Tetraphase to Present New Data at IDWeek on Eravacycline’s Potential Activity in Treating Serious Respiratory Infections

New Drug Approvals

File:Eravacycline-.png

eravacycline

http://www.ama-assn.org/resources/doc/usan/eravacycline.pdf

1-Pyrrolidineacetamide, N-[(5aR,6aS,7S,10aS)-9-(aminocarbonyl)-7-(dimethylamino)-
4-fluoro-5,5a,6,6a,7,10,10a,12-octahydro-1,8,10a,11-tetrahydroxy-10,12-dioxo-2-
naphthacenyl]-
(4S,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-
[(pyrrolidin-1-ylacetyl)amino]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide

MOLECULAR FORMULA C27H31FN4O8
MOLECULAR WEIGHT 558.6

SPONSOR Tetraphase Pharmaceuticals, Inc.
CODE DESIGNATION TP-434
CAS REGISTRY NUMBER 1207283-85-9
WHO NUMBER 9702

Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) today announced that it will present two posters at IDWeek 2013 that examine the potential of its lead antibiotic candidate eravacycline to treat serious multi-drug resistant (MDR) infections. The first will highlight positive results of a Phase 1 study assessing the bronchopulmonary disposition safety and tolerability of eravacycline in healthy men and women; this study represents the first clinical assessment of eravacycline for potential use in treating pneumonia. The second poster will provide the results of a study that examined the activity of eravacycline in vitro against multiple Gram-negative and Gram-positive pathogens to set quality-control limits for monitoring eravacycline activity in future testing programs.
http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=79335#.Uk6MOoanonU
More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=79335#.Uk6MOoanonU#ixzz2gkEMTtQm

Eravacycline (TP-434) is a synthetic fluorocycline antibiotic in development.

Eravacycline…

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Orexigen files obesity drug Contrave for approval in Europe

New Drug Approvals

Orexigen files obesity drug Contrave for approval in Europe

Orexigen Therapeutics  has submitted the Marketing Authorization Application (MAA) for Contrave, an investigational weight-loss drug to the European Medicines Agency (EMA). 

OREXIGNEThe La Jolla, CA-based  drug firm is using the EMA’s centralised procedure to seek approval for Contrave  Orexigen (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification. The company filed the application after meeting with the European agency to discuss the filing strategy and “both were supportive” of the company’s plan to file in advance of an eagerly-anticipated interim analysis of a cardiovascular outcomes trial called the Light study. Orexigen and the European regulator have also agreed upon an investigation plan in children and adolescents.

read all at

http://www.pharmatopics.com/2013/10/orexigen-files-obesity-drug-contrave-approval-europe/

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