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AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder

AstraZeneca and Targacept, Inc. today announced initiation of a Phase 2b clinical trial of TC-5214, a nicotinic channel blocker, as a "switch" monotherapy treatment for patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant therapy. This study is in addition to the companies' Phase 3 RENAISSANCE Program for TC-5214 as an adjunctive treatment for MDD.

7 Feb 2011

The Lancet journal publishes BENLYSTA BLISS-52 study against SLE

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced publication of the BLISS-52 study of BENLYSTA in autoantibody-positive patients with active systemic lupus erythematosus in The Lancet.

7 Feb 2011

Positive results from EpiCept NP-1 Phase IIb trial in patients with CPN

EpiCept Corporation today announced positive results from a Phase IIb trial evaluating the efficacy and safety of EpiCept NP-1 in chemotherapy-induced peripheral neuropathy. EpiCept NP-1 is a topical analgesic cream containing two FDA-approved drugs, amitriptyline and ketamine, in development for the relief of pain from various peripheral neuropathies.

7 Feb 2011

Phase II results of VELCADE in patients with aggressive lymphoma published in Journal of Clinical Oncology

Millennium: The Takeda Oncology Company today announced that Phase II results of a clinical trial examining VELCADE (bortezomib) in patients with previously untreated aggressive lymphoma were published in the Journal of Clinical Oncology.

5 Feb 2011

Amgen, Pfizer present Enbrel new trial results against psoriasis at 69th AAD meeting in New Orleans, LA

Amgen and Pfizer Inc. today announced results from a new trial that demonstrated Enbrel significantly improved scalp involvement in adult patients with moderate to severe plaque psoriasis, compared with placebo. The data will be presented today at the 69th Annual American Academy of Dermatology meeting in New Orleans, La.

5 Feb 2011

Anacor initiates dosing in AN2728 Phase 2b trial for psoriasis

Anacor Pharmaceuticals announced today that the first patient has been dosed in a Phase 2b trial of AN2728, a topical anti-inflammatory product candidate for the treatment of psoriasis. Psoriasis is a chronic inflammatory skin disease that affects approximately 7.5 million people in the United States and over 100 million people worldwide.

4 Feb 2011

Positive results from Photocure's Allumera RevitAll study to improve skin's appearance

Photocure, a Norwegian specialty pharmaceutical company focused in dermatology and cancer, today announced positive results from its consumer trial with Allumera™, a breakthrough cosmetic treatment formulated to improve the skin's appearance.

4 Feb 2011

EntreMed announces publication of ENMD-2076 Phase 1 results against solid tumors in AACR journal

EntreMed, Inc., today announced the publication of key papers on the clinical and preclinical development of ENMD-2076, an Aurora A/angiogenic kinase inhibitor. The clinical data were published in the December 3, 2010 on-line issue of the American Association for Cancer Research journal, Clinical Cancer Research, and are expected to appear soon in the print version of the publication.

4 Feb 2011

Positive results from KYTHERA's ATX-101 Phase IIb study for reduction of submental fat

KYTHERA Biopharmaceuticals, Inc. today announced that it has successfully completed a third Phase II clinical study with ATX-101, a first-in-class adipolytic agent that is under investigation for the reduction of submental ('under-the-chin') fat.

4 Feb 2011

FDA sets new PDUFA date for AstraZeneca's ticagrelor

AstraZeneca announced today that the US Food and Drug Administration (FDA) has acknowledged receipt of the company's reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA).

4 Feb 2011

CVBT seeks FDA 'fast track' designation for CVBT-141B to treat ischemic diabetic wounds

CardioVascular BioTherapeutics, Inc. today announced it has submitted an application to the U.S. FDA to obtain "fast track" designation for CVBT-141B, its biological therapy to treat ischemic diabetic wounds based on the active ingredient fibroblast growth factor-1 (FGF-1).

4 Feb 2011

MicroCHIPS commences first hPTH clinical study in women with osteoporosis

MicroCHIPS, a developer of innovative drug delivery systems, is initiating the first clinical study to demonstrate precisely controlled delivery of a peptide from a multi-reservoir, programmable, implant system.

