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Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products. -
Disease Progression and Pharmacological Intervention in a Nutrient‑Defcient Rat Model of Nonalcoholic Steatohepatitis
Digestive Diseases and Sciences https://doi.org/10.1007/s10620-018-5395-7 ORIGINAL ARTICLE Disease Progression and Pharmacological Intervention in a Nutrient‑Defcient Rat Model of Nonalcoholic Steatohepatitis Kirstine S. Tølbøl1,3,4 · Birgit Stierstorfer2 · Jörg F. Rippmann2 · Sanne S. Veidal1 · Kristofer T. G. Rigbolt1 · Tanja Schönberger2 · Matthew P. Gillum4 · Henrik H. Hansen1 · Niels Vrang1 · Jacob Jelsing1 · Michael Feigh1 · Andre Broermann2 Received: 14 June 2018 / Accepted: 22 November 2018 © The Author(s) 2018 Abstract Background There is a marked need for improved animal models of nonalcoholic steatohepatitis (NASH) to facilitate the development of more efcacious drug therapies for the disease. Methods Here, we investigated the development of fbrotic NASH in male Wistar rats fed a choline-defcient L-amino acid- defned (CDAA) diet with or without cholesterol supplementation for subsequent assessment of drug treatment efcacy in NASH biopsy-confrmed rats. The metabolic profle and liver histopathology were evaluated after 4, 8, and 12 weeks of dieting. Subsequently, rats with biopsy-confrmed NASH were selected for pharmacological intervention with vehicle, elafbranor (30 mg/kg/day) or obeticholic acid (OCA, 30 mg/kg/day) for 5 weeks. Results The CDAA diet led to marked hepatomegaly and fbrosis already after 4 weeks of feeding, with further progression of collagen deposition and fbrogenesis-associated gene expression during the 12-week feeding period. Cholesterol supple- mentation enhanced the stimulatory efect of CDAA on gene transcripts associated with fbrogenesis without signifcantly increasing collagen deposition. Pharmacological intervention with elafbranor, but not OCA, signifcantly reduced stea- tohepatitis scores, and fbrosis-associated gene expression, however, was unable to prevent progression in fbrosis scores. -
A61p1/16 (2006.01) A61p3/00 (2006.01) Km, Ml, Mr, Ne, Sn, Td, Tg)
( (51) International Patent Classification: TR), OAPI (BF, BJ, CF, CG, Cl, CM, GA, GN, GQ, GW, A61P1/16 (2006.01) A61P3/00 (2006.01) KM, ML, MR, NE, SN, TD, TG). A61K 31/192 (2006.01) C07C 321/28 (2006.01) Declarations under Rule 4.17: (21) International Application Number: — as to the applicant's entitlement to claim the priority of the PCT/IB2020/000808 earlier application (Rule 4.17(iii)) (22) International Filing Date: Published: 25 September 2020 (25.09.2020) — with international search report (Art. 21(3)) (25) Filing Language: English — before the expiration of the time limit for amending the claims and to be republished in the event of receipt of (26) Publication Language: English amendments (Rule 48.2(h)) (30) Priority Data: 62/906,288 26 September 2019 (26.09.2019) US (71) Applicant: ABIONYX PHARMA SA [FR/FR] ; 33-43 Av¬ enue Georges Pompidou, Batiment D, 31130 Bahna (FR). (72) Inventor: DASSEUX, Jean-Louis, Henri; 7 Allees Charles Malpel, Bat. B, 31300 Toulouse (FR). (74) Agent: HOFFMANN EITLE PATENT- UND RECHTSANWALTE PARTMBB, ASSOCIATION NO. 151; Arabellastrasse 30, 81925 Munich (DE). (81) Designated States (unless otherwise indicated, for every kind of national protection available) : AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, IT, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, WS, ZA, ZM, ZW. -
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. -
Hepatitis B and Hepatitis D Luis S
Hepatitis B and Hepatitis D Luis S. Marsano, MD Professor of Medicine Division of Gastroenterology, Hepatology and Nutrition University of Louisville and Louisville VAMC June 2020 Hepatitis B Hepatitis B • 42 nm, partially double-stranded circular DNA virus. • 250 million carriers world-wide; – causes 500000 to 1 million deaths a year (686,000 in 2013) • 1.25 million carriers in USA.