$MYL (Mylan N.V.)

$MYL {{ '2016-06-20T16:04:39+0000' | timeago}} • Announcement

Pharma company $MYL said the Attorney General of the Netherlands has rejected the request of the Dutch group VEB to initiate enquiry proceedings at the Enterprise Chamber of the Amsterdam Court of Appeal in respect of VEB's opinion that $MYL's shareholders should approve its public offer for all shares in Meda Aktiebolag.

$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.

$MYL {{ '2017-05-10T12:01:51+0000' | timeago}} • Announcement

Generic pharmaceutical company $MYL reported higher 1Q17 earnings, positively impacted by the increase in earnings from operations. Net income increased 377.69% to $66.4MM or $0.12 per share from $13.9MM or $0.03 per share a year ago. Revenue increased 24.1% YoY to $2.71Bil. Excluding items, $MYL earned $0.93 per share, up 22% YoY.

$MYL {{ '2017-05-01T17:25:57+0000' | timeago}} • Announcement

$MYL's BoD nominated Sjoerd Vollebregt as a candidate for election to its Board at the 2017 Annual Meeting to be held on June 22, 2017. The directors Douglas Leech, Joseph Maroon and Rodney Piatt will retire from the Board effective June 22, 2017 and have not been nominated for reelection at the Annual Meeting.

$MYL {{ '2017-04-20T18:47:12+0000' | timeago}} • Announcement

$MYL announced the US launch of Perphenazine Tablets, a generic version of the reference listed drug, Trilafon Tablets, originally marketed by Schering. $MYL received final approval from the US FDA for its ANDA for this product, used in treatment of schizophrenia and for the control of severe nausea and vomiting in adults.

$MYL {{ '2017-03-28T13:54:33+0000' | timeago}} • Announcement

Pharmaceutical company $MYL appointed Daniel Gallagher as Chief Legal Officer. Gallagher will be joining the company on April 17, 2017.

$MYL {{ '2017-03-20T20:24:10+0000' | timeago}} • Announcement

$MYL gets tentative approval from FDA for its HIV/AIDS drug TLE400 under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). TLE400 is a fixed-dose combination of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate tablets.

$MYL {{ '2017-03-14T10:40:15+0000' | timeago}} • Announcement

$MYL launched Exemestane Tablets, 25 mg, in the US, a generic version of the reference listed drug, $PFE's Aromasin tablets. The company received final approval from the U.S. FDA for its ANDA for this product, which is indicated in the treatment of certain types of breast cancer in women after menopause.

$MYL {{ '2017-03-13T14:45:03+0000' | timeago}} • Announcement

$MYL said that it has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin. Additionally, $MYL has agreed to withdraw its pending Inter Partes Review challenges against two US Genentech patents (patent numbers 6,407,213 and 6,331,415) as part of the settlement.

$MYL {{ '2017-02-16T16:53:22+0000' | timeago}} • Announcement

$MYL and Biocon announced that the U.S. Food and Drug Administration has accepted $MYL's Biologics License Application for MYL-1401H, a proposed biosimilar to Neulasta  (pegfilgrastim), for filing through the 351(k) pathway. The proposed biosimilar to Neulasta is used to reduce duration of neutropenia in adult patients treated with chemotherapy.

$MYL {{ '2017-01-31T16:10:56+0000' | timeago}} • Announcement

$MYL said the District Court of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents relating to Copaxone 40 mg/mL invalid based on obviousness. The invalidated patents are owned by Yeda Research & Development and licensed to Teva Pharmaceuticals.

$MYL {{ '2017-01-11T14:03:26+0000' | timeago}} • Announcement

$MYL and Biocon said the U.S. Food and Drug Administration has accepted $MYL's biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers.

$MYL {{ '2017-01-09T13:33:48+0000' | timeago}} • Announcement

$MYL agreed to buy global rights to Cold-EEZE brand cold remedy line from ProPhase Labs. The closing of the proposed sale is currently expected to occur in 1Q17. Cold-EEZE will become $MYL's largest U.S. OTC brand franchise and further augment its growing U.S. OTC business.

$MYL {{ '2016-12-29T12:21:48+0000' | timeago}} • Announcement

$MYL launched its generic tablet Zovia in U.S. Jai Pharma Ltd, $MYL's subsidiary, got the final approval from FDA for Zovia, which is used by women to prevent pregnancy.

$MYL {{ '2016-12-27T14:16:09+0000' | timeago}} • Announcement

$MYL said the results of the HERITAGE study have been published in the Journal of the American Medical Association. Study results confirm the efficacy and safety of MYL-1401O, the proposed biosimilar trastuzumab co-developed by $MYL and Biocon Ltd, compared to branded trastuzumab, for the treatment of certain types of breast and gastric cancers.

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