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Repligen's fiscal 2010 total revenue decreases to $20,971,000

Repligen Corporation today reported results for the fourth quarter and fiscal year 2010, ended March 31, 2010. Total revenue for the year was $20,971,000 compared to total revenue of $29,362,000 for fiscal year 2009 ended March 31, 2009.

9 Jun 2010

Discovery Labs reports preliminary results from Surfaxin Phase 2 trial in children with Acute Respiratory Failure

Discovery Laboratories, Inc., reports preliminary results from its Phase 2 clinical trial of Surfaxin® in children with Acute Respiratory Failure (ARF), a critical condition often caused in children by severe respiratory infections. The objective of the study was to evaluate the safety and tolerability of intratracheal administration of Surfaxin and to assess whether Surfaxin treatment could decrease the duration of mechanical ventilation in children with ARF.

9 Jun 2010

NWBT announces release of new detailed report by Pharmaceuticals and Biotech Analyst

Northwest Biotherapeutics, Inc., developer of the DCVax personalized cancer vaccine, today announced the release of a new detailed report by Pharmaceuticals and Biotech Analyst Dr. Navid Malik of the London-based Matrix Group.

9 Jun 2010

Vital Therapies commences enrollment in ELAD SILVER trial for acute-on-chronic liver failure

Vital Therapies, Inc., (VTI) is pleased to announce that the first two subjects have been enrolled at King's College Hospital in London in the expansion of its SILVER (Stabilization In LiVER failure) clinical trial in Europe. The trial is evaluating whether VTI's biological cellular therapy product, ELAD®, can prevent deterioration of liver function and improve the survival of patients with acute-on-chronic liver failure (ACLF).

9 Jun 2010

Lantheus Medical Imaging reports Phase 1 data of LMI 1195 heart failure PET imaging agent

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced Phase 1 data for its novel heart failure Positron Emission Tomography (PET) imaging agent, LMI 1195, which is in development for the evaluation of patients at risk of heart failure or sudden cardiac death.

9 Jun 2010

Breast tomosynthesis holds promise for early breast cancer detection

In the U.S., one out of eight women will develop breast cancer in her lifetime. The earlier the breast cancer is found, the more likely a woman will live a normal life, said Stephen Rose, M.D., a breast radiologist at Memorial Hermann Memorial City.

9 Jun 2010

DSM commences cGMP-manufacturing of Novacta's C. difficile compound

DSM BioSolutions today announced that it has entered into an agreement with Novacta Biosystems Limited, Welwyn Garden City, UK, for the process development and cGMP production of its C. difficile molecule, a new class of lantibiotic compounds.

9 Jun 2010

Blood vessel-blocking drug slows prostate cancer progression: Experts

A blood vessel-blocking drug called tasquinimod slowed the rate of disease progression in a clinical trial of 200 prostate cancer patients, according to experts at Johns Hopkins, Roswell Park Cancer Institute and Duke University.

9 Jun 2010

FDA approves City of Hope's neural stem cell-based therapy study for recurrent high-grade gliomas

City of Hope researchers received approval from the U.S. Food and Drug Administration (FDA) to conduct the first-in-human study of a neural stem cell-based therapy targeting recurrent high-grade gliomas, the most aggressive type of brain tumor. Karen S. Aboody, M.D., associate professor in City of Hope's Department of Neurosciences, leads the research team that developed this treatment strategy. Jana Portnow, M.D., assistant professor and assistant director of the Brain Tumor Program at City of Hope, is the principal investigator for the clinical trial.

9 Jun 2010

Covance opens state-of-the-art biorepository facility at Greenfield

Covance Inc., a leading provider of drug development services, announced today that it has opened a state-of-the-art biorepository facility at its Greenfield, Indiana location. The 20,000-square-foot building is dedicated to long-term storage of clinical trial specimens. The facility is able to store a wide-range of specimens, including plasma, serum, whole blood, DNA, PBMC, and tissue.

9 Jun 2010

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

Helix BioPharma Corp. today announced results from the Phase II clinical trial assessing the efficacy and safety of Topical Interferon Alpha-2b cream for the treatment of ano-genital warts (AGW).

9 Jun 2010

PharmaMar commences Aplidin Phase III registration trial for multiple myeloma

PharmaMar SA today announced that a registration trial in relapsed/refractory multiple myeloma patients has been initiated with Aplidin(R) (plitidepsin) in combination with dexamethasone versus dexamethasone alone.

