Copyright 2008 Medical News Today Latest Regulatory Affairs / Drug Approvals News From Medical News Today. http://www.medicalnewstoday.com/sections/regulatoryaffairs/ admin@medicalnewstoday.com (MNT Admin) editors@medicalnewstoday.com (MNT Editors) en-us Tue, 13 May 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/107195.php Accelerating the creation of new inhalable drug delivery devices, Cambridge Consultants (http://www.cambridgeconsultants.com) is announcing the licensing of a range of technology development tools at the Respiratory Drug Delivery Conference in Scottsdale, Ariz. Tue, 13 May 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/107193.php Celgene Limited expressed disappointment at the advice given by the Scottish Medicines Consortium (SMC) that Revlimid® (lenalidomide) is not recommended for use within the NHS in Scotland for the treatment of multiple myeloma, on the grounds of cost effectiveness. It is estimated that, on average patients, in desperate need of treatment, could gain nearly 3 additional years of life when treated with Revlimid compared with previous standards of care. Tue, 13 May 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/107115.php Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and autoimmune diseases, announced that it has received an Orphan Drug designation for oral tetrathiomolybdate (oral TTM) from the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a deadly pulmonary disease with no FDA-approved therapy. Mon, 12 May 2008 17:00:00 PDT http://www.medicalnewstoday.com/articles/106999.php The United States House Energy and Commerce Committee began aninvestigation in March of the potential conflicts of interest thatscientific panels advising the Environmental Protection Agency on thehuman health effects of toxic chemicals. Eight scientists wereidentified by this committee as serving as consultants of members ofEPA science advisory panels while receiving research support from thechemical industry to study the chemicals under review. Mon, 12 May 2008 16:00:00 PDT http://www.medicalnewstoday.com/articles/107101.php The U.S. Food and Drug Administration approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years. "Approval of this product for room temperature storage creates greater flexibility in disease management for both patients and physicians," said Jesse L. Goodman, M.D., M.P.H. Mon, 12 May 2008 14:00:00 PDT http://www.medicalnewstoday.com/articles/107100.php The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome. Ropinirole hydrochloride tablets have been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram. Mon, 12 May 2008 07:00:00 PDT http://www.medicalnewstoday.com/articles/107086.php If you're one of the nearly 30 million Americans* who suffers from migraine headaches, you now have a new way to fight them. This month, a new drug is expected to land in pharmacies that combines two existing migraine drugs. Most days, Richard Higgins is very active. If he's not training for triathlons, he's doing karate with his kids. The only thing that seems to slow him down is his migraine headaches. Mon, 12 May 2008 06:00:00 PDT http://www.medicalnewstoday.com/articles/107076.php Controlling direct-to-consumer (DTC) advertising of prescription drugs has an important role to play in making prescription drugs more affordable for the overall U.S. health care system.A recent AARP study revealed that, on average, pharmaceutical manufacturer prices for the 220 brand name drugs most widely used by older Americans rose at more than two and one-half times the rate of general inflation in 2007. Mon, 12 May 2008 01:00:00 PDT http://www.medicalnewstoday.com/articles/106968.php Talecris Biotherapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has granted a Priority Review of Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The Priority Review designation is intended to expedite the review process for therapies that may provide a significant improvement in the treatment of serious or life-threatening diseases. Mon, 12 May 2008 01:00:00 PDT http://www.medicalnewstoday.com/articles/106962.php The European Medicines Agency (EMEA) has announced the marketing authorisation of Mycamine®, Astellas Pharma Europe's treatment for invasive candidiasis, oesophageal candidiasis and prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation. Mycamine® will initially be available in the U.K and across the European market shortly after this. Sat, 10 May 2008 03:00:00 PDT http://www.medicalnewstoday.com/articles/107000.php The US Food and Drug Administration (FDA) has found some hospitals and medical centers are still stocking potentially contaminated heparin among their supplies, showing that they failed to respond to recall notices and alerts about the blood thinner made by Baxter International. Sat, 10 May 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/106998.php The joint United Nations Program on HIV/AIDS, on which significanteffort has been focused, is damaging health systems and distortinghealth financing, writes Roger England, Chairman of theHealth Systems Network, in a View & Review feature released onMay 9, 2008 in BMJ. As a result, he believes thatUNAIDS should be closed down immediately. He writes that the amount spent on HIV in comparison the amount spenton other diseases in disproportionate. Sat, 10 May 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/106853.php