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CDR Clinical Review Report for Soliqua
CADTH COMMON DRUG REVIEW Clinical Review Report Insulin glargine and lixisenatide injection (Soliqua) (Sanofi-Aventis) Indication: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) alone or in combination with metformin. Service Line: CADTH Common Drug Review Version: Final (with redactions) Publication Date: January 2019 Report Length: 118 Pages Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. -
Numeric Listing of Manufacturers That Have Signed Rebate Agreements
Wisconsin Medicaid Pharmacy Data Table Manufacturers with Signed Rebate Agreements January 1, 2020 NEWLABELER NAME START END SC NEW LABELER NAME START END SC 00002 ELI LILLY AND COMPANY 1/1/1991 Y 00172 IVAX PHARMACEUTICALS, INC. 1/1/1991 Y 00003 E.R. SQUIBB & SONS, LLC. 1/1/1991 Y 00173 GLAXOSMITHKLINE 1/1/1991 00004 HOFFMANN-LA ROCHE 1/1/1991 00178 MISSION PHARMACAL COMPANY 1/1/1991 00006 MERCK & CO., INC. 1/1/1991 Y 00182 GOLDLINE LABORATORIES, INC. 1/1/1991 00007 GLAXOSMITHKLINE 1/1/1991 00185 EON LABS, INC. 1/1/1991 Y 00008 WYETH LABORATORIES 1/1/1991 Y 00186 ASTRAZENECA PHARMACEUTICAL 1/1/1991 Y 00009 PHARMACIA AND UPJOHN COMPA 1/1/1991 Y 00187 BAUSCH HEALTH US, LLC. 1/1/1991 Y 00013 PHARMACIA AND UPJOHN COMPA 1/1/1991 Y 00206 WYETH PHARMACEUTICALS LLC 1/1/1991 Y 00015 MEAD JOHNSON AND COMPANY 1/1/1991 Y 00224 KONSYL PHARMACEUTICALS, INC. 1/1/1992 00023 ALLERGAN INC 1/1/1991 00225 B. F. ASCHER AND COMPANY, INC. 1/1/1991 00024 SANOFI-AVENTIS, US LLC 1/1/1991 Y 00228 ACTAVIS ELIZABETH LLC 1/1/1991 Y 00025 GD. SEARLE LLC DIVISION OF PFIZ 1/1/1991 Y 00245 UPSHER-SMITH LABORATORIES, I 1/1/1991 Y 00026 BAYER HEALTHCARE LLC 1/1/1991 Y 00254 PAR PHARMACEUTTICAL INC. 9/28/2018 00029 GLAXOSMITHKLINE 1/1/1991 00258 FOREST LABORATORIES INC 1/1/1991 00032 ABBVIE INC. 1/1/1991 Y 00259 MERZ PHARMACEUTICALS 1/1/1991 00037 MEDA PHARMACEUTICALS, INC. -
Comparison of Clinical Outcomes and Adverse Events Associated with Glucose-Lowering Drugs in Patients with Type 2 Diabetes: a Meta-Analysis
Online Supplementary Content Palmer SC, Mavridis D, Nicolucci A, et al. Comparison of clinical outcomes and adverse events associated with glucose-lowering drugs in patients with type 2 diabetes: a meta-analysis. JAMA. doi:10.1001/jama.2016.9400. eMethods. Summary of Statistical Analysis eTable 1. Search Strategies eTable 2. Description of Included Clinical Trials Evaluating Drug Classes Given as Monotherapy eTable 3. Description of Included Clinical Trials Evaluating Drug Classes Given as Dual Therapy Added to Metformin eTable 4. Description of Included Clinical Trials Evaluating Drug Classes Given as Triple Therapy When Added to Metformin Plus Sulfonylurea eTable 5. Risks of Bias in Clinical Trials Evaluating Drug Classes Given as Monotherapy eTable 6. Risks of Bias in Clinical Trials Evaluating Drug Classes Given as Dual Therapy Added to Metformin eTable 7. Risks of Bias in Clinical Trials Evaluating Drug Classes Given as Triple Therapy When Added to Metformin plus Sulfonylurea eTable 8. Estimated Global Inconsistency in Networks of Outcomes eTable 9. Estimated Heterogeneity in Networks eTable 10. Definitions of Treatment Failure Outcome eTable 11. Contributions of Direct Evidence to the Networks of Treatments eTable 12. Network Meta-analysis Estimates of Comparative Treatment Associations for Drug Classes Given as Monotherapy eTable 13. Network Meta-analysis Estimates of Comparative Treatment Associations for Drug Classes When Used in Dual Therapy (in Addition to Metformin) eTable 14. Network Meta-analysis Estimates of Comparative Treatment Effects for Drug Classes Given as Triple Therapy eTable 15. Meta-regression Analyses for Drug Classes Given as Monotherapy (Compared With Metformin) eTable 16. Subgroup Analyses of Individual Sulfonylurea Drugs (as Monotherapy) on Hypoglycemia eTable 17. -
Modifications to the Harmonized Tariff Schedule of the United States To
