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Effects of Supplementary Protection Mechanisms for Pharmaceutical Products
Final report, May 2018 Effects of supplementary protection mechanisms for pharmaceutical products www.technopolis-group.com Effects of supplementary protection mechanisms for pharmaceutical products technopolis |group| May 2018 Thyra de Jongh* Alfred Radauer Sven Bostyn Joost Poort * Corresponding author. [email protected] About the authors Thyra de Jongh PhD, is a Senior Consultant Health & Life Sciences at Technopolis Group in Amsterdam. She specialises in analysis of health systems and policies, and research and innovation in the health and life sciences. She has a particular interest in pharmaceutical innovation and access to medicine. (thyra.dejongh@technopolis- group.com) Alfred Radauer, is Senior Consultant at Technopolis Group in Vienna and leads the Intellectual Property & Standards (IPS) group within Technopolis. His and the IPS group work elaborate on the interfaces between legal, technological and economic issues of IP and standards in innovation policy as well as the interaction of IP with regulation and other policy areas. ([email protected]) Sven Bostyn Lic.Jur, LL.M, PhD, is a senior lecturer in Intellectual Property Law at the University of Liverpool Law School. He is also an assistant professor at the Institute for Information Law, University of Amsterdam. He is one of the leading experts in Europe in patent law and related subjects in the areas of life sciences and pharmaceutical inventions, and has more than sixty single-authored publications. ([email protected]) Joost Poort PhD, is an associate professor in economics at the Institute for Information law, University of Amsterdam. He brings an economic perspective to various multidisciplinary research projects, with particular interest in intellectual property. -
Drug Delivery Technology Y
* DDT Nov-Dec 2007 Working 11/9/07 2:29 PM Page 1 November/December 2007 Vol 7 No 10 IN THIS ISSUE Company Profiles 12 Drug Delivery Technologies 58 Excipients, Polymers, Liposomes & Lipids 78 Contract Pharmaceutical & Biological Development Services 83 Machinery & Laboratory Equipment and Software 96 Technology Showcase 102 The science & business of specialty pharma, biotechnology, and drug delivery www.drugdeliverytech.com * DDT Nov-Dec 2007 Working 11/9/07 2:39 PM Page 2 * DDT Nov-Dec 2007 Working 11/9/07 2:40 PM Page 3 * DDT Nov-Dec 2007 Working 11/9/07 2:40 PM Page 4 November/December 2007 Vol 7 No 10 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Coming in 2008 Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Drug Delivery Weekly & Fax: (703) 548-3733 E-mail: [email protected] Specialty Pharma News E-mail: [email protected] West Coast Warren De Graff Western Regional Manager 818 5th Avenue, Suite 301 San Rafael, CA 94901 Tel: (415) 721-0644 Fax: (415) 721-0665 E-mail: [email protected] 0 The weekly electronic newsletter from the publishers of Drug 1 International o N Delivery Technology and Specialty Pharma will provide over 12,000 Ralph Vitaro 7 219 Changebridge Road l o subscribers with the latest news of business deals, alliances, and V Montville, NJ 07045 Tel: (973) 299-1200 7 technology breakthroughs from the pharmaceutical, specialty 0 Fax: (973) 299-7937 0 2 pharmaceutical, drug delivery, and biotechnology industries. -
List of Tuberculosis Pharmaceutical Products Classified According to the Global Fund Quality Assurance Policy
List Of Tuberculosis Pharmaceutical Products classified according to the Global Fund Quality Assurance Policy Edition: Version 104 - 14 July 2021 The list is an overview of pharmaceutical products subject to the Global Fund Quality Assurance Policy that are listed in National and/or WHO standard treatment guidelines and classified according to the various options (A, B, and ERP reviewed) defined in the Global Fund Quality Assurance Policy (July 2009, amended in December 2010). The list is developed as a tool to assist Principal Recipients (PR) of Global Fund grants to identify the status of finished pharmaceutical products according to the Global Fund Quality Assurance Policy. The pharmaceutical products are classified based on the following information A classified product - Listed on WHO prequalification list; B classified product - Stringent NDRA Registration letter/Marketing Authorization; ERP reviewed product- Permitted for time-limited procurement based on advice by the Expert Review Panel (ERP); Please note that the list is not an exhaustive list. A PR can procure product(s) not listed in the current list as long as PR demonstrates that the product is compliant with the Global Fund Quality Assurance Policy. The Global Fund list includes the following information: - "Important Notes" for helpful information; - A, B, and ERP reviewed products; - Period validity of the ERP reviewed products; - "+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product ( i.e. co-blister) - [A+B]+C means A and B are in fixed-dose formulation and C is co-packaged YELLOW signifies a new entry; PINK signifies modification of an existing entry. -
