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Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU.

24 Sep 2010

Cook Medical submits PMA to FDA for new balloon expandable stent for renal artery disease

Cook Medical has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its new balloon expandable stent for renal artery disease. Intended for patients suffering from renal artery stenosis, a narrowing of the arteries that supply blood to the kidneys, the new device features a low profile design and does not shorten upon expansion.

24 Sep 2010

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Enobia Pharma today announced positive results for its Phase II juvenile clinical trial of ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy intended for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages.

24 Sep 2010

Vical prices underwritten common stock public offering

Vical Incorporated today announced the pricing of an underwritten public offering of 15,000,000 shares of its common stock at a price to the public of $2.25 per share. The gross proceeds to us from this offering are expected to be approximately $33.8 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering is expected to close on or about September 29, 2010, subject to customary closing conditions.

24 Sep 2010

Cylene commences CX-4945 Phase I trial in multiple myeloma

Cylene Pharmaceuticals, Inc. announced today the initiation of a Phase I clinical trial of their first-in-class, oral CK2 inhibitor CX-4945 in patients with multiple myeloma. Cylene also announced the simultaneous closing of a $12 million financing with participation from existing investors including Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, Mitsui & Co. and Morningside Venture Investments Ltd.

24 Sep 2010

OrbusNeich completes enrollment in Combo Bio-engineered Sirolimus Eluting Stent clinical trial

OrbusNeich today announced at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 in Washington the completion of patient enrollment in the randomized clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) with 183 patients included at sites in Asia, Australia, Europe and South America.

24 Sep 2010

NSBRI project to develop LTM/iRevive system for astronauts’ medical care

On an exploration mission, an astronaut has an accident and appears to have serious injuries as the spacecraft speeds to its destination. The ensuing scene is hectic as the other crew members try to get a grasp on the situation and provide appropriate treatment. Efficient use of time and resources may be the difference between life and death.

24 Sep 2010

Legislation to help speed research for cystic fibrosis and other rare diseases

Today the U.S. House of Representatives passed the "Improving Access to Clinical Trials Act" (I-ACT), in a victory for the Cystic Fibrosis Foundation, its advocates and 120 other health advocacy organizations.

24 Sep 2010

EMA, FDA announce regulatory decisions on Avandia drug

GlaxoSmithKline confirms that following a review of Avandia (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions.

24 Sep 2010

New data demonstrates safety and efficacy of Resolute drug-eluting stent

Coronary artery disease, a leading cause of death and poor quality of life worldwide, runs the gamut from simple to complex, which complicates the daily practice of interventional cardiology. New clinical data from a second, large international study that enrolled "all comers," regardless of disease complexity and comorbidities, again demonstrated the strong performance of the Resolute drug-eluting stent (DES) from Medtronic, Inc. for patients across this continuum.

24 Sep 2010

Simple treatment may counteract widespread problem of subnormal vitamin levels in acute-care patients

Treatment with vitamin C rapidly improves the emotional state of acutely hospitalized patients, according to a study carried out by researchers at Montreal's Jewish General Hospital (JGH) and the affiliated Lady Davis Institute for Medical Research (LDI).

24 Sep 2010

FDA designates AMT-080 gene therapy for Duchenne muscular dystrophy

Amsterdam Molecular Therapeutics (AMT) Holding N.V. a leader in the field of human gene therapy, announced today that the U.S. Food and Drug Administration (FDA) has designated AMT-080, a gene therapy for Duchenne muscular dystrophy (DMD) as an orphan drug.

24 Sep 2010

TAVI procedure reduces mortality rate in patients with aortic stenosis

Just released data from a clinical trial shows promise for a new minimally invasive treatment option for patients with severe aortic stenosis who are too sick for traditional forms of open-heart surgery. As compared to standard medical therapy, the new procedure, transcatheter aortic valve implantation (TAVI), significantly reduced mortality rates in patients who received the new valve.

24 Sep 2010

CIC proposes criteria to improve endpoints for cancer immunotherapy trials

The Cancer Research Institute (CRI) Cancer Immunotherapy Consortium (CIC), the leading global initiative in advancing the emerging field of immuno-oncology, has proposed criteria for improved endpoints for cancer immunotherapy trials, which were published online on September 8 in the Journal of the National Cancer Institute.

24 Sep 2010

Breast cancer incidence drops, linked to decline in HRT use

A new Canadian study shows that a significant drop in breast cancer incidence among post-menopausal women from 2002 to 2004 coincided with a sharp drop in hormone replacement therapy (HRT) use during the same period. This is the first study to show the link between HRT use and breast cancer among Canadian women.

24 Sep 2010

Advanced Targeting Systems receives NCI award to advance SP-SAP drug

Advanced Targeting Systems, the company that pioneered the targeting of specific cell types to manipulate them for the treatment of diseases and for research into the function of biological systems, has been awarded $3 million from the National Cancer Institute (NCI).

24 Sep 2010

Biothera receives SBIR award to evaluate therapeutic potential of Imprime PGG drug in pancreatic cancer

Biothera has received a National Cancer Institute SBIR award to evaluate the therapeutic potential of its drug candidate Imprime PGG in pancreatic cancer, the company announced today.

24 Sep 2010

Cardialysis and Sticares InterACT announce strategic collaboration

Cardialysis and Sticares InterACT, both Contract Research Organizations (CROs) headquartered in The Netherlands, announced today that they have entered into a strategic collaboration to provide drug development consulting services in the field of cardiovascular and metabolic medicine. Both organizations have substantial experience and success in the execution of clinical research projects for pharmaceutical, biotechnology and medical device companies.

23 Sep 2010

Arrowhead increases ownership in Calando Pharmaceuticals through Series A Preferred Stock exchange

Arrowhead Research Corporation today announced that it has increased its ownership of majority owned subsidiary Calando Pharmaceuticals through the exchange of Calando Series A Preferred Stock for Arrowhead warrants.

23 Sep 2010

Tolerx presents otelixizumab preclinical research at 46th EASD

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the presentation of preclinical research describing the mechanism of action of otelixizumab at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD). In addition, Tolerx also announced that the first European patient was enrolled in DEFEND-2, a confirmatory Phase 3 clinical trial evaluating otelixizumab in autoimmune new-onset type 1 diabetes.

23 Sep 2010