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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

41.45USD
23 Feb 2018
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Latest Key Developments (Source: Significant Developments)

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 To Complete $1 Billion Share Repurchase Plan
Monday, 8 Jan 2018 07:30am EST 

Jan 8 (Reuters) - Mylan Nv ::MYLAN TO COMPLETE $1 BILLION SHARE REPURCHASE PLAN.MYLAN - AS PER AGREEMENT WITH ABBOTT RELATED TO ABBOTT EPD DEAL, ABBOTT NOTIFIED MYLAN IT SOLD REMAINING 20.3 MILLION IN MYLAN SHARES PRIOR TO YEAR-END​.  Full Article

Biocon And Mylan's Biosimilar Trastuzumab Gets Approval From ANVISA, Brazil
Friday, 29 Dec 2017 01:12am EST 

Dec 29 (Reuters) - Biocon Ltd ::CO AND MYLAN'S BIOSIMILAR TRASTUZUMAB RECEIVES APPROVAL FROM ANVISA, BRAZIL THROUGH THEIR PARTNER LIBBS.LIBBS FARMACEUTICA TO COMMERCIALIZE PRODUCT IN BRAZIL UNDER BRAND NAME ZEDORA.  Full Article

Mylan Announces U.S. Regulator's Review Proceedings On All Claims Against Sanofi's Lantus Patents
Thursday, 14 Dec 2017 07:30am EST 

Dec 14 (Reuters) - Mylan Nv ::MYLAN ANNOUNCES THE U.S. PATENT AND TRADEMARK APPEAL BOARD INSTITUTES INTER PARTES REVIEW PROCEEDINGS ON ALL CLAIMS AGAINST SANOFI'S LANTUS® PATENTS.MYLAN SAYS U.S. PTAB INSTITUTED IPR PROCEEDINGS ON CLAIMS AGAINST 2 ORANGE BOOK-LISTED PATENTS OWNED BY SANOFI FOR LANTUS 100 UNITS/ML.  Full Article

Mylan Says Teva Has Dismissed Its Pending Litigation Against Co
Monday, 11 Dec 2017 12:16pm EST 

Dec 11 (Reuters) - Mylan Nv ::MYLAN NV - ANNOUNCED THAT TEVA HAS DISMISSED ITS PENDING DISTRICT COURT LITIGATION AGAINST MYLAN.MYLAN NV - TEVA HAS AGREED TO WITHDRAW IRISH EQUIVALENT TO THE PATENTS FROM RECENTLY FILED PROCEEDING IN IRELAND.MYLAN NV - TEVA'S PENDING LITIGATION AGAINST CO IS REGARDING CO'S GLATIRAMER ACETATE INJECTION 40 MG/ML, FIRST GENERIC VERSION OF COPAXONE 40 MG/ML.  Full Article

Mylan And Aspen Announce Launch Of Generic Busulfex Injection
Monday, 4 Dec 2017 07:30am EST 

Dec 4 (Reuters) - Mylan Nv ::MYLAN AND ASPEN ANNOUNCE LAUNCH OF GENERIC BUSULFEX® INJECTION.MYLAN NV - ‍ANNOUNCED U.S. LAUNCH OF MYLERAN INJECTION, 60 MG/10 ML SINGLE-DOSE VIAL, A GENERIC VERSION OF OTSUKA PHARMACEUTICAL'S BUSULFEX INJECTION​.  Full Article

FDA Approves Mylan's Heparin Sodium Injection
Friday, 1 Dec 2017 10:50am EST 

Dec 1 (Reuters) - Mylan Nv ::FDA APPROVAL OF HEPARIN SODIUM INJECTION CONTINUES TO DEMONSTRATE MYLAN'S DEEP EXPERTISE IN DEVELOPING COMPLEX PRODUCTS.SAYS EXPECT TO MAKE HEPARIN PRODUCTS AVAILABLE TO U.S. HOSPITALS IN COMING WEEKS.  Full Article

EMA Accepts Marketing Authorization Applications For Mylan And Biocon's Proposed Biosimilars
Thursday, 30 Nov 2017 12:55pm EST 

Nov 30 (Reuters) - Mylan NV ::EUROPEAN MEDICINES AGENCY ACCEPTS MARKETING AUTHORIZATION APPLICATIONS FOR MYLAN AND BIOCON'S PROPOSED BIOSIMILARS TRASTUZUMAB AND PEGFILGRASTIM.EMA ACCEPTANCE OF TRASTUZUMAB, PEGFILGRASTIM FOLLOWS EARLIER WITHDRAWAL OF APPLICATIONS IN RESPONSE TO AUDIT OF BIOCON'S DRUG PRODUCT FACILITY.  Full Article

BRIEF-Mylan Receives Tentative Approval For Combination HIV Treatment DTG/FTC/TAF Under FDA's Pepfar Program

* MYLAN RECEIVES TENTATIVE APPROVAL FOR COMBINATION HIV TREATMENT DTG/FTC/TAF UNDER FDA'S PEPFAR PROGRAM