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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Mylan NV Plans To Launch HIV Self-Test In Global Markets In Early 2019
Monday, 24 Sep 2018 

Sept 24 (Reuters) - Mylan NV ::MYLAN NV - STRATEGIC PARTNERSHIP TO COMMERCIALIZE CE-MARKED IN VITRO HIV RAPID DIAGNOSTIC TESTS FOR SELF-TESTING IN LOW- AND MIDDLE-INCOME COUNTRIES.MYLAN NV - HAS EXCLUSIVE RIGHTS TO COMMERCIALIZE PRODUCTS IN OVER 100 COUNTRIES IN AFRICA, ASIA, MIDDLE EAST, CIS AND LATIN AMERICA.MYLAN NV - PLANS TO LAUNCH MYLAN HIV SELF-TEST IN GLOBAL MARKETS IN EARLY 2019.  Full Article

Sandoz Wins U.S. FDA's Approval For Busulfan - FDA Wesbite
Friday, 21 Sep 2018 

Sept 21 (Reuters) - FDA ::SANDOZ INC WINS U.S. FDA'S APPROVAL FOR BUSULFAN - FDA WESBITE.  Full Article

Mylan Launches Authorized Generic Of Ampyra Tablets
Friday, 21 Sep 2018 

Sept 21 (Reuters) - Mylan NV ::MYLAN LAUNCHES AUTHORIZED GENERIC OF AMPYRA® TABLETS.MYLAN NV - ANNOUNCED U.S. LAUNCH OF DALFAMPRIDINE EXTENDED-RELEASE TABLETS, 10 MG.  Full Article

Mylan Adds To Cardiovascular Portfolio With Launch Of First Generic Of Brevibloc Injection In Single-Dose Bags
Thursday, 13 Sep 2018 

Sept 13 (Reuters) - Mylan NV ::MYLAN ADDS TO CARDIOVASCULAR PORTFOLIO WITH LAUNCH OF FIRST GENERIC OF BREVIBLOC® INJECTION IN SINGLE-DOSE BAGS.MYLAN - LAUNCH OF ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE INJECTION, 2,500 MG/250 ML SINGLE-DOSE PLASTIC BAG & 2,000 MG/100 ML SINGLE-DOSE PLASTIC BAG.  Full Article

Mylan Closes Deal With Novartis To Commercialize Certain Global Cystic Fibrosis Products
Wednesday, 5 Sep 2018 

Sept 5 (Reuters) - Mylan NV ::MYLAN - CLOSED DEAL WITH NOVARTIS TO BUY WORLDWIDE RIGHTS TO COMMERCIALIZE GLOBAL CYSTIC FIBROSIS PRODUCTS CONSISTING OF TOBI PODHALER & TOBI SOLUTION.  Full Article

FDA Extends Expiration Date For Specific Lots Of EpiPen Medication
Tuesday, 21 Aug 2018 

Aug 21 (Reuters) - U.S. Food and Drug Administration::U.S. FDA SAYS EXTENDING EXPIRATION DATE OF SPECIFIC LOTS OF 0.3 MG EPIPEN AUTO-INJECTOR PRODUCTS MARKETED BY MYLAN BY 4 MONTHS BEYOND LABELED EXPIRATION DATE.U.S. FDA SAYS CHANGE IN LABELING OF EXPIRATION DATE BEYOND APPROVED 20-MONTH SHELF LIFE IS BASED ON STABILITY DATA PROVIDED BY MYLAN & REVIEWED BY FDA.  Full Article

Mylan NV - On May 10, Co's Unit Received Civil Investigative Demand From Civil Division Of DOJ Seeking Information Relating To Pricing, Sale Of Generic Drug Products
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - Mylan NV ::MYLAN NV - ON MAY 10, CO'S UNIT RECEIVED CIVIL INVESTIGATIVE DEMAND FROM CIVIL DIVISION OF DOJ SEEKING INFORMATION RELATING TO PRICING,SALE OF GENERIC DRUG PRODUCTS.  Full Article

Mylan Says Continues To Develop Details Of Cost Reduction Initiatives, Including Workforce Actions, Other Restructuring Beyond Programs Already Announced
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - Mylan NV ::MYLAN- CONTINUES TO DEVELOP DETAILS OF COST REDUCTION INITIATIVES, INCLUDING WORKFORCE ACTIONS ,OTHER RESTRUCTURING BEYOND PROGRAMS ALREADY ANNOUNCED.MYLAN NV - CONTINUED RESTRUCTURING ACTIONS ARE EXPECTED TO BE IMPLEMENTED THROUGH FISCAL YEAR 2018 -SEC FILING.MYLAN NV - COMPANY NOW ANTICIPATES TOTAL AGGREGATE PRE-TAX CHARGES FOR COMMITTED RESTRUCTURING ACTIVITIES RANGING BETWEEN $500.0 MILLION AND $600.0 MILLION.MYLAN - BELIEVES POTENTIAL ANNUAL SAVINGS FROM COMMITTED RESTRUCTURING ACTIVITIES WILL BE BETWEEN ABOUT $400.0 MILLION AND $475.0 MILLION ONCE FULLY IMPLEMENTED.MYLAN NV - AS ADDITIONAL RESTRUCTURING ACTIVITIES ARE UNDERTAKEN, COMPANY EXPECTS TO INCUR ADDITIONAL COSTS INCLUDING EMPLOYEE RELATED COSTS.  Full Article

