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IP Vol.2 No.2 Jul-Dec 2014.Pmd
International Physiology63 Short Communication Vol. 2 No. 2, July - December 2014 Role of Polyol Pathway in Pathophysiology of Diabetic Peripheral Neuropathy: An Updated Overview Kumar Senthil P.*, Adhikari Prabha**, Jeganathan*** Abstract The aim of this short communication article was to enlighten the role of polyol pathway in pathophysiology of diabetic peripheral neuropathy (DPN) through an evidence-informed overview of current literature. Findings from experimental models of DPN suggest that altered glutathione redox state, with exaggerated NA(+)-K(+)-ATPase activity, increased malondialdehyde content, decreased red blood cell 2,3-diphosphoglycerate concentration, reduced cyclic adenosine monophosphate, reduced myo- inositol and excessive sorbitol in peripheral nerves were indicative of polyol metabolic pathwayin producing pathophysiological changes of DPN, and treatments using aldose reductase inhibitors were found to reverse those changes. Keywords: Polyol pathway; Myo-inositol; Sorbitol; Neurophysiology; Endocrinology. The aim of this short communication oxidized (GSSG) glutathione levels in crude article was to enlighten the role of polyol homogenates of rat sciatic nerve. The study pathway in pathophysiology of diabetic concluded that altered glutathione redox peripheral neuropathy (DPN) through an state played no detectable role in the evidence-informed overview of current pathogenesis of this defect in diabetic literature. peripheral nerve. Calcutt et al[1] measured motor nerve Finegold et al[3] studied the effect of conduction velocity (MNCV), Na(+)-K(+)- polyol pathway blockade with sorbinil, a ATPase activity, polyol-pathway specific inhibitor of aldose reductase, on metabolites, and myo-inositol in sciatic nerve myo-inositol content in acutely nerves from control mice, galactose-fed streptozotocin-diabetic ratswhich (20% wt/wt diet) mice, and galactose-fed completely prevented the fall in nerve myo- mice given the aldose reductase inhibitor inositol. -
(12) United States Patent (10) Patent No.: US 7,700,128 B2 Doken Et Al
US007700128B2 (12) United States Patent (10) Patent No.: US 7,700,128 B2 Doken et al. (45) Date of Patent: Apr. 20, 2010 (54) SOLID PREPARATION COMPRISING AN 5,726,201 A * 3/1998 Fekete et al. ................ 514,471 INSULIN SENSITIZER, AN INSULIN 6,599,529 B1* 7/2003 Skinha et al. .... ... 424/458 SECRETAGOGUE ANDA 2003/0147952 A1* 8, 2003 Lim et al. ................... 424/468 POLYOXYETHYLENE SORBITAN EATTY 2003. O180352 A1 9, 2003 Patel et al. ACD ESTER 2004/O147564 A1 7/2004 Rao et al. 2004/0175421 A1* 9, 2004 Gidwani et al. ............. 424/465 (75) Inventors: Kazuhiro Doken, Osaka (JP); Tetsuya FOREIGN PATENT DOCUMENTS Kawano, Osaka (JP); Hiroyoshi EP O749751 A2 12/1996 Koyama, Osaka (JP): Naoru FR 2758461 7, 1998 Hamaguchi, Osaka (JP) GB 23990 15 9, 2004 JP 58065213 * 4f1983 (73) Assignee: Takeda Pharmaceutical Company WO WO95/12385 5, 1995 Limited, Osaka (JP) WO WO98, 11.884 3, 1998 WO WO 98,31360 7, 1998 (*) Notice: Subject to any disclaimer, the term of this WO WO 98/36755 8, 1998 patent is extended or adjusted under 35 WO WO98,57649 12/1998 U.S.C. 154(b) by 711 days. WO WO99.03476 1, 1999 WO WO99.03477 1, 1999 (21) Appl. No.: 10/544,581 WO WO99.03478 1, 1999 WO WOOO,274O1 5, 2000 WO WOOO.28989 5, 2000 (22) PCT Filed: Oct. 21, 2004 WO WOO1? 41737 A2 6, 2001 WO WOO1, 51463 T 2001 (86). PCT No.: PCT/UP2004/O15958 WO WOO2,04024 1, 2002 WO WO O2/O55009 T 2002 S371 (c)(1), WO WO 03/066028 A1 8, 2003 (2), (4) Date: Apr. -
Emblica Officinalis and Its Enriched Tannoids Delay Streptozotocin-Induced Diabetic Cataract in Rats P
