Key Developments (Source: Significant Developments)

FDA Approves Label Update For Genentech's Rituxan
4:35pm BST 

Oct 19 (Reuters) - Genentech::FDA APPROVES LABEL UPDATE FOR GENENTECH'S RITUXAN (RITUXIMAB) IN TWO RARE FORMS OF VASCULITIS.GENENTECH - RITUXAN LABEL UPDATED TO INCLUDE INFORMATION FOR PATIENTS WITH 2 RARE VASCULITIS FORMS HAVING ACHIEVED DISEASE CONTROL WITH INDUCTION TREATMENT.GENENTECH - PRECAUTION ON LIMITED DATA AVAILABILITY, NON-ESTABLISHMENT OF RITUXAN RETREATMENT SAFETY, EFFICACY REMOVED FROM RITUXAN PRESCRIBING INFORMATION.  Full Article

Roche CEO Says Confident In Ability To Sustain Growth Beyond 2018
Wednesday, 17 Oct 2018 

Oct 17 (Reuters) - Roche Holding AG ::SHARES SEEN RISING 1.9 PERCENT AFTER Q3 RESULTS - PREMARKET INDICATORS JBPRE01.CEO SAYS CONFIDENT IN ABILITY TO CONTINUE GROWTH BEYOND 2018.CEO SAYS NO PLANS TO CUT JOBS IN SWITZERLAND, HEAD COUNT HAS REMAINED STABLE OVER FIRST NINE MONTHS OF 2018.DRUGS HEAD SAYS CONTINUES TO BELIEVE THAT HERCEPTIN EROSION DUE TO BIOSIMILARS WILL MIRROR RITUXAN'S SALES DECLINE.DRUGS HEAD EXPECTS MABTHERA/RITUXAN BIOSIMILARS TO ENTER IN US IN FIRST HALF OF 2019, HERCEPTIN BIOSIMILARS IN 2ND HALF OF 2019.DRUGS HEAD EXPECTS PERJETA, KADCYLA TO ENABLE COMPANY TO GROW HER2 FRANCHISE THROUGH ENTRY OF HERCEPTIN BIOSIMILARS.DRUGS HEAD SAYS RETURN RATES FOR OCREVUS PATIENTS IN MS ARE WITHIN RANGE OF EXPECTATIONS.DRUGS HEAD SAYS EXPECTS GROWTH IN CHINA TO CONTINUE AS MORE MEDICINES APPROVED.  Full Article

Roche Signs Collaboration Agreement To Expand Access To Therapy Information By Integrating Insulin Data From Connected Pens To Its Open Ecosystem
Monday, 1 Oct 2018 

Oct 1 (Reuters) - Roche Holding AG ::ROCHE SIGNS COLLABORATION AGREEMENT TO EXPAND ACCESS TO THERAPY INFORMATION BY INTEGRATING INSULIN DATA FROM CONNECTED PENS TO ITS OPEN ECOSYSTEM.ROCHE - SIGNED DEVELOPMENT & COLLABORATION DEAL WITH NOVO NORDISK.  Full Article

FDA Approves Genentech's Xolair Prefilled Syringe Formulation
Friday, 28 Sep 2018 

Sept 28 (Reuters) - Roche Holding AG ::FDA APPROVES GENENTECH'S XOLAIR (OMALIZUMAB) PREFILLED SYRINGE FORMULATION.GENENTECH SAYS NEW XOLAIR PFS FORMULATION IS EXPECTED TO BE AVAILABLE BY END OF THIS YEAR IN U.S.  Full Article

Tusk Therapeutics To Be Acquired By Roche
Friday, 28 Sep 2018 

Sept 28 (Reuters) - TUSK THERAPEUTICS::TUSK THERAPEUTICS TO BE ACQUIRED BY ROCHE.TUSK THERAPEUTICS - DEAL INCLUDES ADDITIONAL CONTINGENT PAYMENTS OF UP TO EURO 585 MILLION BASED ON MILESTONES.TUSK THERAPEUTICS LTD - UNDER TERMS OF AGREEMENT, TUSK'S SHAREHOLDERS TO GET UPFRONT CASH PAYMENT OF EURO 70 MILLION.  Full Article