Letter Without Tagline
CH D Press release DONGBAO TO ACQUIRE FERRING’S MALMÖ MANUFACTURING OPERATION Saint Prex, Switzerland and Shanghai, China, Friday 17 November, 2006 – Ferring Pharmaceuticals and Shanghai Dongbao Biopharmaceutical Company announced today the signing of an agreement by which Dongbao Biopharmaceutical will purchase Ferring’s manufacturing operation at Malmö in Sweden. Earlier this year, Ferring informed staff of its plan to cease manufacturing at Malmö by the end of March 2008. However, the acquisition by Dongbao Biopharmaceutical has secured the jobs of around 50 members of staff. The agreement will become effective on 1 January, 2007. “From the very beginning, our aim has been to find a solution which would maintain the Malmö production site,” commented Ferring Pharmaceuticals Chief Operating Officer, Michel Pettigrew. “This agreement is a boost for the local community and has secured the long-term future of the factory for around 50 employees, whose experience will be invaluable to Dongbao Biopharmaceutical.” “We see great potential for the manufacturing centre at Malmö,” added Dr George Li, President of Dongbao Biopharmaceutical. “The site is technically very developed and the current team, who will be an important part of our future business development, offer a lot of knowledge and competencies.” Ends Ferring International Center S.A., Chemin de la Vergognausaz 50, 1162 Saint‐Prex, Switzerland Tel: +41 58 301 00 00, Fax: +41 58 301 00 10, www.ferring.com CH About Ferring: Ferring is a Swiss-based research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology. -
Points of Excellence
POINTS OF EXCELLENCE www.rtu.lv Riga Technical University, 2016 Published by: International Relations Department Design and layout: Arnis Grinbergs Photo credits: Arturs Pērkons, Eduards Lapsa, Edgars Špengelis, Aleksandrs Kendenkovs, Andris Eglītis, Jānis Knāķis, Edijs Pālēns / LETA, Imants Urtāns, Valts Kleins POINTS OF EXCELLENCE 6 Riga Technical University (RTU) – Strategic Partner for Excellence 72 Riga Business School 8 Latvia and Riga – “Added Value” of RTU 73 BALTECH Study Center 10 The Republic of Latvia 74 Affiliations 14 The Capital City – Riga 75 Engineering High School 20 History of RTU 76 Research at RTU 28 RTU in the 21st Century 77 Research Management 30 RTU Ķīpsala Campus 78 Research platforms and main research areas 36 RTU Structure 80 Selected Research Projects 39 RTU Strategy 94 Cooperation with Enterprises 40 Studies at RTU 95 Start-Up and Spin-Off Enterprises 40 Study Process Management 96 Business Incubators 42 Faculty of Architecture and Urban Planning 98 Design Factory 46 Faculty of Civil Engineering 100 Scientific Library 48 Faculty of Computer Science and Information Technology 104 Student Parliament 50 Faculty of Electronics and Telecommunications 106 International Relations CONTENTS 54 Faculty of Power and Electrical Engineering 116 Sports 58 Faculty of E-Learning Technologies and Humanities 120 Culture 60 Faculty of Engineering Economics and Management 128 RTU Alumni Association 64 Faculty of Materials Science and Applied Chemistry 136 RTU Contacts 68 Faculty of Mechanical Engineering, Transport and Aeronautics niversity should not just react at Despite a marked focus on engineering, we pay changes in the society; it should be the much attention to sports and cultural activities – driving force for change! Riga Technical RTU teams in basketball, volleyball and floorball University adheres to this principle in have won medals in both Latvian and European Uthe field of tertiary education and is constantly championships. -
Downloads but Many Other Countries — Such As the RCMP Said the Policy Revisions /JJ Release on April30.Pdf)
CMAJ News For the record Published at www.cmaj.ca between Apr. The new warning letter regards in persistent or significant disability or 20 and May 18 breaches uncovered during a July– incapacity, be life-threatening or result August 2009 FDA inspection of an in death. Apotex receives second FDA Apotex facility located at 150 Signet The report indicates that there has Drive in Toronto, during which “sev- been a steady increase of adverse reac- warning eral violations that are identical” to tion reports since 2001, when roughly those found during the inspection of the 11 000 incidents were reported (www.hc he United States Food and Drug Etobicoke facility were discovered. -sc.gc.ca/dhp-mps/alt_formats/pdf/med Administration (FDA) has “These identical CGMP violations eff/bulletin/carn-bcei_v20n2-eng.pdf). T issued a second warning letter demonstrated a lack of adequate Roughly 70% (18 301) of 2009 inci- in a year to Toronto, Ontario-based process controls and raised serious dents involved pharamaceuticals, while generic drug manufacturer Apotex Inc. questions regarding your corporation’s 23% (5998) involved biotechnology for lapses in good manufacturing prac- quality and production systems,” the products. There were 833 adverse reac- tices. warning letter states. tion reports involving biologics, 516 The violations cause Apotex drug The violations included contamina- involving natural health products, 379 products to be considered “adulterated” tion of a diabetes drug with an “active involving radiopharmaceuticals and 34 within US regulations -