Washington University School of Medicine Digital Commons@Becker Open Access Publications 2007 Emblica officinalis and its enriched tannoids delay streptozotocin-induced diabetic cataract in rats P. Suryanarayana National Institute of Nutrition, India Megha Saraswat National Institute of Nutrition, India J. Mark Petrash Washington University School of Medicine in St. Louis G. Bhanuprakash Reddy National Institute of Nutrition, India Follow this and additional works at: https://digitalcommons.wustl.edu/open_access_pubs Recommended Citation Suryanarayana, P.; Saraswat, Megha; Petrash, J. Mark; and Reddy, G. Bhanuprakash, ,"Emblica officinalis and its enriched tannoids delay streptozotocin-induced diabetic cataract in rats." Molecular Vision.13,. 1291-7. (2007). https://digitalcommons.wustl.edu/open_access_pubs/1810 This Open Access Publication is brought to you for free and open access by Digital Commons@Becker. It has been accepted for inclusion in Open Access Publications by an authorized administrator of Digital Commons@Becker. For more information, please contact [email protected]. Molecular Vision 2007; 13:1291-7 <http://www.molvis.org/molvis/v13/a141/> ©2007 Molecular Vision Received 26 May 2007 | Accepted 20 July 2007 | Published 24 July 2007 Emblica officinalis and its enriched tannoids delay streptozotocin- induced diabetic cataract in rats P. Suryanarayana,1 Megha Saraswat,1 J. Mark Petrash,2 G. Bhanuprakash Reddy1 1Biochemistry Division, National Institute of Nutrition, Hyderabad, India; 2Department of Ophthalmology and Visual Sciences, Washington University, St. Louis, MO Purpose: Aldose reductase (AR) has been a drug target because of its involvement in the development of secondary complications of diabetes including cataract. We have previously reported that the aqueous extract of Emblica officinalis and its constituent tannoids inhibit AR in vitro and prevent hyperglycemia-induced lens opacification in organ culture. -
WO 2016/118476 Al 28 July 2016 (28.07.2016) W P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2016/118476 Al 28 July 2016 (28.07.2016) W P O P C T (51) International Patent Classification: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61K 38/46 (2006.01) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (21) International Application Number: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PCT/US2016/013847 PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, (22) International Filing Date: SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 19 January 2016 (19.01 .2016) TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (30) Priority Data: TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 62/105,342 20 January 2015 (20.01.2015) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (71) Applicant: THE CHILDREN'S MEDICAL CENTER LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, CORPORATION [US/US]; 300 Longwood Avenue, Bo SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, ston, Massachusetts 021 15-5724 (US). -
203313Orig1s000 203314Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 203313Orig1s000 203314Orig1s000 PROPRIETARY NAME REVIEW(S) PROPRIETARY NAME MEMORANDUM Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) *** This document contains proprietary information that cannot be released to the public*** Date of This Review: September 1, 2015 Application Type and Number: NDA 203313 Product Name and Strength: Ryzodeg 70/30 (insulin degludec and insulin aspart) injection, 100 units/mL Product Type: Combination (Drug + Device) Rx or OTC: Rx Applicant/Sponsor Name: Novo Nordisk Panorama #: 2015-1341036 DMEPA Primary Reviewer: Sarah K. Vee, PharmD DMEPA Team Leader: Yelena Maslov, PharmD Reference ID: 3813971 1 INTRODUCTION The Applicant submitted the proposed proprietary name, Ryzodeg on March 26, 2015 (b) (4) Division of Medication Error Prevention and Analysis (DMEPA) found the name conditionally acceptable in our previous review1 . On August 19, 2015, the Agency recommended that the Applicant consider including the modifier “70/30” to the proposed proprietary name to indicate the concentrations of the two insulins in the formulation. Since Ryzodeg is a mixed insulin formulation containing 70 % insulin degludec and 30 % insulin aspart, the addition of the modifier 70/30 would be consistent with current naming approach for mixed insulins. Thus, the Applicant submitted the name, Ryzodeg 70/30, for review on August 21, 2015. We note that the product characteristics are the same. This memorandum is to communicate that DMEPA finds the proposed proprietary name, Ryzodeg 70/30 (b) (4) is acceptable from both a misbranding and safety perspective. -
Muraglitazar Bristol-Myers Squibb/Merck Daniella Barlocco
Muraglitazar Bristol-Myers Squibb/Merck Daniella Barlocco Address Originator Bristol-Myers Squibb Co University of Milan . Istituto di Chimica Farmaceutica e Tossicologica Viale Abruzzi 42 Licensee Merck & Co Inc 20131 Milano . Italy Status Pre-registration Email: [email protected] . Indications Metabolic disorder, Non-insulin-dependent Current Opinion in Investigational Drugs 2005 6(4): diabetes © The Thomson Corporation ISSN 1472-4472 . Actions Antihyperlipidemic agent, Hypoglycemic agent, Bristol-Myers Squibb and Merck & Co are co-developing Insulin sensitizer, PPARα agonist, PPARγ agonist muraglitazar, a dual peroxisome proliferator-activated receptor-α/γ . agonist, for the potential treatment of type 2 diabetes and other Synonym BMS-298585 metabolic disorders. In November 2004, approval was anticipated as early as mid-2005. Registry No: 331741-94-7 Introduction [579218], [579221], [579457], [579459]. PPARγ is expressed in Type 2 diabetes is a complex metabolic disorder that is adipose tissue, lower intestine and cells involved in characterized by hyperglycemia, insulin resistance and immunity. Activation of PPARγ regulates glucose and lipid defects in insulin secretion. The disease is associated with homeostasis, and triggers insulin sensitization [579216], older age, obesity, a family history of diabetes and physical [579218], [579458], [579461]. PPARδ is expressed inactivity. The prevalence of type 2 diabetes is increasing ubiquitously and has been found to be effective in rapidly, and the World Health Organization warns that, controlling dyslipidemia and cardiovascular diseases unless appropriate action is taken, the number of sufferers [579216]. PPARα agonists are used as potent hypolipidemic will double to over 350 million individuals by the year compounds, increasing plasma high-density lipoprotein 2030. Worryingly, it is estimated that only half of sufferers (HDL)-cholesterol and reducing free fatty acids, are diagnosed with the condition [www.who.int]. -
The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances
WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. -
7-Azaindoles and Their Use As Ppar Agonists 7-Azaindole Und Ihre Verwendung Als Ppar-Agonisten 7-Azaindoles Et Leur Utilisation Comme Agonistes De Ppar
(19) TZZ___T (11) EP 1 794 159 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: C07D 471/04 (2006.01) A61K 31/437 (2006.01) 01.08.2012 Bulletin 2012/31 A61P 3/10 (2006.01) (21) Application number: 05778246.8 (86) International application number: PCT/EP2005/009269 (22) Date of filing: 27.08.2005 (87) International publication number: WO 2006/029699 (23.03.2006 Gazette 2006/12) (54) 7-AZAINDOLES AND THEIR USE AS PPAR AGONISTS 7-AZAINDOLE UND IHRE VERWENDUNG ALS PPAR-AGONISTEN 7-AZAINDOLES ET LEUR UTILISATION COMME AGONISTES DE PPAR (84) Designated Contracting States: • GLIEN, Maike AT BE BG CH CY CZ DE DK EE ES FI FR GB GR 65195 Wiesbaden (DE) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI • SCHAEFER, Hans-Ludwig SK TR 65239 Hochheim (DE) • WENDLER, Wolfgang (30) Priority: 11.09.2004 EP 04021667 65618 Selters (DE) • BERNARDELLI, Patrick (43) Date of publication of application: F-78450 Villepreux (FR) 13.06.2007 Bulletin 2007/24 • TERRIER, Corinne F-93190 Livry Gargan (FR) (73) Proprietor: Sanofi-Aventis Deutschland GmbH • RONAN, Baptiste 65929 Frankfurt am Main (DE) F-92140 Clamart (FR) (72) Inventors: (56) References cited: • KEIL, Stefanie EP-A- 1 445 258 WO-A-2004/074284 65719 Hofheim (DE) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
