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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

15.69USD
23 Oct 2020
Change (% chg)

$0.09 (+0.58%)
Prev Close
$15.60
Open
$15.75
Day's High
$15.80
Day's Low
$15.44
Volume
898,931
Avg. Vol
1,740,715
52-wk High
$23.11
52-wk Low
$12.76

Latest Key Developments (Source: Significant Developments)

Mylan, Biocon Biologics Announce Launch Of Semglee In U.S.
Monday, 31 Aug 2020 

Aug 31 (Reuters) - Biocon Ltd ::MYLAN AND BIOCON BIOLOGICS ANNOUNCE LAUNCH OF SEMGLEE (INSULIN GLARGINE INJECTION) IN U.S. TO EXPAND ACCESS FOR PATIENTS LIVING WITH DIABETES.MYLAN - OFFERING SEMGLEE AT A WHOLESALE ACQUISITION COST OF $147.98 PER PACKAGE OF FIVE 3ML PENS AND $98.65 PER 10ML VIAL.MYLAN NV - LIST PRICE OF SEMGLEE PEN IS EQUIVALENT TO LANTUS LAUNCH PRICE IN 2007, AND SEMGLEE VIAL IS LISTED AT LANTUS'S 2010 PRICING.MYLAN NV - SUBMITTED TO FDA ALL NECESSARY DOCUMENTATION TO REQUEST APPROVAL OF SEMGLEE AS A BIOSIMILAR TO LANTUS UNDER 351(K) PATHWAY.MYLAN - EXPECT SEMGLEE TO CONTRIBUTE SIGNIFICANTLY TO ACHIEVING $1 BILLION REVENUE BY END OF FY22 FOR BIOCON BIOLOGICS.  Full Article

U.S. FDA Grants Approval Of Semglee (Insulin Glargine Injection) To Mylan
Thursday, 11 Jun 2020 

June 11 (Reuters) - FDA: :FDA - APPROVES SEMGLEE TO IMPROVE GLYCEMIC CONTROL IN ADULTS, PEDIATRIC PATIENTS WITH TYPE 1 DIABETES MELLITUS, IN ADULTS WITH TYPE 2 DIABETES MELLITUS.FDA - GRANTS APPROVAL OF SEMGLEE (INSULIN GLARGINE INJECTION) TO MYLAN PHARMACEUTICALS, INC.FDA - SEMGLEE IS CONTRAINDICATED DURING EPISODES OF HYPOGLYCEMIA & IN PATIENTS WITH HYPERSENSITIVITY TO INSULIN GLARGINE OR ITS EXCIPIENTS.  Full Article

Mylan Invalidates Sanofi's Lantus Solostar Device Patents In IPR Proceedings
Saturday, 30 May 2020 

May 29 (Reuters) - Mylan NV ::MYLAN INVALIDATES SANOFI'S LANTUS® SOLOSTAR® DEVICE PATENTS IN IPR PROCEEDINGS.MYLAN - PTAB RULED IN FAVOR OF CO IN IPR PROCEEDINGS FINDING ALL CHALLENGED CLAIMS OF SANOFI'S LANTUS SOLOSTAR DEVICE PATENTS.MYLAN - PTAB FOUND THREE CLAIMS OF 9,604,008 PATENT UNPATENTABLE, AND TWO CLAIMS TO BE PATENTABLE.  Full Article

Pfizer Says Upjohn-Mylan Combination Remains On Track For Mid-Year 2020 Close
Tuesday, 28 Jan 2020 

Jan 28 (Reuters) - Pfizer Inc ::PFIZER INC SAYS UPJOHN-MYLAN COMBINATION REMAINS ON TRACK FOR A MID-YEAR 2020 CLOSE - EARNINGS PRESENTATION.  Full Article

Mylan Says 2019 Revenue From Wixela To Be Slightly Lower Than Expected
Tuesday, 5 Nov 2019 

