Abbott Labora Tories Zambon Actelion Wockhardt Ajinomoto W a Tson Pharmaceuticals Alexion Pharmaceuticals W Arner Chilcott Aller

Total Page:16

File Type:pdf, Size:1020Kb

Abbott Labora Tories Zambon Actelion Wockhardt Ajinomoto W a Tson Pharmaceuticals Alexion Pharmaceuticals W Arner Chilcott Aller ZAMBON ABBOTT LABORATORIES WOCKHARDT ACTELION WATSON PHARMACEUTICALS AJINOMOTO WARNER CHILCOTT ALEXION PHARMACEUTICALS VERTEX PHARMACEUTICALS ALLERGAN VALEANT PHARMACEUTICALS ALMIRALL UNITED THERAPEUTICS AMGEN UCB AMYLIN PHARMACEUTICALS TORAY INDUSTRIES ASAHI KASEI TEVA ASPEN PHARMACARE TEIJIN ASTELLAS TAKEDA ASTRAZENECA TAISHO PHARMACEUTICAL BAXTER INTERNATIONAL SUN PHARMACEUTICAL INDUSTRIES BAYER STADA BIOGEN IDEC SIGMA-TAU BOEHRINGER INGELHEIM SHIRE BRISTOL-MYERS SQUIBB SHIONOGI CADILA SERVIER CELGENE SAWAI PHARMACEUTICAL CHIESI SANTEN CIPLA SANOFI COVIDIEN ROCHE CSL RECORDATI CUBIST PHARMACEUTICALS PIERRE FABRE DAIICHI SANKYO PHARMSTANDARD DAINIPPON SUMITOMO PFIZER DONG-A PAR PHARMACEUTICAL COMPANIES dr reddy’s OTSUKA HOLDINGS EISAI ORION PHARMA ELAN ONO PHARMACEUTICAL ENDO PHARMACEUTICALS NOVO NORDISK ESTEVE NOVARTIS FERRING NIPPON SHINYAKU FOREST LABORATORIES MYLAN GALDERMA MOCHIDA GALENICA AG MITSUBISHI TANABE GEDEON RICHTER 100 MERZ GILEAD SCIENCES MERCK KGAA GLAXOSMITHKLINE MERCK & CO GREEN CROSS MENARINI GRUENENTHAL MEIJI HOLDINGS HISAMITSU MEDICIS PHARMACEUTICAL HOSPIRA MEDA IPSEN MARUHO JAPAN TOBACCO LUPIN JOHNSON & JOHNSON LUNDBECK KAKEN PHARMACEUTICAL LILLY KISSEI LEO PHARMA KRKA KYOWA HAKKO KIRIN KYORIN HOLDINGS Pharma&Biotech Looking for an Easier Way? Bridge the Gap with Lonza’s Easy Access Services for ADCs Lonza offers early development and manufacturing services for your antibody-drug conjugates (ADCs). Take advantage of the best characteristics of monoclonal antibodies (mAbs) and the potency of cytotoxic molecules with Lonza’s early access ADC programs. – Preparation of ADC sample panels using a variety of linker, drug, and mAb combinations – R&D safety labs for process development and/or toxic batches (5mg–40g) – GMP suites for clinical supply (50–150g) – Complete analytical development packages with mAb/ADC harmonization – Quick turnaround of R&D projects, toxicology batches and Phase I GMP production – Dedicated staff and over 60 GMP clinical ADC batches released with very high success rates – Production capacity for all your early stage, late stage and full commercial needs Order your ADC sample preparation at www.lonza.com/adc [email protected] North America + 1 201 316 9200, Europe +41 61 316 9200 www.lonza.com SCRIP 100.COM Contents How to feed your giant SCRIP 100 5 BUSINESS 10 Since 2009, the pharma industry has C-SUITE 17 cut almost 150,000 jobs in the US alone. If news of layoffs were not LEADERSHIP 24 uncomfortable enough, the challenges facing this industry – which have CAREERS 31 never been so present nor acute – make the cuts even more painful and R&D 38 even more necessary. At a time when the pharma giant CLINICAL TRIALS 48 confronts its greatest tests head on (data disclosure, an anachronistic THE PATIENT 59 business model, patent expiries, and reimbursement to name a few), will the EMERGING MARKETS 65 limbs that have survived amputation be strong enough to drag the weighty POLICY & REGULATION 75 torso of the injured behemoth over the Our front cover image shows the top 100 modern healthcare horizon? MARKET ACCESS 83 pharma companies, ranked by total 2011 Of course, it is down to those that