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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

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22 Nov 2017
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Latest Key Developments (Source: Significant Developments)

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

Momenta Pharma says Q3 loss per share $0.44
Wednesday, 1 Nov 2017 08:05am EDT 

Nov 1 (Reuters) - Momenta Pharmaceuticals Inc -:Momenta Pharmaceuticals reports third quarter 2017 financial results and provides corporate update.Q3 revenue $24.1 million versus $29.1 million.Q3 revenue view $30.6 million -- Thomson Reuters I/B/E/S.Q3 loss per share $0.44.Q3 earnings per share view $-0.45 -- Thomson Reuters I/B/E/S.Momenta Pharmaceuticals - co and Mylan are targeting a first regulatory submission for clinical development of M710 by early 2018​.Momenta Pharmaceuticals - ‍updated non-GAAP operating expense guidance of about $200 million - $210 million for 2017 and $43 million - $53 million for Q4 of 2017​.Momenta Pharmaceuticals Inc - ‍expects to recognize $50 million upfront payment from CSL as revenue in Q4 of 2017​.Momenta Pharmaceuticals Inc - ‍estimates that collaborative reimbursement revenues will be approximately $0 - $2 million in Q4 of 2017​.  Full Article

Momenta And Mylan report initial results from phase 1 clinical trial for M834
Wednesday, 1 Nov 2017 08:00am EDT 

Nov 1 (Reuters) - Momenta Pharmaceuticals Inc :Momenta And Mylan report initial results from phase 1 clinical trial for M834, a proposed biosimilar of Orencia® (abatacept).Mylan NV - ‍M834, a proposed biosimilar of Orencia (Abatacept), did not meet its primary pharmacokinetic (PK) endpoints in phase 1 study​.Mylan NV - ‍Momenta And Co continue to gather and analyze data to inform next steps for M834 program ​.  Full Article

Mylan says found no evidence of price fixing on its part
Tuesday, 31 Oct 2017 12:00pm EDT 

Oct 31 (Reuters) - Mylan NV ::Mylan provides statement in response to announcement of proposed amendments to civil complaint.Says "‍have found no evidence of price fixing on part of Mylan or its employees"​.Review of Connecticut Attorney General's press release underpinning complaint does not change co's views on price fixing allegations​‍​.Says co and its president Rajiv Malik both intend to defend the generic drug price-fixing complaint.  Full Article

Mylan wins UK court ruling related to Copaxone 40 mg/ml patent
Thursday, 26 Oct 2017 05:23am EDT 

Oct 26 (Reuters) - Mylan NV :Mylan wins UK court ruling related to Copaxone® 40 mg/ml patent.Mylan NV - ‍ Court issued decision in favor of Mylan and Synthon, finding all claims of Teva's patent relating to Copaxone 40 mg/ml invalid.Mylan NV - Co recently learned of Teva's latest action with filing of an infringement action against Mylan's Irish subsidiary Mylan Teoranta in court.Mylan - ‍ Infringement action against co's Irish unit alleging that Mylan's glatiramer acetate 40 mg/ml injection infringes 2 European patents​.  Full Article

Sanofi files suit in the U.S. to defend patent rights
Tuesday, 24 Oct 2017 04:06pm EDT 

Oct 24 (Reuters) - Sanofi SA :Sanofi files suit in the U.S. to defend its patent rights on Lantus® and Lantus® Solostar®.Sanofi - co ‍filed a patent infringement suit against Mylan​.Sanofi - ‍suit triggered by notifications from Mylan stating that it had filed NDA with FDA for insulin glargine pre-filled pen and vial drug products​.  Full Article

BRIEF-Theravance Biopharma and Mylan submit marketing application to FDA for revefenacin

* Theravance Biopharma and Mylan submit new drug application to FDA for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease