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Pfizer announces IES analysis of Aromasin in breast cancer recurrence

Pfizer today announced results from an exploratory analysis of the Intergroup Exemestane Study (IES) at a median follow-up of 91 months in estrogen-receptor positive (ER+) or estrogen-receptor unknown (ER-unknown) women that looked at breast cancer free survival (BCFS) and censored deaths that occurred prior to breast cancer relapse.

11 Dec 2009

ThromboGenics initiates Phase II trial of microplasmin for wet AMD

ThromboGenics NV, a biopharmaceutical company focused on innovative medicines for eye disease, vascular disease and cancer, announces today that it has started a Phase II trial of microplasmin for the treatment of exudative (wet) Age-related Macular Degeneration (AMD).

11 Dec 2009

Genentech and Biogen Idec report positive outcome from ocrelizumab-MTX combination study in RA

Genentech, Inc. a wholly owned member of the Roche Group, and Biogen Idec announced today a Phase III study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by American College of Rheumatology or ACR20 response) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks.

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

Initiation of multi-national Phase III study of Stimuvax announced

Merck KGaA, Darmstadt, Germany, today announced the initiation of its multi-national Phase III study of the investigational therapeutic cancer vaccine Stimuvax® (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC).

11 Dec 2009

DMC recommends Novartis and Nordic Bioscience to continue oral calcitonin Phase III studies

Unigene Laboratories, Inc. (http://www.unigene.com) announced that an independent Data Monitoring Committee (DMC) has recommended that Novartis and its partner Nordic Bioscience proceed as planned with their ongoing oral calcitonin Phase III studies for osteoporosis and osteoarthritis.

11 Dec 2009

Fulvestrant 500 mg reduces risk of disease progression in women with metastatic breast cancer

AstraZeneca (NYSE: AZN) today announced that data from a Phase III study of postmenopausal women with hormone receptor-positive advanced breast cancer presented at the San Antonio Breast Cancer Symposium (Abstract 25) showed treatment with fulvestrant (FASLODEX) 500 mg reduced the risk of disease progression (assessed as time to progression (TTP)) by 20%

11 Dec 2009

Positive results from BioAlliance Pharma's acyclovir Lauriad phase III trial

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announces final positive results of its pivotal phase III clinical study in immunocompetent patients with recurrent herpes labialis (LIP Study) treated with acyclovir Lauriad®. Primary and secondary endpoints have been met with marked efficacy and good tolerance.

10 Dec 2009

FDA approves Azaya Therapeutics' Taxotere for Phase I clinical study

Azaya Therapeutics, Inc. announced today that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its lead product “ATI-1123,” a novel and improved formulation of Taxotere® (docetaxel), a leading chemotherapy drug with worldwide annual sales of over $2.8 billion.

10 Dec 2009

DMC recommends Emisphere Technologies' to proceed with oral calcitonin trial for OP and OA

Emisphere Technologies, Inc. today announced that an independent Data Monitoring Committee (“DMC”) informed Novartis and its partner Nordic Bioscience about their recommendation to proceed with the Osteoporosis (“OP”) Phase 3 Study 2303 and the Osteoarthritis (“OA”) Phase 3 Study 2301 exploring the safety and efficacy of an oral formulation of salmon calcitonin to treat patients with osteoporosis and osteoarthritis of the knee.

10 Dec 2009

Targacept commences TC-5619 Phase 2 study of cognitive dysfunction in schizophrenia

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR TherapeuticsTM, today announced that it has initiated a Phase 2 clinical proof of concept trial of TC-5619 in cognitive dysfunction in schizophrenia.

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

Second-quarter fiscal 2010 results announced by Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. today announced financial results for the second quarter of fiscal year (FY) 2010 ended October 31, 2009. Total revenue for the second quarter of FY 2010 increased 255% to $6,896,000, compared to $1,941,000 for the comparable prior year quarter.

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

Immune-based treatment promising for AD

The results of a new study on immune-based treatment of Alzheimer's disease (AD), which was conducted at 30 sites around the country, will be published in the December 15 issue of Neurology®. Lead author, Stephen P. Salloway, MD, MS, director of the Butler Hospital Memory and Aging Program and a professor of neurology and psychiatry at the Warren Alpert Medical School of Brown University, says that this 18-month phase two study on slowing the disease process in Alzheimer's patients offers promising results.

10 Dec 2009

Rituxan improves patients with previously untreated CLL, shows Phase III study CLL8

Roche announced today at the 51st Meeting of the American Society of Hematology (ASH) in New Orleans, LA (USA) that the pivotal Phase III study CLL8 showed that patients with previously-untreated chronic lymphocytic leukemia (CLL) survived their disease longer when treated with Rituxan (rituximab) compared to chemotherapy alone.

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

Initiation of dose-finding study to evaluate safety and efficacy of MP4OX treatment

Sangart, Inc., a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic (oxygen deprived) tissues through targeted oxygen delivery, today announced the initiation of a dose-finding study designed to evaluate the safety and efficacy of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock.

10 Dec 2009

Second pivotal Phase 3 trial to evaluate investigational Lp-PLA2 inhibitor darapladib initiated

Attached is a press release issued earlier this morning by GlaxoSmithKline, announcing that GSK has initiated its second pivotal Phase 3 trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with acute coronary syndrome (ACS).

10 Dec 2009

Drug Trial News

Pfizer announces IES analysis of Aromasin in breast cancer recurrence

ThromboGenics initiates Phase II trial of microplasmin for wet AMD

Genentech and Biogen Idec report positive outcome from ocrelizumab-MTX combination study in RA

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

Initiation of multi-national Phase III study of Stimuvax announced

DMC recommends Novartis and Nordic Bioscience to continue oral calcitonin Phase III studies

Fulvestrant 500 mg reduces risk of disease progression in women with metastatic breast cancer

Positive results from BioAlliance Pharma's acyclovir Lauriad phase III trial

FDA approves Azaya Therapeutics' Taxotere for Phase I clinical study

DMC recommends Emisphere Technologies' to proceed with oral calcitonin trial for OP and OA

Targacept commences TC-5619 Phase 2 study of cognitive dysfunction in schizophrenia

Merck commences Stimuvax Phase 3 trial in Asian patients with NSCLC

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

Second-quarter fiscal 2010 results announced by Peregrine Pharmaceuticals

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

Immune-based treatment promising for AD

Rituxan improves patients with previously untreated CLL, shows Phase III study CLL8

Results from Tulip PETAL Study of elagolix announced by Neurocrine Biosciences

Initiation of dose-finding study to evaluate safety and efficacy of MP4OX treatment

Second pivotal Phase 3 trial to evaluate investigational Lp-PLA2 inhibitor darapladib initiated

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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