Toxicology News and Research

Latest Toxicology News and Research

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

WuXi PharmaTech, JANSSEN division announce collaboration for preclinical services

WuXi PharmaTech, a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, today announced it has reached an agreement with Johnson & Johnson Pharmaceutical Research & Development, a division of Janssen Pharmaceutica N.V. (JANSSEN), to collaborate in the area of preclinical services.

2 Mar 2010

Reversing protein deficiency through gene therapy can improve SMA

Reversing a protein deficiency through gene therapy can correct motor function, restore nerve signals and improve survival in mice that serve as a model for the lethal childhood disorder spinal muscular atrophy, new research shows.

1 Mar 2010

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Absorption Systems, a leader in testing drugs for ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity), has joined the Society of Toxicology, the premier global professional association of toxicologists, as an SOT Affiliate. The firm, a contract research organization, has more than a decade of experience assisting pharmaceutical and biotechnology companies in determining which compounds in development should be advanced into clinical testing.

27 Feb 2010

Eli Lilly, Covance announce key milestones of their first-year partnership

Senior executives from Eli Lilly and Company and Covance Inc. announced Friday that the first year of their landmark alliance has been a win-win for both companies, enabling Lilly to expedite the flow of innovation within its pipeline in order to provide improved outcomes for individual patients.

27 Feb 2010

Anadys Pharmaceuticals' ANA598 combination demonstrates 73% cEVR in ongoing Phase II study for HCV

Anadys Pharmaceuticals, Inc. today announced preliminary results from an ongoing Phase II study demonstrating that 73% of hepatitis C patients treated with 200 mg ANA598 twice daily in combination with pegylated interferon and ribavirin (SOC) achieved undetectable levels of virus (<15 IU/mL) at week 12, known as complete Early Virological Response or cEVR.

25 Feb 2010

Gross sales of Acorda Therapeutics' ZANAFLEX CAPSULES and tablets increase 9.1% to $58.3M in 2009

Acorda Therapeutics, Inc. today announced its financial results for the fourth quarter and full year ended December 31, 2009.

23 Feb 2010

Aetna selects Millennium Laboratories as national pain management services provider

Millennium Laboratories, a leading provider of therapeutic drug monitoring and education to physicians and staff treating chronic pain patients, announced today a national agreement with Aetna, one of the nation’s leading diversified health care benefits companies that serves approximately 36.3 million people. Under the terms of the three-year ancillary services agreement which went into effect February 1, 2010, Millennium Laboratories’ will assist Aetna participating physicians nationwide with state-of-the-art therapeutic drug monitoring services and tools.

23 Feb 2010

Star Scientific seeks FDA marketing approval for Ariva-BDL dissolvable tobacco lozenge

Star Scientific, Inc. announced that on Friday, February 19 the company filed an application with the Food & Drug Administration for approval to market Ariva-BDL™ as a "modified risk" tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009. This submission is the first such application to be filed with the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

23 Feb 2010

WuXi PharmaTech's Suzhou non-clinical safety testing facility receives AAALAC accreditation

WuXi PharmaTech, a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that its Suzhou non-clinical safety testing facility received full accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC). As a result of an extensive on-site evaluation, AAALAC determined that WuXi PharmaTech's facility meets the highest standards of animal care and research practices.

22 Feb 2010

Major challenge facing today's toxicologists: Developing test systems to predict toxicity of compounds

Attagene Inc., a leader in developing innovative technologies for analyzing gene regulatory pathways, announced today the online publication of a paper in Chemical Research in Toxicology, a journal of the American Chemical Society, that highlights results of their collaborative work with the Environmental Protection Agency's National Center for Computational Toxicology (NCCT).

19 Feb 2010

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

Depomed, Inc. today announced that it has received final meeting minutes from the FDA for a pre-NDA meeting related to DM-1796 for postherpetic neuralgia (PHN) held in December 2009. Depomed also commented on recent public disclosures related to the Complete Response letter from the U.S. Food and Drug Administration regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets.

