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Biopure submits IND for trial in patients with acute myeloid leukemia

Biopure Corporation has announced that it has submitted to the Food and Drug Administration (FDA) an investigational new drug (IND) application to conduct a pilot phase 2 clinical trial of the company's oxygen therapeutic Hemopure [hemoglobin glutamer - 250 (bovine)].

17 Dec 2008

Voriconazole effective in combating fungal infections

The effectiveness of voriconazole in combating fungal infections has been confirmed by a new study to be featured in the International Journal of Antimicrobial Agents, published by Elsevier.

16 Dec 2008

Lessons from Northwick Park drug-trial disaster

Scientists investigating the 2006 Northwick Park drug-trial disaster that left six healthy volunteers hospitalised say they have developed new pre-clinical tests that could have stopped the trial from ever going ahead.

From The University of Manchester 15 Dec 2008

Aspirin does not provide protection against Lynch syndrome

Aspirin, recommended as a preventive approach for patients at risk of hereditary colorectal cancer, does not provide protection against Lynch syndrome, the most common form of hereditary colorectal cancer, according a study published in the Dec. 11 issue of the New England Journal of Medicine.

15 Dec 2008

Three studies of bioTheranostics molecular breast cancer diagnostics presented at symposium

bioTheranostics, a bioMerieux company that discovers, develops and commercializes new molecular diagnostic tests in oncology, reported today findings from three studies using the company's molecular breast cancer assay to predict risk of disease recurrence in individual patients.

14 Dec 2008

Cymbalta (duloxetine HCl) shown to delay new episodes of depression

New data suggest that Cymbalta (duloxetine HCl) 60 mg to 120 mg once daily delayed the onset of a new episode of depression in patients who had previously responded to the medication and who had recurrent depressive disorder, defined in the study as those patients who experienced at least three depressive episodes in the previous five years, compared with placebo (p < .001).

14 Dec 2008

Doxil and docetaxel combination treatment delays disease progression in metastatic breast cancer

Results from a Phase 3 study show that patients with metastatic breast cancer who were treated previously with an anthracycline in the adjuvant setting experienced a significant improvement in time to disease progression (TTP) and overall response rates after receiving a combination of DOXIL (doxorubicin HCl liposome injection) and docetaxel as compared to docetaxel alone.

14 Dec 2008

Exparel (DepoBupivacaine) shows promise in hernia repair

A Phase II trial of a single intraoperative administration of Exparel (DepoBupivacaine) resulted in significantly reduced pain with activity in the first 8 to 24 hours following surgery, when pain is generally greatest, compared to conventional treatment.

14 Dec 2008

Planned safety analysis of a breast cancer prevention study reveals encouraging news for Exemestane

An interim analysis of a breast cancer prevention study using exemestane (Aromasin) finds an "acceptable" level of bone loss.

14 Dec 2008

Paliperidone palmitate shows positive results for treatment of schizophrenia

Paliperidone palmitate, an investigational long-acting therapy (LAT) demonstrated statistically significant symptom control compared with placebo according to the results of a 13-week study.

14 Dec 2008

Zometa (zoledronic acid) shown to enhance chemotherapy in reducing breast tumor size

New data released demonstrates that the addition of Zometa (zoledronic acid) injection to standard chemotherapy before breast cancer surgery reduces the size of breast tumors more effectively than chemotherapy alone in women with early-stage disease.

14 Dec 2008

Promising clinical trial for Progeria "premature aging" disease

One of the fastest translations of a basic research discovery into a promising clinical trial for an "untreatable" and fatal disorder will be discussed publicly for the first time by the key players in this remarkable research story, on Sunday, Dec. 14, at the American Society for Cell Biology (ASCB)'s annual meeting in San Francisco.

14 Dec 2008

Femara shows reduced risk of death versus tamoxifen after breast cancer surgery

Femara showed reduced risk of death by 13% (P=0.08) versus tamoxifen, despite inclusion of patients who had switched over from tamoxifen to Femara during the study period, following the study's unblinding.