(0.5 %); – > 8% in Alaskan Eskimos. • Represents 5-10% of liver transplants worldwide. • New infections: decreasing in frequency – 260,000/y in 1980’s; – now 73,000/y • Greatest decline among children & adolescents (vaccine effect). Hepatitis B • Highest rate of disease in 20 to 49 year-olds • 20-30% of chronically infected americans acquired infection in childhood. • High prevalence in: – Asian-Pacific with 5-15% HBsAg(+) – Eastern European immigrants • Transmission: – In USA predominantly sexual and percutaneous during adult age. – In Alaska predominantly perinatal. Epidemiology and public health burden1 • Worldwide ≈250 million chronic HBsAg carriers2,3 • 686,000 deaths from HBV-related liver disease and HCC in 20134 HBsAg prevalence, adults (19−49 years), 20053 <2% Decreasing prevalence 2−4% in some endemic countries, e.g. Taiwan7 5−7% Possible reasons: ≥8% • Improved Not applicable socioeconomic status • Vaccination • Effective treatments Increasing prevalence in some European countries:5,6 • Migration from high endemic countries 1. EASL CPG HBV. J Hepatol 2017;67:370–98; 2. Schweitzer A, et al. Lancet 2015;386:1546–55; 3. Ott JJ, et al. Vaccine 2012;30:2212–9; 4. GBD 2013 Mortality and Causes of Death Collaborators. Lancet 2015;385:117–71; 5. Coppola N, et al. -
Editorial Udc: 615:378 Doi: 10.18413/2313-8971-2017-3-4-3
Pokrovskii M.V., Avtina T.V., Zakharova E.V., Belousova Yulia V. Oswald Schmiedeberg – the “father” of experimental pharmacology. Research Result: Pharmacology and Clinical 3 Pharmacology. 2017;3(4):3-19. EDITORIAL Rus. UDC: 615:378 DOI: 10.18413/2313-8971-2017-3-4-3-19 Mikhail V. Pokrovskii1 Tatyana V. Avtina T. OSWALD SCHMIEDEBERG –THE “FATHER” OF Elena V. Zakharova EXPERIMENTAL PHARMACOLOGY Yulia. V. Belousova Belgorod State National Research University, 85 Pobedy St., Belgorod, 308015 Russia Corresponding author, 1e-mail: [email protected] “Our tribute to the memory of the Teachers and those who were pioneers of pharmacology is an invaluable gift to our descendants” Abstract Biography. Oswald Schmiedeberg (1838-1921) was a son of a bailiff and a maid of honour, the eldest of the six children in the family. He was born and educated in the Russian Empire. Scientific activity. All his life he was completely devoted to science, making experimental pharmacology an independent scientific discipline, and was able to bring it to the international level. O. Schmiedeberg studied the action of muscarine and nicotine, digitoxin, hypnotics and analeptics. He was the first to introduce the concept of ―pharmacodynamics‖ and ―pharmacokinetics‖ of a drug. With his participation, the world‘s first pharmacological journal was founded, which is still published today. Science school. Working for many years at the University of Strasbourg, Schmiedeberg managed to educate about 120 students – professors from 20 countries of the world, many of whom later founded experimental pharmacology in their countries, for example, Abel in the USA, and N.P. Kravkov in Russia. -
Meeting of the OECD Global Parliamentary Network 1-2 October 2020 List of Participants
as of 02/10/2020 Meeting of the OECD Global Parliamentary Network 1-2 October 2020 List of participants MP or Chamber or Political Party Country Parliamentary First Name Last Name Organisation Job Title Biography (MPs only) Official represented Pr. Ammar Moussi was elected as Member of the Algerian Parliament (APN) for the period 2002-2007. Again, in the year Algerian Parliament and Member of Peace Society 2017 he was elected for the second term and he's now a member of the Finance and Budget commission of the National Algeria Moussi Ammar Parliamentary Assembly Member of Parliament Parliament Movement. MSP Assembly. In addition, he's member of the parliamentary assembly of the Mediterranean PAM and member of the executif of the Mediterranean bureau of tha Arab Renewable Energy Commission AREC. Abdelmajid Dennouni is a Member of Parliament of the National People’s Assembly and a Member of finances and Budget Assemblée populaire Committee, and Vice president of parliamentary assembly of the Mediterranean. He was previously a teacher at Oran Member of nationale and Algeria Abdelmajid Dennouni Member of Parliament University, General Manager of a company and Member of the Council of Competitiveness, as well as Head of the Parliament Parliamentary Assembly organisaon of constucng, public works and hydraulics. of the Mediterranean Member of Assemblée Populaire Algeria Amel Deroua Member of Parliament WPL Ambassador for Algeria Parliament Nationale Assemblée Populaire Algeria Parliamentary official Safia Bousnane Administrator nationale Lucila Crexell is a National Senator of Argentina and was elected by the people of the province of Neuquén in 2013 and reelected in 2019. -
