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Clinical trial of 2009 H1N1 influenza vaccine

HIV-infected adults currently are being recruited to participate in a clinical trial of 2009 H1N1 influenza vaccine. The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health, will enroll approximately 240 men and women between the ages of 18 and 64.

13 Dec 2009

Lapatinib plus trastuzumab extend lives of HER2-positive breast cancer patients

Lapatinib plus trastuzumab are significantly better than lapatinib alone in extending the lives of breast cancer patients whose tumors are HER2-positive, according to Kimberly Blackwell, M.D., associate professor of medicine at Duke University Medical Center.

12 Dec 2009

Enrollment of patients for Phase IIb clinical trial of WBI-1001 commenced

Welichem today announced that the Company has begun to enroll patients in a Phase IIb clinical trial with its lead candidate, WBI-1001. The Phase IIb clinical trial is a double-blinded, placebo-controlled, 12-week-treatment study.

12 Dec 2009

Phase 1 clinical trial of iCo-007 demonstrates positive safety profile

iCo Therapeutics Inc. - iCo Therapeutics ("iCo") is pleased to announce that its Phase 1 clinical trial of iCo-007, having enrolled all patients in four cohorts of increasing concentration (110ug, 350ug, 700ug, 1000ug), has to date demonstrated a positive safety profile.

12 Dec 2009

Phase 2 pivotal trial of AC220 initiated by Ambit Biosciences

Ambit Biosciences Corporation announced today the enrollment and dosing at the University of Texas M. D. Anderson Cancer Center of the first patient in the ACE (AC220 Monotherapy Efficacy) Phase 2 pivotal trial in patients with relapsed or refractory acute myeloid leukemia (AML).

11 Dec 2009

Pfizer's Prevenar 13 granted European marketing authorization

The European Commission has granted Pfizer Inc. a European marketing authorization for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]). Prevenar 13 is indicated for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 Streptococcus pneumoniae serotypes in infants and children from 6 weeks to 5 years of age. Invasive pneumococcal disease includes sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema.

11 Dec 2009

Arena Pharmaceuticals' lorcaserin demonstrates low abuse potential

Arena Pharmaceuticals, Inc. reported that positive data from a clinical trial evaluating the abuse potential of lorcaserin were presented in a poster session at the 48th Annual Meeting of the American College of Neuropsychopharmacology. Data from the trial demonstrate that the risk for abuse associated with lorcaserin is very low.

11 Dec 2009

New data suggests bisphosphonate drug may play a role in reducing recurrent breast cancer

Bisphosphonates are routinely given to women with postmenopausal breast cancer, but new data suggests that these agents may play a role in reducing recurrent breast cancer as well.

11 Dec 2009

Chemotherapy improves overall survival in postmenopausal breast cancer patients

Chemotherapy generally improves survival in postmenopausal breast cancer patients, according to a landmark study led by Dr. Kathy Albain of Loyola University Health System.

11 Dec 2009

Senior research scientist to receive 2009 Astellas USA Foundation Award

Fredrick Khachik, Ph.D., a senior research scientist in the Department of Chemistry and Biochemistry at the University of Maryland, College Park, has been chosen to receive a 2009 Astellas USA Foundation Award.

11 Dec 2009

Tasigna demonstrates greater efficacy over Gleevec in chronic Ph+ CML patients

In a large Phase III clinical trial, Tasigna (nilotinib capsules) demonstrated greater efficacy over Gleevec (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The new clinical data were just presented as a late breaking abstract at the 51st annual meeting of the American Society of Hematology (ASH), in New Orleans, Louisiana.

11 Dec 2009

Cequent Pharmaceuticals' IND application for CEQ508 approved for clinical trial

Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, announced that the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) approved Cequent's first IND (investigational new drug) application yesterday.

10 Dec 2009

Merck commences Stimuvax Phase 3 trial in Asian patients with NSCLC

Oncothyreon Inc. today announced that Merck KGaA of Darmstadt, Germany, has initiated a Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC). The trial, named INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response), is anticipated to enroll approximately 420 patients in China, Hong Kong, South Korea, Singapore and Taiwan.

10 Dec 2009

Schizophrenia: Once-monthly INVEGA SUSTENNA not inferior to bi-weekly RISPERDAL CONSTA

Treatment with once-monthly INVEGA® SUSTENNA(TM) is not inferior to treatment with bi-weekly RISPERDAL® CONSTA®, according to new data from a comparative study of both treatments in patients with schizophrenia. Results of the 13-week clinical trial were released this week.

10 Dec 2009

Convergence between EDC and RTSM solutions simplifies workflow management

Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (Nasdaq: PRXL), today introduced unique product convergence between its DataLabs® EDC solution and ClinPhone® Randomization and Trial Supply Management (RTSM) technologies.

From Parexel 10 Dec 2009

Fourth-quarter and full year fiscal 2009 results announced by Biodel

Biodel Inc. today reported financial results for the fourth quarter and fiscal year ended September 30, 2009.

10 Dec 2009

Promising trial on immunotherapy for preventing childhood cancer recurrence

CHILDREN in the UK with a high risk form of the childhood cancer neuroblastoma are set to benefit from a new international clinical trial - funded by Cancer Research UK - which uses immunotherapy to help prevent the disease from coming back.

10 Dec 2009

ACR Image Metrix presents computerized system validation for imaging clinical trials at the DIA forum

Brenda K. Young, BA, CCRA, senior director of clinical operations at ACR Image Metrix™, an imaging contract research organization (CRO) located in Philadelphia, Pennsylvania, has presented her experience in computerized system validation to the Drug Information Association (DIA) 3rd Annual Clinical Forum held in Nice, France, on October 19, 2009.

10 Dec 2009

Medifocus begins common stock trading on OTC Pink Sheets market

Medifocus, Inc., a biotechnology company focused on the commercialization of a proprietary and patented microwave focused heat system for the treatment of breast cancer is pleased to announce that the Company had begun trading its common stock on the OTC Pink Sheets market on Dec. 7, 2009.

10 Dec 2009

Results from Tulip PETAL Study of elagolix announced by Neurocrine Biosciences

Neurocrine Biosciences, Inc. today announced top-line efficacy and safety results from the Tulip PETAL Study (703 Study), its fifth Phase 2 clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

10 Dec 2009