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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

38.99USD
21 Sep 2018
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Latest Key Developments (Source: Significant Developments)

Mylan, Fujifilm Kyowa Receive European Marketing Authorization For Hulio, Biosimilar Adalimumab
Thursday, 20 Sep 2018 07:00am EDT 

Sept 20 (Reuters) - Mylan NV ::MYLAN AND FUJIFILM KYOWA KIRIN BIOLOGICS RECEIVE EUROPEAN MARKETING AUTHORIZATION FOR HULIO®, BIOSIMILAR ADALIMUMAB.MYLAN NV - FUJIFILM KYOWA KIRIN BIOLOGICS HAS A NONEXCLUSIVE ROYALTY BEARING LICENSE WITH ABBVIE FOR USE AND SALE OF HULIO IN EUROPEAN COUNTRIES.MYLAN NV - MYLAN PLANS TO LAUNCH HULIO ACROSS VARIOUS MARKETS IN EUROPE ON OR AFTER OCT. 16..MYLAN NV - EC APPROVAL OF HULIO APPLIES TO ALL 28 EUROPEAN UNION (EU) MEMBER COUNTRIES AND EUROPEAN ECONOMIC AREA (EEA) MEMBER STATES.  Full Article

Mylan Launches Generic Angiomax® Injection
Monday, 18 Jun 2018 02:07pm EDT 

June 18 (Reuters) - Mylan NV ::MYLAN LAUNCHES GENERIC ANGIOMAX® INJECTION.MYLAN NV - ANNOUNCED U.S. LAUNCH OF BIVALIRUDIN FOR INJECTION, 250 MG SINGLE-DOSE VIAL, A GENERIC VERSION OF ANGIOMAX FROM THE MEDICINES COMPANY.  Full Article

Mylan To Acquire The Global Marketing Rights To Glatiramer Acetate Product Through An Investment And Partnership With Israeli Company Mapi Pharma
Tuesday, 10 Apr 2018 07:30am EDT 

April 10 (Reuters) - Mylan NV ::MYLAN TO ACQUIRE THE GLOBAL MARKETING RIGHTS TO A ONCE-MONTHLY GLATIRAMER ACETATE PRODUCT THROUGH AN INVESTMENT AND PARTNERSHIP WITH ISRAELI COMPANY MAPI PHARMA.CO, MAPI PHARMA TO PARTNER ON DEVELOPMENT & COMMERCIALIZATION OF GA DEPOT, A LONG-ACTING GLATIRAMER ACETATE PRODUCT.  Full Article

Mylan Launches Generic Mutamycin Injection For Cancer
Tuesday, 20 Mar 2018 08:05am EDT 

March 20 (Reuters) - Mylan Nv ::MYLAN ADDS TO GROWING ONCOLOGY PORTFOLIO WITH LAUNCH OF GENERIC MUTAMYCIN® INJECTION.MYLAN NV - ‍U.S. LAUNCH OF ONCOLOGY DRUG MITOMYCIN FOR INJECTION USP, 5 MG/VIAL, 20 MG/VIAL AND 40 MG/VIAL SINGLE DOSE VIALS​.  Full Article

Mylan To Introduce Two New Cost-Saving HIV Combination Treatments In The U.S.
Friday, 2 Mar 2018 07:30am EST 

March 2 (Reuters) - Mylan Nv ::MYLAN TO INTRODUCE TWO NEW COST-SAVING HIV COMBINATION TREATMENTS IN THE U.S..MYLAN NV - WILL LAUNCH TWO NEW HIV TREATMENTS, SYMFI LO AND CIMDUO, WHICH WERE APPROVED IN FEBRUARY BY U.S. FOOD AND DRUG ADMINISTRATION.MYLAN NV - ANTICIPATES INTRODUCING SYMFI LO IN COMING WEEKS AND CIMDUO IN Q2 THIS YEAR.MYLAN NV - SYMFI LO'S LIST PRICE WILL BE DISCOUNTED "SIGNIFICANTLY" FROM WHOLESALE ACQUISITION COST OF ANY OTHER STR ON U.S. MARKET.MYLAN - CIMDUO'S LIST PRICE WILL LIKEWISE BE AT "A SIGNIFICANT DISCOUNT" TO ANY OTHER TENOFOVIR-BASED DOUBLE COMBINATION PRODUCT ON THE U.S. MARKET.  Full Article

Mylan Reports Q4 Adjusted Earnings Per Share $1.43
Wednesday, 28 Feb 2018 04:37pm EST 