Triptorelin Pamoate (Subcutaneous Injection) for Prostate Cancer NIHRIO (HSRIC) ID: 20540 NICE ID: 9841
NIHR Innovation Observatory Evidence Briefing: May 2018 Triptorelin pamoate (subcutaneous injection) for prostate cancer NIHRIO (HSRIC) ID: 20540 NICE ID: 9841 LAY SUMMARY Prostate cancer is cancer of the prostate gland (a small organ in a man’s pelvis) and is the second most common cancer in the UK. There are three stages: localised, locally‐advanced and advanced (or metastatic) prostate cancer. The symptoms of prostate cancer may vary depending on the stage of cancer but can include pain, tiredness, problems emptying the bladder and the bowels. About half of men diagnosed with locally‐advanced prostate cancer will see their cancer spread to other body organs (i.e. becoming metastatic). Triptorelin is being developed as an injection under the skin (subcutaneous) for the treatment of locally advanced or metastatic prostate cancer. It is already marketed for this condition but is given by injection deep into the muscles (intramuscular). Triptorelin is an artificial analogue of natural gonadotropin‐releasing hormone that acts to slowly reduce the level of testosterone in the body. The first administration of triptorelin stimulates an increase in testosterone levels but prolonged administration leads to a fall in plasma testosterone or oestradiol to castrate levels which is maintained for as long as the product is administered. Triptorelin as a subcutaneous injection formulation has the potential advantage of improved safety and local tolerability when compared to intramuscular injection formulation. This briefing reflects the evidence available at the time of writing. A version of the briefing was sent to the company for a factual accuracy check. The company was available to provide comment. -
Progress Report January 2009 – December 2011
North Carolina State University Professional Science Master’s Program Progress Report January 2009 – December 2011 The Graduate School College of Agriculture & Life Sciences College of Design College of Education College of Engineering College of Humanities & Social Sciences Poole College of Management College of Natural Resources College of Physical & Mathematical Sciences College of Textiles College of Veterinary Medicine First-Year College 1 Greetings From the UNC System PSM Director The Professional Science Master’s (PSM) Program is one of the University of North Carolina (UNC) System’s ways to close the existing skills gap in the workplace. Together with local employers, we design graduate education and training regimens to match employers’ needs. The UNC System has undertaken a collaborative effort to develop these new programs in key areas of importance to North Carolina’s local economies. I am pleased to report that NC State University now offers nine PSM programs. Several new programs are at various planning stages, and numerous new central resources and services are available or under way for these programs. A special milestone in 2010 was the establishment of the PSM Council at NC State University. Members of this group include faculty who direct PSM programs or are planning to offer them in the future. The PSM Council oversees new program development and determines the future strategy for the PSM programs at NC State University. Another important milestone was the award of a new UNC System grant from the Alfred P. Sloan Foundation and support from the UNC General Administration for multiple online tools. I am greatly indebted to the many employers, professors and students who contribute to the collective success of NC State University’s PSM programs. -
Introducing the IMED Biotech Unit What Science Can Do Introduction What Science Can Do
