NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public

The U.S. Food and Drug Administration and the National Institutes of Health has unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.
The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development [...]

Initiation of Clinical Development Builds Upon Broad Potential Shown in Preclinical Studies

Infinity Pharmaceuticals, Inc. (NasdaqGM:INFI – News), an innovative cancer drug discovery and development company, today announced that it has initiated a Phase 1 clinical trial of its oral Hedgehog signaling pathway inhibitor, IPI-926, in patients with advanced and/or metastatic solid tumors.
IPI-926 is a novel, proprietary inhibitor of the Hedgehog signaling pathway. It is a derivative [...]

Boston Scientific Inc. announced comprehensive data from the TAXUS ATLAS clinical program

Boston Scientific Corporation today announced comprehensive data from the TAXUS ATLAS clinical program, a series of global, prospective, multi-center, single-arm, historically controlled trials, which evaluate the TAXUS® Liberte® Paclitaxel-Eluting Stent System in a variety of lesions and patient groups. The TAXUS Liberte Stent received U.S. Food and Drug Administration approval on Friday. Results from the [...]

Video: Boston Scientific Announces FDA Approval of Second-Generation TAXUS(R) Liberte(R) Drug-Eluting Stent

Boston Scientific Corporation today announced it has received approval from the U.S. Food and Drug Administration to market its second-generation TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System. The Company plans to launch the TAXUS Liberte stent early next month in the United States, following completion of the introduction of its TAXUS® Expresss2(TM) Atom(TM) Paclitaxel-Eluting Coronary Stent [...]

Biomet Announces Financial Results for First Quarter of Fiscal Year 2009

Biomet, Inc. announced today financial results for its first fiscal quarter ended August 31, 2008.
* Net sales increased 13% (9% constant currency) to $607 million
* Worldwide knee sales increased 20% (16% constant currency)
* Worldwide hip sales increased 18% (13% constant currency)
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Early Data Show Potential for Imatinib Mesylate Tablets to Treat Life-Threatening Form of Pulmonary Artery Disease

An early proof-of-concept study presented today shows promising results for imatinib mesylate in the treatment of pulmonary arterial hypertension (PAH), a severe, incurable blood vessel disorder.
Preliminary findings from a 59-patient, multi-center Phase II clinical trial suggest imatinib mesylate provides a treatment benefit, as demonstrated by a significant improvement in pulmonary vascular resistance and a numerical [...]

Enza Chooses Fluidigm BioMark System to Help Assure Core Seed Quality

Fluidigm Corporation and BIOKÉ, a licensed distributor for the company, today announced that Enza Zaden, one of the world’s leading suppliers of high-quality vegetable seeds for agriculture, has chosen the Fluidigm’s BioMark™ System for Genetic Engineering and the new 96.96 Dynamic Array to help assure the quality of its seed supply.
As the world’s food supply [...]

A global healthcare company on New IVIG Facility

Today, Grifols SA (Grifols), a global healthcare company based in Barcelona, Spain, broke ground on a new 92,000 square foot, intravenous immune globulin (IVIG) production facility at its manufacturing complex in Los Angeles, California. This new facility is the initial realization of the $600 million long-range investment plan announced in October 2007 to increase production [...]

USU is the nation’s federal school of medicine and graduate school of nursing.

A collaborative team of scientists from the Uniformed Services University of the Health Sciences (USU) and the Tumor Vaccines and Biotechnology Branch, Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration have characterized the immune response and inflammatory gene response in Venezuelan equine encephalitis virus (VEEV).
In an article [...]