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Science journal names UNC HIV prevention study as 2011 Breakthrough of the Year

The HIV Prevention Trials Network 052 study, led by Myron S. Cohen, MD of the University of North Carolina at Chapel Hill, has been named the 2011 Breakthrough of the Year by the journal Science.

23 Dec 2011

ThromboGenics submits ocriplasmin BLA with FDA to treat symptomatic VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that it has submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ocriplasmin Intravitreal Injection, 2.5 mg/mL, for the treatment of symptomatic VMA including macular hole.

23 Dec 2011

EpiCept receives FDA approval to commence AmiKet Phase III trial for CIPN

EpiCept Corporation today announced that at a meeting earlier this week with the U.S. Food and Drug Administration (FDA), the Company was granted permission to initiate immediately the Phase III clinical development of AmiKet.

23 Dec 2011

Azithromycin shows promise against trachoma-related blindness

A UCSF study shows a popular treatment for a potentially blinding eye infection is just as effective if given every six months versus annually. This randomized study on trachoma, the leading cause of infection-caused blindness in the world, could potentially treat twice the number of patients using the same amount of medication.

22 Dec 2011

AVEO initiates enrollment in tivozanib and mFOLFOX6 Phase 2 combination trial for CRC

AVEO Pharmaceuticals, Inc. today announced the initiation of patient enrollment in an open-label, multicenter, randomized Phase 2 clinical trial, called BATON-CRC, evaluating tivozanib in combination with modified FOLFOX6 (mFOLFOX6) compared to bevacizumab in combination with mFOLFOX6 as first-line therapy in patients with advanced metastatic colorectal cancer.

22 Dec 2011

Researchers evaluate Clade C HIV envelope protein in Phase I trial

In the first clinical trial of an injectable vaccine containing trimeric HIV envelope protein (gp140) relevant to the predominant strain of HIV in Africa, researchers from four UK academic centers (St George's University London, Imperial College, Hull York Medical School (HYMS; University of York) and the Medical Research Council Clinical Trial Unit) and from the Infectious Disease Research Institute (IDRI) have come together to evaluate whether the vaccine is safe for use in human volunteers.

22 Dec 2011

Denali Concrete Management initiates enrollment in CF101 phase 3 study for Dry Eye Syndrome

Denali Concrete Management Inc. announced today that it has commenced patient enrollment for a phase 3 clinical study of the safety and efficacy of CF101, daily administered orally, in patients with moderate-to-severe Dry Eye Syndrome.

21 Dec 2011

Chlorthalidone may reduce risk of death in patients with systolic hypertension

Patients with systolic hypertension who were treated with the diuretic chlorthalidone for 4.5 years as part of a clinical trial had a significantly lower rate of death and a gain in life expectancy free from cardiovascular death about 20 years later compared to patients who received placebo, according to a study in the December 21 issue of JAMA.

21 Dec 2011

Antihypertensive drug therapy associated with longer life expectancy

More than 68 percent of Americans 65 and older - 80 percent age 75 and over - have hypertension (high blood pressure), according to a 2010 report by the Centers for Disease Control. Left untreated, this chronic condition can lead to stroke, heart attack, heart failure or premature death. Researchers at UMDNJ-Robert Wood Johnson Medical School have shown in a follow-up to the landmark clinical trial, Systolic Hypertension in the Elderly Program (SHEP), that the use of antihypertensive drug therapy is associated with longer life expectancy.

21 Dec 2011

University of Western Ontario receives FDA approval to begin SAV001 HIV trial

The first and only preventative HIV vaccine based on a genetically modified killed whole virus has received approval by the United States Food and Drug Administration (FDA) to start human clinical trials.

21 Dec 2011

Vacc-4x nasal vaccine can effectively treat HIV

Thirty years after AIDS was first described, there is still no effective vaccine against the HIV virus. Worldwide, roughly 33 million people are HIV-positive. Researchers are working to find out whether a HIV vaccine developed by a Norwegian biotech company can be administered nasally.

21 Dec 2011

UCB initiates EXXELERATE study in rheumatoid arthritis

UCB today announced the start of the EXXELERATE study which will evaluate the short- and long-term efficacy of Cimzia (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira(adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.

21 Dec 2011

Takeda enters agreement to acquire Intellikine

Takeda Pharmaceutical Company Limited and Intellikine, Inc. today announced that Takeda America Holdings, Inc., a wholly-owned subsidiary of Takeda, and Intellikine, a privately-held company focused on the discovery and development of innovative, small molecule drugs, have entered into an agreement for Takeda America Holdings to acquire Intellikine by cash.

21 Dec 2011

DHEA hormone may help a woman's menopausal symptoms, sex life

A new study has shown that the DHEA, a hormone mostly secreted by the adrenal glands, may be able to help a woman's menopausal symptoms, as well as giving her a better sex life.

20 Dec 2011

Top-line results from Genzyme's teriflunomide and Rebif Phase III comparison trial on RMS

Genzyme, a Sanofi company, today reported top-line results from TENERE, a Phase III clinical trial comparing the effectiveness, safety and tolerability of once-daily oral teriflunomide to interferon beta-1a, an approved injectable therapy, in people with relapsing forms of multiple sclerosis.

20 Dec 2011

Top-line results from AstraZeneca and Targacept's TC-5214 Phase 3 study on MDD

AstraZeneca and Targacept, Inc. today announced top-line results from the second of four RENAISSANCE Phase 3 studies investigating the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant treatment.

20 Dec 2011

Impax commences IPX159 Phase IIb trial in Restless Legs Syndrome

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., announced that it has initiated a Phase IIb trial of its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome.

20 Dec 2011

Atox Bio to advance AB103 Phase 2 study with $3.25M financing

Atox Bio, developer of therapeutics for diseases mediated by an excessive inflammatory response, today announced that it has raised $3.25 million in an initial closing. The investment was co-led by Esperante and a private US-based investor and will be used to advance AB103, currently in phase 2 clinical studies for the treatment of Necrotizing Soft Tissue Infections (NSTI).

19 Dec 2011

Phase I clinical study of Selexys SelG1 for sickle cell disease completed

Selexys Pharmaceuticals announced today that it has completed a Phase I clinical study of its lead compound SelG1, an antibody specific for the pro-inflammatory cell adhesion molecule P-selectin.

19 Dec 2011

ALS TDI, Biogen Idec and UCB enter agreement to study anti-CD40L antibody for ALS

The ALS Therapy Development Institute today announced a research agreement with Biogen Idec and UCB Pharma SA to investigate the use of an anti-CD40L antibody as a potential therapy for Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's or Motor Neuron Disease.

19 Dec 2011