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Positive results from Orexo's OX219 clinical study on opioid dependence

Orexo AB (STO:ORX) today announced that it has obtained positive results in a clinical study with OX219, which is being developed for the treatment of opioid dependence.

21 Sep 2011

Niiki Pharma announces positive data from ongoing trial of novel anti-cancer agent NKP-1339

Niiki Pharma Inc. announced interim results from the ongoing Phase I clinical trial of its lead product, NKP-1339. NKP-1339 is a first-in-class transferrin targeted small molecule that down-regulates GRP78, a key regulator of mis-folded protein processing and a tumor survival factor.

20 Sep 2011

Gilead’s new 4 in 1 combo HIV pill works

Gilead Sciences Inc's four-drug experimental HIV pill worked as well as a regimen containing protease inhibitor Reyataz in the second pivotal trial of the drug, the company announced this Monday. Although the trial succeeded, it did not show the experimental pill, called the Quad, was superior to the Reyataz regimen and Gilead shares fell less than a percentage point.

20 Sep 2011

U-M Professor to review data from three prominent studies on heart failure

Roughly 5 million people in the United States live with heart failure, a condition in which the heart is unable to pump blood around the body effectively. The causes and types of heart failure vary greatly, and treatment must be tailored to each patient. In some cases, doctors will prescribe a class of diuretic drugs called aldosterone antagonists.

20 Sep 2011

Gilead’s Quad Phase 3 clinical study in treatment-naïve HIV-1 patients meets 48-week primary objective

Gilead Sciences, Inc. today announced that the second pivotal Phase 3 clinical trial of its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada.

20 Sep 2011

New research has potential to alleviate side effects of cancer treatments

Beth Faiman MSN, CNP, a doctoral candidate at the Frances Payne Bolton School of Nursing at Case Western Reserve University, is studying whether an over-the-counter medication could ease chemotherapy side effects for people with blood and bone marrow cancers.

20 Sep 2011

Tokai raises $23M in Series D3 financing

Tokai Pharmaceuticals, a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that it has raised $23 million in a Series D3 financing.

20 Sep 2011

Major donors should consider funding for potential malaria vaccine

When the results of a large clinical trial testing the effectiveness of the RTS,S malaria vaccine among children in Africa are made available later this year, "it will be time to start discussing what to do with the vaccine," Orin Levine, executive director of the International Vaccine Access Center at Johns Hopkins University, writes in a Huffington Post opinion piece.

20 Sep 2011

Top-line data from Santarus' budesonide MMX extended use study on ulcerative colitis

Santarus, Inc., a specialty biopharmaceutical company, today announced that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX 6 mg or placebo will be provided as support for the company's planned submission of a New Drug Application (NDA) for budesonide MMX 9 mg to the U.S. Food and Drug Administration (FDA) for the induction of remission of mild or moderate active ulcerative colitis.

20 Sep 2011

Keryx completes enrollment in Zerenex Phase 3 long-term study for hyperphosphatemia

Keryx Biopharmaceuticals today announced completion of patient enrollment in the long-term study component of its Phase 3 registration program of Zerenex, the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

20 Sep 2011

Infant formulas fortified with LCPUFA are good for developing brains and hearts

University of Kansas scientists have found new evidence that infant formulas fortified with long chain polyunsaturated fatty acids (LCPUFA) are good for developing brains and hearts.

20 Sep 2011

LA BioMed andrologist leads new male contraceptive Phase I clinical study

Christina Wang, M.D., lead investigator at Los Angeles Biomedical Research Institute (LA BioMed) - one of the leading biomedical research institutes in the country - is currently working on a Phase I single dose and multiple dose study that tests the safety and tolerability of a new androgen dimethandrolone undecanoate that is being developed as a potential male contraceptive agent.

20 Sep 2011

Scientists pioneer new combination treatment for prostate cancer

Scientists at Queen's University have pioneered a new combination treatment for prostate cancer. The treatment, which has been successful in phase one of trials, will now be tested for efficacy in a second phase.

20 Sep 2011

Positive data from NovaDigm's NDV-3 vaccine preclinical study on VVC

NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced the presentation of positive data from a preclinical study evaluating the efficacy its NDV-3 vaccine in a model of vulvovaginal candidiasis (VVC), which is primarily caused by Candida albicans.

20 Sep 2011

Preclinical studies shows EmPAC more effective than Taxol

Cornerstone Pharmaceuticals, Inc. has announced the publication of data from preclinical studies on EmPAC™, its nanoparticle reformulation of paclitaxel, in the August issue of the Journal of Nanoscience and Nanotechnology. The publication highlights data demonstrating improved safety and efficacy of EmPAC™ versus Taxol®, the generic formulation of paclitaxel and one of the most widely prescribed chemotherapies. EmPAC™ is a nanoemulsion formulation of Paclitaxel and is the lead product candidate of Cornerstone’s proprietary Emulsiphan™ cancer selective delivery nanotechnology platform. Taxol®, an injectable formulation of Paclitaxel, is currently used to treat a variety of cancers, including ovarian carcinomas, breast cancer, non-small cell lung cancer, and AIDS-related Kaposi’s sarcoma.

19 Sep 2011

Phenex commences Px-102 first-in-man Phase I study for Metabolic Syndrome and NAFLD

Phenex Pharmaceuticals AG announced today the start of a first-in-man Phase I study with its clinical drug candidate Px-102, a synthetic non-steroidal FXR agonist. The volunteers of the first dose level received the drug and showed no signs of discomfort or other adverse effects.

19 Sep 2011

Positive Phase 1 data for NovaDigm NDV-3 vaccine presented at 51st ICAAC

NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced the presentation of positive Phase 1 data for its NDV-3 vaccine program at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

19 Sep 2011

Tarsa reports positive data from OSTORA Phase III ORACAL trial for postmenopausal osteoporosis

Tarsa Therapeutics today reported that it presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA, the company's oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.

19 Sep 2011

Top-line data from Spectrum's SPI-1620 Phase 1 combination study on carcinoma

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that top-line data from part one of a two-part Phase 1 study of SPI-1620 in combination with docetaxel was presented in an oral presentation at the 12th International Conference on Endothelin, held in Cambridge, United Kingdom, from September 11-14, 2011. Part one of the study has been completed, while part two is ongoing.

19 Sep 2011

Inhibitex initiates INX-189 combination Phase 2 trial in HCV-infected genotype 2/3 patients

Inhibitex, Inc., announced today that it has recently commenced dosing in a 90-patient randomized, placebo controlled, treatment guided, Phase 2 clinical trial to evaluate the safety, tolerability and antiviral activity of INX-189 in combination with pegylated interferon and ribavirin in chronic HCV-infected genotype 2 and 3 treatment naïve patients.

19 Sep 2011