$MYL (Mylan N.V.)

$MYL {{ '2017-10-02T17:33:18+0000' | timeago}} • Announcement

$MYL announced the U.S. launch of Caspofungin Acetate for Injection, one of the first generic version of $MRK's Cancidas. $MYL received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for this antifungal which has multiple indications.

$MYL {{ '2017-12-11T17:45:35+0000' | timeago}} • Announcement

$MYL announced that Teva has dismissed its pending district court litigation against Mylan regarding Mylan's Glatiramer Acetate Injection 40 mg/mL. Teva dropped litigation on these patents after the U.S. District Court for the District of Delaware issued a decision adopting Mylan's interpretation of the patents' claims.

$MYL {{ '2017-12-04T14:12:44+0000' | timeago}} • Announcement

$MYL and its Johannesburg-listed partner Aspen announced the U.S. launch of Myleran Injection, a busulfan single-dose drug, with Aspen receiving final approval from the FDA for its Abbreviated New Drug Application (ANDA) for this product.

$MYL {{ '2017-12-01T17:51:46+0000' | timeago}} • Announcement

$MYL received final approval from the FDA for its Abbreviated New Drug Applications (ANDAs) for Heparin Sodium Injection USP, 1,000 USP/mL, 5,000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.

$MYL {{ '2017-11-30T20:16:55+0000' | timeago}} • Announcement

$MYL and India-listed Biocon Ltd announced that the European Medicines Agency (EMA) accepted for review Mylan's Marketing Authorization Applications (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim. Trastuzumab is used to treat certain HER2-positive breast and gastric cancers.

$MYL {{ '2017-11-09T13:14:25+0000' | timeago}} • Announcement

$MYL announced the U.S. launch of Clofarabine Injection, 20 mg/20 mL Single-Dose Vials, a generic version of Genzyme's Clolar. Mylan received final approval from FDA regarding the drug in the treatment of pediatric patients with relapsed or refractory acute lymphoblastic leukemia.

$MYL {{ '2017-11-06T19:56:57+0000' | timeago}} • Webcast

$MYL expects the mid-single-digit global generic price deflation in 3Q17 to continue for FY17.

$MYL {{ '2017-11-06T17:23:02+0000' | timeago}} • Infographic

$MYL Mylan N.V. Earnings AlphaGraphic: Q3 2017 Highlights

$MYL {{ '2017-11-06T13:26:48+0000' | timeago}} • Announcement

Primarily as a result of the launch of generic Copaxone, $MYL now sees FY17 total revenues in the range of $11.75-12.50Bil. Adjusted EPS for the year is now expected to be $4.45-4.70 per share.

$MYL {{ '2017-11-06T13:24:31+0000' | timeago}} • Announcement

With slumping sales of EpiPen troubling $MYL, the specialty pharma company saw total revenue slumping 2% to $2.99Bil in 3Q17. Mylan turned to profit, with net earnings jumping more than 170% to $88.3MM or $0.16 per share in the quarter.

$MYL {{ '2017-10-17T16:40:23+0000' | timeago}} • Announcement

$MYL announced that the United States District Court for the Eastern District of Texas issued a decision finding all asserted claims of the patents relating to Restasis invalid. The Court recognized that $AGN's patent protection for Restasis ended in 2014.

$MYL {{ '2017-10-04T11:50:31+0000' | timeago}} • Announcement

Pharma company $MYL said it received FDA approval for its Abbreviated New Drug Applications for two variants of Glatiramer Acetate injection, a generic version of $TEVA’s Copaxone - indicated for the treatment of multiple sclerosis. Mylan expects to start shipping of the medicines soon, which will be available by prescription only.

$MYL {{ '2017-10-02T17:33:18+0000' | timeago}} • Announcement

$MYL announced the U.S. launch of Caspofungin Acetate for Injection, one of the first generic version of $MRK's Cancidas. $MYL received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for this antifungal which has multiple indications.

$MYL {{ '2017-09-29T21:46:47+0000' | timeago}} • Announcement

$MYL announced the US launch of Imatinib Mesylate Tablets, a generic version of Novartis's Gleevec Tablets. $MYL received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which has multiple indications, including for several blood cancers.

$MYL {{ '2017-09-14T19:22:15+0000' | timeago}} • Announcement

$MYL announced the US launch of Norethindrone Acetate and Ethinyl Estradiol Tablets USP, and Ferrous Fumarate Tablets, which is indicated for use by women to prevent pregnancy. $MYL’s subsidiary, Mylan Laboratories Limited, received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for this product.

$MYL {{ '2017-09-13T15:45:16+0000' | timeago}} • Announcement

$MYL appointed Dennis Zeleny as chief human relations officer. Zeleny joins Mylan with 30 years of experience leading global, corporate HR organizations and consulting on HR policy matters.

$MYL {{ '2017-09-08T21:46:48+0000' | timeago}} • Announcement

$MYL issued statement on warning letter issued to $PFE's EpiPen auto-injector manufacturing site. Pfizer is continuing to work with the FDA to resolve the points raised in the warning letter regarding Pfizer’s manufacturing of the EpiPen products and Mylan will do whatever it can to support this process.

$MYL {{ '2017-09-08T21:46:14+0000' | timeago}} • Announcement

$MYL issued statement on warning letter issued to $PFE's EpiPen auto-injector manufacturing site. The letter was issued in connection with FDA's inspection of Pfizer’s pharmaceutical manufacturing facility located in Brentwood, Missouri, where the EpiPen products are manufactured.

$MYL {{ '2017-08-17T20:41:08+0000' | timeago}} • Announcement

$MYL, a pharma company, announced that its subsidiaries, Mylan Inc. and Mylan Specialty L.P., have signed an agreement with the U.S. Department of Justice and two relators. This is to finalize the Medicaid drug rebate settlement that the company announced on Oct 7, 2016 for $465MM.

$MYL {{ '2017-08-10T14:13:12+0000' | timeago}} • Announcement

Pharma company $MYL has launched three generic drugs for HIV treatment, in Canada. The company recently received final approval for the products from Health Canada. The new products offer generic alternative to popular HIV drugs Truvada, Atripla and Viread.

$MYL {{ '2017-08-09T21:34:36+0000' | timeago}} • Announcement

$MYL cut down its outlook for FY17, hit by the price erosion and delay in the launch of its new drugs. Mylan lowered its revenue expectation to $11.5-12.5Bil from the prior range of $12.25-13.75Bil. Adjusted EPS target was cut down to $4.30-4.70 from the prior estimate of $5.15-5.55 for FY17, and from $6.00 to currently "at least $5.40" for FY18.

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