Aldose Reductase Inhibitors for Diabetic Cataract: a Study of Disclosure Patterns in Patents and Peer Review Papers
Ophthalmology Research: An International Journal 2(3): 137-149, 2014, Article no. OR.2014.002 SCIENCEDOMAIN international www.sciencedomain.org Aldose Reductase Inhibitors for Diabetic Cataract: A Study of Disclosure Patterns in Patents and Peer Review Papers H. A. M. Mucke1*, E. Mucke1 and P. M. Mucke1 1H. M. Pharma Consultancy, Enenkelstr. 28/32, A-1160 Wien, Austria. Authors’ contributions This work was carried out in collaboration between all authors. Author MHAM designed the study, performed the analysis, and drafted the manuscript. Authors EM and PMM performed data curation and iterative information retrieval. All authors read and approved the final manuscript. Received 29th September 2013 th Original Research Article Accepted 11 December 2013 Published 15th January 2014 ABSTRACT Aims: To investigate, for 13 aldose reductase inhibitors that had been in development for diabetic cataract, whether patent documents could provide earlier dissemination of knowledge to the ophthalmology community than peer review papers. Methodology: Searches for intellectual property disclosures were conducted in our internal database of ophthalmology patent documents, and were supplemented by online searches in the public Espacenet and Google Patents databases. Searches for peer review papers were performed in Pub Med and Google Scholar, and in our internal database of machine-readable ophthalmology publications. Results: For sorbinil, tolrestat, fidarestat and GP-1447 patent documents clearly preempted the peer review literature in terms of data-supported information on potential effectiveness in diabetic cataract, typically by 7-17 months. For alrestatin, zenarestat, zopolrestat, indomethacin, and quercitrin academic journals were clearly first to properly report this therapeutic utility, preempting the corresponding patents by 6 months to several years. -
Curriculum Vitae: Marc Stephen Rendell, Md
P a g e | 1 CURRICULUM VITAE: MARC STEPHEN RENDELL, M.D. ADDRESS: The Rose Salter Medical Research Foundation 34 Versailles Newport Coast, CA 92657-0065 clinic office 355 Placentia Avenue, Suite 308b Newport Beach, CA 92663 TELEPHONE: 402 -578-1580 HOSPITAL AND FACULTY APPOINTMENTS: 12/1977-6/1983 Active Staff and Assistant Professor Division of Endocrinology Department of Medicine The Johns Hopkins Hospital Baltimore, Maryland 6/1980-6/1983 Assistant Professor Division of Nuclear Medicine Department of Radiology The Johns Hopkins University School of Medicine Baltimore, Maryland 12/1977-6/1983 Chief, Endocrinology Director, Radioimmunoassay Laboratory The US Public Health Service Hospital Baltimore, Maryland 7/1983-11/1984 Director, Diabetes Institute City of Faith Medical and Research Center Associate Professor, Medicine and Pathology ORU School of Medicine Tulsa, Oklahoma 2/1985- 9/2016 Director, Creighton Diabetes Center Associate Professor of Medicine Associate Professor of Biomedical Sciences (1993-1995) P a g e | 2 Professor of Medicine and Biomedical Sciences (1996-2016 ) Creighton University School of Medicine Omaha, Nebraska 3/1999- Medical Director: Rose Salter Medical Research Foundation Baltimore, Maryland, Omaha, Nebraska, Newport Beach, California CLINICAL PRACTICE 12/1977-6/1983 Active