4 Feb 2011

Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported results through month 36 of the completed FAME™ Study.

4 Feb 2011

Positive top-line results from ILUVIEN Phase 3 trial in patients with DME

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN for the treatment of Diabetic Macular Edema, today announced month 36, top-line readout results for the FAME Study prepared by its licensee, Alimera Sciences.

4 Feb 2011

Ceregene initiates enrollment and dosing in CERE-120 Phase 2b trial for Parkinson's disease

Ceregene, a biopharmaceutical company, announced today that it is progressing with enrollment and dosing in its CERE-120 Phase 2b multi-center, sham-surgery, double-blinded controlled trial in Parkinson's disease.

3 Feb 2011

Positive results from Derma Sciences' Phase 2 trial with DSC127 in patients with diabetic foot ulcers

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced positive results from its Phase 2 clinical trial with DSC127 in patients with diabetic foot ulcers, including meeting the trial's primary endpoint, the proportion of study ulcers healed by 12 weeks as defined by 100% epithelialized with no drainage, as well as all secondary endpoints measured at this time.

3 Feb 2011

New England Journal publishes fidaxomicin Phase 3 trial results against CDI

Optimer Pharmaceuticals, announced The New England Journal of Medicine has published results from the North American Phase 3 trial evaluating the safety and efficacy of the Company's novel antibiotic fidaxomicin as a treatment for patients with Clostridium difficile infection.

3 Feb 2011

Inspiration presents IB1001 PK data for treatment of hemophilia B

Inspiration Biopharmaceuticals, today presented pharmacokinetic data on its lead product, IB1001, a recombinant factor IX for the treatment and prevention of bleeding in individuals with hemophilia B.

3 Feb 2011

First therapeutic vaccine designed from dendritic cells of patient achieves significant response

The therapeutic vaccines are a priority research line of the HIVACAT, the catalan programme for the development of therapeutic vaccines and prevention against the Human Immunodeficiency Virus (HIV). This type of therapeutic vaccine helps the patients who are carriers of the virus, combat infection and control the appearance of AIDS in the same way as with the current antiretroviral treatments.

3 Feb 2011

Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV

Shionogi-ViiV Healthcare, LLC announced today that the first patient has entered the clinical study, SINGLE (ING114467), designed to support a new fixed-dose combination (FDC) therapy for the treatment of HIV.

3 Feb 2011

Drug Trial News

AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder

The Lancet journal publishes BENLYSTA BLISS-52 study against SLE

Positive results from EpiCept NP-1 Phase IIb trial in patients with CPN

Phase II results of VELCADE in patients with aggressive lymphoma published in Journal of Clinical Oncology

Amgen, Pfizer present Enbrel new trial results against psoriasis at 69th AAD meeting in New Orleans, LA

Anacor initiates dosing in AN2728 Phase 2b trial for psoriasis

Positive results from Photocure's Allumera RevitAll study to improve skin's appearance

EntreMed announces publication of ENMD-2076 Phase 1 results against solid tumors in AACR journal

Positive results from KYTHERA's ATX-101 Phase IIb study for reduction of submental fat

FDA sets new PDUFA date for AstraZeneca's ticagrelor

CVBT seeks FDA 'fast track' designation for CVBT-141B to treat ischemic diabetic wounds

MicroCHIPS commences first hPTH clinical study in women with osteoporosis

Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME

Positive top-line results from ILUVIEN Phase 3 trial in patients with DME

Ceregene initiates enrollment and dosing in CERE-120 Phase 2b trial for Parkinson's disease

Positive results from Derma Sciences' Phase 2 trial with DSC127 in patients with diabetic foot ulcers

New England Journal publishes fidaxomicin Phase 3 trial results against CDI

Inspiration presents IB1001 PK data for treatment of hemophilia B

First therapeutic vaccine designed from dendritic cells of patient achieves significant response

Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV

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