Mylan NV: Statement From Mylan's Board Of Directors
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - Mylan NV ::STATEMENT FROM MYLAN'S BOARD OF DIRECTORS.MYLAN NV - OUR INTERNATIONAL BUSINESS, NOW REPRESENTS MORE THAN 60% OF COMPANY'S GLOBAL SALES.MYLAN NV - BOARD FORMED STRATEGIC REVIEW COMMITTEE, ACTIVELY EVALUATING WIDE RANGE OF ALTERNATIVES TO UNLOCK TRUE VALUE OF OUR ONE-OF-A-KIND PLATFORM.MYLAN NV - BOARD HAS NOT SET A TIMETABLE FOR ITS EVALUATION OF ALTERNATIVES.MYLAN NV - EXPECT CONTINUED GROWTH IN CO'S INTERNATIONAL BUSINESS.MYLAN - BELIEVE U.S. PUBLIC MARKETS CONTINUE TO "UNDERAPPRECIATE AND UNDERVALUE" CO'S GLOBAL DIVERSIFIED BUSINESS.MYLAN - BELIEVE "NEGATIVE TRENDS & DYNAMICS" PLAYING OUT IN U.S. MARKET PLACE ARE "UNSUSTAINABLE" FOR HEALTHCARE SYSTEM OVER LONG-TERM.MYLAN - BELIEVE CO IS WELL POSITIONED TO "SUCCESSFULLY WEATHER AND NAVIGATE" NEGATIVE TRENDS AND DYNAMICS PLAYING OUT IN U.S. MARKET PLACE.  Full Article

Mylan Reports Q2 earnings per share of $0.07
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - Mylan NV ::MYLAN REPORTS SECOND QUARTER 2018 RESULTS AND UPDATES 2018 GUIDANCE.SEES FY 2018 ADJUSTED EARNINGS PER SHARE $4.55 TO $4.90.QTRLY TOTAL REVENUES OF $2.81 BILLION, DOWN 5% COMPARED TO PRIOR YEAR PERIOD..QTRLY U.S. GAAP DILUTED EARNINGS PER ORDINARY SHARE ("U.S. GAAP EPS") OF $0.07.QTRLY ADJUSTED DILUTED EARNINGS PER ORDINARY SHARE ("ADJUSTED EPS") OF $1.07.Q2 EARNINGS PER SHARE VIEW $1.22, REVENUE VIEW $2.96 BILLION -- THOMSON REUTERS I/B/E/S.SEES 2018 ADJUSTED EPS $4.55 - $4.90.SEES 2018 TOTAL REVENUES $11,250 MILLION - $12,250 MILLION.SEES 2018 ADJUSTED FREE CASH FLOW $2,100 MILLION - $2,500 MILLION.FY2018 EARNINGS PER SHARE VIEW $5.25, REVENUE VIEW $12.17 BILLION -- THOMSON REUTERS I/B/E/S.COMPANY COMMENCED A RESTRUCTURING AND REMEDIATION PROGRAM AT MORGANTOWN MANUFACTURING FACILITY.PROGRAM INCLUDES REDUCTION OF WORKFORCE, DISCONTINUATION OF A NUMBER OF PRODUCTS, IS AIMED AT REDUCING COMPLEXITY AT MORGANTOWN FACILITY.MYLAN - EXPECTS REMEDIATION ACTIVITIES, LOWER PRODUCTION LEVELS, NEGATIVE IMPACT ON OPERATIONS AND RELATED EXPENSES TO CONTINUE THROUGH END OF 2018..RESTRUCTURING ACTIONS HAVE HAD A "SIGNIFICANTLY NEGATIVE IMPACT ON PRODUCTION LEVELS, PRODUCT SUPPLY AND OPERATIONS".U.S. FDA RECENTLY COMPLETED AN INSPECTION AT MYLAN'S PLANT IN MORGANTOWN, WEST VIRGINIA AND MADE OBSERVATIONS THROUGH A FORM 483.  Full Article

Samsung launches third rival to AbbVie's Humira drug in EU

LONDON South Korea's Samsung Bioepis and its partner Biogen have launched a third rival to AbbVie's blockbuster medicine Humira in Europe, ramping up competition for a slice of the world's top-selling prescription drug's sales.