pharmaceutical sales, and in alphabetical have survived the lopping of limbs to MANUFACTURING 89 order. The companies with more sales have save the day, coming to the rescue of a longer line. Designed by Emily Foster. both themselves and the bruised FUTUROLOGY 96 colossus. The message to this group of people is clear: now is the time to provide the muscle, now is the time to SCRIP 100 EDITOR INDIA EDITOR CONTRIBUTORS SCRIP HEAD OFFICE Joanne Payne Anju Ghangurde John Bird Informa Pharma, be your own hero. Pharma has never Dr Christine Blazynski 119 Farringdon Road, CHIEF CONTENT WASHINGTON EDITOR been more in need of good ideas – Neena Brizmohun London EC1R 3DA OFFICER, DATAMONITOR Donna Young Dr Peter Charlish Tel: +44 (0)20 7017 5000 intellectual nutrition to bolster its HEALTHCARE Tracy DeGregorio US WEST COAST EDITOR Fax: +44 (0)20 7017 6965 Mike Ward Duncan Emerton waning health – and it is the strongest Mandy Jackson Wang Fangqing US OFFICE CHIEF OF CONTENT, leaders that will find the heroes to Ben Goldacre 52 Vanderbilt Avenue, SCRIP GROUP SENIOR REPORTER George Green 7th Floor, provide this life-saving elixir. Christopher Bowe Francesca Bruce Michael Hay New York In the meantime, the lost limbs of MANAGING EDITOR EDITORIAL ASSISTANT Maura Musciacco NY10017, US the immobile giant have scuttled off, John Hodgson Gemma Sharman Josh Owide Tel: +1 212 972 4899 Ian Schofield Fax: +1 212 972 4855 EDITORIAL INTERN often morphing into innovators that HEAD OF DATA & Andy Smith Lucie Ellis Japan OFFICE may yet herald the salvation of the RESEARCH Ashley Yeo Alex Shimmings T Hirata, Shiryo Kenkyujo DESIGNER healthcare industry, and return to feed SUBSCRIPTIONS Co Ltd Emily Foster 3-5-20-405 Sotokanda, the giant on their own terms. ASIA EDITOR Tel: +(0)800 012 8020 Ian Haydock Chiyoda-ku Tokyo PUBLISHING DIRECTOR Fax: +44 (0)20 7017 6985 101-0021, Japan However, it may yet be those Phil Jarvis [email protected] EMEA EDITOR Tel: +81 3 3258 9207 survivors that nourish the staggering Eleanor Malone ADVertising Subscription rates Fax: +81 3 3258 9209 goliath and that navigate new NEWS EDITOR Rakesh Chauhan UK £2,630; Europe €3,900 pathways, that create a future – and a Dr Sukaina Virji James Kenney US/Canada US$5,090 Neil Hartley giant – worth saving. All articles published are the copyright of Informa Healthcare, a trading division of Informa Group plc, and should not be reproduced or copied in whole or in part without the written permission of the publisher. Every effort has been made to ensure the contents of this publication are factually correct but neither the authors nor the publisher accepts liability for injury, damages or losses arising from the material published in this journal. All images courtesy of shutterstock.com unless otherwise stated. Joanne Payne, Editor Printed by Wyndeham Grange, Southwick ISSN 2042-9622 © Informa UK Ltd 2012 FORMERLY EURAND PHARMACEUTICAL TECHNOLOGIES Proprietary technologies for differentiated oral products CUSTOMIZED BIOAVAILABILITY TASTE MASKING DRUG RELEASE ENHANCEMENT AND ODTs Aptalis Pharmaceutical Technologies develops and manufactures enhanced pharmaceutical products using its broad range of proprietary oral pharmaceutical technologies. Visit us at www.AptalisPharmaceuticalTechnologies.com to view our current product portfolio available for out-licensing and learn more about our full service co-development capabilities using our technologies. F01 Scrip100 Print Ad 208X273mm.indd 1 