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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

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22 Jun 2018
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Wed, Jun 13 2018

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FDA finds deficiencies in Mylan's generic Advair; shares fall

Mylan NV said on Wednesday that U.S. health regulators were unable to approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug Advair for the second time, as they found "minor deficiencies" in the treatment.

UPDATE 2-FDA finds deficiencies in Mylan's generic Advair; shares fall

* Shares fall 4.5 pct after market (Adds analyst comment; updates shares)

FDA finds deficiencies in Mylan's generic Advair

June 13 U.S. drugmaker Mylan NV said on Wednesday that U.S. health regulators could not approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug, Advair, and cited "minor deficiencies" with the copycat version.

FDA approves Mylan drug as first biosimilar to Amgen's Neulasta

Mylan NV on Monday beat a clutch of drugmakers racing to get a biosimilar to Amgen Inc's blockbuster drug, Neulasta, to market, with U.S. health regulators approving its version of the infection-fighting treatment.

UPDATE 2-FDA approves Mylan drug as first biosimilar to Amgen's Neulasta

* Mylan shares up 5.2 pct, Amgen down 1.7 pct after market (Adds analyst comment, updates shares)

FDA approves Mylan's biosimilar to Neulasta

June 4 The U.S. Food And Drug Administration on Monday approved a drug from Mylan NV as the first biosimilar to Amgen's drug Neulasta to help reduce the risk of infection during cancer treatment.

DoJ investigates Mylan on trade compliance for certain products

Pharmaceuticals company Mylan NV said on Thursday that one of its subsidiary received a civil investigative demand from the U.S. Department of Justice regarding its compliance with the Trades Agreement Act (TAA) for certain products, according to a filing with the U.S. Securities and Exchange Commission.

U.S. DoJ investigates Mylan on trade compliance for certain products

May 10 Pharmaceuticals company Mylan NV said on Thursday that one of its subsidiary received a civil investigative demand from the U.S. Department of Justice regarding its compliance with the Trades Agreement Act (TAA) for certain products, according to a filing with the U.S. Securities and Exchange Commission. The company also said certain employees of Mylan S.p.A. were served with search warrants issued by the public prosecutor's office in Milan, Italy, seeking information concerni

BRIEF-Mylan Says Non-Contingent Payments For 4 Agreements Total About $265 Mln

* MYLAN NV - NON-CONTINGENT PAYMENTS FOR 4 AGREEMENTS, 3 OF WHICH WERE ENTERED INTO AFTER MARCH 31, 2018, TOTAL ABOUT $265.0 MILLION - SEC FILING

In Europe, Mylan's rivals try to plug EpiPen shortages

LONDON European makers of emergency allergy treatments are stepping up production of alternative life-saving adrenaline shots to try to fill intermittent shortages of Mylan's market-leading EpiPen injection.

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