Roche's Genentech Presents Interim Results Of Phase III Tecentriq Trial
Monday, 24 Sep 2018 

Sept 24 (Reuters) - Roche Holding AG ::PHASE III TRIAL OF GENENTECH'S TECENTRIQ IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY SHOWED REDUCED RISK OF DISEASE WORSENING OR DEATH IN A TYPE OF PREVIOUSLY UNTREATED ADVANCED LUNG CANCER.INTERIM ANALYSIS SHOWED THAT TECENTRIQ AND CHEMOTHERAPY REDUCED RISK OF DISEASE WORSENING OR DEATH (PROGRESSION-FREE SURVIVAL, PFS) BY 40 PERCENT COMPARED WITH CHEMOTHERAPY ALONE.SAYS ON TECENTRIQ TRIAL - AT THIS INTERIM ANALYSIS STATISTICAL SIGNIFICANCE HAS NOT YET BEEN MET.  Full Article

Abbvie Receives Positive CHMP Opinion Fo Chemotherapy-Free Combination Of Venclyxto With Rituximab
Friday, 21 Sep 2018 

Sept 21 (Reuters) - AbbVie Inc ::ABBVIE RECEIVES POSITIVE CHMP OPINION FOR A NOVEL, CHEMOTHERAPY-FREE COMBINATION OF VENCLYXTO® (VENETOCLAX TABLETS) WITH RITUXIMAB AS A TREATMENT WITH A FIXED DURATION FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY.ABBVIE - SAFETY PROFILE OF COMBINATION OF VENCLYXTO PLUS RITUXIMAB IS CONSISTENT WITH KNOWN SAFETY PROFILE OF EACH MEDICINE ALONE.  Full Article

Affimed To Collaborate With Genentech To Develop Novel Nk Cell Engager-Based Immunotherapeutics
Monday, 27 Aug 2018 

Aug 27 (Reuters) - Affimed NV ::AFFIMED ANNOUNCES COLLABORATION WITH GENENTECH TO DEVELOP NOVEL NK CELL ENGAGER-BASED IMMUNOTHERAPEUTICS FOR MULTIPLE CANCER TARGETS.AFFIMED NV - TO RECEIVE $96 MILLION UPFRONT AND COMMITTED FUNDING AND IS ELIGIBLE FOR UP TO AN ADDITIONAL $5.0 BILLION INCLUDING MILESTONE PAYMENTS.AFFIMED NV - ADDITIONAL $5.0 BILLION CO MAY RECEIVE ALSO INCLUDES ROYALTIES ON SALES.  Full Article

Genentech Says FDA Grants Breakthrough Therapy Designation For Xolair (Omalizumab) For Food Allergies
Monday, 13 Aug 2018 

Aug 13 (Reuters) - Genentech Inc::FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION FOR XOLAIR (OMALIZUMAB) FOR FOOD ALLERGIES.  Full Article

Hoffmann-La Roche Ltd - Health Canada Has Approved Hemlibra (Emicizumab Injection)
Tuesday, 7 Aug 2018 

Aug 7 (Reuters) - Roche Holding AG ::HOFFMANN-LA ROCHE LIMITED - HEALTH CANADA HAS APPROVED HEMLIBRA (EMICIZUMAB INJECTION) FOR HEMOPHILIA A (CONGENITAL FACTOR VIII DEFICIENCY) PATIENTS.  Full Article

BRIEF-FDA Approves Label Update For Genentech's Rituxan

* FDA APPROVES LABEL UPDATE FOR GENENTECH'S RITUXAN (RITUXIMAB) IN TWO RARE FORMS OF VASCULITIS