11/2/12 10:49 AM SCRIP 100 Pharma slims down to retain healthy heart John Bird Lead Analyst, This year’s Scrip 100 company rankings, based on total 2011 pharmaceutical Datamonitor sales, reveal a story of an industry still trying to evolve into a more modern Healthcare beast. John Bird takes a closer look. Total pharmaceutial sales of the Scrip highest-placed pharma company in decline by $600 million in the final 100 league table members in 2011 2011, French firm Sanofi. These top quarter of 2011 (a significant amount equaled $687 billion, with the leading two players had contrasting years, given generics were only available in the 100 prescription pharmaceutical Pfizer posted a year-on-year sales US for roughly half of that quarter). In companies’ total increasing by 7.8% decline of 1.3%, whereas Sanofi total, sales of Lipitor declined by over over 2010’s figure of $637 billion, or (boosted by consolidating sales of 10% during 2011, versus its 2010 figure. $50 billion in absolute terms. Genzyme following the completion of However, it is not just the leading the acquisition of the US biotech in statin’s sales declines that Pfizer has to EXPIRIES HAVE FINAL WORD April, 2011) ramped up its topline by contend with. Pfizer faces the problems On top of the Scrip 100 table for 2011, 15.2% over its 2010 total. of a maturing portfolio with an extensive with sales of almost $58 billion, is once In the final quarter of 2011, Pfizer’s array of high sales generating-drugs again the US pharma giant Pfizer. The long standing flagship product, the that are experiencing, or are soon to New York-based firm still commands a anti-dyslipidemia therapeutic Lipitor experience, generic sales erosion. dominant position, with its 2011 total (atorvastatin) lost patent protection in In total, over $12 billion in sales are (from prescription pharmaceuticals) a its key US market and with the ensuing expected to be wiped from Pfizer’s clear $11 billion ahead of the second generic sales entry saw its global sales topline over the period 2011-17 which SCRIP100.COM SCRIP 100 5 SCRIP 100 By 2017, equates to over 20% of the company’s therapy for chronic myeloid leukemia DOMESTIC BRIC companies NOT Datamonitor total sales in 2011. Lipitor is responsible Gleevec/Glivec (imatinib) and its QUITE THERE YET expects Novartis for over $7 billion of this expiry successful 2011 launch of MS drug In terms of the emerging markets, it is to be the biggest portfolio decline, with other significant Gilenya (fingolimod), along with the India that dominates with six companies industry player declines expected to come from continued uptake of the cancer therapy inside the Scrip 100 list (the third Celebrex (celecoxib), Geodon/Zeldox Afinitor (everolimus) will position the highest total for an individual country). (ziprasidone) and Zyvox (linezolid). company as the best performing of the Surprisingly, Chinese pharmaceutical Such is the maturity of Pfizer’s pharma companies with sales in excess firms are absent from the top 100. In offering, Datamonitor has identified 40 of $10 billion. fact, the largest firm from the world’s key brands that are positioned within By 2017, Datamonitor expects highest populated country was in 129th Pfizer’s portfolio that are currently Novartis (including sales from its generic place, the China Pharmaceutical Group, facing generic sales erosion, or will in business unit Sandoz) to be the biggest with 2011 prescription pharma sales the near future.