U.S. International Trade Commission COMMISSIONERS Shara L. Aranoff, Chairman Daniel R. Pearson, Vice Chairman Deanna Tanner Okun Charlotte R. Lane Irving A. Williamson Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement the Dominican Republic- Central America-United States Free Trade Agreement With Respect to Costa Rica Publication 4038 December 2008 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 18, 2008, set forth in the Appendix hereto, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement the Dominican Republic- Central America-United States Free Trade Agreement, as approved in the Dominican Republic-Central America- United States Free Trade Agreement Implementation Act, with respect to Costa Rica. (This page is intentionally blank) Annex I Effective with respect to goods that are entered, or withdrawn from warehouse for consumption, on or after January 1, 2009, the Harmonized Tariff Schedule of the United States (HTS) is modified as provided herein, with bracketed matter included to assist in the understanding of proclaimed modifications. The following supersedes matter now in the HTS. (1). General note 4 is modified as follows: (a). by deleting from subdivision (a) the following country from the enumeration of independent beneficiary developing countries: Costa Rica (b). -
Comparative Safety and Effectiveness of Type 2 Diabetes Medicines Final Report September 2014
Type 2 Diabetes review – ToR 4 COMPARATIVE SAFETY AND EFFECTIVENESS OF TYPE 2 DIABETES MEDICINES FINAL REPORT SEPTEMBER 2014 A report by the Centre for Applied Health Economics (CAHE), Griffith University Type 2 Diabetes review – ToR 4 This report was commissioned by the Pharmaceutical Evaluation Branch, Department of Health, the Australian Government. Researchers: Erika Turkstra Senior research fellow, health technology assessment Martin Downes Research fellow, health technology assessment Emilie Bettington Senior research assistant Tracy Comans Senior research fellow, health technology assessment Paul Scuffham Professor and chair in health economics The assistance of Sanjeewa Kularatna with the data extraction and Gabor Mihala with the statistical analyses is appreciated. The advice provided by the Post-Market Review Section, Pharmaceutical Evaluation Branch, Department of Health and the Reference Group is also appreciated. Type 2 Diabetes review – ToR 4 CONTENTS ACRONYMS ............................................................................................................. III EXECUTIVE SUMMARY ............................................................................................ 1 PURPOSE OF THE REVIEW ........................................................................................... 1 BACKGROUND ............................................................................................................ 1 REVIEW OF CLINICAL GUIDELINES ............................................................................... -
Obesity, Diabetes, & Diet
Obesity, Diabetes, & Diet COMBINING EVIDENCE FOR ALL THREE INTO IMPROVED PATIENT CARE Case Study Louis J. Aronne, MD, FACP Weill Cornell Medical College Columbia University College of Physicians and Surgeons Louis J. Aronne, MD, FACP Disclosures !! Research/Grants: Amylin Pharmaceuticals, Inc.; Arena Pharmaceuticals, Inc.; F. Hoffmann-La Roche, Ltd.; Metabolous Pharmaceuticals, Inc.; Norvo Nordisk; Orexigen Therapeutics, Inc.; Pfizer Inc.; TransTech Pharma, Inc. !! Speakers Bureau: None !! Consultant: Allergan, Inc.; Amylin Pharmaceuticals, Inc.; GI Dynamics, Inc.; GlaxoSmithKline Consumer Healthcare, LP; Johnson & Johnson Pharmaceutical Research & Development, LLC; NeuroSearch, Inc.; Novo Nordisk; Orexigen Therapeutics, Inc.; Roche Laboratories, Inc.; VIVUS, Inc.; Wyeth Pharmaceuticals, Inc. !! Stockholder: Cardiometabolic Support Network, LLC !! Other Financial Interest: None !! Advisory Board: Allergan, Inc.; Amylin Pharmaceuticals, Inc.; GI Dynamics, Inc.; GlaxoSmithKline Consumer Healthcare, LP; Johnson & Johnson Pharmaceutical Research & Development, LLC; NeuroSearch, Inc.; Novo Nordisk; Orexigen Therapeutics, Inc.; Roche Laboratories, Inc.; VIVUS, Inc.; Wyeth Pharmaceuticals, Inc. Father A.V. 04May09: 378 lbs, 5’ 11”, BMI = 53 !! Dx w/ DMII in 2004 !! Long history of obesity !! Can’t control his eating, binges !! HbA1c = 8.4% !! FPG = 166 !! TG = 241 !! UA Microalbumin = 973 !! “Can’t tolerate metformin” !! Considering RYGB, but afraid to have surgery DMII = diabetes mellitus type II; Hb = hemoglobin; FPG = fasting plasma glucose; -
