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Mylan NV (MYL.O)

MYL.O on Nasdaq

40.52USD
15 Dec 2017
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Latest Key Developments (Source: Significant Developments)

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

Theravance Biopharma and Mylan submit marketing application to FDA for revefenacin
Monday, 13 Nov 2017 09:28am EST 

Nov 13 (Reuters) - Theravance Biopharma Inc -:Theravance Biopharma and Mylan submit new drug application to FDA for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease.Theravance Biopharma Inc - ‍NDA is supported by companies' Phase 3 program for revefenacin​.  Full Article

Mylan announces voluntary delisting from the Tel Aviv Stock Exchange (TASE)
Friday, 10 Nov 2017 04:45pm EST 

Nov 10 (Reuters) - Mylan Nv :Mylan announces voluntary delisting from the Tel Aviv Stock Exchange (TASE).Mylan NV - ‍announced it is voluntarily delisting company's ordinary shares from trading on tel aviv stock exchange​.Mylan NV - ‍ delisting of Mylan's ordinary shares from tase will become effective in three months, on February 12, 2018​.  Full Article

Mylan says received civil investigative demand from AG of state of Missouri
Tuesday, 7 Nov 2017 07:07am EST 

Nov 7 (Reuters) - Mylan Nv ::Says on Aug 29, 2017 received civil investigative demand from attorney general of state of Missouri - SEC Filing‍​.Says civil investigative demand seeks information relating to opioids manufactured, marketed or sold by co from Jan 1, 2010 to present related subject matter.Says on October 10, co, Meda Pharmaceuticals got notice CMA was opening investigation for possible infringement of Competition Act 1998, article 101 of TFEU.Says notice regarding CMA investigation was in respect to alleged agreements related to Nefopam, a product from Meda's portfolio.Says on October 16, CMA issued notice under section 26 of Competition Act 1998 to co, Meda Pharma to provide specified information, specified documents.  Full Article

Mylan reports Q3 adjusted earnings per share $1.10
Monday, 6 Nov 2017 07:00am EST 

Nov 6 (Reuters) - Mylan Nv :Mylan reports third quarter 2017 results and updates 2017 guidance.Sees FY 2017 adjusted earnings per share $4.45 to $4.70.Q3 adjusted earnings per share $1.10.Sees FY 2017 revenue $11.75 billion to $12.5 billion.Q3 revenue $2.99 billion versus I/B/E/S view $3.09 billion.Q3 earnings per share view $1.20 -- Thomson Reuters I/B/E/S.Mylan NV - Qtrly ‍U.S. GAAP diluted earnings per ordinary share of $0.16​.Mylan - Primarily due to launch of generic Copaxone, co is increasing midpoint of 2017 adjusted EPS guidance & total revenue range by increasing low end of ranges.Mylan NV - ‍​Sales of EpiPen auto-injector in North America segment declined in current quarter by $245.1 million.Mylan- EpiPen auto-injector sales in North America fell in current quarter from higher governmental rebates from $465 million settlement with U.S. DoJ, among others.Mylan NV says ‍​"remain confident" in 2018 target of at least $5.40 in adjusted EPS.  Full Article

Theravance Biopharma and Mylan reports positive Phase 3 data for Revefenacin
Wednesday, 1 Nov 2017 08:30am EDT 

Nov 1 (Reuters) - Mylan Nv :Theravance Biopharma and mylan report additional positive phase 3 data for Revefenacin (TD-4208) in multiple presentations at 2017 Chest Annual Meeting.Theravance Biopharma Inc - ‍remain on track to submit an NDA for Revefenacin Q4 of 2017​.Theravance Biopharma Inc - ‍results demonstrated statistically significant and clinically meaningful improvements for revefenacin over placebo ​.Theravance Biopharma Inc - ‍both doses of revefenacin had comparable rates of adverse events to placebo​.  Full Article

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Perrigo lines up bid for Merck's consumer health unit: sources

LONDON/FRANKFURT Generic drugmaker Perrigo has decided to enter the fray for Merck KGaA's consumer health unit, sources told Reuters, and is preparing an indicative offer for the $4.7 billion business ahead of a deadline on Friday.