Recommended publications
  • Nilotinib in Patients with Chronic Myeloid Leukemia: STAT2 Trial in Japan
    Haematologica HAEMATOL/2018/194894 Version 3 Haematologica HAEMATOL/2018/194894 Version 3 Treatment-free remission after two-year consolidation therapy with nilotinib in patients with chronic myeloid leukemia: STAT2 trial in Japan Naoto Takahashi, Kaichi Nishiwaki, Chiaki Nakaseko, Nobuyuki Aotsuka, Koji Sano, Chikako Ohwada, Jun Kuroki, Hideo Kimura, Michihide Tokuhira, Kinuko Mitani, Kazuhisa Fujikawa, Osamu Iwase, Kohshi Ohishi, Fumihiko Kimura, Tetsuya Fukuda, Sakae Tanosaki, Saori Takahashi, Yoshihiro Kameoka, Hiroyoshi Nishikawa, and Hisashi Wakita Disclosures: 1. This study was supported by research funding from Novartis Pharmaceuticals to N.T. 2. N.T reports grants from Novartis Pharmaceuticals, during the conduct of the study; grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Otsuka, grants and personal fees from Pfizer, personal fees from Bristol-Myers Squibb, outside the submitted work; K.N reports grants from Zenyaku Kogyo Company, Limited, grants from Chugai Pharmaceutical, grants from Novartis Pharma K.K., grants from Kyowa Hakko Kirin Co, Ltd, grants from Nippon Shinyaku Co, Ltd, outside the submitted work; C.N reports personal fees from Novartis, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from Pfizer, grants and personal fees from Takeda pharmaceuticals, grants and personal fees from Kyowa Hakko Kirin, grants and personal fees from Otsuka Pharmaceutical, grants and personal fees from Ono Pharmaceutical, grants and personal fees from Chugai Pharmaceutical, grants and personal fees from Asahi Kasei Pharma, grants and personal fees from Shionogi, personal fees from Shire, personal fees from Jannsen, personal fees from Celgene, outside the submitted work; M.T. reports personal fees from Bristol-Myers Squib, personal fees from Pfizer, outside the submitted work; K.M reports grants from Kyowa Hakko Kirin Co.
    [Show full text]
  • Scientific Program Saturday, 17. July 2021 Factor VIII, Factor IX and Rare
    Scientific programThe XXIX Congress of the International Society on Thrombosis and Haemostasis July 17-21, 2021 Philadelphia, U.S. Saturday, 17. July 2021 SSC Session 08:00 - 10:00 R1 Factor VIII, Factor IX and Rare Coagulation Disorders Introduction 08:00 - 08:02 Speaker: Johnny Mahlangu, ZA Non-Factor Replacement Therapies 08:02 - 08:02 Moderators: Johnny Mahlangu, South Africa, Tarek Owaidah, Saudi Arabia In Patients on Non-Factor Therapies, Exposure to Clotting 08:02 - 08:14 Factor Replacement Should Be Early (Debate) Speaker: Manuel Carcao, CA In Patients on Non-Factor Therapies, Exposure to Clotting 08:14 - 08:26 Factor Replacement Should Be Early (Debate) Speaker: Jayanthi Alamelu, GB Non-Factor Replacement Therapy Versus Factor Replacement 08:26 - 08:38 Therapy Risks -There Is No Free Lunch (Debate) Speaker: Bhavya Doshi, US Non-Factor Replacement Therapy Versus Factor Replacement 08:38 - 08:50 Therapy Risks -There Is No Free Lunch (Debate) Speaker: Gili Kenet, IL Beyond Annualized Bleed Rates What Should Be the Alternative 08:50 - 09:02 Endpoints for Non-Replacement Therapies Speaker: Alok Srivastava, IN Q&A Session 09:02 - 09:06 Gene Therapy 09:06 - 09:06 Moderators: Valder Arruda, United States, Savita Rangarajan, United Kingdom Anti Adeno-Associated Virus Antibodies Antibodies: What Are 09:06 - 09:18 the Standardization Issues? Speaker: David Lillicrap, CA Rationale for Adeno-associated Virus (AAV) Mediated Gene 09:24 - 09:30 Therapy in Patients With Anti Adeno-associated Virus Antibodies Speaker: David Cooper, NL What Should We Be Following-up Post Gene Therapy? 09:30 - 09:42 Speaker: Barbara A.
    [Show full text]
  • Biotechnology Worldwide
    Biotechnology Worldwide There are several countries that are making special efforts to both develop and capitalise on Biotechnology. Chief amongst them is America, though cutting edge work is also going on in the UK, Ireland, Germany, Korea, Singapore, China and Japan. • America is the world leader in biotechnology, it has 1,379 biotechnology companies and employs 174,000 people. It spends £9 billion on research into biotechnology. • The European market for goods and services dependent on biotechnology is currently estimated at £30 billion and is forecast to exceed £100 billion by the year 2005 • The UK leads Europe in biotechnology and employs 19,000 people • The UK has 300 dedicated biotechnology companies and a further 250-300 involved in broader bioscience related activities • The industrial sectors which stand to benefit from biotechnology are pharmaceutical, agriculture, food and drink, chemicals and environmental technologies • Germany is the second strongest country in Europe, with 332 companies but fewer products in development than the UK. UK The UK biotechnology industry is regarded as second only to the huge effort taking place in the States. UK biotechnology companies generate over a billion pounds in revenue; half of this is pumped back into research and development. The industry has particular strengths, for example: • Britain was a key player in the world wide project of sequencing the 30,000 genes of the human genome. The announcement of the first working draft of the human genome marks a significant step forward in our understanding of the way in which we understand and develop treatments for incurable genetic conditions.
