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ARCA biopharma submits Gencaro trial protocol for review under the FDA’s SPA process

ARCA biopharma, Inc. today announced that it has submitted a study protocol for review under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of GencaroTM, in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator.

23 Dec 2009

US Phase 2 clinical trial of RVX-208 commenced by Resverlogix

Resverlogix Corp. ("Resverlogix" or the "Company") announced today that it has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD).

23 Dec 2009

Eritoran well tolerated in Phase II trial for severe sepsis

The investigational compound, eritoran tetrasodium ("eritoran," also known as E5564) appeared to be well tolerated in patients with severe sepsis in a Phase II trial published in the January issue of Critical Care Medicine, the official journal of the Society of Critical Care Medicine, the largest multiprofessional organization dedicated to ensuring excellence and consistency in the practice of critical care.

22 Dec 2009

Effectiveness of Genfit’s GFT505 clinical drug candidate questioned

It has come to the attention of Genfit, a leading biotech company listed on Alternext, that an undisclosed group of so-called “well known scientific experts” have issued a press release, via a news wire, purporting to put into question the effectiveness of Genfit’s main clinical drug candidate GFT 505.

22 Dec 2009

Study results of CSL’s pandemic H1N1 2009 vaccine published in JAMA

CSL Limited, Australia’s leading biopharmaceutical company, announced the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study CSL’s pandemic H1N1 2009 ‘swine’ flu vaccine.

22 Dec 2009

DSM BioSolutions to manufacture Mayoly Spindler's 'MS1819' lipase biotherapeutic

DSM BioSolutions today announced that it has entered into an agreement with Laboratoires Mayoly Spindler, Chatou Cedex, France, for the manufacture of "MS1819" lipase.

22 Dec 2009

LEO Pharma announces positive results for two Phase III AK clinical trials

LEO Pharma today announced positive results for the company’s two Phase III actinic (solar) keratosis (AK) clinical trials using PEP005 (ingenol mebutate) Gel for the treatment of lesions on head treatment areas, which include the face and scalp.

22 Dec 2009

Results from Phase I trial of Bryan Oncor's targeted radiopharmaceutical therapy reported

Bryan Oncor reports the results of a Phase I trial of its targeted radiopharmaceutical therapy using Re-88 P2045, a radiolabeled synthetic peptide, for the treatment of advanced lung cancer.

21 Dec 2009

Oxford Finance to provide Titan Pharmaceuticals a $3M term loan

Titan Pharmaceuticals, Inc. today announced that it has entered into a Loan and Security Agreement with Oxford Finance Corporation ("Oxford") for a $3 million term loan. The loan will bear interest at an approximate rate of 13% per annum and be payable over three years. Under the terms of the agreement, Titan will pay Oxford an initial facility fee of $60,000 and a final payment fee of $180,000.

21 Dec 2009

Neurocrine to advance its NBI-98854 VMAT2 Inhibitor into a multiple repeated dose Phase 1 study

Neurocrine Biosciences, Inc. today announced their highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, NBI-98854, will be advanced in clinical development.

21 Dec 2009

Positive interim results from Idera Pharmaceuticals' IMO-2125 Phase 1 clinical trial for HCV

Idera Pharmaceuticals, Inc. today announced positive interim results from a Phase 1 clinical trial of IMO-2125 in patients with chronic hepatitis C virus infection (HCV). IMO-2125 is an agonist of Toll-like Receptor 9 that Idera designed to treat HCV by inducing endogenous interferon-alpha and other Th1-type cytokines and chemokines.

21 Dec 2009

Teva Pharmaceutical Industries, OncoGenex Pharmaceuticals announce collaboration in cancer therapy

Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced today that they have entered into a global license and collaboration agreement to develop and commercialize OGX-011, as well as an agreement to purchase shares in OncoGenex. OGX-011 is a Phase III cancer therapy designed to inhibit cancer treatment resistance.

