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Roche Holding AG (ROG.S)

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17 Aug 2018
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Latest Key Developments (Source: Significant Developments)

U.S. FDA Updates Prescribing Information For Keytruda & Tecentriq
Thursday, 16 Aug 2018 06:31pm EDT 

Aug 16 (Reuters) - U.S. Food and Drug Administration::FDA - UPDATES PRESCRIBING INFORMATION FOR KEYTRUDA (PEMBROLIZUMAB) & TECENTRIQ (ATEZOLIZUMAB) TO REQUIRE USE OF FDA-APPROVED COMPANION DIAGNOSTIC TEST.FDA SAYS TWO COMPANION DIAGNOSTIC TESTS APPROVED; ONE FOR USE WITH KEYTRUDA & ONE FOR TECENTRIQ.FDA - SECOND-LINE INDICATIONS IN UROTHELIAL CARCINOMA FOR KEYTRUDA (PEMBROLIZUMAB) & TECENTRIQ (ATEZOLIZUMAB) REMAIN UNCHANGED.FDA - UPDATED PRESCRIBING INFORMATION FOR KEYTRUDA & TECENTRIQ TO REQUIRE USE OF APPROVED TEST FOR SELECTION OF PATIENTS WHO ARE CISPLATIN-INELIGIBLE.  Full Article

Roche Says Plans To Launch Coaguchek Vantus System
Monday, 11 Jun 2018 07:00am EDT 

June 11 (Reuters) - Roche Holding AG ::ROCHE - PLANS TO LAUNCH COAGUCHEK VANTUS SYSTEM, EXPECTED TO BE COMMERCIALLY AVAILABLE IN U.S. IN SUMMER OF 2018.  Full Article

Roche Says FDA approved Venclexta Plus Rituxan As Blood Cancer Treatment
Friday, 8 Jun 2018 02:55pm EDT 

June 8 (Reuters) - Roche Holding AG ::GENENTECH ANNOUNCES FDA APPROVAL FOR VENCLEXTA PLUS RITUXAN FOR PEOPLE WITH PREVIOUSLY TREATED CHRONIC LYMPHOCYTIC LEUKEMIA.GENENTECH SAYS FDA ALSO UPDATED INDICATION FOR VENCLEXTA AS SINGLE AGENT, WHICH IS NOW APPROVED FOR TREATMENT OF PEOPLE WITH CLL OR SLL.  Full Article

Roche Holding AG CEO Says Very Confident We Can Grow In Spite Of The Entry Of Biosimilars
Thursday, 26 Apr 2018 02:27am EDT 

April 26 (Reuters) - Roche Holding AG ::CEO SAYS CONFIDENT OF ROCHE'S ABILITY TO CONTINUE GROWTH BEYOND 2018 DESPITE BIOSIMILAR ENTRIES.CEO SAYS INCREASE IN GUIDANCE IS FOR BOTH SALES AND EPS.DRUG DIVISION CHIEF SAYS RITUXAN DECLINE IN EUROPE WAS BROADLY EXPECTED, SEES EUROPEAN EROSION TO CONTINUE IN SECOND HALF OF YEAR COUPLED WITH ARRIVAL OF FIRST HERCEPTIN COPY.DRUG DIVISION CHIEF SAYS STILL CONFIDENT CAN COMPENSATE FOR BIOSIMILAR EROSION OF OLDER DRUGS.DRUG DIVISION CHIEF SEES CONTINUED STRONG OCREVUS GROWTH.CEO SAYS WE ARE ON THE CONSTANT LOOKOUT FOR NEW TECHNOLOGIES, WE SCREEN THE MARKET FOR OPPORTUNITIES.CEO SAYS CONTINUES TO LOOK FOR BOLT-ON ACQUISITIONS.CEO SAYS TYPICALLY DOES NOT MAKE SENSE TO PURSUE LATE-STAGE TRANSACTIONS THAT END UP IN BIDDING PROCESS, CLEARLY HAS FOCUS ON EARLIER STAGE ASSETS.CEO SAYS HAS 15 NEW MOLECULAR ENTITITES IN LATE STAGE PORTFOLIO.CEO SAYS VERY CONFIDENT WE CAN GROW IN SPITE OF THE ENTRY OF BIOSIMILARS.  Full Article