    [Show full text]
  • Bebulin VH Corifact Factor VII Concentrate
    P RODUCTS TO TREAT RARE FACTOR DEFICIENCIES Product Plasma source Fractionation Viral inactivation Vial size Storage Availability USA: volunteer, Vapour heat @ 60°C for 10 hr at Available through Special Bebulin VH remunerated Ion exchange 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Shire donors distributed in all provinces. Comments Factor IX complex containing factors II, VII, IX and X, heparin added. Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Purification steps: 1) Precipitation/adsorption 250 IUs USA: volunteer, (4 mL of diluent) 2) Ion exchange chromatography Corifact remunerated Multiple Licensed by Health Canada. 1,250 IUs 2‐8°C Manufactured by plasmapheresis precipitation 3) Heat‐treatment (+60°C for 10 (20 mL of diluent) Distributed in all provinces. CSL Behring donors hours in an aqueous solution) 4) Virus filtration over two 20 nm Mix2Vial filters in series Comments Indicated for routine prophylaxis and peri‐operative management of surgical bleeding in patients with congenital factor XIII deficiency. Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Factor VII USA: volunteer, Aluminium Vapour heat @ 60°C for 10 hr at Available through Special remunerated concentrate hydroxide 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Distributed in all provinces. Shire donors Comments Used to treat factor VII deficiency. 1 Product Plasma source Fractionation Viral inactivation Vial size Storage Availability Factor XI USA: volunteer, Affinity heparin Available through Special concentrate remunerated sepharose Dry heat @ 80°C, 72 hr 1,000 IUs 2‐8°C Access Programme.
    [Show full text]
  • Factset-Top Ten-0521.Xlsm
    Pax International Sustainable Economy Fund USD 7/31/2021 Port. Ending Market Value Portfolio Weight ASML Holding NV 34,391,879.94 4.3 Roche Holding Ltd 28,162,840.25 3.5 Novo Nordisk A/S Class B 17,719,993.74 2.2 SAP SE 17,154,858.23 2.1 AstraZeneca PLC 15,759,939.73 2.0 Unilever PLC 13,234,315.16 1.7 Commonwealth Bank of Australia 13,046,820.57 1.6 L'Oreal SA 10,415,009.32 1.3 Schneider Electric SE 10,269,506.68 1.3 GlaxoSmithKline plc 9,942,271.59 1.2 Allianz SE 9,890,811.85 1.2 Hong Kong Exchanges & Clearing Ltd. 9,477,680.83 1.2 Lonza Group AG 9,369,993.95 1.2 RELX PLC 9,269,729.12 1.2 BNP Paribas SA Class A 8,824,299.39 1.1 Takeda Pharmaceutical Co. Ltd. 8,557,780.88 1.1 Air Liquide SA 8,445,618.28 1.1 KDDI Corporation 7,560,223.63 0.9 Recruit Holdings Co., Ltd. 7,424,282.72 0.9 HOYA CORPORATION 7,295,471.27 0.9 ABB Ltd. 7,293,350.84 0.9 BASF SE 7,257,816.71 0.9 Tokyo Electron Ltd. 7,049,583.59 0.9 Munich Reinsurance Company 7,019,776.96 0.9 ASSA ABLOY AB Class B 6,982,707.69 0.9 Vestas Wind Systems A/S 6,965,518.08 0.9 Merck KGaA 6,868,081.50 0.9 Iberdrola SA 6,581,084.07 0.8 Compagnie Generale des Etablissements Michelin SCA 6,555,056.14 0.8 Straumann Holding AG 6,480,282.66 0.8 Atlas Copco AB Class B 6,194,910.19 0.8 Deutsche Boerse AG 6,186,305.10 0.8 UPM-Kymmene Oyj 5,956,283.07 0.7 Deutsche Post AG 5,851,177.11 0.7 Enel SpA 5,808,234.13 0.7 AXA SA 5,790,969.55 0.7 Nintendo Co., Ltd.