19 Feb 2010

SRI International establishes new Neurodegenerative Diseases Research Program

SRI International, an independent nonprofit research and development institute, announced today that a new Neurodegenerative Diseases Research Program has been established within its Center for Health Sciences. This new SRI group of neuroscientists and researchers working at the cutting edge of science brings $6.2 million of funding from the National Institutes of Health (NIH), including the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Environmental Health Sciences (NIEHS), and National Institute of General Medical Sciences (NIGMS).

19 Feb 2010

Group B streptococcus may have significant public health implications: Study

A common bacteria found in many healthy adult females that can cause life-threatening infections when passed to newborns could be introduced to some women through frequent contact with cows, according to a research team led by a Michigan State University pediatrician.

19 Feb 2010

BPA has no effects on brain development: New study

This new study, which exposed pregnant rodents to a range of BPA dietary doses from low to high, concluded that BPA had no effects on brain development or behavior in their offspring that had been exposed to BPA in utero and throughout development. The robust study was conducted by highly qualified researchers at WIL Research Laboratories.

18 Feb 2010

Phase III data reveals potential of Merck’s GARDASIL in preventing HPV and HPV-related cancers

Merck & Co., Inc. announced today that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.

18 Feb 2010

NCI's NCL to conduct characterization studies of Celator Pharmaceuticals' HDPN formulation

Celator Pharmaceuticals today announced that the National Cancer Institute's (NCI) Nanotechnology Characterization Laboratory (NCL), operated by SAIC-Frederick (Frederick, Maryland), has agreed to conduct characterization studies to advance the development of the company's nanoparticle drug formulation technology.

18 Feb 2010

BioMimetic Therapeutics annouces completion of Augment Bone Graft PMA submission

BioMimetic Therapeutics, Inc. today announced it has submitted the third and final module of its Premarket Approval (PMA) application for marketing of Augment™ Bone Graft in the U.S. This final module, containing a comprehensive review of the clinical data related to Augment, completes the PMA application to the FDA. The Company previously announced the filing of both the pre-clinical pharmacology/toxicology and quality/manufacturing modules with the FDA in June of 2009.

18 Feb 2010

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for drug dependence, smoking cessation and obesity, announced today that the company has retained Exponential Pharma Ventures LLC to assist in establishing a clinical development partnership for its cocaine dependence program with a fully integrated pharmaceutical company.

17 Feb 2010

Adding rosemary extracts in ground beef can reduce cancer-causing agents

The addition of rosemary extract to ground beef actually reduces cancer-causing agents that can form upon cooking, according to a recent study in the Journal of Food Science, published by the Institute of Food Technologists.

16 Feb 2010

Toxicology News and Research

Latest Toxicology News and Research

InterMune seeks European marketing approval for pirfenidone

WuXi PharmaTech, JANSSEN division announce collaboration for preclinical services

Reversing protein deficiency through gene therapy can improve SMA

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Eli Lilly, Covance announce key milestones of their first-year partnership

Anadys Pharmaceuticals' ANA598 combination demonstrates 73% cEVR in ongoing Phase II study for HCV

Gross sales of Acorda Therapeutics' ZANAFLEX CAPSULES and tablets increase 9.1% to $58.3M in 2009

Aetna selects Millennium Laboratories as national pain management services provider

Star Scientific seeks FDA marketing approval for Ariva-BDL dissolvable tobacco lozenge

WuXi PharmaTech's Suzhou non-clinical safety testing facility receives AAALAC accreditation

Major challenge facing today's toxicologists: Developing test systems to predict toxicity of compounds

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

SRI International establishes new Neurodegenerative Diseases Research Program

Group B streptococcus may have significant public health implications: Study

BPA has no effects on brain development: New study

Phase III data reveals potential of Merck’s GARDASIL in preventing HPV and HPV-related cancers

NCI's NCL to conduct characterization studies of Celator Pharmaceuticals' HDPN formulation

BioMimetic Therapeutics annouces completion of Augment Bone Graft PMA submission

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

Adding rosemary extracts in ground beef can reduce cancer-causing agents

Forensics And Toxicology eBook

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Toxicology News and Research

Latest Toxicology News and Research

Forensics And Toxicology eBook

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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