Feb 28 (Reuters) - Mylan Nv ::MYLAN REPORTS FULL YEAR AND FOURTH QUARTER 2017 RESULTS AND PROVIDES 2018 GUIDANCE.SEES FY 2018 ADJUSTED EARNINGS PER SHARE $5.20 TO $5.60.Q4 GAAP EARNINGS PER SHARE $0.46.SEES ‍2018 REVENUES OF $11.75 BILLION TO $13.25 BILLION​.QTRLY TOTAL REVENUES OF $3.24 BILLION, DOWN 1% COMPARED TO PRIOR YEAR PERIOD.SEES ‍FY ADJUSTED EPS IN RANGE OF $5.20 TO $5.60​.Q4 ADJUSTED EARNINGS PER SHARE $1.43.Q4 EARNINGS PER SHARE VIEW $1.41, REVENUE VIEW $3.30 BILLION -- THOMSON REUTERS I/B/E/S.ABSORBED DECLINE IN PROFITABILITY OF ABOUT $500 MILLION ASSOCIATED WITH REBASING OF EPIPEN IN QUARTER.FY2018 EARNINGS PER SHARE VIEW $5.39, REVENUE VIEW $12.76 BILLION -- THOMSON REUTERS I/B/E/S.MYLAN - QTRLY EARNINGS INCLUDE TAX EXPENSE OF $82.8 MILLION​.SEES FY 2018 CAPITAL EXPENDITURES $300 MILLION - $500 MILLION.  Full Article

Mylan NV Defeats Allergan's Maneuver To Rent Tribal Sovereign Immunity To Avoid Restasis Patent Challenge
Monday, 26 Feb 2018 08:00am EST 

Feb 26 (Reuters) - Mylan NV ::MYLAN NV - ‍U.S. PTAB DENIED ST. REGIS MOHAWK TRIBE'S MOTION TO TERMINATE CO'S PATENT CHALLENGE REGARDING 6 PATENTS RELATED TO ALLERGAN'S RESTASIS​.  Full Article

Mylan Receives Tentative Approval For Combination HIV Treatment DTG/FTC/TAF Under FDA's Pepfar Program
Tuesday, 20 Feb 2018 07:30am EST 

Feb 20 (Reuters) - Mylan Nv ::MYLAN RECEIVES TENTATIVE APPROVAL FOR COMBINATION HIV TREATMENT DTG/FTC/TAF UNDER FDA'S PEPFAR PROGRAM.MYLAN NV - ‍ ANTIRETROVIRAL WILL BE IMMEDIATELY AVAILABLE IN DEVELOPING COUNTRIES AS A FIRST-LINE REGIMEN FOR PEOPLE BEING TREATED FOR HIV/AIDS​.  Full Article

Mylan Expands Access To HIV/AIDS Medicines With Launch Of First Generic Sustiva Tablets
Thursday, 1 Feb 2018 07:30am EST 

Feb 1 (Reuters) - Mylan Nv ::MYLAN EXPANDS ACCESS TO HIV/AIDS MEDICINES WITH LAUNCH OF FIRST GENERIC SUSTIVA® TABLETS.MYLAN - ANNOUNCED U.S. LAUNCH OF EFAVIRENZ TABLETS USP, 600 MG, FIRST GENERIC VERSION OF BRISTOL-MYERS' SUSTIVA.MYLAN NV - CO ELIGIBLE FOR 180 DAYS OF GENERIC DRUG EXCLUSIVITY IN RELATION TO GENERIC SUSTIVA TABLETS.  Full Article

Mylan And Biocon Receive Positive CHMP Opinion For Semglee, Biosimilar Insulin Glargine
Monday, 29 Jan 2018 06:00am EST 

Jan 29 (Reuters) - Biocon Ltd ::MYLAN AND BIOCON RECEIVE POSITIVE CHMP OPINION FOR SEMGLEE™, BIOSIMILAR INSULIN GLARGINE.MYLAN NV - CHMP POSITIVE OPINION WILL BE CONSIDERED BY EUROPEAN COMMISSION.MYLAN NV - EUROPEAN COMMISSION DECISION ON APPROVAL IS EXPECTED IN APRIL.MYLAN NV - EUROPEAN COMMISSION DECISION ON APPROVAL IS EXPECTED IN APRIL.MYLAN - IN ADDITION TO EUROPEAN SUBMISSION, MARKETING APPLICATIONS FOR SEMGLEE BEEN SUBMITTED IN AUSTRALIA, CANADA, U.S. & PLANNED FOR KEY EMERGING MARKETS.  Full Article

Mylan, Fujifilm win EU okay for copy of AbbVie's Humira

LONDON, Sept 20 Mylan and Fujifilm Kyowa Kirin Biologics said on Thursday they had won European approval to market a cheaper copy of AbbVie's $18-billion-a-year biologic drug Humira, the world's best-selling prescription medicine.