The Opportunities and Challenges of Peroxisome Proliferator-Activated Receptors Ligands in Clinical Drug Discovery and Development
International Journal of Molecular Sciences Review The Opportunities and Challenges of Peroxisome Proliferator-Activated Receptors Ligands in Clinical Drug Discovery and Development Fan Hong 1,2, Pengfei Xu 1,*,† and Yonggong Zhai 1,2,* 1 Beijing Key Laboratory of Gene Resource and Molecular Development, College of Life Sciences, Beijing Normal University, Beijing 100875, China; [email protected] 2 Key Laboratory for Cell Proliferation and Regulation Biology of State Education Ministry, College of Life Sciences, Beijing Normal University, Beijing 100875, China * Correspondence: [email protected] (P.X.); [email protected] (Y.Z.); Tel.: +86-156-005-60991 (P.X.); +86-10-5880-6656 (Y.Z.) † Current address: Center for Pharmacogenetics and Department of Pharmaceutical Sciences, University of Pittsburgh, Pittsburgh, PA 15213, USA. Received: 22 June 2018; Accepted: 24 July 2018; Published: 27 July 2018 Abstract: Peroxisome proliferator-activated receptors (PPARs) are a well-known pharmacological target for the treatment of multiple diseases, including diabetes mellitus, dyslipidemia, cardiovascular diseases and even primary biliary cholangitis, gout, cancer, Alzheimer’s disease and ulcerative colitis. The three PPAR isoforms (α, β/δ and γ) have emerged as integrators of glucose and lipid metabolic signaling networks. Typically, PPARα is activated by fibrates, which are commonly used therapeutic agents in the treatment of dyslipidemia. The pharmacological activators of PPARγ include thiazolidinediones (TZDs), which are insulin sensitizers used in the treatment of type 2 diabetes mellitus (T2DM), despite some drawbacks. In this review, we summarize 84 types of PPAR synthetic ligands introduced to date for the treatment of metabolic and other diseases and provide a comprehensive analysis of the current applications and problems of these ligands in clinical drug discovery and development. -
Pharmaceuticals Compositions Comprising Sulphonylurea-Class Insulin Secretagogue and Polyethylene Glycol Castor Oil
(19) & (11) EP 2 438 911 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 11.04.2012 Bulletin 2012/15 A61K 9/20 (2006.01) A61K 31/4439 (2006.01) A61K 31/64 (2006.01) A61K 9/16 (2006.01) (21) Application number: 10013440.2 (22) Date of filing: 08.10.2010 (84) Designated Contracting States: (72) Inventor: The designation of the inventor has not AL AT BE BG CH CY CZ DE DK EE ES FI FR GB yet been filed GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR (74) Representative: Hodzar, Damjan et al Designated Extension States: Lek Pharmaceuticals d.d. BA ME Verovskova 57 1526 Ljubljana (SI) (71) Applicant: LEK Pharmaceuticals d.d. 1526 Ljubljana (SI) (54) Pharmaceuticals compositions comprising sulphonylurea-class insulin secretagogue and polyethylene glycol castor oil (57) The present invention relates to the field of a rea-class insulin secretagogue active pharmaceutical in- pharmaceutical technology. More specifically, the gredient and at the same time, when both formulated into present invention relates to a pharmaceutical composi- a pharmaceutical composition, ensures satisfying or ex- tion comprising sulphonylurea-class insulin secreta- ceeding other parameters like for example stability, hard- gogue and a surface active agent. Surface active agent ness, friability and handling of said pharmaceutical com- obtainable by reacting castor oil or hydrogenated castor position. oil with ethylene oxide, preferably hydrogenated castor oil, substantially improves dissolution of the sulphonylu- EP 2 438 911 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 438 911 A1 Description Field of the invention 5 [0001] The present invention relates to the field of a pharmaceutical technology. -
