$CARA (Cara Therapeutics Inc.)

$CARA {{ '2015-12-09T14:25:56+0000' | timeago}} • Announcement

Biotechnology company $CARA announced positive topline results from its Phase 2a trial of oral CR845 in patients with osteoarthritis of the knee or hip. All tablet strengths were generally well tolerated with no drug-related SAEs. Based on these results, $CARA plans to conduct a larger double-blind, placebo-controlled Phase 2b trial in 2016.

$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.

$NKTR {{ '2017-07-18T13:13:43+0000' | timeago}} • Announcement

Pharma company $NKTR said a study on pain relief drug NKTR-181 demonstrated less abuse potential, compared to commonly used medicine oxycodone.  The study was designed to assess the relative oral abuse potential of the formulation at its maximum dose. The FDA has granted NKTR-181 fast track designation for treatment of moderate to severe pain.

$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.

$SYK {{ '2017-06-19T12:28:25+0000' | timeago}} • Announcement

$SYK agreed to buy $NVDQ. The transaction is expected to be dilutive to $SYK's 2017 adjusted EPS by $0.03-0.05. There is no change in $SYK's 2017 adjusted EPS forecast of $6.35-6.45. For 2018, this transaction is expected to be neutral to $SYK's earnings and accretive thereafter.

$SYK {{ '2017-06-19T12:26:47+0000' | timeago}} • Announcement

$SYK agreed to buy $NVDQ for $11.75 per share, or $701MM with a net purchase price of $654MM, reflecting net cash of about $47MM. The transaction is expected to close at the end of 3Q17.

$NKTR {{ '2017-06-05T13:23:39+0000' | timeago}} • Announcement

$NKTR presented new clinical data from two studies of NKTR-214, a CD122-biased agonist, its lead immuno-oncology candidate at the 2017 American Society of Clinical Oncology Annual Meeting. This is designed to expand specific cancer-fighting CD8 effector T cells and natural killer cells directly in tumor micro-environment.

$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.

$NKTR {{ '2017-05-09T21:43:12+0000' | timeago}} • Announcement

Biopharmaceutical company $NKTR 1Q17 net loss widened to $63.9MM, or $0.42 per share, compared to $19.5MM, or $0.14 per share during 1Q16. The increase in YoY loss was mainly due to the recognition of $28MM received from AstraZeneca.

$NKTR {{ '2017-05-03T18:46:17+0000' | timeago}} • Announcement

$NKTR announced the appointment of Brian Kotzin, M.D. as Head of Clinical Development for its Immunology Program. Dr. Kotzin will lead clinical development for NKTR-358, a first-in-class regulatory T cell stimulator, being developed for the treatment of immune and inflammatory disorders.

$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.

$NKTR {{ '2017-03-20T17:10:03+0000' | timeago}} • Announcement

$NKTR announced positive results from the SUMMIT-07 Phase 3 efficacy study of NKTR-181, an opioid painkiller. The FDA granted the investigational drug a fast track designation for the treatment of moderate to severe chronic pain.

$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.

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