Staff Division of Endocrinology Department of Medicine The Johns Hopkins Hospital Baltimore, Maryland 12/1977-6/1983 Chief, Endocrinology Director, Radioimmunoassay Laboratory The US Public Health Service Hospital Baltimore, Maryland 7/1983-11/1984 Director, Diabetes Institute City of Faith Medical and Research Center ORU School of Medicine Tulsa, Oklahoma 2/1985- 9/2016 Director, Creighton Diabetes Center Creighton University Medical Center Omaha, Nebraska 9/2016- Medical Director: Rose Salter Diabetes Center Newport Beach, California 1/2017- Telemedicine Physician Teladoc and MDLive EDUCATION: 9/1964-6/1968 B.S. -
The Leading Source of Diabetes Business News the Long View Fall
The Leading Source of Diabetes Business News The Long View Fall 2011 • No. 108 Although change isn’t literally in the air for me – here in San Francisco, we still get a few more weeks of summer – autumn brings some notable shifts in the world of diabetes, and I’m looking forward to hearing all about them in companies’ third-quarter financial updates. Perhaps most importantly, Amylin/Lilly/Alkermes’ Bydureon, the first once-weekly diabetes therapy, has now made its debut in several European countries. That means this earnings’ season will be the first chance to hear how the launch has gone, and we’ll get our first real indicator of what to expect in the quarters to come. Will patients flock to the every-seven-days dosage schedule, forcing rival GLP-1 companies to accelerate development of their own once-weekly products (and encouraging Amylin/Lilly/Alkermes to stay on course with their phase 2 once-monthly exenatide)? Or will factors like needle size, injection simplicity – and even the regularity of daily dosing, considered an advantage by some – give the edge to Victoza? (Novo Nordisk certainly isn’t resting on the success of this soon-to- be-blockbuster, having most recently launched Victoza in the swiftly growing Chinese market – a topic we explore in this issue’s interview with Novo Nordisk’s head of China, Ron Christie.) The global GLP-1 contest was already intensely competitive and has become more so, even before Bydureon’s entry to the US or the arrival of new players (e.g., Sanofi’s Lyxumia). -
(12) United States Patent (10) Patent No.: US 6,218,409 B1 Ikeda Et Al
USOO6218409B1 (12) United States Patent (10) Patent No.: US 6,218,409 B1 Ikeda et al. (45) Date of Patent: Apr. 17, 2001 (54) PHARMACEUTICAL COMPOSITION Akanuma et al., J. Clinical Therapeutics & Medicines, 9 Suppl. 3, p. 19-37, 36-60 (1993) (English translation). (75) Inventors: Hitoshi Ikeda, Higashiosaka; Takashi M. Tominaga et al. “Thiazolidinediones (AD-4833 and Sohda, Takatsuki; Hiroyuki Odaka, CS-045) Improve Hepatic Insulin Resistance in Streptozo Kobe, all of (JP) ticin-Induced Diabetic Rats', Endocrine Journal, vol. 40, No. 3, pp. 345–349, 1993. (73) Assignee: Takeda Chemical Industries, Ltd., C. Hofmann et al., “Glucose Transport Deficiency in Dia Osaka (JP) betic Animals is Corrected by Treatment with the Oral Antihyperglycemic Agent PioglitaZone', Endocrinology, (*) Notice: Subject to any disclaimer, the term of this vol. 129, No. 4, pp. 1915–1925, 1991. patent is extended or adjusted under 35 J. Karam, “Type II Diabetes and Syndrome X,Endocrinol U.S.C. 154(b) by 0 days. ogy and Metabolism Clinics of North America, vol. 21, No. 2, pp. 329-350, 1992. (21) Appl. No.: 09/610,994 S. Suter et al., “Metabolic Effects of New Oral Hypoglyce (22) Filed: Jul. 6, 2000 mic Agent CS-045 in NIDDM Subjects”, Diabetes Care, vol. 15, No. 2, pp. 193-203, 1992. Related U.S. Application Data T. Toyoda, Iyaku Journal, vol. 30, No. 4, pp. 1130-1134, 1994. (62) Division of application No. 09/303,497, filed on Apr. 30, Y. Sugiyama et al., “Effects of Pioglitazone on Glucose and 1999, now Pat. No. 6,156,773, which is a division of application No.