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Mylan NV (MYL.O)

MYL.O on Nasdaq

28 Apr 2017
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Latest Key Developments (Source: Significant Developments)

Mylan launches generic Trilafon Tablets
Thursday, 20 Apr 2017 01:39pm EDT 

April 20 (Reuters) - Mylan NV ::Mylan launches generic Trilafon Tablets.U.S. launch of Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg and 16 mg, a generic version of Trilafon Tablets originally marketed by Schering.  Full Article

U.S. FDA alerts consumers of nationwide voluntary recall of Epipen and Epipen JR
Friday, 31 Mar 2017 06:08pm EDT 

U.S. FDA : U.S. FDA alerts consumers of nationwide voluntary recall of epipen and epipen jr . U.S. FDA says at this time, 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only Epipen lots impacted by the U.S. recall Further company coverage: [MYL.O] ((Bangalore.newsroom@thomsonreuters.com;)).  Full Article

Mylan provides update on Meridian Medical Technologies', expands voluntary worldwide recall of epipen auto-injector
Friday, 31 Mar 2017 05:11pm EDT 

Mylan Nv : Mylan provides update on meridian medical technologies', a Pfizer company, expanded voluntary worldwide recall of epipen® auto-injector . Mylan - recall is being conducted as result of receipt of 2 previously disclosed reports of failure to activate device due to potential defect in supplier component . Mylan NV - expanded voluntary recall is being initiated in U.S. And also will extend to additional markets in Europe, Asia, North and South America. . Mylan NV - recall is being expanded to include additional lots as a precautionary measure . Mylan NV says recall impacts 0.3 mg and 0.15 mg strengths of epipen auto-injector .Mylan NV- none of recalled lots include authorized generic for epipen auto-injector, which is also manufactured by meridian medical technologies.  Full Article

Mylan receives CRL for generic Advair Diskus ANDA
Wednesday, 29 Mar 2017 01:16pm EDT 

Mylan NV : Mylan comments on generic Advair Diskus abbreviated new drug application . In conjunction with Mylan's GDUFA goal date, company received a complete response letter from FDA regarding its ANDA for generic Advair Diskus .Is in process of reviewing the response and will provide an update on its application as soon as practicable once it has completed its review.  Full Article

Mylan says no comment at this point on U.S. generic Advair application
Wednesday, 29 Mar 2017 07:30am EDT 

Mylan : Spokeswoman says company has no comment at this point on its U.S. FDA application for generic copy of GlaxoSmithKline's Advair . For more on this story see [nL5N1H6149] Further company coverage: [MYL.O] (Reporting by Ben Hirschler) ((uk.online@reuters.com;)).  Full Article

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

More From Around the Web

Sanofi files U.S. antitrust lawsuit against Mylan over EpiPen

France's Sanofi SA on Monday sued Mylan NV, accusing the pharmaceutical company of engaging in illegal conduct to squelch competition to its EpiPen allergy treatment, which has been at the center of a public debate over drug prices.