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Novartis AG (NOVN.S)

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Latest Key Developments (Source: Significant Developments)

Novartis Receives European Approval For Self-Administration Of Xolair
Thursday, 13 Dec 2018 01:15am EST 

Dec 13 (Reuters) - Novartis AG ::NOVARTIS RECEIVES EUROPEAN COMMISSION APPROVAL FOR SELF-ADMINISTRATION OF XOLAIR® ACROSS ALL INDICATIONS.EC APPROVAL UNDERSCORES LONG-TERM SAFETY AND EFFICACY OF XOLAIR DEMONSTRATED IN CLINICAL STUDIES AND BY 13 YEARS OF REAL-WORLD USE IN EUROPE.XOLAIR(®) (OMALIZUMAB) PREFILLED SYRINGE (PFS) IS FIRST AND ONLY BIOLOGIC TO RECEIVE EUROPEAN COMMISSION (EC) APPROVAL FOR SELF-ADMINISTRATION IN SEVERE ALLERGIC ASTHMA (SAA) AND CHRONIC SPONTANEOUS URTICARIA (CSU).  Full Article

Adamis Pharmaceuticals Provides Update On Symjepi's U.S. Launch
Thursday, 6 Dec 2018 09:30am EST 

Dec 6 (Reuters) - Adamis Pharmaceuticals Corp ::ADAMIS PHARMACEUTICALS PROVIDES UPDATE ON THE U.S. LAUNCH OF SYMJEPI.ADAMIS PHARMACEUTICALS - PROVIDED BUSINESS UPDATE ANNOUNCING U.S. LAUNCH OF FDA-APPROVED SYMJEPI 0.3MG INJECTION IS PLANNED FOR EARLY Q1 2019..ADAMIS PHARMACEUTICALS - MANUFACTURE OF COMMERCIAL BATCHES COMPLETED, ADAMIS WILL BEGIN SHIPPING TO SANDOZ DISTRIBUTION CENTERS DURING DEC.  Full Article

Novartis - Eu Approval Of Gilenya For Children And Adolescents With MS
Thursday, 29 Nov 2018 01:15am EST 

Nov 29 (Reuters) - Novartis AG ::ANNOUNCES EU APPROVAL OF GILENYA® FOR CHILDREN AND ADOLESCENTS WITH MS, MAKING IT FIRST AND ONLY ORAL DISEASE-MODIFYING TREATMENT FOR THESE PATIENTS IN EUROPE.APPROVAL BASED ON LANDMARK PARADIGMS STUDY SHOWING GILENYA (FINGOLIMOD) SIGNIFICANTLY REDUCED RELAPSE RATES BY 82% VERSUS INTERFERON BETA-1A; ADDITIONALLY, 85.7% OF GILENYA PATIENTS WERE RELAPSE-FREE AT TWO YEARS1.EC'S APPROVAL IS BASED ON PARADIGMS TRIAL, A LANDMARK PHASE III CLINICAL STUDY IN MS, SPECIFICALLY DESIGNED FOR CHILDREN AND ADOLESCENTS 10 TO 17 YEARS OLD.EC DECISION IS APPLICABLE TO ALL 28 EUROPEAN UNION MEMBER STATES PLUS ICELAND, NORWAY AND LIECHTENSTEIN.GILENYA WAS INITIALLY APPROVED FOR ADULTS AGED 18 YEARS AND OLDER WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS IN US AND EUROPE.  Full Article

Novartis AG Alcon Unit Incoming CEO Says Has No Plans To Return To Eye Drugs Space Following Spinoff
Tuesday, 27 Nov 2018 11:38am EST 

Novartis AG ::ALCON UNIT INCOMING CEO SAYS HAS NO PLANS TO RETURN TO EYE DRUGS SPACE FOLLOWING SPINOFF.  Full Article

FDA Warns About Severe Worsening Of Multiple Sclerosis After Stopping The Medicine Gilenya
Tuesday, 20 Nov 2018 01:26pm EST 

Nov 20 (Reuters) - U.S. Food and Drug Administration::FDA WARNS ABOUT SEVERE WORSENING OF MULTIPLE SCLEROSIS AFTER STOPPING THE MEDICINE GILENYA (FINGOLIMOD).FDA SAYS ADDED NEW WARNING ABOUT THE MULTIPLE SCLEROSIS WORSENING RISK TO PRESCRIBING INFORMATION OF THE GILENYA DRUG LABEL & PATIENT MEDICATION GUIDE.  Full Article

