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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

FDA Drugs Advisory Committee recommends approval for Gilead Sciences' aztreonam for inhalation solution

Gilead Sciences, Inc. today announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended that aztreonam for inhalation solution be approved for the treatment of infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF).

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

ARTs safe without routine lab tests, Lancet study finds

A Lancet study published online Tuesday validates the safety of administering first-line antiretroviral therapy (ART) to patients with HIV without routine toxicity and efficacy lab tests, "[b]ut tests of immune-system function might still be a good idea to monitor the progression of the disease and guide the second year of treatment," HealthDay/U.S. News & World Report reports. Patients in Africa "often receive [HIV] drug treatment ... without routine laboratory monitoring," according to the article.

10 Dec 2009

Abbott submits SIMCOR sNDA for two new dosage strengths

Abbott has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR®, a cholesterol medication. SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin.

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

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

YM BioSciences announces results of collaborative antibody development program

YM BioSciences Inc., today announced the first results of a collaborative program between YM and the National Research Council of Canada's Biotechnology Research Institute (NRC-BRI). Utilizing YM's IntelliMab(TM) technology, the program is designed to generate novel antibodies that target cell surface receptors associated with cancer, uniquely optimized to produce efficacy with reduced toxicities.

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

Cell transplants may yield new therapies for dementia patients

Nerve cells transplanted into brain-damaged rats helped them to fully recover their ability to learn and remember, probably by promoting nurturing, protective growth factors, according to a new study.

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

BIOGUARD barrier gauze dressings offer high antiviral efficacy against H1N1

Derma Sciences, Inc. (OTC Bulletin Board: DSCI), a specialty medical device and pharmaceutical company focused on advanced wound care, today released an independent laboratory report indicating that the company's BIOGUARD barrier gauze dressings exhibit high antiviral efficacy against the H1N1 virus.

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

Cardiologists receive K23 research grant from NIH

Brian H. Annex, M.D., chief of the Division of Cardiovascular Medicine at the University of Virginia Health System, says he feels like the coach of a championship team. "Going three for three is truly extraordinary," he says with a mixture of pride and awe in his voice.

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

Additional data from ALS patients enrolled in confirmatory Phase III STAR trial announced

AVANIR Pharmaceuticals, Inc. today announced additional data from the subset of patients with amyotrophic lateral sclerosis (ALS) enrolled in the confirmatory Phase III STAR trial.

9 Dec 2009