In Re Incretin-Based Therapies Products Liability Litigation Transfer Order
Case MDL No. 2452 Document 71 Filed 08/26/13 Page 1 of 4 UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION IN RE: INCRETIN MIMETICS PRODUCTS LIABILITY LITIGATION MDL No. 2452 TRANSFER ORDER Before the Panel: Pursuant to 28 U.S.C. § 1407, plaintiffs in two Southern District of California actions move to centralize this litigation, which involves four anti-diabetic medications that plaintiffs contend cause pancreatic cancer, in the Southern District of California. This litigation currently consists of 53 actions pending in seven districts, as listed on Schedule A.1 All responding parties support centralization. Plaintiffs in fifteen Southern District of California actions and a District of Arizona action support plaintiffs’ motion in its entirety. Defendants2 support centralization in the Southern District of California or, alternatively, the District of Colorado or the Western District of Oklahoma. On the basis of the papers filed and hearing session held, we find that these actions involve common questions of fact, and that centralization of all actions in the Southern District of California will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. Plaintiffs in all actions allege that the use of one or more of four anti-diabetic incretin- based medications – Janumet (sitagliptin combined with metformin), Januvia (sitagliptin), Byetta (exenatide) and Victoza (liraglutide) – caused them or their decedent to develop pancreatic cancer. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings (particularly on such matters as Daubert rulings); and conserve the resources of the parties, their counsel, and the judiciary. We are “typically hesitant to centralize litigation against multiple, competing defendants which marketed, manufactured and sold similar products.” In re Yellow Brass Plumbing Component Prods. -
11/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 20:25:21 Report Id 2794D051 Page: 01
MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 11/09/2016 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 20:25:21 REPORT ID 2794D051 PAGE: 01 NUMERIC COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 01/01/2017 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 00002 ELI LILLY AND COMPANY 00145 STIEFEL LABORATORIES, INC, 00003 E.R. SQUIBB & SONS, LLC. 00149 WARNER CHILCOTT PHARMACEUTICALS INC. 00004 HOFFMANN-LA ROCHE 00168 E FOUGERA AND CO. 00006 MERCK & CO., INC. 00169 NOVO NORDISK, INC. 00007 GLAXOSMITHKLINE 00172 IVAX PHARMACEUTICALS, INC. 00008 WYETH LABORATORIES 00173 GLAXOSMITHKLINE 00009 PFIZER, INC 00178 MISSION PHARMACAL COMPANY 00013 PFIZER, INC. 00182 GOLDLINE LABORATORIES, INC. 00015 MEAD JOHNSON AND COMPANY 00185 EON LABS, INC. 00023 ALLERGAN INC 00186 ASTRAZENECA LP 00024 SANOFI-AVENTIS, US LLC 00187 VALEANT PHARMACEUTICALS NORTH AMERICA 00025 PFIZER, INC. 00206 LEDERLE PIPERACILLIN 00026 BAYER HEALTHCARE LLC 00224 KONSYL PHARMACEUTICALS, INC. 00029 GLAXOSMITHKLINE 00225 B. F. ASCHER AND COMPANY, INC. 00032 SOLVAY PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 00037 MEDA PHARMACEUTICALS, INC. 00245 UPSHER-SMITH LABORATORIES, INC. 00039 SANOFI-AVENTIS, US LLC 00258 FOREST LABORATORIES INC 00046 AYERST LABORATORIES 00259 MERZ PHARMACEUTICALS 00049 PFIZER, INC 00264 B. BRAUN MEDICAL INC. 00051 UNIMED PHARMACEUTICALS, INC 00281 SAVAGE LABORATORIES 00052 ORGANON USA INC. 00299 GALDERMA LABORATORIES, L.P. 00053 CSL BEHRING 00300 TAP PHARMACEUTICALS INC 00054 ROXANE LABORATORIES, INC. 00310 ASTRAZENECA LP 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00327 GUARDIAN LABS DIV UNITED-GUARDIAN INC 00062 ORTHO MCNEIL PHARMACEUTICALS 00338 BAXTER HEALTHCARE CORPORATION 00064 HEALTHPOINT, LTD. 00378 MYLAN PHARMACEUTICALS, INC. -