21 Dec 2009

OncoGenex Pharmaceuticals to pay Isis Pharmaceuticals $10M for license of OGX-011 to Teva Pharmaceutical Industries

Isis Pharmaceuticals, Inc. today announced that it will receive a $10 million payment from OncoGenex Pharmaceuticals, Inc. as a result of OncoGenex' license of OGX-011 to Teva Pharmaceutical Industries Ltd. ( TEVA). OGX-011 is a second-generation antisense drug co-discovered by Isis and OncoGenex that has completed a successful Phase 2 program in patients with advanced prostate cancer and advanced non-small cell lung cancer.

21 Dec 2009

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

CPEX Pharmaceuticals, Inc. today announced that the ongoing Phase 2a clinical trial of Nasulin™, the Company’s intranasal insulin candidate, has now completed enrollment. The study was initiated in February of this year and randomized 94 subjects. Results are expected at the end of the first quarter or beginning of the second quarter of 2010.

21 Dec 2009

Eli Lilly, Incyte announce collaboration for development and commercialization of INCB28050 oral inhibitor

Eli Lilly and Company and Incyte Corporation announced today that they have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of Incyte's oral JAK1/JAK2 inhibitor, INCB28050, and certain follow on compounds, for inflammatory and autoimmune diseases. The lead compound, INCB28050, is currently being studied in a six-month dose-ranging Phase II trial for rheumatoid arthritis.

21 Dec 2009

Intra-Cellular Therapies announces results of its ITI-007 antipsychotic drug Phase I study

Intra-Cellular Therapies, Inc. (ITI) announced at a recent conference on neuropsychiatric diseases the results from a recently completed Phase I clinical study demonstrating ITI-007, the Company's lead antipsychotic drug, interacts with important targets in the living human brain. These key targets are critical to drug action in many neuropsychiatric and related disorders.

21 Dec 2009

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Medicago Inc. a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

21 Dec 2009

Soligenix commences SGX201 Phase 1/2 clinical trial for acute radiation enteritis prevention

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP), for the prevention of acute radiation enteritis.

21 Dec 2009

Preliminary results from Phase III study of afamelanotide in EPP announced

Clinuvel Pharmaceuticals Limited today announced that it has obtained promising 4-months results in testing afamelanotide in a multicentre randomised double-blind placebo controlled Phase III study in EPP (CUV017).

21 Dec 2009

Taro Pharmaceutical Industries initiates its T2007 non-sedating barbiturate compound Phase I clinical trials

Taro Pharmaceutical Industries Ltd. announced that it has begun Phase I clinical trials in Canada with T2007, the second in the Company’s class of proprietary non-sedating barbiturate compounds to be approved for studies in humans.

18 Dec 2009

Drug Trial News

ARCA biopharma submits Gencaro trial protocol for review under the FDA’s SPA process

US Phase 2 clinical trial of RVX-208 commenced by Resverlogix

Eritoran well tolerated in Phase II trial for severe sepsis

Effectiveness of Genfit’s GFT505 clinical drug candidate questioned

Study results of CSL’s pandemic H1N1 2009 vaccine published in JAMA

DSM BioSolutions to manufacture Mayoly Spindler's 'MS1819' lipase biotherapeutic

LEO Pharma announces positive results for two Phase III AK clinical trials

Results from Phase I trial of Bryan Oncor's targeted radiopharmaceutical therapy reported

Oxford Finance to provide Titan Pharmaceuticals a $3M term loan

Neurocrine to advance its NBI-98854 VMAT2 Inhibitor into a multiple repeated dose Phase 1 study

Positive interim results from Idera Pharmaceuticals' IMO-2125 Phase 1 clinical trial for HCV

Teva Pharmaceutical Industries, OncoGenex Pharmaceuticals announce collaboration in cancer therapy

OncoGenex Pharmaceuticals to pay Isis Pharmaceuticals $10M for license of OGX-011 to Teva Pharmaceutical Industries

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

Eli Lilly, Incyte announce collaboration for development and commercialization of INCB28050 oral inhibitor

Intra-Cellular Therapies announces results of its ITI-007 antipsychotic drug Phase I study

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Soligenix commences SGX201 Phase 1/2 clinical trial for acute radiation enteritis prevention

Preliminary results from Phase III study of afamelanotide in EPP announced

Taro Pharmaceutical Industries initiates its T2007 non-sedating barbiturate compound Phase I clinical trials

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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