New Approaches to the Treatment of Chronic Hepatitis B
Journal of Clinical Medicine Review New Approaches to the Treatment of Chronic Hepatitis B Alexandra Alexopoulou 1,*, Larisa Vasilieva 1 and Peter Karayiannis 2 1 Department of Medicine, Medical School, National & Kapodistrian University of Athens, Hippokration General Hospital, 11527 Athens, Greece; [email protected] 2 Department of Basic and Clinical Sciences, Medical School, University of Nicosia, Engomi, CY-1700 Nicosia, Cyprus; [email protected] * Correspondence: [email protected]; Tel.: +30-2132-088-178; Fax: +30-2107-706-871 Received: 3 September 2020; Accepted: 28 September 2020; Published: 1 October 2020 Abstract: The currently recommended treatment for chronic hepatitis B virus (HBV) infection achieves only viral suppression whilst on therapy, but rarely hepatitis B surface antigen (HBsAg) loss. The ultimate therapeutic endpoint is the combination of HBsAg loss, inhibition of new hepatocyte infection, elimination of the covalently closed circular DNA (cccDNA) pool, and restoration of immune function in order to achieve virus control. This review concentrates on new antiviral drugs that target different stages of the HBV life cycle (direct acting antivirals) and others that enhance both innate and adaptive immunity against HBV (immunotherapy). Drugs that block HBV hepatocyte entry, compounds that silence or deplete the cccDNA pool, others that affect core assembly, agents that degrade RNase-H, interfering RNA molecules, and nucleic acid polymers are likely interventions in the viral life cycle. In the immunotherapy category, molecules that activate the innate immune response such as Toll-like-receptors, Retinoic acid Inducible Gene-1 (RIG-1) and stimulator of interferon genes (STING) agonists or checkpoint inhibitors, and modulation of the adaptive immunity by therapeutic vaccines, vector-based vaccines, or adoptive transfer of genetically-engineered T cells aim towards the restoration of T cell function. -
Hepatic Macrophage Responses in Inflammation, a Function Of
REVIEW published: 09 June 2021 doi: 10.3389/fimmu.2021.690813 Hepatic Macrophage Responses in Inflammation, a Function of Plasticity, Heterogeneity or Both? Christian Zwicker 1,2†, Anna Bujko 1,2† and Charlotte L. Scott 1,2,3* 1 Laboratory of Myeloid Cell Biology in Tissue Damage and Inflammation, VIB-UGent Center for Inflammation Research, Ghent, Belgium, 2 Department of Biomedical Molecular Biology, Faculty of Science, Ghent University, Ghent, Belgium, 3 Department of Chemical Sciences, Bernal Institute, University of Limerick, Limerick, Ireland With the increasing availability and accessibility of single cell technologies, much attention has been given to delineating the specific populations of cells present in any given tissue. In recent years, hepatic macrophage heterogeneity has also begun to be examined using these strategies. While previously any macrophage in the liver was considered to be a Kupffer cell (KC), several studies have recently revealed the presence of distinct subsets of Edited by: hepatic macrophages, including those distinct from KCs both under homeostatic and Ioannis Kourtzelis, non-homeostatic conditions. This heterogeneity has brought the concept of macrophage University of York, United Kingdom plasticity into question. Are KCs really as plastic as once thought, being capable of Reviewed by: responding efficiently and specifically to any given stimuli? Or are the differential responses Ian Nicholas Crispe, University of Washington Tacoma, observed from hepatic macrophages in distinct settings due to the presence of multiple United States subsets of these cells? With these questions in mind, here we examine what is currently Takayoshi Suganami, understood regarding hepatic macrophage heterogeneity in mouse and human and Nagoya University, Japan *Correspondence: examine the role of heterogeneity vs plasticity in regards to hepatic macrophage Charlotte L. -
Lessons from Liver-Specific PPAR-Null Mice
