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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 finalizes settlement on Medicaid rebate classification for Epipen
Thursday, 17 Aug 2017 10:43am EDT 

Aug 17 (Reuters) - Mylan NV ::Mylan finalizes settlement agreement on Medicaid rebate classification for Epipen auto-injector.Will reclassify Epipen auto-injector for purposes of Medicaid drug rebate program​.Settlement resolves claims relating to classification of Epipen auto-injector & Epipen Jr auto-injector for purposes of Medicaid drug rebate program​.Subsidiaries signed agreement finalizing Medicaid drug rebate settlement that company announced on Oct 7, 2016 for $465 million​.Mylan will ‍pay rebate applicable to innovator products effective as of April 1, 2017​.Settlement does not contain an admission or finding of wrongdoing​.Mylan has also entered into a corporate integrity agreement with Office of Inspector General of Department Of Health and Human Services​.Settlement provides for resolution of all potential medicaid rebate liability claims by federal government, potential claims by certain hospitals.  Full Article

Mylan says got subpoena from U.S. DOJ seeking information on opioids sold by company
Wednesday, 9 Aug 2017 05:30pm EDT 

Aug 9 (Reuters) - Mylan Nv :Mylan - On July 27, got subpoena from U.S. DOJ seeking information relating to opioids manufactured, marketed/sold by co from Jan 1, 2013 to Dec 31, 2016.Mylan - responded to letter from ranking member of Senate Committee on Homeland Security and Governmental Affairs on sales, marketing, educational strategies for opioid products.  Full Article

Mylan reports Q2 GAAP earnings per share $0.55
Wednesday, 9 Aug 2017 08:00am EDT 

Aug 9 (Reuters) - Mylan Nv :Mylan reports second quarter 2017 results and updates 2017 guidance.Q2 adjusted earnings per share $1.10.Q2 GAAP earnings per share $0.55.Q2 revenue $2.96 billion versus I/B/E/S view $3.03 billion.Q2 earnings per share view $1.16 -- Thomson Reuters I/B/E/S.Sees FY 2017 adjusted earnings per share $4.30 to $4.70.Sees FY 2017 revenue up 8 percent.Sees fy 2017 revenue $11.5 billion to $12.5 billion.Mylan NV - Qtrly earnings per share ‍$0.55​.Mylan NV - ‍"Expect generic price erosion for year of mid-single digits globally, with high-single-digit erosion expected in North America"​.‍Sales of Epipen auto-injector declined in current quarter as a result of increased competition​.Mylan NV - ‍have elected to defer all major U.S. launches from full year 2017 financial guidance to 2018​.Mylan NV - ‍As co looks to 2018, co moving target of $6.00 in adjusted EPS to at least $5.40​.‍Is not providing forward looking guidance for U.S. GAAP reported financial measures​.Mylan NV - ‍Contributing to overall increase in qtrly revenues were net sales from acquisitions of Meda and topicals business of about $633.1 million​.Mylan NV - ‍Decrease in existing products net sales in quarter was due primarily to lower pricing and, to a lesser extent, lower volumes ​.Mylan NV - ‍Sees FY 2017 capital expenditures $400 - $500 million ​.  Full Article

Mylan receives tentative approval for "TLD" under PEPFAR
Monday, 7 Aug 2017 08:00am EDT 

Aug 7 (Reuters) - Mylan Nv :Mylan receives tentative approval for "TLD" under PEPFAR.Mylan - ‍Tentative approval from U.S. FDA for NDA for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, 50 mg/300 mg/300 mg​.  Full Article

Mylan receives who prequalification for Generic Sovaldi
Wednesday, 26 Jul 2017 09:45am EDT 

July 26 (Reuters) - Mylan Nv :Mylan receives who prequalification for generic sovaldi®.Approval from World Health Organization prequalification of medicines program of its application for Sofosbuvir tablets, 400 mg.Sofosbuvir, a directly acting antiretroviral, will be available in developing countries to treat hepatitis C.  Full Article

Immune Pharmaceuticals signs agreement to regain worldwide rights for Ceplene
Thursday, 15 Jun 2017 09:28am EDT 

June 15 (Reuters) - Immune Pharmaceuticals Inc -:Immune Pharmaceuticals signs agreement to regain worldwide rights for Ceplene.Immune Pharmaceuticals Inc - under terms of acquisition agreement, immune has agreed to pay mylan a fixed price, which is payable in installments.Immune Pharmaceuticals Inc - ‍cytovia intends to pursue continued development of ceplene towards potential regulatory approval in united states​.Immune Pharmaceuticals - intends, through its immuno-oncology subsidary, cytovia inc to undertake commercialization efforts in europe, asia, latin america.Immune Pharmaceuticals - assets acquired include rights to marketing authorizations, trademarks, patents, other intellectual property related to ceplene.Immune Pharmaceuticals Inc - cytovia intends to pursue continued development of ceplene towards potential regulatory approval in united states.  Full Article

Prophase Labs repurchases 1,061,980 shares of its common stock
Tuesday, 13 Jun 2017 04:30pm EDT 

June 13 (Reuters) - Prophase Labs Inc : :Prophase Labs repurchases 1,061,980 shares of its common stock.Prophase Labs- Mark Leventhal, persons and entities associated with leventhal ceased to hold any direct or indirect ownership interest in co.Prophase Labs-anticipate incurring operating losses for foreseeable future related to costs incurred for cold-eeze business transition to unit of Mylan N.V..  Full Article

Mylan enters into definitive documentation
Thursday, 8 Jun 2017 04:49pm EDT 

June 8 (Reuters) - Mylan Nv :Entered into definitive documentation to establish an unsecured commercial paper program -SEC filing.Company may issue short-term, unsecured commercial paper notes.Amounts available under CP program may be borrowed, repaid and re-borrowed with principal amount of CP notes outstanding not to exceed $1.65 billion.  Full Article

Proxy firm ISS responds to Mylan's letter - filing
Thursday, 8 Jun 2017 06:21am EDT 

June 8 (Reuters) - :Proxy firm ISS responds to Mylan's letter, ISS says it does not normally allow pre-publication reviews of any analysis relating to any special meeting or any meeting - SEC filing.Proxy firm ISS says report "we issue in connection with Mylan’s upcoming meeting will be prepared consistent with our established policy guidelines".ISS says it appreciates the further information in Mylan's letter regarding "Mr. Coury’s continuing role with Mylan and your perspective on Mylan’s interactions with teva".  Full Article

Mylan launches generic Azilect tablets
Friday, 2 Jun 2017 08:00am EDT 

June 2 (Reuters) - Mylan NV ::Mylan launches generic Azilect® tablets.Mylan NV - ‍u.s. Launch of rasagiline tablets, 0.5 mg and 1 mg, a generic version of reference listed drug, Teva's azilect tablets​.Mylan NV - received final approval from u.s. Food and drug administration (FDA) for its abbreviated new drug application (ANDA) for rasagiline tablets.  Full Article

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Mylan, U.S. finalize $465 million EpiPen settlement

BOSTON Mylan NV has finalized a $465 million settlement resolving U.S. Justice Department claims it overcharged the government for its EpiPen emergency allergy treatment, which became the center of a firestorm over price increases.