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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 receives tentative approval from U.S. FDA for "TLE400" under PEPFAR
Monday, 20 Mar 2017 01:14pm EDT 

Mylan NV : Mylan receives tentative approval for "TLE400" under PEPFAR . TLE400 will be available in developing countries as a first-line regimen for people being treated for HIV/AIDS .Receipt of tentative approval from U.S. FDA under U.S. President's Emergency Plan for AIDS Relief for NDA for TLE400.  Full Article

Mylan reports global settlement, license agreements with Genentech, Roche
Monday, 13 Mar 2017 08:00am EDT 

Mylan NV : Mylan announces global settlement and license agreements with Genentech and Roche on herceptin . Mylan NV- all other terms and conditions of settlement and license agreement are confidential . Mylan NV- has agreed to withdraw its pending inter partes review challenges against two U.S. Genentech patents as part of settlement . Mylan NV- licenses pertain to all countries except Japan, Brazil and Mexico . Mylan NV- settlement also eliminates further patent litigation expenses associated with Genentech and Roche .Mylan NV- has agreed to terms of a global settlement with Genentech, Inc. And F. Hoffmann-La Roche Ltd. in relation to patents for herceptin.  Full Article

Mylan launches generic pristiq tablets
Friday, 10 Mar 2017 07:30am EST 

Mylan NV : Mylan launches generic pristiq tablets .Mylan NV - received final approval from U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for the product.  Full Article

Mylan records pre-tax restructuring charges of $149.7 mln during 2016
Wednesday, 1 Mar 2017 05:02pm EST 

Mylan Nv : Mylan -related to restructuring activities, recorded pre-tax restructuring charges of $149.7 million for certain workforce reduction and cost savings initiatives during 2016 . Mylan -continues to develop details of cost reduction initiatives, including workforce actions and other potential restructuring activities beyond programs announced . Mylan NV says continued restructuring actions are expected to be implemented through fiscal year 2018 .Mylan -for restructuring activities approved to date, estimates aggregate pre-tax charges ranging between $175.0 million and $225.0 million, including $149.7 million incurred.  Full Article

Mylan reports Q4 GAAP earnings per share $0.78
Wednesday, 1 Mar 2017 07:45am EST 

Mylan NV : Mylan reports fourth quarter and full year 2016 results and provides 2017 guidance . Q4 adjusted earnings per share $1.57 . Q4 revenue rose 31 percent to $3.27 billion . Q4 GAAP earnings per share $0.78 . Q4 revenue view $3.17 billion -- Thomson Reuters I/B/E/S . Q4 earnings per share view $1.42 -- Thomson Reuters I/B/E/S . Sees FY 2018 adjusted earnings per share $6.00 . Sees FY 2017 adjusted earnings per share $5.15 to $5.55 . Sees FY 2017 revenue $12.25 billion to $13.75 billion . Midpoint of FY 2017 revenue outlook up 17 percent from 2016 revenue . With regard to pricing environment, continued to see erosion both globally, in U.S. generics in mid-single digits . Sees 2017 capital expenditures $400 million - $500 million . Continue to expect a comparable environment in 2017 with regard to generics pricing . Sees 2017 adjusted free cash flow $2,000 million - $2,400 million . Sees 2017 adjusted gross margin 54.5% - 56.5% . Sees full year 2017 adjusted research and development as percent of total revenues 5.5% - 6.5% . FY2017 revenue view $12.64 billion -- Thomson Reuters I/B/E/S .FY2017 earnings per share view $5.33 -- Thomson Reuters I/B/E/S.  Full Article

FDA accepts BLA for Mylan, Biocon's proposed biosimilar pegfilgrastim for review
Thursday, 16 Feb 2017 08:08am EST 

Mylan NV : U.S. FDA accepts Biologics License Application (BLA) for Mylan and Biocon's proposed biosimilar pegfilgrastim for review .Mylan NV says FDA goal date set under biosimilar user fee act (BSUFA) is Oct. 9, 2017.  Full Article

Vanguard Group Inc reports 5.3 pct passive stake in Mylan NV as of Dec 31, 2016
Friday, 10 Feb 2017 12:42pm EST 

:Vanguard Group Inc reports 5.3 percent passive stake in Mylan NV as of Dec 31, 2016 - SEC filing.  Full Article

Cumberland defeats Mylan appeal in Acetadote patent case
Thursday, 26 Jan 2017 09:31am EST 

U.S. Appeals Court Rules In Favor Of Cumberland Pharmaceuticals : In patent dispute with mylan related to acetadote formulation-ruling . Federal circuit court of appeals upholds lower court ruling against mylan . Cumberland had accused mylan of patent infringement related to its antidote for overdoses of acetaminophen . Mylan had stiplulated to infringement, but asserted that cumberland's claims were invalid; lower court had disagreed with mylan on that point Further company coverage: [CPIX.O] [MYL.O].  Full Article

Prophase labs announces agreement to sell cold-eeze(r) brand
Monday, 9 Jan 2017 07:30am EST 

Prophase Labs Inc : Prophase labs announces agreement to sell cold-eeze(r) brand . Deal for $50 million . Mylan will purchase substantially all of company's assets and other rights relating to cold-eeze cold remedy brand . As part of transaction, company, through its Pharmaloz subsidiary, will enter into a manufacturing and supply agreement with Mylan .As part of transaction, company, through its Pharmaloz subsidiary, will enter into a manufacturing and supply agreement with Mylan.  Full Article

Mylan NV launches generic Cerebyx injection
Thursday, 29 Dec 2016 07:00am EST 

Mylan NV : Mylan launches generic Cerebyx® injection .Mylan NV says U.S. launch of fosphenytoin sodium injection USP.  Full Article

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