Science and Enterprise

Category: Regulations

  • NIH Funds Study of Chemical Effects on Adult Stem Cells

    Bioengineers at Rensselaer Polytechnic Institute in Troy, New York and University of California at Berkeley, have been awarded a grant from  National Institutes of Health (NIH) to study how chemicals in drugs and the environment affect human stem cells. The four-year grant of more than $2 million will fund teams led by Rensselaer’s chemical and…

  • BASF to Move Plant Biotech Work to U.S. from Germany

    The German chemical company BASF says it will move much of its plant science R&D work to the U.S. to take advantage of a more favorable regulatory climate than in Europe. The company expects to relocate its facilities in Limburgerhof, Germany and elsewhere in Europe to a new site in Research Triangle Park near Raleigh,…

  • Novartis to Restructure, Cut 1,960 U.S. Jobs

    The Swiss company Novartis Pharmaceuticals said on Friday it plans to reorganize its General Medicines division in the U.S. resulting in a loss of 1,960 jobs. The company said it expects the job cuts to take place in the second quarter of 2012. Novartis plans to reduce its General Medicines field workforce by 1,630 jobs…

  • Standards Proposed for Pharmaceutical Supply Chain Integrity

    The U.S. Pharmacopeial Convention (USP) is proposing a set of recommended best practices to help ensure supply chain integrity, and reduce the risks of counterfeit or mishandled medicines. USP released the draft standards for comment in advance of a workshop on supply chain integrity at its headquarters in Rockville, Maryland on 22-23 May 2012. Supply…

  • FDA Approves Pneumococcal Disease Vaccine for Older Adults

    At the end of December, the U.S. Food and Drug Administration (FDA) approved the vaccine Prevnar 13 for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium Streptococcus pneumoniae (S. pneumoniae). The drug is manufactured by the Wyeth Pharmaceuticals division of Pfizer Inc. Pneumococcal pneumonia is caused when…

  • Clinical Trial to Test Leukemia Drug Combination [UPDATED]

    UPDATE, 29 December 2011: Emergent Biosolutions, Abbott Labs End Collaboration Emergent BioSolutions Inc. in Rockville, Maryland has started a phase 2 clinical study of its drug candidate TRU-016 in combination with the chemotherapy drug bendamustine for patients with relapsed chronic lymphocytic leukemia (CLL). The company is developing TRU-016 in a partnership with Abbott Laboratories. Chronic…

  • FDA Approves Portable Device to Spot Brain Bleeding

    The Food and Drug Administration approved last week a hand-held device designed to detect bleeding in the skull, a life-threatening condition. The device, called the Infrascanner, is based on research conducted at University of Pennsylvania and Baylor College of Medicine, and funded in part by the U.S. Office of Naval Research. The Infrascanner detects intracranial…

  • Math Model Helps Predict Unknown Drug Side Effects

    Researchers at Children’s Hospital Boston in Massachusetts have created a new method that combines data from a widely used drug safety database to predict adverse drug reactions. The findings from postdoctoral fellow Aurel Cami (pictured left) and colleagues from the Children’s Hospital Informatics Program, appear online in the the journal Science Translational Medicine (paid subscription…

  • New Methods Proposed for Testing Allergens Without Animals

    A doctoral dissertation at University of Gothenburg in Sweden has outlined testing methods for allergenic substances that do not require the use of lab animals. Ph.D. candidate in chemistry Sofia Andersson (pictured right) defended the dissertation in Gothenburg earlier this month, and is working with the university’s business development office to advance the methods to…

  • Engineered HIV/AIDS Vaccine Approved for Clinical Trials

    A vaccine designed to prevent HIV infection based on a genetically engineered virus has received approval by the U.S. Food and Drug Administration to start clinical trials. The vaccine is a product of a joint venture between Universiy of Western Onatrio in London and the Canadian subsidiary of Korean pharmaceutical venture company Sumagen. Chil-Yong Kang…