    [Show full text]
  • Table A: List of All Commitments/Contributions and Pledges As of 17 February 2010 (Table Ref: R10)
    Table A: List of all commitments/contributions and pledges as of 17 February 2010 http://www.reliefweb.int/fts (Table ref: R10) Compiled by OCHA on the basis of information provided by donors and appealing organizations. Donor Channel Description Funding Uncommitted USD Pledges USD 3Com American RC Disaster relief 10,000 0 3M NGOs Working with key humanitarian partners like 1,000,000 0 Project HOPE and MAP International, 3M has donated numerous boxes and cases containing medical supplies such as Nexcare bandages, 3M Tegaderm transparent dressings, sterile drapes, splints, medical tapes and respiratory protection products. 3M continues to work closely with its nonprofit partners to identify other 3M products that may be needed. Abbott Laboratories UN Agencies, In-kind: Donations of medicines and nutritional 1,000,000 0 NGOs and Red products Cross ACE Charitable Foundation American RC Humanitarian assistance 250,000 0 Actavis Group NGOs Donation from Actavis in the US to Americares 10,000 0 and Operation Smile for health response in Haiti. Actavis Group NGOs; Red Donation of generic drugs, including analgesics 2,100,840 0 Cross and antibiotics. Advent Software PIH Humanitarian assistance 0 25,000 Adventist Development ADRA-Haiti Emergency assistance 0 478,000 and Relief Agency Adventist Development ADRA-Haiti Emergency assistance 0 522,000 and Relief Agency Aetna Foundation MSF Haiti relief efforts 10,000 0 Aetna Foundation American RC Haiti relief efforts 10,000 0 Aetna Foundation Food for the Haiti relief efforts 10,000 0 Poor Aetna Foundation UM For medical missions to Port-au-Prince, 10,000 0 including neurosurgeons, orthopedic surgeons and trauma/emergency physicians.
    [Show full text]
  • Integrated Report 2016 Year Ended March 31, 2016 Strengths That Increase Supporting Sustainable Creating Long-Term Value Our Value to Society Manufacturing Processes
    Integrated Report 2016 Year ended March 31, 2016 Strengths that increase Supporting sustainable Creating long-term value our value to society manufacturing processes The Company Policy of Shionogi Contents Strengths that increase our value to society The Company Policy of Shionogi (Established in 1957) Creating long-term value Supporting sustainable manufacturing processes Data Section Editorial Policy This Integrated Report provides a wide range of information to give shareholders, Forward-looking Statements investors and other stakeholders a deeper understanding of the Shionogi Group’s This report contains forward-looking statements. These statements are based on corporate value. In addition to financial data, readers can access information expectations in light of the information currently available, assumptions that are about management strategy and the Group’s governance, social and environmen- subject to risks, and uncertainties which could cause actual results to differ tal activities. materially from these statements. Risks and uncertainties include general domestic and international economic Period Under Review conditions, such as general industry and market conditions, and changes of Fiscal 2015 (April 1, 2015–March 31, 2016) interest rates and currency exchange rates. Certain activities continuing after fiscal 2015 are also included. These risks and uncertainties particularly apply to forward-looking statements concerning existing products and those under development. Product risks and Scope and Organization uncertainties include, but are not limited to, completion and discontinuation of This Integrated Report encompasses the activities of Shionogi & Co., Ltd. and 37 clinical trials; obtaining regulatory approvals; claims and concerns about product consolidated subsidiaries. safety and efficacy; technological advances; adverse outcome of important In this report, “Shionogi” refers to Shionogi & Co., Ltd.
    [Show full text]
  • Annual Report 2016
    Annexes to the annual report of the European Medicines Agency 2016 Annex 1 – Members of the Management Board ............................................................... 2 Annex 2 - Members of the Committee for Medicinal Products for Human Use ...................... 4 Annex 3 – Members of the Pharmacovigilance Risk Assessment Committee ........................ 6 Annex 4 – Members of the Committee for Medicinal Products for Veterinary Use ................. 8 Annex 5 – Members of the Committee on Orphan Medicinal Products .............................. 10 Annex 6 – Members of the Committee on Herbal Medicinal Products ................................ 12 Annex 7 – Committee for Advanced Therapies .............................................................. 14 Annex 8 – Members of the Paediatric Committee .......................................................... 16 Annex 9 – Working parties and working groups ............................................................ 18 Annex 10 – CHMP opinions: initial evaluations and extensions of therapeutic indication ..... 24 Annex 10a – Guidelines and concept papers adopted by CHMP in 2016 ............................ 25 Annex 11 – CVMP opinions in 2016 on medicinal products for veterinary use .................... 33 Annex 11a – 2016 CVMP opinions on extensions of indication for medicinal products for veterinary use .......................................................................................................... 39 Annex 11b – Guidelines and concept papers adopted by CVMP in 2016 ...........................