9 Jun 2010

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Abbott today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.

9 Jun 2010

Argos presents positive AGS-003 Phase 2 data for newly diagnosed advanced renal cell carcinoma at ASCO

Argos Therapeutics today announced the presentation of positive interim data from a Phase 2 trial that evaluated the clinical activity, safety and immune response of AGS-003 treatment, given in combination with sunitinib, in patients with newly diagnosed advanced renal cell carcinoma (RCC). The data were discussed June 7 in a poster session at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago, IL.

8 Jun 2010

HPV-positive tumor status is strong prognostic factor for head, neck cancer

Oropharyngeal cancer patients whose tumors in the upper part of the throat test positively for the human papillomavirus (HPV) have better overall survival than patients with HPV-negative disease, researchers from The University of Texas MD Anderson Cancer Center report in a study published in The New England Journal of Medicine.

8 Jun 2010

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

Aerovance Inc. today announced top-line results from its Phase 2b clinical trial that show the inhaled dry powder formulation of Aerovant (pitrakinra inhalation powder) is effective in a pre-defined subset of patients with eosinophilic asthma.

8 Jun 2010

GTx reports positive results from toremifene Phase III clinical trial

GTx, Inc. announced today that in the Phase III clinical trial evaluating toremifene 80 mg for the reduction of fractures and treatment of other estrogen deficiency side effects in men with prostate cancer on androgen deprivation therapy (ADT), toremifene treatment demonstrated an improved benefit/risk ratio in men less than 80 years of age. The data were presented yesterday at the 2010 Annual Meeting of the American Society of Clinical Oncology in Chicago.

8 Jun 2010

Idera reports preliminary results from IMO-3100 Phase 1 clinical trial for autoimmune, inflammatory diseases

Idera Pharmaceuticals, Inc. today announced preliminary results from a Phase 1 clinical trial of IMO-3100, its lead Toll-like Receptor (TLR) 7 and TLR9 antagonist drug candidate for potential applications in autoimmune and inflammatory diseases. In this trial, healthy subjects in five dosage cohorts received single doses of IMO-3100 from 0.04 to 0.64 mg/kg. IMO-3100 was well tolerated at all dose levels.

8 Jun 2010

Protalix BioTherapeutics reports positive results from PRX-105 Phase I clinical trial

Protalix BioTherapeutics, Inc. announced today the completion of its phase I clinical trial of PRX-105, a plant cell expressed pegylated recombinant human acetylcholinesterase in development for biodefense indications. The trial established the pharmacokinetics of the protein and demonstrated that single dose, intravenous administration of PRX-105 is safe and well tolerated.

8 Jun 2010

$UC-MSCT improves symptoms, biochemical values in patients with severe refractory SLE: Study$

UC-MSCT improves symptoms, biochemical values in patients with severe refractory SLE: Study

A new study shows that umbilical cord mesenchymal stem cell transplant may improve symptoms and biochemical values in patients with severe refractory systemic lupus erythematosus.

8 Jun 2010

Clinical Trial News and Research

Repligen's fiscal 2010 total revenue decreases to $20,971,000

Discovery Labs reports preliminary results from Surfaxin Phase 2 trial in children with Acute Respiratory Failure

NWBT announces release of new detailed report by Pharmaceuticals and Biotech Analyst

Vital Therapies commences enrollment in ELAD SILVER trial for acute-on-chronic liver failure

Lantheus Medical Imaging reports Phase 1 data of LMI 1195 heart failure PET imaging agent

Breast tomosynthesis holds promise for early breast cancer detection

DSM commences cGMP-manufacturing of Novacta's C. difficile compound

Blood vessel-blocking drug slows prostate cancer progression: Experts

FDA approves City of Hope's neural stem cell-based therapy study for recurrent high-grade gliomas

Covance opens state-of-the-art biorepository facility at Greenfield

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

PharmaMar commences Aplidin Phase III registration trial for multiple myeloma

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Argos presents positive AGS-003 Phase 2 data for newly diagnosed advanced renal cell carcinoma at ASCO

HPV-positive tumor status is strong prognostic factor for head, neck cancer

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

GTx reports positive results from toremifene Phase III clinical trial

Idera reports preliminary results from IMO-3100 Phase 1 clinical trial for autoimmune, inflammatory diseases

Protalix BioTherapeutics reports positive results from PRX-105 Phase I clinical trial

UC-MSCT improves symptoms, biochemical values in patients with severe refractory SLE: Study

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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

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