International Journal of Molecular Sciences Review PPARs as Metabolic Regulators in the Liver: Lessons from Liver-Specific PPAR-Null Mice Yaping Wang 1, Takero Nakajima 1, Frank J. Gonzalez 2 and Naoki Tanaka 1,3,* 1 Department of Metabolic Regulation, Shinshu University School of Medicine, Matsumoto, Nagano 390-8621, Japan; [email protected] (Y.W.); [email protected] (T.N.) 2 Laboratory of Metabolism, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA; [email protected] 3 Research Center for Social Systems, Shinshu University, Matsumoto, Nagano 390-8621, Japan * Correspondence: [email protected]; Tel.: +81-263-37-2851 Received: 21 February 2020; Accepted: 9 March 2020; Published: 17 March 2020 Abstract: Peroxisome proliferator-activated receptor (PPAR) α, β/δ, and γ modulate lipid homeostasis. PPARα regulates lipid metabolism in the liver, the organ that largely controls whole-body nutrient/energy homeostasis, and its abnormalities may lead to hepatic steatosis, steatohepatitis, steatofibrosis, and liver cancer. PPARβ/δ promotes fatty acid β-oxidation largely in extrahepatic organs, and PPARγ stores triacylglycerol in adipocytes. Investigations using liver-specific PPAR-disrupted mice have revealed major but distinct contributions of the three PPARs in the liver. This review summarizes the findings of liver-specific PPAR-null mice and discusses the role of PPARs in the liver. Keywords: PPAR; NAFLD; NASH; insulin resistance; liver fibrosis 1. Introduction Administration of Wy-14643, nafenopin, and fibrate drugs to rodents results in hepatic peroxisome proliferation. These agents are thus designated as peroxisome proliferators (PPs) [1]. To explain a mechanism of rapid and drastic changes following PP administration, the involvement of transcription factors was assumed and the first peroxisome proliferator-activated receptor (PPAR, later defined as PPARα (NR1C1)) was identified in 1990 [2]. -
Gilead to Acquire MYR Pharmaceuticals
Gilead to Acquire MYR Pharmaceuticals December 9, 2020 Forward-Looking Statements This presentation includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, MYR Pharmaceuticals and the acquisition of MYR Pharmaceuticals by Gilead that are subject to risks, uncertainties and other factors, including Gilead’s ability to successfully execute its corporate strategy in its currently anticipated timelines; Gilead’s ability to make progress on any of its long-term ambitions laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its programs; the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; uncertainties relating to the timing or outcome of any filings and approvals relating to the transaction; difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the transaction on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this transaction; the ability of Gilead to advance MYR Pharmaceuticals’ product pipeline and successfully commercialize Hepcludex®; the ability of the parties to initiate and complete clinical trials involving Hepcludex in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving Hepcludex; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the U.S. -
Hepcludex (Bulevirtide) Treatment of Hepatitis Delta Virus Infection EU/3/15/1500 Sponsor: MYR Gmbh
31 July 2020 EMADOC-1700519818-471852 Committee for Orphan Medicinal Products Orphan Maintenance Assessment Report Hepcludex (bulevirtide) Treatment of hepatitis delta virus infection EU/3/15/1500 Sponsor: MYR GmbH Note Assessment report as adopted by the COMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Product and administrative information .................................................. 3 2. Grounds for the COMP opinion ................................................................. 4 3. Review of criteria for orphan designation at the time of marketing authorisation ............................................................................................... 4 Article 3(1)(a) of Regulation (EC) No 141/2000 .............................................................. 4 Article 3(1)(b) of Regulation (EC) No 141/2000 .............................................................. 6 4. COMP position adopted on 29 May 2020 .................................................. 6 31 July 2020 Page 2/6 1. Product and administrative information Product Active substances at the time of orphan Synthetic 47-amino acid N-myristoylated