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FDA provides a Complete Response Letter for Somaxon Pharmaceuticals' Silenor NDA

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

7 Dec 2009

Æterna Zentaris reports Phase 3 results of its cetrorelix pamoate Z-036 trial for BPH

Æterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today reported Phase 3 results for its European efficacy trial Z-036 in benign prostatic hyperplasia (BPH), with cetrorelix pamoate.

7 Dec 2009

UCB presents data on Vimpat AED at AES meeting

UCB today announced new findings on its antiepileptic drug (AED) Vimpat® that offer additional clinical evidence supporting the use of this AED as adjunctive therapy in adult patients with partial-onset seizures. Results of presented research demonstrate sustained efficacy in adult patients taking Vimpat® for up to three years, and a consistent long-term tolerability profile.

7 Dec 2009

ICON, CMFT collaborate to develop translational medicine facilities on the MRI campus

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced details of its new translational medicine unit in Manchester, UK. The unit is the first deliverable from a collaborative agreement between ICON and the Central Manchester University Hospitals Foundation (CMFT) to develop purpose-built translational medicine facilities on the newly-developed Manchester Royal Infirmary (MRI) campus.

7 Dec 2009

Micromedex 2.0, the new version of clinical information system to be released

Thomson Reuters today announced the release of Micromedex 2.0, the newest version of its market-leading clinical information system.

7 Dec 2009

Dabigatran etexilate prevents recurrent VTE with less bleeding than warfarin

Boehringer Ingelheim today announced very positive results from their landmark RE-COVER™ study – the most advanced trial programme assessing a novel oral anticoagulant in development for acute venous thromboemolism (VTE) treatment – presented at the American Society of Hematology Annual Meeting1 and published in the New England Journal of Medicine online.

7 Dec 2009

Positive clinical data from Phase II study of elacytarabine in patients with AML reported

Clavis Pharma ASA announces that positive clinical data from its Phase II study with its lead cancer product candidate elacytarabine in patients with late-stage acute myeloid leukaemia (AML) was presented at the 51st American Society of Hematology (ASH) Annual Meeting in New Orleans, LA, USA.

7 Dec 2009

Anticoagulants used to prevent clots in placental blood vessels ineffective, reveals research

Blood clotting, or coagulation, is an important process that prevents excessive bleeding when a blood vessel is injured. Sometimes, however, clots form on the inside of vessels without an obvious injury or do not dissolve naturally, a potentially life-threatening situation requiring treatment.

7 Dec 2009

New tool to determine the economic impact of diabetes on Canadian society

In a report released today, An Economic Tsunami: The Cost of Diabetes in Canada, the Canadian Diabetes Association has introduced an important new tool in the fight against diabetes in Canada: the Canadian Diabetes Cost Model.

7 Dec 2009

Poster summarizing clinical trial data regarding SB-743921 presented by Cytokinetics

Cytokinetics, Incorporated announced today that a poster summarizing clinical trial data regarding SB-743921 was presented at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition held December 5-8, 2009 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

7 Dec 2009

Researchers explore optimal induction therapies for managing blood cancer

There have been significant scientific advances in the field of blood cancers, and leading experts continue to gain a better understanding of how certain diseases progress in order to discover new treatment options and provide patients with the best care.

7 Dec 2009

New analyses of data from Allos Therapeutics’ pivotal PROPEL trial of FOLOTYN reported

Allos Therapeutics, Inc. today reported new analyses of data from the Company’s pivotal PROPEL trial of FOLOTYN™ (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

7 Dec 2009

Alexion Pharmaceuticals announces positive data from AEGIS study of Soliris

Alexion Pharmaceuticals, Inc. today announced positive data from the 26-week extension of the AEGIS study, an open-label registration study examining Soliris® (eculizumab) for the treatment of Japanese patients with paroxysmal nocturnal hemoglobinuria (PNH).

7 Dec 2009

Amgen announces results from three studies on the safety and efficacy of Nplate

Amgen Inc. today announced results from three studies on the safety and efficacy of Nplate® (romiplostim) in adult patients with myelodysplastic syndromes (MDS).

7 Dec 2009

Updated safety data from Phase 2b 003-A1 study of carfilzomib announced

Onyx Pharmaceuticals, Inc. today announced updated safety data from the pivotal Phase 2b 003-A1 study, known as the 003 trial, demonstrating that carfilzomib is well-tolerated in heavily pre-treated relapsed and refractory multiple myeloma patients.

7 Dec 2009

Study finds substantial variation in hydroxyurea utilization for sickle cell disease

A new study by researchers from the Medical College of Wisconsin, in Milwaukee, found a substantial variation in hydroxyurea utilization for pain and other sickle cell disease complications in children.

7 Dec 2009

Dabigatran etexilate offers effective therapy to prevent recurrent VTE

Results from the landmark RE-COVER(TM) study were presented today at the American Society of Hematology Annual Meeting and published online in the New England Journal of Medicine.

6 Dec 2009

New treatment options for leukemia and myeloproliferative disorders introduced

Leukemia and myeloproliferative disorders are serious and often deadly blood cancers. Research presented today at the 51st Annual Meeting of the American Society of Hematology introduces potential new treatment options and improved diagnostic methods for patients suffering from acute promyelocytic leukemia, chronic myeloid leukemia, infant acute lymphoblastic leukemia, and myelofibrosis that are based on a better understanding of the underlying genetic causes of these conditions.

6 Dec 2009

PharmAthene's Valortim demonstrates potential for anthrax treatment

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the Company is presenting results of a study demonstrating the effectiveness of Valortim® in an inhalation anthrax model in the New Zealand White (NZW) rabbit.

5 Dec 2009

Scientists report cervarix vaccine offers protection against cervical cancer

The Cervarix vaccine provides protection against two types of human papillomavirus (HPV) for more than six years, US scientists have reported.

5 Dec 2009

Efficacy News and Research

FDA provides a Complete Response Letter for Somaxon Pharmaceuticals' Silenor NDA

Æterna Zentaris reports Phase 3 results of its cetrorelix pamoate Z-036 trial for BPH

UCB presents data on Vimpat AED at AES meeting

ICON, CMFT collaborate to develop translational medicine facilities on the MRI campus

Micromedex 2.0, the new version of clinical information system to be released

Dabigatran etexilate prevents recurrent VTE with less bleeding than warfarin

Positive clinical data from Phase II study of elacytarabine in patients with AML reported

Anticoagulants used to prevent clots in placental blood vessels ineffective, reveals research

New tool to determine the economic impact of diabetes on Canadian society

Poster summarizing clinical trial data regarding SB-743921 presented by Cytokinetics

Researchers explore optimal induction therapies for managing blood cancer

New analyses of data from Allos Therapeutics’ pivotal PROPEL trial of FOLOTYN reported

Alexion Pharmaceuticals announces positive data from AEGIS study of Soliris

Amgen announces results from three studies on the safety and efficacy of Nplate

Updated safety data from Phase 2b 003-A1 study of carfilzomib announced

Study finds substantial variation in hydroxyurea utilization for sickle cell disease

Dabigatran etexilate offers effective therapy to prevent recurrent VTE

New treatment options for leukemia and myeloproliferative disorders introduced

PharmAthene's Valortim demonstrates potential for anthrax treatment

Scientists report cervarix vaccine offers protection against cervical cancer

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