Posted on September 30th, 2009 by Health News
ImThera Medical, Inc. has received Ethics Committee clearance to begin human clinical trials in Belgium. The trials will include ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy to treat Obstructive Sleep Apnea (OSA). Along with the clinical trial approvals, ImThera has received ISO 13485 certification of its quality system as a pre-requisite for the future CE [...]
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Posted on September 30th, 2009 by Health News
The EPA must acknowledge the full extent of the uncertainty in its estimation of biofuels’ lifecycle greenhouse gas emissions and ensure that biofuel technologies are not preemptively disqualified from participation in the Renewable Fuel Standard program. The Biotechnology Industry Organization (BIO) released official comments on the Environmental Protection Agency’s (EPA) proposed rule and draft regulatory [...]
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Posted on September 30th, 2009 by Health News
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), announced positive top-line results from a pivotal, non-human primate study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) demonstrating statistical significance at a 90% survival rate against an inhaled lethal dose of plague.
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Posted on September 30th, 2009 by Health News
Counterfeit and adulterated food and drugs and advances in measurement science used to detect them emerged as key themes of the Annual Scientific Meeting (ASM) hosted by the U.S. Pharmacopeial (USP) Convention. Held in Toronto, Canada, more than 300 people from 26 countries attended, making this a truly multinational event.
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Posted on September 30th, 2009 by Health News
Kane Biotech Inc. (TSX VENTURE:KNE), a biotechnology company engaged in the development of products that prevent and remove microbial biofilms is pleased to announce that DispersinB® Topical Wound Gel has passed the FDA-recommended Cytotoxicity and Primary Skin Irritation tests conducted by WuXi AppTec Inc. (St. Paul, MN) in compliance with Good Laboratory Practice (GLP). Thus, [...]
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Posted on September 30th, 2009 by Health News
The history of the pharmaceutical industry is closely linked to the business practices of the combination and purchase of corporations. From the creation of the combined entity of Warner-Lambert in 1955, to the purchase of Warner-Lambert by Pfizer in 2000, to the recent acquisition of Wyeth, pharmaceutical and biotech companies have expanded their pipelines, portfolios, [...]
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Posted on September 30th, 2009 by Health News
Inspirion Delivery Technologies, LLC (”IDT”) announced today that last week the Company completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to determine the clinical and regulatory pathway to advance its abuse deterrent, extended release formulation of oxycodone.
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Posted on September 30th, 2009 by Health News
Emergent BioSolutions Inc. announced today that it was awarded a cooperative agreement from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to further the development of one of Emergent’s advanced anthrax vaccine candidates known as dmPA7909.
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Posted on September 30th, 2009 by Health News
Amicus Therapeutics today announced it plans to initiate a Phase 1 study of AT2220 (1-deoxynojirimycin HCl), its investigational drug in development for the treatment of Pompe Disease.
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Posted on September 30th, 2009 by Health News
Caraco Pharmaceutical Laboratories, Ltd. announced today that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company’s drug manufacturing operations. The decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Detroit area [...]
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