Tag: FDA
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FDA Designates Orphan Drug Made From Tarantula Venom
The U.S. Food and Drug Administration (FDA) has designated the peptide GsMTx4, made by Rose Pharmaceuticals of Buffalo, New York, as an orphan drug for Duchenne muscular dystrophy. Rose Pharmaceuticals is a one-year old company founded by University at Buffalo (UB) medical professor Frederick Sachs and Buffalo stockbroker Jeff Harvey. While Sachs (pictured left) applied…
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FDA Approves Depression Drug for Musculoskeletal Pain
Pharmaceutical manufacturer Eli Lilly and Company in Indianapolis, Indiana said that the U.S. Food and Drug Administration (FDA) has approved its drug Cymbalta (duloxetine HCl) for the management of chronic musculoskeletal pain. FDA already approved Cymbalta to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia. The…
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FDA Designates Anthrax Treatment Candidate as Orphan Drug
Emergent BioSolutions Inc., a biotechnology company in Rockville, Maryland, says the U.S. Food and Drug Administration (FDA) has designated as an orphan drug its human anthrax monoclonal antibody AVP-21D9, in development for the treatment of inhalation anthrax. FDA grants orphan status to drugs and biologics being developed to treat rare conditions, specifically those affecting fewer…
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New Initiative to Speed Pain Treatments
The U.S. Food and Drug Administration (FDA) selected University of Rochester Medical Center in Rochester, New York to lead a new initiative — Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) — to identify better pain treatments more quickly. FDA awarded Rochester a $1 million contract to launch the program that brings together professional societies,…
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FDA Approves Schizophrenia Drug
Sunovion Pharmaceuticals Inc. in Marlborough, Massachusetts says that the U.S. Food and Drug Administration (FDA) approved its drug Latuda (lurasidone HCl) for the treatment of schizophrenia. Latuda is an oral, once-daily antipsychotic in tablet form, offering a treatment for patients with schizophrenia. It is expected to be available in the U.S. during the first quarter…
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FDA Approves Anti-Coagulant Drug
The German pharmaceutical company Boehringer Ingelheim said the U.S. Food and Drug Administration (FDA) approved its drug Pradaxa (dabigatran etexilate), an oral-administered direct thrombin inhibitor to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF). The company says this is the first such approval of a new oral anti-coagulant in the U.S.…
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FDA Clearance Given for Catheter, Spinal Tap Devices
Mirador Biomedical, a medical device developer in Seattle, Washington, says that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for two of its products. A 510(k) clearance is required from FDA to market medical devices, where the manufacturers need to demonstrate the safety and effectiveness of the devices. The Compass Vascular Access,…
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FDA Approves Subcutaneous Delivery of Immunodeficiency Drug
Talecris Biotherapeutics, a biotechnology company in Research Triangle Park, North Carolina said today that the U.S. Food and Drug Administration (FDA) approved its Gamunex-C drug for subcutaneous administration in the treatment of primary immunodeficiency (PI). Subcutaneous administration — illustrated right — delivers the product under the skin into the subcutaneous tissue and intravenous administration is…
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FDA, NIH Award Grant to Study Adaptive Clinical Trial Design
Researchers from academia and business aim to improve the process for testing therapies and medical devices by investigating a new type of clinical trial called adaptive clinical trials. This kind of clinical study makes adjustments to the trial using information accumulated as patients are enrolled, with the goal of improving clinical trials’ efficiency as a…
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FDA Okays Myelodysplastic Syndromes Trial Protocol
Onconova Therapeutics Inc., a biotech company in Newtown, Pennsylvania, says it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of a Phase 3 clinical trial for the company’s drug Estybon. The drug is a monotherapy for patients with myelodysplastic syndromes (MDS), diseases affecting…