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Novartis AG (NOVN.S)

NOVN.S on Virt-X Level 1

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15 Jun 2018
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Latest Key Developments (Source: Significant Developments)

Novartis: Sandoz Receives Positive CHMP Opinion For Proposed Biosimilar Adalimumab
Friday, 1 Jun 2018 

June 1 (Reuters) - Novartis AG ::SANDOZ RECEIVES POSITIVE CHMP OPINION FOR PROPOSED BIOSIMILAR ADALIMUMAB.CHMP OPINION RECOMMENDS PROPOSED SANDOZ BIOSIMILAR ADALIMUMAB FOR TREATMENT OF ALL INDICATIONS OF ITS REFERENCE MEDICINE.  Full Article

Novartis CEO "Looking Hard" At U.S. Solid Generics Business At Sandoz
Wednesday, 16 May 2018 

May 16 (Reuters) - Novartis AG ::CEO SAYS MADE A MISTAKE, NEED TO GET BETTER AND IMPROVE EVERY ELEMENT OF BUSINESS PARTICULARLY REGAINING TRUST OF SOCIETY.CEO SAYS DOING BEST TO BRING CLOSE TO MATTER INVOLVING TRUMP LAWYER CONTRACT.CEO SAYS LOOKING AT HOW BEST TO ORGANISE ON INTEGRITY, COMPLIANCE UNDER NEW GENERAL COUNSEL.CEO SAYS COMPANY IS NOT GOOD AT SUSTAINABLY MANAGING BROAD DIVERSIFICATION AND INTEGRATING NON-INNOVATIVE MEDICINE ACQUISITIONS, CITING ALCON AND SOME GENERICS INTEGRATIONS.CEO SAYS CHALLENGING UPTAKE OF BIOSIMILARS DUE TO STRUCTURE OF U.S. MARKET.CEO SAYS LOOKING AT "ALL OPTIONS" FOR SANDOZ GENERICS IN THE UNITED STATES.CEO SAYS M&A PRIORITIES ARE BOLT-ONS TO STRENGTHEN ONCOLOGY PIPELINE, STRENGTHEN PHARMACEUTICALS, CELL AND GENE THERAPIES AND DIGITAL AND DATA SCIENCE.CEO SAYS MUST GET BETTER AT BOOSTING PERFORMANCE OF LAUNCHES.CEO SAYS PLANS TO DEPLOY DATA ANALYTICS SYSTEM TO MONITOR EMAIL TRAFFIC AS PART OF ETHICS PUSH.CEO SAYS PHYSICIANS ARE GROWING MORE CONFIDENT IN USING ENTRESTO.CEO SAYS ONCOLOGY LAUNCHES HAVE BEEN CHALLENGING, UNDERESTIMATED CHALLENGE FOR KISQUALI IN US.CEO SAYS CONTINUES TO BELIEVE KISQUALI IMPORTANT BUT NOT AS LARGE AS ONCE THOUGHT.CEO SAYS HOPES TO HAVE AIMOVIG APPROVAL IN COMING WEEKS, HOPES TO BE FIRST TO MARKET WITH MIGRAINE MEDICINE.CEO SAYS SEES IMPROVING CHINA GROWTH TREND, SAYS ENVIRONMENT CHANGING AND COUNTRY WANTS TO RAISE BAR ON REGULATORY FRONT WHERE IP IS PROTECTED.  Full Article

Novartis AG seeks to rebuild trust after Trump lawyer payments, bribery allegations
Wednesday, 16 May 2018 

May 16 (Reuters) - Novartis AG ::TO ADDRESS SOUTHERN DISTRICT OF NEW YORK ALLEGED KICKBACK LITIGATION AS PART OF INVESTOR DAY EVENT -- PRESENTATION.SAYS BEGINNING JOURNEY TO REBUILD TRUST WITH SOCIETY -- PRESENTATION.  Full Article

U.S. FDA expands approval of Gilenya to treat multile sclerosis in children
Saturday, 12 May 2018 

May 11 (Reuters) - Novartis AG ::U.S. FDA SAYS APPROVED GILENYA (FINGOLIMOD) TO TREAT RELAPSING MULTIPLE SCLEROSIS IN CHILDREN & ADOLESCENTS AGE 10 YRS & OLDER.U.S. FDA SAYS GRANTED THE APPROVAL OF GILENYA TO NOVARTIS.  Full Article

Durect Announces Amendment To Licensing Agreement With Sandoz
Wednesday, 9 May 2018 

May 9 (Reuters) - DURECT Corp ::DURECT ANNOUNCES AMENDMENT TO LICENSING AGREEMENT WITH SANDOZ RELATED TO POSIMIR® (SABER®-BUPIVACAINE).DURECT CORP - DURECT IS NOW ELIGIBLE FOR UP TO $30 MILLION IN MILESTONE PAYMENTS BASED ON NDA APPROVAL.DURECT CORP - EACH PARTY, PURSUANT TO AMENDMENT, IS ALSO PERMITTED TO DEVELOP OR COMMERCIALIZE COMPETING PRODUCTS.DURECT CORP - PURSUANT TO AMENDED AGREEMENT, DURECT REMAINS ELIGIBLE FOR UP TO AN ADDITIONAL $230 MILLION IN SALES-BASED MILESTONES.DURECT - PURSUANT TO AMENDED AGREEMENT, THERE IS NEW TERMINATION FEE PAYABLE TO DURECT IN EVENT THAT SANDOZ TERMINATES AGREEMENT FOR CONVENIENCE.DURECT CORP - AMENDMENT ALSO INCLUDES MODIFICATIONS TO DURECT'S DEVELOPMENT OBLIGATIONS AND TO BOTH PARTIES' TERMINATION PROVISIONS.DURECT CORP - DURECT HAS RIGHT TO TERMINATE FOR CONVENIENCE PRIOR TO NDA APPROVAL.  Full Article

