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Neptune, Acasti completes preclinical program comparing CaPre with Lovaza

Neptune Technologies & Bioressources Inc. subsidiary, Acasti Pharma Inc., reports the completion of its preclinical program designed to compare the lipid management effects of Acasti's drug candidate CaPre versus prescription drug Lovaza.

25 Nov 2010

Response to PLX4032 drug short lived in BRAF-mutated metastatic melanoma patients

Researchers with UCLA's Jonsson Comprehensive Cancer Center have found that melanoma patients whose cancers are caused by mutation of the BRAF gene become resistant to a promising targeted treatment through another genetic mutation or the overexpression of a cell surface protein, both driving survival of the cancer and accounting for relapse.

25 Nov 2010

Advaxis initiates ADXS11-001 clinical trial for cervix cancer

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has begun dosing patients in its 110 patient clinical trial of ADXS11-001 for the treatment of cervix cancer in women for whom cytotoxic treatment has failed.

24 Nov 2010

Important queries about PrEP, iPrEx trial for HIV infection

The results of the iPrEx PrEP effectiveness trial of once-daily TDF/FTC (brand name Truvada) in gay men, transgender women and other men who have sex with men are a landmark in HIV prevention research.

24 Nov 2010

HIV treatment drugs also help prevent HIV infection in high-risk men: Study

In a significant advance for HIV prevention research, a clinical trial confirms that the same drugs used for treating HIV can also help prevent HIV infection in the first place.

24 Nov 2010

iPrEx study: PrEP reduces HIV infection risk among gay, bisexual men

A daily dose of an oral antiretroviral drug, currently approved to treat HIV infection, reduced the risk of acquiring HIV infection by 43.8 percent among men who have sex with men.

24 Nov 2010

NIH expands genetic and clinical research database to provide access to digital study images

The National Institutes of Health has expanded a genetic and clinical research database to give researchers access to the first digital study images.

24 Nov 2010

iPrEx oral PrEP study achieves major milestone in HIV prevention research

This is a great day in the fight against AIDS. The positive results of the iPrEx oral PrEP study are a major milestone in HIV prevention research and provide important information about how antiretroviral drugs might be used for prevention by HIV-negative people at high risk for HIV infection, said AVAC Executive Director Mitchell Warren.

24 Nov 2010

BioAlliance presents AMEP preclinical, phase I clinical results for melanoma at Electrochemotherapy Meeting

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, presented preclinical and promising preliminary phase I clinical results with its AMEP biotherapy at the "Electrochemotherapy 1st International Users' Meeting"(Bologna, Italy, November 19-20, 2010).

23 Nov 2010

ViiV Healthcare awards $20 million to Idenix for GSK2248761 clinical milestone

Idenix Pharmaceuticals, Inc, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company will receive a payment of $20 million from the ViiV Healthcare Company for the achievement of a clinical milestone relating to GSK2248761.

23 Nov 2010

Implanted devices to treat cardiac dysfunction show success in real world use

Implanted devices that treat cardiac dysfunction in heart failure patients are as successful in "real world" use as they are in controlled clinical trial settings, according to a large new study reported in Circulation: Journal of the American Heart Association.

23 Nov 2010

CEL-SCI holds clinical investigator meeting for Multikine Phase III clinical trial in head, neck cancer

CEL-SCI Corporation today announced that the Company held a clinical investigator meeting during the week of November 14th for its Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer.

23 Nov 2010

DoD awards Regenicin and Lonza $18 million to develop PermaDerm for severe burns

The U.S. Department of Defense recently awarded more than $18 million in funding to a unit of Lonza Group, Ltd. for the development and commercialization of the therapeutic candidate, PermaDerm™ for the treatment of severe burns among U.S. troops and civilians. The funding was announced at a conference celebrating advancements in regenerative medicine on November 9th in Walkersville, MD.

23 Nov 2010

Apricus files protocol of PrevOnco Phase 3 clinical trial for FDA SPA program

Apricus Biosciences, Inc., today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco, its proprietary treatment for hepatocellular carcinoma (liver cancer), with the U.S. Food and Drug Administration (FDA).

23 Nov 2010

BioCancell raises $5.1 million by excess demand in public offering

Success for BioCancell Therapeutics Inc. Excess demand in BioCancell's public offering of shares and warrants generated immediate proceeds of $5.1 million, 18% above its stated minimal fundraising goal of $4.3 million.

23 Nov 2010

Stem cell trial for eye disease receives FDA approval

The second clinical trial involving stem cells from human embryonic cells has received the go-ahead. The news came from Advanced Cell Technology Inc. this Monday. The company announced that the U.S. Food and Drug Administration has cleared the way for its Phase I/II trial of retinal cells for patients with Stargardt’s macular dystrophy, a childhood version of macular degeneration.

22 Nov 2010

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

22 Nov 2010

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

Neurocrine Biosciences, Inc. today announced results from the open-label portion of the six month Phase II Daisy PETAL study (901 study) using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

22 Nov 2010

FDA grants ACT clearance for Phase I/II clinical trial of hESC derived retinal cells in patients with SMD

Advanced Cell Technology, Inc. announced today that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt's Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world. The decision removes the clinical hold that the FDA had placed on the trial.

22 Nov 2010

Mimetogen initiates MIM-D3 Phase II clinical trial for dry eye disease

Mimetogen Pharmaceuticals Inc., a clinical-stage biotechnology company focused on developing novel small molecule compounds that mimic the effects of neurotrophins, today announced that it has initiated the first human clinical trial evaluating MIM-D3, a mimetic of nerve growth factor (NGF), in a Phase II clinical trial in patients with moderate to severe dry eye disease. MIM-D3 is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye that is responsible for the maintenance of corneal nerves and epithelium, mucin and tear production.

22 Nov 2010

Clinical Trial News and Research

Neptune, Acasti completes preclinical program comparing CaPre with Lovaza

Response to PLX4032 drug short lived in BRAF-mutated metastatic melanoma patients

Advaxis initiates ADXS11-001 clinical trial for cervix cancer

Important queries about PrEP, iPrEx trial for HIV infection

HIV treatment drugs also help prevent HIV infection in high-risk men: Study

iPrEx study: PrEP reduces HIV infection risk among gay, bisexual men

NIH expands genetic and clinical research database to provide access to digital study images

iPrEx oral PrEP study achieves major milestone in HIV prevention research

BioAlliance presents AMEP preclinical, phase I clinical results for melanoma at Electrochemotherapy Meeting

ViiV Healthcare awards $20 million to Idenix for GSK2248761 clinical milestone

Implanted devices to treat cardiac dysfunction show success in real world use

CEL-SCI holds clinical investigator meeting for Multikine Phase III clinical trial in head, neck cancer

DoD awards Regenicin and Lonza $18 million to develop PermaDerm for severe burns

Apricus files protocol of PrevOnco Phase 3 clinical trial for FDA SPA program

BioCancell raises $5.1 million by excess demand in public offering

Stem cell trial for eye disease receives FDA approval

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

FDA grants ACT clearance for Phase I/II clinical trial of hESC derived retinal cells in patients with SMD

Mimetogen initiates MIM-D3 Phase II clinical trial for dry eye disease

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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