    [Show full text]
  • Therapeutics Advisory Group
    Therapeutics Advisory Group CCG and NHS Trusts in Norfolk and Waveney Index of TAG recommendations Generic name Indication BNFclass Trafficlight IQoro euromuscular training Hiatus hernia - improving symptoms No BNF entry - device Double Red Not recommended for device routine use / Not commissioned (L-) Carnitine Carnitine Deficiency 9.8.1 Drugs used in Red Hospital / Specialist metabolic disorders only (Para-)aminosalicylic acid Tuberculosis 5.1.9 Antituberculosis Double Red Not recommended for drugs - routine use / Not Antimycobacterials commissioned 5-fluorouracil + salicyclic acid Hyperkeratotic actinic keratosis 13.8.1 Photodamage Double-GreenSuitable for GPs to topical solution initiate and prescribe 5-fluorouracil 5% w/w cream Non-hypertrophic actinic keratosis 13.8.1 Photodamage Double-GreenSuitable for GPs to initiate and prescribe Abacavir HIV infection in combination with other 5.3.1 HIV Infection Red Hospital / Specialist antiretroviral drugs only Abacavir + dolutegravir + HIV infection in combination with other 5.3.1 HIV Infection Red Hospital / Specialist lamivudine antiretroviral drugs only Abacavir and lamivudine HIV infection in combination with other 5.3.1 HIV Infection Red Hospital / Specialist antiretroviral drugs only Abaloparatide Male and juvenile osteoporosis 6.6.1 Calcitonin and Double Red Not recommended for Calcitonin and routine use / Not parathyroid hormone commissioned Abatacept Rheumatoid arthritis - 1st line biologic 10.1.3 Drugs that suppress Red Hospital / Specialist after failure of non-biologic DMARDs
    [Show full text]
  • Etf-Sparpläne
    ETF-SPARPLÄNE ISIN NAME IE00B8KGV557 ISHARES EDGE MSCI EM MIN VOL USD (ACC) IE00B86MWN23 ISHARES EDGE MSCI EUROPE MIN VOLATILITY EUR (ACC) IE00B8FHGS14 ISHARES EDGE MSCI WORLD MIN VOLATILITY USD (ACC) IE00B6SPMN59 ISHARES EDGE S&P 500 MIN VOL USD (ACC) IE00B87G8S03 ISHARES GLOBAL AAA-AA GOV BOND USD (DIST) DE0005933931 ISHARES CORE DAX EUR (ACC) IE0032523478 ISHARES CORP BOND LARGE CAP EUR (DIST) IE00B14X4T88 ISHARES ASIA PACIFIC DIVIDEND USD (DIST) IE00B1W57M07 ISHARES BRIC 50 USD (DIST) DE000A0F5UG3 ISHARES DOW JONES EU SUSTAINABLE EUR (DIST) IE00B6R52143 ISHARES AGRIBUSINESS USD (ACC) IE00B0M62Y33 ISHARES AEX EUR (DIST) DE000A0D8Q23 ISHARES ATX EUR (DIST) IE00B1FZSC47 ISHARES USD TIPS USD (ACC) IE00B14X4S71 ISHARES USD TREASURY BOND 1-3Y USD (DIST) IE00B1FZS798 ISHARES USD TREASURY BOND 7-10Y USD (DIST) IE00B1FZSD53 ISHARES GBP INDEX-LINKED GILTS GBP (DIST) IE00B6QGFW01 ISHARES EMERGING ASIA LOCAL GOV BOND USD (DIST) IE00B5M4WH52 ISHARES JPM EM LOCAL GOV BOND USD (DIST) IE00B3DKXQ41 ISHARES EURO AGGREGATE BOND EUR (DIST) IE00B3F81R35 ISHARES CORE EURO CORP BOND EUR (DIST) IE00B4L60045 ISHARES EURO CORP BOND 1-5Y EUR (DIST) IE00B4L5ZG21 ISHARES EURO CORP BOND EX-FIN EUR (DIST) IE00B4L5ZY03 ISHARES EURO CORP BOND EX-FIN 1-5Y EUR (DIST) IE00B6X2VY59 ISHARES EURO CORP BOND INT. RATE HEDGED (DIST) IE00B14X4Q57 ISHARES EURO GOV BOND 1-3Y EUR (DIST) IE00B4WXJH41 ISHARES EURO GOV BOND 10-15Y EUR (DIST) IE00B1FZS913 ISHARES EURO GOV BOND 15-30Y EUR (DIST) IE00B1FZS681 ISHARES EURO GOV BOND 3-5Y EUR (DIST) IE00B4WXJG34 ISHARES EURO GOV BOND
    [Show full text]
  • Guidelines with Regard to the Composition, Calculation and Management of the Index
