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Novartis AG (NOVN.S)

NOVN.S on Virt-X Level 1

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22 Jan 2018
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Latest Key Developments (Source: Significant Developments)

Amgen Reports Aimovig Met All Primary, Secondary Endpoints
3:00am IST 

Jan 22 (Reuters) - Amgen Inc ::AMGEN REPORTS AIMOVIG™ (ERENUMAB) MET ALL PRIMARY AND SECONDARY ENDPOINTS IN UNIQUE PHASE 3B STUDY IN EPISODIC MIGRAINE PATIENTS WHO HAVE FAILED MULTIPLE PRIOR PREVENTIVE TREATMENTS.AMGEN INC - FDA HAS SET A PRESCRIPTION DRUG USER FEE ACT (PDUFA) TARGET ACTION DATE OF MAY 17, 2018.AMGEN INC - IF APPROVED, NOVARTIS AND AMGEN WILL CO-COMMERCIALIZE AIMOVIG IN U.S..AMGEN INC - SAFETY DATA ARE CONSISTENT WITH PREVIOUS STUDIES OF AIMOVIG TO DATE.AMGEN INC - LIBERTY ALSO MET ALL SECONDARY ENDPOINTS, INCLUDING REDUCTION OF MONTHLY MIGRAINE DAYS, REDUCTION IN DAYS NEEDING ACUTE MEDICATION.  Full Article

Biocon Announces Exclusive Global Collaboration With Sandoz On Next-Generation Biosimilars
Thursday, 18 Jan 2018 

Jan 18 (Reuters) - Biocon Ltd ::ANNOUNCES EXCLUSIVE GLOBAL COLLABORATION WITH SANDOZ ON NEXT-GENERATION BIOSIMILARS'.SAYS WORLDWIDE COMMERCIALIZATION REPONSIBILITIES TO BE DIVIDED.  Full Article

Novartis says data reinforces ‍Cosentyx effectiveness
Tuesday, 16 Jan 2018 

Jan 16 (Reuters) - Novartis AG ::NOVARTIS NEW DATA REINFORCES SUPERIORITY OF COSENTYX® VERSUS STELARA®* IN ACHIEVING SKIN CLEARANCE FOR PSORIASIS PATIENTS.‍CLARITY STUDY SHOW COSENTYX(®) (SECUKINUMAB) WAS SIGNIFICANTLY MORE EFFECTIVE THAN STELARA(®*) (USTEKINUMAB) IN DELIVERING CLEAR AND ALMOST CLEAR SKIN AT 12 WEEKS AND AT 16 WEEKS​.‍COSENTYX CONTINUED TO HAVE A FAVORABLE AND CONSISTENT SAFETY PROFILE​.  Full Article

FDA accepts Novartis submission of biosimilar version of Humira
Tuesday, 16 Jan 2018 

Jan 16 (Reuters) - Novartis AG ::SANDOZ REGULATORY SUBMISSION FOR PROPOSED BIOSIMILAR ADALIMUMAB ACCEPTED BY FDA.US FOOD AND DRUG ADMINISTRATION (FDA) ACCEPTED ITS BIOLOGICS LICENSE APPLICATION (BLA), SUBMITTED UNDER THE 351 (K) PATHWAY, FOR PROPOSED BIOSIMILAR ADALIMUMAB TO THE REFERENCE MEDICINE, HUMIRA.‍DATA PACKAGE PROVIDED IS EXPECTED TO DEMONSTRATE THAT SANDOZ PROPOSED BIOSIMILAR ADALIMUMAB MATCHES REFERENCE BIOLOGIC MEDICINE IN TERMS OF SAFETY, EFFICACY AND QUALITY​.  Full Article

