United States

Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

19 May 2017
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Latest Key Developments (Source: Significant Developments)

Mylan says EpiPen sales suffer from increased competition
Wednesday, 10 May 2017 11:18am EDT 

May 10 (Reuters) - Mylan :President says EpiPen will account for less than 5 percent of global revenue and less than 10 percent of north american sales.President says EpiPen will account for less than 5 percent of global revenue and less than 10 percent of north american sales in 2017 (adds year).Says still expects profits from EpiPen to be down $400 million in 2017 from last year.  Full Article

Mylan reports Q1 GAAP earnings per share $0.12
Wednesday, 10 May 2017 07:30am EDT 

May 10 (Reuters) - Mylan NV : :Mylan reports first quarter 2017 results.Q1 adjusted earnings per share $0.93.Q1 GAAP earnings per share $0.12.Q1 revenue $2.72 billion versus I/B/E/S view $2.84 billion.Q1 earnings per share view $0.92 -- Thomson Reuters I/B/E/S.Sees FY 2018 adjusted earnings per share $6.00 including items.Mylan NV - not providing forward looking guidance for u.s. Gaap reported financial measures.Mylan NV - "remain confident in our guidance and our business outlook for full year 2017, including our adjusted EPS guidance range".Mylan NV - also not providing forward looking guidance for quantitative reconciliation of forward-looking non-GAAP financial measures.Mylan NV - sales of epipen auto-injector declined in current quarter as a result of increased competition and impact of launch of authorized generic.Mylan NV - overall expectations for global pricing environment are unchanged and "we are still predicting mid-single digit price erosion globally for year".  Full Article

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

More From Around the Web


Mylan disagrees with FDA over generic Advair delay

Generic drug maker Mylan NV on Wednesday said it disagrees with the reasoning behind the U.S. Food and Drug Administration's decision not to approve its generic for GlaxoSmithKline Plc's blockbuster Advair in March. | Video