Novartis Receives Positive CHMP Opinion To Expand Breast Cancer Therapy
Friday, 16 Nov 2018 08:10am EST 

Nov 16 (Reuters) - Novartis AG ::NOVARTIS RECEIVES POSITIVE CHMP OPINION TO EXPAND KISQALI® COMBINATION THERAPY TO ALL WOMEN WITH HR+/HER2- LOCALLY ADVANCED OR METASTATIC BREAST CANCER.CHMP OPINION IS SUPPORTED BY TWO PIVOTAL PHASE III TRIALS SHOWING CLINICAL BENEFIT OF KISQALI-BASED REGIMENS, REGARDLESS OF COMBINATION PARTNER OR MENOPAUSAL STATUS, AS FIRST OR SECOND-LINE TREATMENT.KISQALI PLUS FULVESTRANT DEMONSTRATED SUPERIOR EFFICACY IN PATIENTS WITH DE NOVO ADVANCED BREAST CANCER, AND IN THOSE WHO HAD NOT RECEIVED ADJUVANT THERAPY IN MORE THAN A YEAR VERSUS. FULVESTRANT ALONE IN LARGE PHASE III TRIAL POPULATION.S CHMP OPINION BRINGS US ONE STEP CLOSER TO PROVIDING MORE WOMEN WITH HR+/HER2- ADVANCED BREAST CANCER IN EUROPE WITH A TREATMENT OPTION.  Full Article

Zhejiang Huahai Pharmaceutical Clarifies Reports Related To Sandoz's Product Recall
Friday, 9 Nov 2018 11:26am EST 

Nov 10 (Reuters) - Zhejiang Huahai Pharmaceutical Co Ltd <600521.SS>::SAYS IT CLARIFIES ONLINE REPORTS ON HUAHAI BEING INVOLVED IN MANUFACTURING RAW MATERIALS CONTAINING NDEA IMPURITIES THAT PROMPTED SANDOZ TO RECALL A BATCH OF ITS LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE TABLETS.SAYS THE REPORTS WERE VAGUE AND DID NOT CLEARLY STATE THE FACTS,WHICH HAS MISLED INVESTORS.  Full Article

Sandoz Issues Voluntary Nationwide Recall Of 1 Lot Of Losartan Potassium & Hydrochlorothiazide
Thursday, 8 Nov 2018 05:39pm EST 

Nov 8 (Reuters) - Novartis AG ::SANDOZ INC. ISSUES VOLUNTARY NATIONWIDE RECALL OF ONE LOT OF LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE DUE TO THE DETECTION OF TRACE AMOUNTS OF NDEA (N-NITROSODIETHYLAMINE) IMPURITY FOUND IN THE ACTIVE PHARMACEUTICAL INGREDIENT (API).SANDOZ - NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO LOT OF LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE TABLETS, USP 100MG/25MG BEING RECALLED.  Full Article

Novartis Pharma Reports 20.7 Pct Stake In Gamida Cell
Thursday, 8 Nov 2018 05:33pm EST 

Nov 8 (Reuters) - Novartis Pharma Ag ::NOVARTIS PHARMA AG REPORTS 20.7 PERCENT STAKE IN GAMIDA CELL LTD AS OF OCTOBER 26, 2018 - SEC FILING.NOVARTIS AG REPORTS STAKE OF 20.7 PERCENT IN GAMIDA CELL AS OF OCTOBER 26, 2018 - SEC FILING.  Full Article

Novartis Receives Approval For Cosentyx Label Update In Europe
Friday, 26 Oct 2018 01:15am EDT 

Oct 26 (Reuters) - Novartis AG ::NOVARTIS RECEIVES APPROVAL FOR COSENTYX® LABEL UPDATE IN EUROPE TO INCLUDE DOSING FLEXIBILITY IN PSORIATIC ARTHRITIS.  Full Article

BRIEF-Novartis Receives European Approval For Self-Administration Of Xolair

* NOVARTIS RECEIVES EUROPEAN COMMISSION APPROVAL FOR SELF-ADMINISTRATION OF XOLAIR® ACROSS ALL INDICATIONS