Novartis Says Receives FDA Approval Of Tafinlar + Mekinist For Adjuvant Treatment Of Braf V600-Mutant Melanoma
Tuesday, 1 May 2018 

April 30 (Reuters) - Novartis AG ::RECEIVES FDA APPROVAL OF TAFINLAR + MEKINIST FOR ADJUVANT TREATMENT OF BRAF V600-MUTANT MELANOMA.  Full Article

Novartis Says Phase III Data For Brolucizumab Demonstrate Reliability Of 12-Week Treatment Interval
Tuesday, 1 May 2018 

April 30 (Reuters) - Novartis AG ::PHASE III DATA FOR BROLUCIZUMAB DEMONSTRATE RELIABILITY OF 12-WEEK TREATMENT INTERVAL.NOVARTIS- PATIENTS FOR BROLUCIZUMAB 12-WEEK TREATMENT IN PHASE III HAWK AND HARRIER TRIALS HAD 87% AND 83% PROBABILITY OF CONTINUING 12-WEEK INTERVAL THROUGH WEEK 48.BROLUCIZUMAB SAFETY WAS COMPARABLE TO AFLIBERCEPT WITH OVERALL INCIDENCE OF ADVERSE EVENTS BALANCED ACROSS ALL TREATMENT GROUPS IN BOTH STUDIES.  Full Article

Novartis says EXPAND study shows siponimod's (Baf312) efficacy
Friday, 20 Apr 2018 

April 20 (Reuters) - Novartis AG says::EXPAND study showed siponimod (BAF312) reduced the risk of disability progression largely disassociated from relapses in patients with secondary progressive multiple sclerosis.In EXPAND, siponimod also had a meaningful benefit on patients' cognitive processing speed.  Full Article

Novartis expects cost cuts, rising Entresto, Cosentyx sales to help meet 2018 op. profit targets
Thursday, 19 Apr 2018 

April 19 (Reuters) - Novartis AG ::CEO SAYS BELIEVES COSENTYX SALES FOR FULL YEAR WILL BE IN LINE WITH CONSENSUS, HAD SOME DESTOCKING BY SPECIALTY PHARMA IN Q1 BUT BELIEVES DRUG WILL OVERCOME THAT.CEO SAYS SANDOZ HAD A TOUGH FIRST QUARTER, STRONG PERFORMANCE OUTSIDE US BUT CONTINUED PRICE PRESSURES THERE, LOOKING FORWARD TO UPCOMING BIOSIMILARS LAUNCHES.CEO SAYS ALCON ON NICE GROWTH TRAJECTORY, NOVARTIS REMAINS ON COURSE FOR POTENTIAL CAPITAL MARKETS ACTION IN 2019.CEO SAYS CONTINUES TO LOOK FOR BOLT-ON ACQUISITIONS IN CORE THERAPEUTIC AREAS, NEW TECHNOLOGY PLATFORMS.CEO SAYS WILL CONTINUE TO EVALUATE ORAL SOLIDS BUSINESS AT SANDOZ IN UNITED STATES, NO DECISIONS MADE YET.CEO SAYS KYRIAH OFF TO A SOLID START IN PEDIATRIC ALL, EXPECTS DLBCL APPROVAL IN US, EUROPE LATER THIS YEAR, REMAINS CONFIDENT WILL BE A BLOCKBUSTER MEDICINE.CEO SAYS ENTRESTO SALES GROWTH, COST CUTS, CONTINUED ALCON DEVELOPMENT WILL HELP SPUR CORE OPERATING PROFIT IMPROVEMENTS IN 2018 COMPARED TO Q1.CEO SAYS CURRENTLY SEARCHING FOR NEW HEAD OF BUSINESS SERVICES, BUT FEELS GOOD WITH WHERE NOVARTIS IS AS A TEAM FOLLOWING JOHN TSAI'S APPOINTMENT AS NEW DRUG DEVELOPMENT CHIEF, CHIEF MEDICAL OFFICER.  Full Article

Pear Therapeutics, Sandoz Announce Deal To Commercialize Prescription Digital Therapeutics
Thursday, 19 Apr 2018 

April 18 (Reuters) - Pear Therapeutics: :PEAR THERAPEUTICS AND SANDOZ ANNOUNCE DEAL TO COMMERCIALIZE PRESCRIPTION DIGITAL THERAPEUTICS.PEAR THERAPEUTICS - DEAL WITH SANDOZ, A DIVISION OF NOVARTIS, TO COMMERCIALIZE ITS TWO LEAD PRODUCTS, RESET AND RESET-O.PEAR THERAPEUTICS SAYS DEAL INCLUDES RESEARCH AND DEVELOPMENT FUNDING, COMMERCIAL MILESTONES, AND A PROFIT SPLIT ON NET SALES OF BOTH THERAPEUTICS.PEAR THERAPEUTICS SAYS SANDOZ WILL ASSUME RESPONSIBILITY FOR GLOBAL COMMERCIAL LAUNCH OF RESET, AND RESET-O.PEAR THERAPEUTICS- PEAR WILL CONTINUE TO DEVELOP BOTH DIGITAL THERAPEUTICS AND WILL ALSO SUPPORT PATIENT SERVICES THROUGH ITS DIGITAL HUB SERVICE.  Full Article

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Novartis touts effectiveness, safety of autoimmune drug copies

ZURICH Novartis on Friday touted safety and efficacy of its biosimilar copies of Johnson & Johnson's Remicade and Amgen Inc's Enbrel, citing a study it hopes will help convince doctors that switching from the original medicines is a viable alternative for treating autoimmune diseases.