Category: Regulations
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FDA Grants Orphan Status for Neuromuscular Drug
Acceleron Pharma, Inc., a biopharmaceutical company in Cambridge, Massachusetts, today said the U.S. Food and Drug Administration (FDA) granted ACE-031, its treatment for Duchenne Muscular Dystrophy (DMD), with an orphan drug designation. DMD is a debilitating and fatal genetic disorder characterized by the progressive loss of muscle strength and function. The disease affects mainly boys…
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Group to Develop Cell Therapy Industry Standards
The International Society for Cellular Therapy (ISCT) in Vancouver, Canada has rechartered an industry committee to develop standards for business processes that lead to late-stage clinical trials. ISCT expects larger health care and pharmaceutical companies to participate in this group. According to Ed Horwitz, M.D., President of ISCT, the group — called the ISCT Industry…
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FDA Fast-Tracks Treatment for Hepatitis C Infection
Pharmasset Inc., in Princeton, New Jersey, received a fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug PSI-7977, developed for the treatment of chronic hepatitis C virus (HCV) infection. PSI-7977 is an oral nucleotide analog inhibitor of HCV. Pharmasset recently completed dosing in a Phase 2a trial to evaluate PSI-7977 in…
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FDA Committee Advances Anti-Epileptic Drug
GlaxoSmithKline in Research Triangle Park, North Carolina and Valeant Pharmaceuticals International in Aliso Viejo, California announced that a U.S. Food and Drug Administration (FDA) advisory committee voted that clinical studies offered substantial evidence of the effectiveness of the companies’ drug ezogabine as an added treatment for adults with partial-onset seizures. The FDA’s Peripheral and Central…
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CE Mark Awarded for Male Urinary Health Device
American Medical Systems (AMS) of Minnetonka, Minnesota, announced today it has received the Conformité Européenne (CE) Mark for AdVance XP, an implant for the treatment of male stress urinary incontinence (SUI). The CE marking certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Male SUI is a common…
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New Standard Advanced for Labeling on Injectable Medications
An expert committee of the United States Pharmacopeia (USP), a standards–setting body for prescription and over–the–counter medicines, has advanced a new labeling standard for injectable products, to reduce the likelihood of errors in the administration of these drugs. The new standard, to be published on 1 November 2010, applies to the top (circle) surface of…
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Study: Industry Drug Trials Show More Favorable Results
A study published in today’s issue of the Annals of Internal Medicine reviews drug trials appearing on the Web site ClinicalTrials.gov, and finds those trials funded by industry sources are more likely to report data favorable to the drug being tested. The investigators — Florence Bourgeois and Kenneth Mandl of Children’s Hospital Boston in Massachusetts…
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Clinical Trial Approved of Potential Treatment for Asthma, COPD
N30 Pharmaceuticals in Boulder, Colorado, announced today approval by the U.S. Food and Drug Administration to begin a phase I clinical trial of a drug called N6022, that the company says has the potential to be a treatment for acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease. The trial, involving…
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FDA Approves Drug for Neurological Movement Disorders
According to Merz Pharmaceuticals in Greensboro, North Carolina, the U.S. Food and Drug Administration (FDA) has approved its drug Xeomin for the treatment of adults with cervical dystonia or blepharospasm, disorders characterized by involuntary, sustained muscle contractions. Merz Pharmaceuticals says the FDA approved the drug, with the generic name incobotulinumtoxinA, based on results from two…
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New E. Coli Test Announced, Certfied
The biotech company Life Technologies in Carlsbad, California unveiled a new, faster test for E. coli bacteria at the International Association for Food Protection annual meeting now in progress. This particular assay detects the E. coli O157:H7 strain known for causing serious diseases in humans. E. coli O157:H7, according to the U.S. Centers for Disease…