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Mylan NV (MYL.O)

MYL.O on Nasdaq

38.29USD
19 Oct 2017
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Latest Key Developments (Source: Significant Developments)

Biocon says ‍U.S. FDA issued complete response letter for proposed biosimilar Pegfilgrastim​
Monday, 9 Oct 2017 11:26pm EDT 

Oct 10 (Reuters) - Biocon Ltd ::Says ‍US FDA issues complete response letter (CRL) for proposed biosimilar Pegfilgrastim​.Says ‍CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity​.Says ‍do not expect CRL to impact commercial launch timing of biosimilar Pegfilgrastim in US​.‍CRL relates to pending update of BLA with certain data from facility requalification activities post recent plant modifications​.  Full Article

Mylan launches first AP-rated generic Avelox injection
Thursday, 5 Oct 2017 07:30am EDT 

Oct 5 (Reuters) - Mylan NV : :Mylan launches first AP-rated generic Avelox® injection.Mylan NV - ‍announced U.S. launch of Moxifloxacin Hydrochloride, first AP-rated generic version of Bayer's Avelox ​.  Full Article

Mylan confirms U.S. Launch of first generic for Copaxone 40 mg/ml 3-times-a-week
Wednesday, 4 Oct 2017 06:28pm EDT 

Oct 4 (Reuters) - Mylan Nv :Mylan confirms U.S. Launch of first generic for Copaxone 40 mg/ml 3-times-a-week and generic for Copaxone 20 mg/ml once-daily.Says ‍shipments for Copaxone​ to customers have commenced.  Full Article

Teva comments on anticipated at-risk U.S. Launch of generic Glatiramer Acetate
Wednesday, 4 Oct 2017 09:26am EDT 

Oct 4 (Reuters) - Teva Pharmaceutical Industries Ltd :Teva comments on anticipated at-risk U.S. Launch of generic Glatiramer Acetate 40mg/ml and launch of generic Glatiramer Acetate 20mg/ml.‍Any launch by Mylan of generic version of Copaxone prior to final resolution of pending patent litigation should be considered "at-risk" launch​.‍Early assessment of impact of generic launches to earnings for Q4 ended Dec 31, 2017 is that it could be affected by at least $0.25 cents/share​.  Full Article

Mylan launches generic Cancidas for injection
Monday, 2 Oct 2017 12:39pm EDT 

Oct 2 (Reuters) - Mylan Nv ::Mylan launches generic Cancidasfor injection.Mylan received final approval from U.S. FDA for its Abbreviated New Drug Application for this antifungal which has multiple indications.  Full Article

Mylan launches generic Gleevec tablets
Friday, 29 Sep 2017 05:00pm EDT 

Sept 29 (Reuters) - Mylan Nv :Mylan launches generic Gleevec® tablets.Mylan - Annouces U.S. launch of imatinib mesylate tablets, 100 mg, 400 mg ; co received final approval from U.S. FDA for ANDA on the product​.  Full Article

Mylan expands women's healthcare portfolio with launch of generic Minastrin 24 FE tablets
Thursday, 14 Sep 2017 12:04pm EDT 

Sept 14 (Reuters) - Mylan NV ::Mylan expands women's healthcare portfolio with launch of generic Minastrin 24 FE tablets.Announced U.S. launch of Norethindrone Acetate and Ethinyl Estradiol tablets USP, and Ferrous Fumarate Tablets, 1 mg/20 mcg.  Full Article

Otsuka and Mylan announce license agreement to commercialize Delamanid
Thursday, 24 Aug 2017 03:00am EDT 

Aug 24 (Reuters) - Mylan Nv :Mylan NV- Otsuka Pharmaceutical Co Ltd, co entered into license agreement between their respective subsidiaries ONPG and Mylan Pharmaceuticals Private Limited.Mylan NV- license deal to commercialize Delamanid for treatment of adults with pulmonary multidrug-resistant tuberculosis in low & middle-income countries.Mylan NV- under terms of the agreement, Mylan has been granted license by Otsuka to prioritize access to Deltyba™ in South Africa and India.  Full Article

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

BRIEF-‍Mylan invalidates Allergan's patents on Restasis​

* U.S. district court for Eastern District of Texas issued decision finding asserted claims of patents relating to Restasis invalid ​