$MYL (Mylan N.V.)

$MYL {{ '2015-11-19T20:11:26+0000' | timeago}} • Announcement

$MYL said that it has launched its generic version of $TEVA's Adderall (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate) tablets in the U.S., 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg, for the treatment of ADHD. According to the IMS Health, the U.S. market is about $570.4MM.

$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.

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

$MYL, which got the approval to launch its HIV drug in India recently, reported a 76% jump in 2Q17 profit, aided by the acquisition of Swedish drugmaker Meda last year. Net earnings were $297MM in the quarter and GAAP EPS surged 67% to $0.55. Revenue grew 16% to $2.96Bil, while adjusted EPS slipped 5% to $1.10.

$MYL {{ '2017-08-09T15:03:57+0000' | timeago}} • Infographic

$MYL Mylan N.V. Earnings AlphaGraphic: Q2 2017 Highlights

$TBPH {{ '2017-07-20T12:32:48+0000' | timeago}} • Announcement

$TBPH and $MYL announced positive results from a 12-month Phase 3 safety study of revefenacin in patients with chronic obstructive pulmonary disease (COPD). The study of 1,055 patients with COPD demonstrated that revefenacin was generally well-tolerated, and no new safety issues were identified.

$MYL {{ '2017-07-14T12:05:52+0000' | timeago}} • Announcement

Pharma firm $MYL said the FDA Oncologic Drugs Advisory Committee has recommended approval of the biosimilar trastuzumab developed by Mylan along with India-based Biocon Ltd. for  treatment of breast cancer. The committee determined no clinically meaningful differences exist between the biosimilar product and cancer drug Herceptin.

$TBPH {{ '2017-05-23T15:28:15+0000' | timeago}} • Announcement

$TBPH and $MYL announced the presentation of additional efficacy and safety data from the three-month, pivotal Phase 3 studies of revefenacin at the American Thoracic Society International Conference in Washington, D.C. Revefenacin is an investigational long-acting muscarinic antagonist.

$MYL {{ '2017-05-10T15:37:21+0000' | timeago}} • Webcast

On the Advair issue, $MYL said the Food and Drug Administration (FDA) has not asked the company to do any additional clinical endpoints or device related studies. The FDA has rejected the company's generic version of Advair, a $GSK's drug to treat asthma and chronic lung conditions.

$MYL {{ '2017-05-10T15:14:54+0000' | timeago}} • Webcast

In terms of new products, $MYL said it is working towards the roadmap of launching new products worth about $850MM for 2017. The company is on track on generating $850MM from those new product introductions and expects the launches to be heavier in 2H17.

$MYL {{ '2017-05-10T12:55:59+0000' | timeago}} • Infographic

$MYL Mylan N.V. Earnings AlphaGraphics: Q1 2017 highlights

$MYL {{ '2017-05-10T12:08:49+0000' | timeago}} • Announcement

$MYL's third party net sales in all three of its segments increased for 1Q17, helped by net sales from the acquisition of Meda and the Topicals Business. In North America, third party net sales increased 5% YoY to $1.21Bil, while in Europe net sales increased 53% to $892MM. Rest of World third party net sales increased 34% to $580.5MM.

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