Eli Lilly and Company (NYSE: LLY) announced that the United States Food and Drug Administration (FDA) has approved Strattera(R) (atomoxetine HCI) for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults. Fri, 09 May 2008 11:00:00 PDT http://www.medicalnewstoday.com/articles/106958.php An editorial published this week in The Lancetcalls attention to the growing crisis concerning counterfeit drugs.Currently, America is dealing with a potential case of counterfeitingin the drug heparin. It is possible that a contaminant found in batchesof heparin has led to the death of at least 81 patients. Fri, 09 May 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/106838.php Osteologix, Inc. (OLGX.OB), a specialty biopharmaceutical company, announced that the U. S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead development candidate NB S101 (strontium malonate), for the treatment and prevention of osteoporosis. NB S101, a dual acting bone agent, has a demonstrated ability to decrease resorption of bone while maintaining formation of new bone. Thu, 08 May 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/106728.php Vaccinogen Inc. said Dutch health authorities licensed it to manufacture its break-through OncoVAX anti-colon cancer vaccine, immediately clearing the path to more than US$100 million of potential European sales.The Dutch approval of the company's facility based in Emmen, The Netherlands also paves the way to its pivotal US FDA Phase IIIb clinical trial -- the final step before the vaccine can be sold in the United States. Thu, 08 May 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/106726.php Yesterday H. Con. Res. 342 was introduced by Rep. Mike Ross (D-Ark.) and Jo Ann Emerson (R-Mo.) opposing the Food and Drug Administration's (FDA) decision to restrict Estriol (a form of Estrogen), a compounded hormone preparation used by women to alleviate the symptoms of menopause. The action was taken after the FDA sent letters to seven pharmacies in January asking them to cease and desist with the use of estriol. Thu, 08 May 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/106680.php Cynosure, Inc. (Nasdaq: CYNO), a leading developer and manufacturer of a broad array of light-based aesthetic treatment systems, announced that it has received market approval from the Korea Food & Drug Administration (KFDA) for its flagship Accolade(TM) workstation for the removal of pigmented lesions. Wed, 07 May 2008 04:00:00 PDT http://www.medicalnewstoday.com/articles/106601.php The U.S. Food and Drug Administration has cleared for marketing a new safety engineered short-term peripheral Intra-Venous (IV) Catheter. The product, VantageCath™, is designed to significantly reduce exposure to bloodborne pathogens during the placement of the catheter and also provide the clinician with desirable feature sets. Wed, 07 May 2008 03:00:00 PDT http://www.medicalnewstoday.com/articles/106535.php W. L. Gore & Associates (Gore) announced that it has received approval from the US Food & Drug Administration (FDA) to proceed with the Gore REDUCE* Clinical Study. The Gore REDUCE Clinical Study is a prospective, randomized, multi-center, multinational trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for Patent Foramen Ovale (PFO) closure in patients with a PFO and history of cryptogenic stroke or imaging confirmed Transient Ischemic Attack (TIA). Wed, 07 May 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/106526.php ParagonDx, a leader in genetic testing diagnostics, has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its in vitro diagnostic test. The Rapid Genotyping Assay is to be used to detect the presence of variations in the genes CYP2C9 and VKORC1. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients at greater risk for warfarin sensitivity. Wed, 07 May 2008 00:00:00 PDT http://www.medicalnewstoday.com/articles/106546.php Vascular Insights LLC announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ClariVein(TM) infusion catheter for infusion of physician-specified agents in the peripheral vasculature. ClariVein(TM) is a percutaneous, 2 2/3 Fr (0.035") catheter, containing a rotating wire driven by a motor, that enhances fluid dispersion in the treatment area. "We are delighted with this development," said John P. Tue, 06 May 2008 02:00:00 PDT http://www.medicalnewstoday.com/articles/106338.php Ipsen (Paris:IPN) announced that the European Commission granted marketing authorisation for Adenuric® (febuxostat) for the treatment of chronic hyperuricaemia in gout. Adenuric® thus pioneers the first major treatment alternative for gout, a severe debilitating disease, for more than 40 years. Mon, 05 May 2008 07:00:00 PDT http://www.medicalnewstoday.com/articles/106197.php FDA Center for Drug Evaluation and Research Director Janet Woodcock on Thursday during a House hearing "backed away" from a Tuesday comment that the agency would need an estimated $225 million to improve inspections of foreign medication manufacturing plants, the Wall Street Journal reports (Mundy, Wall Street Journal, 5/2). Mon, 05 May 2008 06:00:00 PDT http://www.medicalnewstoday.com/articles/106188.php FDA on April 28 sent a warning letter to Merck officials informing them that agency investigators discovered manufacturing deficiencies at the company's vaccine plant in West Point, Pa., the Wall Street Journal reports.