Possible Role of Rivoglitazone Thiazolidine Class of Drug As Dual
Medical Hypotheses 131 (2019) 109305 Contents lists available at ScienceDirect Medical Hypotheses journal homepage: www.elsevier.com/locate/mehy Possible role of rivoglitazone thiazolidine class of drug as dual-target therapeutic agent for bacterial infections: An in silico study T ⁎ Vidyasrilekha Yele , Niladri Saha, Afzal Azam Md Department of Pharmaceutical Chemistry, JSS College of Pharmacy, Ootacamund, JSS Academy of Higher Education & Research, Mysuru 643001, India ARTICLE INFO ABSTRACT Keywords: Infections due to resistant bacteria are the life-threatening and leading cause of mortality worldwide. The Rivoglitazone current therapy for bacterial infections includes treatment with various drugs and antibiotics. The misuse and ParE over usage of these antibiotics leads to bacterial resistance. There are several mechanisms by which bacteria MurE exhibit resistance to some antibiotics. These include drug inactivation or modification, elimination of antibiotics Docking through efflux pumps, drug target alteration, and modification of metabolic pathway. However, it is difficult to MM-GBSA treat infections caused by resistant bacteria by conventional existing therapy. In the present study binding af- Molecular dynamic simulations fi Anti-bacterial agent nities of some glitazones against ParE and MurE bacterial enzymes are investigated by in silico methods. As evident by extra-precision docking and binding free energy calculation (MM-GBSA) results, rivoglitazone ex- hibited higher binding affinity against both ParE and MurE enzymes compared to all other selected compounds. Further molecular dynamic (MD) simulations were performed to validate the stability of rivoglitazone/4MOT and rivoglitazone/4C13 complexes and to get insight into the binding mode of inhibitor. Thus, we hypothesize that structural modifications of the rivoglitazone scaffold can be useful for the development of an effective antibacterial agent. -
Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for BYETTA
Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for BYETTA SAN DIEGO and INDIANAPOLIS, Aug 26, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) in a conference call today provided context and additional information regarding the August 18, 2008 U.S. Food and Drug Administration (FDA) update to a prior alert for BYETTA® (exenatide) injection referencing pancreatitis. The companies were aware of the pancreatitis cases referenced in the alert, as well as others, and previously reported these cases to the FDA. The complete conference call replay will be available through Amylin's and Lilly's corporate websites after the call. Since 2006, the U.S. prescribing information for BYETTA has included information about pancreatitis. A recent study has also shown that patients with type 2 diabetes were at nearly three times the risk of developing pancreatitis than those without diabetes.(1) While a definite causal relationship between BYETTA and pancreatitis has not been proved, to better understand the suspected relationship, Amylin and Lilly continue to pursue a comprehensive drug safety program that includes extensive internal and external review of individual cases, and clinical and epidemiologic studies. "At Amylin and Lilly, patient safety is our foremost concern. We are committed to continuing to work closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products," said Orville G. Kolterman, Senior Vice President, Research and Development at Amylin. "It is important to understand that pancreatitis, an inflammatory condition of the pancreas, is a rare event.