Nov 5 (Reuters) - Mylan NV ::MYLAN NV CEO SAYS HAVE LAUNCHED NEW PRODUCTS WORTH $800 MILLION SO FAR THIS YEAR; ON TRACK TO BRING IN PRODUCTS WORTH $1 BILLION IN 2019 - CONF CALL.MYLAN EXECUTIVE SAYS ONGOING BUSINESS TRANSFORMATION PLAN INCLUDES RE-EVALUATING PIPELINE, EXPECTED TO HAVE A NEGATIVE IMPACT ON REVENUE - CONF CALL.MYLAN EXECUTIVE SAYS FULL-YEAR REVENUE FROM WIXELA TO BE SLIGHTLY LOWER THAN EXPECTED DUE TO CO'S "AGGRESSIVE SHARE RETENTION ACTIONS" - CONF CALL.MYLAN EXECUTIVE SAYS COMPLETED AROUND 80% TO 90% OF PRODUCT RE-EVALUATION IN THE U.S. AS PART OF BUSINESS TRANSFORMATION PLAN - CONF CALL.  Full Article

Mylan Initiates Voluntary Nationwide Recall Of One Lot Of Alprazolam Tablets Due To Potential Of Foreign Substance
Saturday, 26 Oct 2019 

Oct 25 (Reuters) - Mylan NV ::MYLAN PHARMACEUTICALS INITIATES VOLUNTARY NATIONWIDE RECALL OF ONE LOT OF ALPRAZOLAM TABLETS, USP C-IV 0.5 MG, DUE TO THE POTENTIAL OF FOREIGN SUBSTANCE.MYLAN NV - LOT IS BEING RECALLED DUE TO POTENTIAL PRESENCE OF FOREIGN SUBSTANCE.MYLAN NV - CLINICAL IMPACT FROM FOREIGN MATERIAL, IF PRESENT, EXPECTED TO BE RARE, BUT REMOTE RISK OF INFECTION TO PATIENT CANNOT BE RULED OUT.  Full Article

Biocon And Mylan Launch First Insulin In Australia
Thursday, 3 Oct 2019 

Oct 3 (Reuters) - Biocon Ltd ::BIOCON AND MYLAN LAUNCH FIRST INSULIN GLARGINE BIOSIMILAR, SEMGLEE, IN AUSTRALIA.  Full Article

Mylan Finalizes Previously Disclosed Settlement With U.S. Securities And Exchange Commission
Friday, 27 Sep 2019 

Mylan NV ::MYLAN FINALIZES PREVIOUSLY DISCLOSED SETTLEMENT WITH U.S. SECURITIES AND EXCHANGE COMMISSION.MYLAN NV - SETTLEMENT FULLY RESOLVES SEC'S INVESTIGATION.  Full Article

U.S. SEC says Mylan to pay $30 million over EpiPen
Friday, 27 Sep 2019 

Sept 27 (Reuters) - u.s. Sec says mylan to pay $30 million for disclosure and accounting failures relating to epipen:.  Full Article

Revance Therapeutics Inc - Co & Mylan Ireland Amended Collaboration & License Agreement Dated Feb 28, 2018
Tuesday, 27 Aug 2019 

Aug 27 (Reuters) - Revance Therapeutics Inc ::REVANCE THERAPEUTICS INC - CO & MYLAN IRELAND AMENDED COLLABORATION & LICENSE AGREEMENT DATED FEB 28, 2018.REVANCE- WILL EXTEND TIME PERIOD FOR MYLAN TO DECIDE ON CONTINUATION OF DEVELOPMENT OF BIOSIMILAR TO BRANDED BIOLOGIC PRODUCT (ONABOTULINUMTOXINA).REVANCE THERAPEUTICS INC - MYLAN HAS AGREED TO PAY CO $5 MILLION INCREMENTAL TO PREVIOUSLY AGREED NON-REFUNDABLE UPFRONT PAYMENT OF $25 MILLION.  Full Article

UPDATE 1-European cities plead for more flu shots as winter looms, pandemic rages

WARSAW/MILAN/VIENNA, Oct 22 A surge in demand for vaccines to ward off the winter flu has led to shortages in some European cities, raising the risk of a potentially lethal "twindemic" as COVID-19 cases soar.