    INDEX METHODOLOGY Solactive Pharma Breakthrough Value Index Version 2.1 dated September 03, 2020 Contents Important Information 1. Index specifications 1.1 Short Name and ISIN 1.2 Initial Value 1.3 Distribution 1.4 Prices and Calculation Frequency 1.5 Weighting 1.6 Index Committee 1.7 Publication 1.8 Historical Data 1.9 Licensing 2. Composition of the Index 2.1 Selection of the Index Components 2.2 Ordinary Adjustment 2.3 Extraordinary Adjustment 3. Calculation of the Index 3.1 Index Formula 3.2 Accuracy 3.3 Adjustments 3.4 Dividends and other Distributions 3.5 Corporate Actions 3.6 Correction Policy 3.7 Market Disruption 3.8 Consequences of an Extraordinary Event 4. Definitions 5. Appendix 5.1 Contact Details 5.2 Calculation of the Index – Change in Calculation Method 2 Important Information This document (“Index Methodology Document”) contains the underlying principles and regulations regarding the structure and the operating of the Solactive Pharma Breakthrough Value Index. Solactive AG shall make every effort to implement regulations. Solactive AG does not offer any explicit or tacit guarantee or assurance, neither pertaining to the results from the use of the Index nor the Index value at any certain point in time nor in any other respect. The Index is merely calculated and published by Solactive AG and it strives to the best of its ability to ensure the correctness of the calculation. There is no obligation for Solactive AG – irrespective of possible obligations to issuers – to advise third parties, including investors and/or financial intermediaries, of any errors in the Index.
    [Show full text]
  • Translation for Reference Only Ticker Code: 4507 to All Shareholders June 5, 2018
    Translation for reference only Ticker Code: 4507 To All Shareholders June 5, 2018 Notice of Convocation of the 153rd Annual General Meeting of Shareholders The 153rd Annual General Meeting of Shareholders will be convened at the time and location listed below. On behalf of the directors of the Company, we cordially invite you to attend this shareholders’ meeting. If you are unable to attend, you can exercise your voting rights with the proxy form on the back of this notice. If you wish to vote by using the proxy form, you are kindly requested to take the time to review the reference information provided below and exercise it by 5:00 p.m., Tuesday June 19, 2018.1 Yours faithfully, Isao Teshirogi Representative director and president and CEO Shionogi & Co., Ltd. 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan Annual General Meeting of Shareholders 1. Date and time: 10:00 a.m., Wednesday, June 20, 2018 2. Location: HERBIS HALL 5-25, Umeda 2-chome, Kita-ku, Osaka 530-0001, Japan 3. Agenda: Items to report: 1. The Business Report, the Consolidated Financial Statements and the Non-Consolidated Financial Statements for the 153rd Fiscal Term (year ended March 31, 2018) 2. The Audit Report of the Consolidated Financial Statements for the 153rd Fiscal Term (year ended March 31, 2018) by the Accounting Auditor and the Board of Corporate Auditors Items for resolution: Proposal No. 1: Appropriation of Surplus Proposal No. 2: Amendments to the Articles of Incorporation Proposal No. 3: Election of Six (6) Directors Proposal No.
    [Show full text]