Science and Enterprise

Tag: FDA

  • FDA Releases Draft Biosimilars Guidance

    The Food and Drug Administration has issued three guidance documents in draft on biosimilar therapeutics — functional equivalents of biologic therapies — that the agency says will soon be open for public comment. Guidance documents offer insights into the current thinking of FDA on key scientific and regulatory topics, and are not binding on the…

  • FDA Grants Priority Review to Breast Cancer Therapy

    Genentech in South San Francisco, California, says the Food and Drug Administration has granted priority review status to its drug pertuzumab to treat human epidermal growth factor receptor 2- (HER2-) positive breast cancer. Genentech is a division of the global pharmaceutical company Roche, headquartered in Switzerland. FDA applies the priority review status in this case…

  • Sanofi to Cut Genzyme Massachusetts Research Staff

    The French pharmaceutical maker Sanofi says it will reduce its research workforce employed in and around Boston, as a result of its acquisition of Genzyme Corporation a year ago. Sanofi confirmed the cuts today in a statement to the industry Web site Fierce Biotech. Genzyme, headquartered in Cambridge, Massachusetts, was acquired by Sanofi last year…

  • FDA Approves Genentech Skin Cancer Drug

    The Food and Drug Administration today approved the drug vismodegib to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug, marketed under the brand name Erivedge by Genentech in South San Francisco, is intended for use in patients with locally advanced basal cell cancer who are not candidates…

  • Knee Replacement Maker Lands $89M Series E Financing

    ConforMIS Inc. in Burlington, Massachusetts, a developer of customized knee-replacement implant technology, has raised $89 million in a series E round of funding, the fifth investment cycle after start up. The privately held company says the investments were made by private equity funds, led by AGC Equity Partners and Axel Johnson Inc., along with government…

  • FDA Approves Pfizer Drug for Advanced Kidney Cancer

    The Food and Drug Administration today approved the drug axitinib to treat patients with renal cell carcinoma, a form of advanced kidney cancer, who have not responded to another drug for this type of cancer. The drug is made by Pfizer Inc. in New York and marketed under the brand name Inlyta. Renal cell carcinoma…

  • U.S. Patent Granted for Anti-Microbial Polymer Technology

    Quick-Med Technologies Inc. in Gainesville, Florida says it has received a patent for its process that combines disinfectant and polymer to apply anti-microbial properties to surfaces, including human skin. Patent number 8,088,400, awarded on 3 January 2012 by the U.S. Patent and Tradmark Office, covers the company’s solution with opposite-charged polymers built into its line…

  • 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…

  • NIH Establishes Medical Translational Science Center

    The federal 2012 fiscal year spending bill passed by Congress and signed by President Obama before Christmas includes approval for National Institutes of Health (NIH) to form a new research center devoted to turning discoveries in the lab into new drugs, diagnostics, and devices. The National Center for Advancing Translational Sciences (NCATS), with a budget…

  • 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…