Category: Regulations
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Clinical Trial of Embryonic Stem Cell Therapy Authorized
Geron Corporation of Menlo Park, California said today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s investigational new drug and its Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed. GRNOPC1 is Geron’s lead human embryonic stem cell (hESC)-based candidate.…
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Coronary Stent Approved for Sale in Europe
Devax Inc., a medical device developer in Lake Forest, California says it received the Conformité Européenne (CE) mark for its AXXESS stent system designed for the treatment of coronary and vascular bifurcation lesions. The CE mark certifies that a product has met EU health, safety, and environmental requirements, allowing the company to market the stent…
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Acute Radiation Syndrome Drug Granted FDA Fast Track Status
Cleveland BioLabs Inc., a biotechnology company in Buffalo, New York, today announced that CBLB502, a drug developed for the treatment of acute radiation syndrome (ARS), has been granted fast track status by the U.S. Food and Drug Administration (FDA). CBLB502 is derived from a microbial protein that can reduce injury from acute stresses, such as…
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NIH Extends Comment Period on New Conflict Regulations
National Institutes of Health (NIH) extended the comment period on proposed conflict-of-interest rules for researchers to 19 August 2010. The extended period on the new rules, officially known as “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors,” seeks comments on specific topics that arose since…
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Cosmetics Group Calls for More FDA Oversight of Ingredients
A cosmetics and personal care products trade group on Friday called for the U.S. Food and Drug Administration (FDA) to play a larger role in assessing the safety of ingredients used in their products. The Personal Care Products Council says it favors establishment of formal processes for FDA to review ingredients for safety at the…
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Robotic Exoskeleton Provides Disabled More Precise Mobility
An Auckland, New Zealand company has built a pair of robotic legs strapped to and worn outside the body that helps disabled people stand, walk, climb steps and ramps, and move in any direction. The company, Rex Bionics, says the robotic exoskeleton has undergone seven years of development and testing, including regulatory approval in New…
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Genzyme to Expand its Suburban Boston Campus
Genzyme Corporation, a biotech company in Cambridge, Massachusetts, plans to double the size of its manufacturing and research facilities in nearby Framingham, according to a story by Scott Van Voorhis in yesterday’s Boston Globe. The plan involves doubling the size of that facility and adding up to 1,000 new jobs, according to a company executive…