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FDA approves Cephalon's REMS for GABITRIL

Cephalon, Inc. today announced that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication GABITRIL(R) (tiagabine hydrochloride) has been approved by the U.S. Food and Drug Administration (FDA). The GABITRIL REMS consists of a Medication Guide to inform patients about the potential risks associated with the use of GABITRIL.

15 Oct 2010

Genzyme reports five-year patient data from Phase 2 multiple sclerosis trial

Genzyme Corporation today reported five-year patient data from its completed Phase 2 multiple sclerosis (MS) trial. This sub-group analysis found that nearly 90 percent of alemtuzumab-treated patients were free of sustained accumulation of disability, and that patients receiving alemtuzumab also maintained improved mean disability scores and a low risk of relapse over the 60-month follow-up period.

15 Oct 2010

Moores Cancer Center files IND application for topical NexACT-based formulation

Apricus Biosciences, backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Moores Cancer Center at the University of California San Diego (UCSD) has filed an Investigational New Drug Application with the U.S. Food & Drug Administration ("FDA") for approval to test Nupen, Apricus Bio's proprietary, topical NexACT-based formulation of filgrastim (Neupogen).

15 Oct 2010

FDA approves Gamunex-C for primary immunodeficiency treatment

Talecris Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

15 Oct 2010

Kineta awarded second NIH contract to identify new drug targets and candidates

Kineta announced today it has been awarded its second NIH contract in twelve months - the latest focused on mining vast, existing, basic research databases with the goal of identifying new drug targets and candidates. The project will be directed at five key therapeutic areas: infectious, cardiovascular, neurological, metabolic and autoimmune diseases.

14 Oct 2010

Patient-specific experimental vaccine to prevent recurrence of glioblastoma

Mary Lee's primary care physician is also a family friend. When he walked into the exam room in October 2006 with tears in his eyes, she knew something serious was wrong. But she was shocked to learn she had a brain tumor - and later found out it was the most aggressive malignant type, a glioblastoma multiforme.

14 Oct 2010

Top biopharma leaders to share strategies at Windhover's 2nd PharmAsia Summit

Elsevier Business Intelligence, publisher of PharmAsia News, IN VIVO and The Pink Sheet, today announced the agenda for Windhover's 2nd PharmAsia Summit (Oct. 25-26). This year's Summit will bring top biopharma leaders from Asia and the U.S. to San Francisco to share what works and what doesn't in China, India, Japan and the Pacific Rim.

14 Oct 2010

LFA announces award of new grants for lupus research

The Lupus Foundation of America, Inc. (LFA) today announced the awarding of six new research grants to address gaps in the science and understanding of key areas of lupus research, including pediatric lupus, reproductive health issues in people with lupus, lupus nephritis (kidney involvement), and neuropsychiatric lupus, which affects the brain and nervous system.

14 Oct 2010

Psychological and social challenges faced by parents of children with undiagnosed learning disorders

Parents of children with undiagnosed learning disorders, developmental deficits, and congenital abnormalities face a host of psychological and social challenges, which are explored in detail in a reflective article in Genetic Testing and Molecular Biomarkers, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com).

14 Oct 2010

Federal guidance aims to reduce misuse of synthetic DNA to create dangerous organisms

Federal guidance issued today aims to reduce the risk that synthetic DNA will be misused deliberately to create dangerous organisms. Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA, issued by the U.S. Department of Health and Human Services, supports national biosecurity goals and balances the promise of synthetic DNA with its potential biosecurity risks.

14 Oct 2010

Stony Brook professor receives 2010 NIH Director's New Innovator Award

Balaji Sitharaman, Ph.D., Assistant Professor of Biomedical Engineering at Stony Brook University, is a 2010 recipient of the National Institutes of Health (NIH) Director's New Innovator Award.

14 Oct 2010

Workshop to focus on FDA process that grants orphan drug designation

The U.S. Food and Drug Administration has scheduled the third in a series of workshops on orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process for Nov. 4-5, 2010, in Lansdowne, Va.

14 Oct 2010

Stony Brook professor receives NIH grant to optimize cardiovascular devices

Danny Bluestein, Ph.D., Professor of Biomedical Engineering at Stony Brook University, has been awarded a five-year, $7.5 million grant by the National Institutes of Health. The award marks the first time a Stony Brook professor has received a Phase II Quantum Grant, given by The National Institute of Biomedical Imaging and Bioengineering (NIBIB), a division of the NIH, to make a profound improvement or quantum leap forward—in health care.

14 Oct 2010

NIH awards grant to Bavarian to advance early research in filoviruses

Bavarian Nordic A/S announced today that the company has received funding from the U.S. National Institutes of Health (NIH) to advance its early research in filoviruses (Ebola and Marburg virus).

14 Oct 2010

Dyadic International receives sixth USPTO patent

Dyadic International, Inc. a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, announced today that it has been issued U.S. Patent No. 7,794,962 by the United States Patent and Trademark Office.

14 Oct 2010

AusBiotech 2010 set to demystify the impact of US Healthcare Reforms on Australian biotech

Australian biotechnology and pharmaceutical companies are seeking to understand the implications of the US Healthcare Reform Bill, says Australia’s biotechnology industry organisation, AusBiotech. In order to remain compliant and globally competitive, biotechs need to identify and work within a gamut of new requirements, complications and hurdles imposed by this new regulatory environment.

13 Oct 2010

Discovery Labs enter agreement for new investment from PharmaBio

Discovery Laboratories, Inc. a biotechnology company developing its novel synthetic surfactant and aerosol technologies for respiratory diseases, today announces that it has entered into an agreement for a new investment of $0.5 million from PharmaBio Development Inc. (PharmaBio), the former strategic investing subsidiary of Quintiles Transnational Corp.

13 Oct 2010

Medicago and PATH partner on development of broad coverage influenza vaccine

Medicago Inc., a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that it has been awarded $946,000 in funding by U.S.-based PATH pursuant to a research collaboration agreement. Medicago and PATH will work together on a broad coverage influenza vaccine based on Medicago's proprietary plant-based Virus-Like Particle (VLP) technologies for the developing world.

13 Oct 2010

ImmunoCellular develops ICT-107 cell-based vaccine for GBM treatment

ImmunoCellular Therapeutics, a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that it has developed an innovative method for manufacturing the company's lead product candidate, ICT-107, a dendritic cell-based vaccine for the treatment of glioblastoma multiforme (GBM).

13 Oct 2010

USPTO grants HemoShear patent for human cell-based surrogate systems

HemoShear LLC, a biotechnology research company and leading developer of human cell-based surrogate systems for discovery and assessment of new drug compounds, today announced that the U.S. Patent and Trademark Office (USPTO) has granted it patent no. 7,811,782 entitled "Use of An In Vitro Hemodynamic Endothelial/Smooth Muscle Cell Co-Culture Model to Identify New Therapeutic Targets for Vascular Disease."

13 Oct 2010