Novartis poaches Pfizer oncology head Elizabeth Barrett
Thursday, 11 Jan 2018 

Jan 11 (Reuters) - Novartis says::Elizabeth (Liz) Barrett, currently Global President Oncology at Pfizer, Inc. <<>>, has been appointed CEO Novartis Oncology and a member of the Executive Committee of Novartis, effective February 1, 2018.Barrett succeeds Bruno Strigini who decided to retire from Novartis for personal reasons.  Full Article

Sandoz Canada Says Ontario Has Added Erelzi To Its Public Drug Plan
Tuesday, 9 Jan 2018 

Jan 9 (Reuters) - Novartis Ag ::SANDOZ CANADA SAYS ONTARIO HAS ADDED ERELZI(TM) (ETANERCEPT) TO ITS PUBLIC DRUG PLAN FOR TREATMENT OF MULTIPLE INFLAMMATORY DISEASES​.  Full Article

Luye Pharma Group‍ Announces Update on Patent Litigation Regarding Rivastigmine 1 Day Patch
Thursday, 28 Dec 2017 

Dec 28 (Reuters) - Luye Pharma Group Ltd <2186.HK>::COURT OF APPEAL FOR DISTRICT OF MUNICH, GERMANY DISMISSES APPEAL FROM NOVARTIS AG AS CLAIMANT IN PATENT INFRINGEMENT LAWSUIT.‍PATENT INFRINGEMENT LAWSUIT ON GROUP'S RIVASTIGMINE 1 DAY PATCH​.‍NOVARTIS AG HAS REIMBURSED GROUP OF RELEVANT LEGAL EXPENSES ​.  Full Article

FDA Updates Label Of Tasigna To Reflect That Certain Patients With Type Of Leukemia May Be Eligible To Stop Treatment After Sustained Response
Saturday, 23 Dec 2017 

Dec 22 (Reuters) - U.S. FDA::FDA UPDATES LABEL OF NOVARTIS' TASIGNA TO REFLECT THAT CERTAIN PATIENTS WITH TYPE OF LEUKEMIA MAY BE ELIGIBLE TO STOP TREATMENT AFTER SUSTAINED RESPONSE.FDA SAYS UPDATED PRODUCT LABEL FOR CANCER DRUG TASIGNA TO INCLUDE INFORMATION FOR PROVIDERS ABOUT HOW TO DISCONTINUE THE DRUG IN CERTAIN PATIENTS.FDA - FDA GRANTED THE APPROVAL OF THE TASIGNA LABEL CHANGES TO NOVARTIS PHARMACEUTICALS CORPORATION.  Full Article

Novartis Multiple Sclerosis Therapy Fingolimod Granted FDA Breakthrough Therapy Designation For Pediatric MS
Monday, 18 Dec 2017 

Dec 18 (Reuters) - Novartis Ag ::NOVARTIS MULTIPLE SCLEROSIS THERAPY FINGOLIMOD GRANTED FDA BREAKTHROUGH THERAPY DESIGNATION FOR PEDIATRIC MS.NOVARTIS- U.S. FDA GRANTED BREAKTHROUGH THERAPY DESIGNATION FOR FINGOLIMOD FOR TREATMENT OF CHILDREN, ADOLESCENTS 10 YEARS OR OLDER WITH RELAPSING MS.  Full Article

Ultragenyx Sells Priority Review Voucher For $130 Mln
Monday, 18 Dec 2017 

Dec 18 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX SELLS PRIORITY REVIEW VOUCHER FOR $130 MILLION.ENTERED INTO A DEFINITIVE AGREEMENT TO SELL ITS RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER TO NOVARTIS.  Full Article

BRIEF-Genmab Gets USD 50 Mln From Novartis For Lost Potential Milestones And Royalties​

* ANNOUNCES NOVARTIS’ INTENTION TO TRANSITION ARZERRA® (OFATUMUMAB) FROM COMMERCIAL AVAILABILITY TO LIMITED AVAILABILITY VIA COMPASSIONATE USE PROGRAMS FOR THE TREATMENT OF CLL IN NON-US MARKETS