Roche Holding Receives FDA Clearance For Cobas® Ct/Ng For Cobas® 6800/8800 Systems
Monday, 16 Apr 2018 01:00am EDT 

April 16 (Reuters) - Roche Holding AG ::ROCHE RECEIVES FDA CLEARANCE FOR COBAS® CT/NG FOR COBAS® 6800/8800 SYSTEMS.  Full Article

Olerup QTYPE Receives CE Mark Certification
Friday, 13 Apr 2018 08:00am EDT 

April 13 (Reuters) - Caredx Inc ::OLERUP QTYPE® RECEIVES CE MARK CERTIFICATION.OLERUP QTYPE RECEIVED CE MARK APPROVAL AND IS AVAILABLE ON BOTH ROCHE & APPLIED BIOSYSTEMS PLATFORMS.  Full Article

Zealand And Roche Diabetes Care Enter Phase 3 Study Collaboration For Treatment Of Congenital Hyperinsulinism With Dasiglucagon
Wednesday, 11 Apr 2018 07:55am EDT 

April 11 (Reuters) - Zealand Pharma A/S - Co Is Responsible For Conducting Phase 3 Trials, While Roche Diabetes Care Provides Its Accu ::ZEALAND AND ROCHE DIABETES CARE ENTER PHASE 3 STUDY COLLABORATION FOR TREATMENT OF CONGENITAL HYPERINSULINISM WITH DASIGLUCAGON.SURGICAL TREATMENT FOR CHILDREN WITH CHI.PHASE 3 TRIALS OF DASIGLUCAGON ARE SET TO START IN SECOND HALF OF 2018.CHEK COMBO PUMP SYSTEM FOR STUDY.  Full Article

Health Canada Approves Rituxan Subcutaneous Formulation For Canadians With Chronic Lymphocytic Leukemia
Thursday, 22 Mar 2018 08:05am EDT 

March 22 (Reuters) - Roche Holding AG ::HEALTH CANADA APPROVES RITUXAN® SUBCUTANEOUS FORMULATION FOR CANADIANS WITH CHRONIC LYMPHOCYTIC LEUKEMIA.‍HOFFMANN-LA ROCHE - HEALTH CANADA APPROVES RITUXAN SC FORMULATION FOR CANADIANS WITH CHRONIC LYMPHOCYTIC LEUKEMIA​.  Full Article

FDA Approves Roche's Lucentis prefilled syringe For Diabetic Macular Edema, Diabetic Retinopathy
Wednesday, 21 Mar 2018 12:35pm EDT 

March 21 (Reuters) - Roche Holding Ag ::FDA APPROVES GENENTECH’S LUCENTIS (RANIBIZUMAB INJECTION) 0.3 MG PREFILLED SYRINGE FOR DIABETIC MACULAR EDEMA AND DIABETIC RETINOPATHY.GENENTECH - LUCENTIS 0.3 MG PFS IS EXPECTED TO BE AVAILABLE IN Q2 OF 2018.GENENTECH - PREFILLED SYRINGE OPTIONS ARE NOW FDA-APPROVED FOR ALL LUCENTIS INDICATIONS.  Full Article

Tesaro collaborates with Roche to evaluate their combination treatment for bladder cancer
Monday, 26 Feb 2018 03:00pm EST 

Feb 26 (Reuters) - Tesaro Inc ::TESARO ANNOUNCES COLLABORATION TO EVALUATE COMBINATION OF ZEJULA® (NIRAPARIB) AND ANTI-PD-L1 CANCER IMMUNOTHERAPY IN METASTATIC BLADDER CANCER.TESARO INC - ‍PLANNED TRIAL WILL BE CONDUCTED BY GENENTECH AND IS EXPECTED TO BEGIN MID-2018​.TESARO INC - ‍COLLABORATION INCLUDES TESTING EXPERIMENTAL COMBINATION IN MORPHEUS, ROCHE'S CANCER IMMUNOTHERAPY DEVELOPMENT PLATFORM​.  Full Article

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Pfizer bets on biotech flu vaccine in $425 million BioNTech alliance

FRANKFURT Pfizer has agreed to pay German biotech firm BioNTech up to $425 million in an alliance to develop more effective influenza jabs, the latest among several major pharma companies to bank on a promising new genetic approach.