14 Dec 2008

Novavax announces positive results in trial of seasonal influenza VLP (trivalent) vaccine candidate

Novavax, Inc. has announced favorable results from a Phase IIa human clinical trial of its seasonal influenza VLP (trivalent) vaccine candidate.

12 Dec 2008

Aromatase inhibitors most effective in preventing breast cancer from coming back

Two separate meta-analyses of clinical trials from around the world that tested tamoxifen against aromatase inhibitor drugs in postmenopausal women with early breast cancer have each reached the same conclusion: aromatase inhibitors are more effective in preventing breast cancer from coming back.

12 Dec 2008

Delcath Systems enrols first fifty percent in trial treating metastatic cutaneous and ocular melanoma to the liver

Delcath Systems, Inc. has announced that the first fifty percent (46 of 92) of patients have been enrolled in the Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver.

12 Dec 2008

Trial looks at new treatment for solid cancer tumors and non-Hodgkin's lymphoma

Researchers at The Cancer Institute of New Jersey (CINJ) have opened a clinical trial, which aims to evaluate a new treatment for solid cancer tumors and non-Hodgkin's lymphoma (NHL) in combination with a chemotherapy agent called cyclophosphamide.

12 Dec 2008

Vaxfectin-formulated H5N1 pandemic influenza achieves T-cell responses and cross-clade reactivity in humans

Vical Incorporated has announced that the company's Vaxfectin-formulated H5N1 pandemic influenza DNA vaccines induced T-cell responses against a matching strain of influenza virus and demonstrated cross-clade antibody responses against a different strain in a Phase 1 clinical trial.

11 Dec 2008

AEterna Zentari completes recruitment for phase 3 trial with Cetrorelix in benign prostatic hyperplasia

AEterna Zentaris Inc. has reported it has reached its goal of recruiting 500 patients for the safety study of the Phase 3 program in benign prostatic hyperplasia (BPH) with its flagship product candidate, cetrorelix, a novel investigational luteinizing hormone-releasing hormone (LHRH) antagonist.

11 Dec 2008

$Proteolix announces positive data for carfilzomib in patients with relapsed and refractory multiple myeloma$

Proteolix announces positive data for carfilzomib in patients with relapsed and refractory multiple myeloma

Proteolix, Inc. today announced positive clinical data demonstrating that the company's lead product, carfilzomib, has single-agent activity and promotes durable responses in patients with relapsed and refractory multiple myeloma.

10 Dec 2008

Drug Trial News

Biopure submits IND for trial in patients with acute myeloid leukemia

Voriconazole effective in combating fungal infections

Lessons from Northwick Park drug-trial disaster

Aspirin does not provide protection against Lynch syndrome

Three studies of bioTheranostics molecular breast cancer diagnostics presented at symposium

Cymbalta (duloxetine HCl) shown to delay new episodes of depression

Doxil and docetaxel combination treatment delays disease progression in metastatic breast cancer

Exparel (DepoBupivacaine) shows promise in hernia repair

Planned safety analysis of a breast cancer prevention study reveals encouraging news for Exemestane

Paliperidone palmitate shows positive results for treatment of schizophrenia

Zometa (zoledronic acid) shown to enhance chemotherapy in reducing breast tumor size

Promising clinical trial for Progeria "premature aging" disease

Femara shows reduced risk of death versus tamoxifen after breast cancer surgery

Novavax announces positive results in trial of seasonal influenza VLP (trivalent) vaccine candidate

Aromatase inhibitors most effective in preventing breast cancer from coming back

Delcath Systems enrols first fifty percent in trial treating metastatic cutaneous and ocular melanoma to the liver

Trial looks at new treatment for solid cancer tumors and non-Hodgkin's lymphoma

Vaxfectin-formulated H5N1 pandemic influenza achieves T-cell responses and cross-clade reactivity in humans

AEterna Zentari completes recruitment for phase 3 trial with Cetrorelix in benign prostatic hyperplasia

Proteolix announces positive data for carfilzomib in patients with relapsed and refractory multiple myeloma

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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