Introducing the IMED Biotech Unit What science can do Introduction What science can do At AstraZeneca, our purpose is to push the Our IMED Biotech Unit applies its research and Our approach to R&D development capabilities and technologies to The IMED Biotech Unit plays a critical boundaries of science to deliver life-changing accelerate the progress of our pipeline. Through role in driving AstraZeneca’s success. Working together with MedImmune, medicines. We achieve this by placing science great collaboration across our three science units, our global biologics arm and Global we are confident that we can deliver the next wave Medicines Development (GMD), our at the centre of everything we do. late-stage development organisation, of innovative medicines to transform the lives of we are ensuring we deliver an innovative patients around the world. and sustainable pipeline. Pancreatic beta cells at different Eosinophil prior to Minute pieces of circulating tumour DNA stages of regeneration apoptosis (ctDNA) in the bloodstream IMED Biotech Unit MedImmune Global Medicines Development Focuses on driving scientific advances Focuses on biologics research and Focuses on late-stage development in small molecules, oligonucleotides and development in therapeutic proteins, of our innovative pipeline, transforming other emerging platforms to push the monoclonal antibodies and other next- exciting science into valued new boundaries of medical science. generation molecules to attack a range medicines and ensuring patients of diseases. around the world can access them. It’s science that compels us to push the boundaries of what is possible. We trust in the potential of ideas and pursue them, alone and with others, until we have transformed the treatment of disease. -
PIIS0016508516348168(1).Pdf
Gastroenterology 2016;151:651–659 CLINICAL—LIVER High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis Edward Gane,1 Fred Poordad,2 Stanley Wang,3 Armen Asatryan,3 Paul Y. Kwo,4 Jacob Lalezari,5 David L. Wyles,6 Tarek Hassanein,7 Humberto Aguilar,8 Benedict Maliakkal,9 Ran Liu,3 Chih-Wei Lin,3 Teresa I. Ng,3 Jens Kort,3 and Federico J. Mensa3 1University of Auckland, Auckland, New Zealand; 2Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas; 3AbbVie, Inc, North Chicago, Illinois; 4Indiana University School of Medicine, Indianapolis, Indiana; 5Quest Clinical Research, San Francisco, California; 6University of California San Diego, La Jolla, California; 7Southern California GI and Liver Centers and Southern California Research Center, Coronado, California; 8Louisiana Research Center, Shreveport, Louisiana; 9University of Rochester Medical Center, Rochester, New York to liver decompensation, as defined by ascites, jaundice, See Covering the Cover synopsis on page 571; encephalopathy, or variceal bleeding.2 Achievement of a CLINICAL LIVER see editorial on page 587. sustained virologic response (SVR) reduces the risk of hepatic decompensation events, end-stage liver disease, 3–5 BACKGROUND & AIMS: The combination of ABT-493 (NS3/4A hepatocellular carcinoma, and liver-related mortality. protease inhibitor) plus ABT-530 (NS5A inhibitor) has shown Recognizing the need to prevent these complications, the high rates of sustained virologic response at post-treatment American Association for the study of Liver Diseases/ week 12 (SVR12) in noncirrhotic patients infected with hepa- Infectious Disease Society of America, and the European titis C virus (HCV) genotypes (GTs) 1–6. -
Radius Health, Inc
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Definitive Proxy Statement ☐ Definitive Additional Materials ☐ Soliciting Material Pursuant to §240.14a-12 RADIUS HEALTH, INC. (Name of Registrant as Specified in its Charter) (Name of Person(s) Filing Proxy Statement, if Other Than the Registrant) Payment of Filing Fee (Check the appropriate box): ☒ No fee required. ☐ Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. (1) Title of each class of securities to which transaction applies: (2) Aggregate number of securities to which transaction applies: (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined): (4) Proposed maximum aggregate value of transaction: (5) Total fee paid: ☐ Fee paid previously with preliminary materials: ☐ Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. (1) Amount previously paid: (2) Form, Schedule or Registration Statement No.: (3) Filing Party: (4) Date Filed: April 20, 2018 To Our Stockholders: You are cordially invited to attend the 2018 Annual Meeting of Stockholders of Radius Health, Inc. -
PATENTES, DESENHOS INDUSTRIAIS, CONTRATOS, PROGRAMAS DE COMPUTADOR, INDICAÇÕES GEOGRÁFICAS O REVISTA DA PROPRIEDADE INDUSTRIAL N 1964 26 De Agosto De 2008
PATENTES, DESENHOS INDUSTRIAIS, CONTRATOS, PROGRAMAS DE COMPUTADOR, INDICAÇÕES GEOGRÁFICAS o REVISTA DA PROPRIEDADE INDUSTRIAL N 1964 26 de Agosto de 2008 SEÇÃO I REPÚBLICA FEDERATIVA DO BRASIL Presidente Luís Inácio Lula da Silva MINISTÉRIO DO DESENVOLVIMENTO, INDÚSTRIA E COMÉRCIO EXTERIOR Ministro do Desenvolvimento, Indústria e Comércio Exterior Miguel João Jorge Filho INSTITUTO NACIONAL DA PROPRIEDADE INDUSTRIAL PRESIDENTE PARANÁ Jorge de Paula Costa Ávila Chefe: Renee Fernando Senger Pernambuco Rua Marechal Deodoro, 344, 16º andar Universitária Federal de Pernambuco - UFPE VICE-PRESIDENTE Ademir Tardelli Edifício Atalaia, Centro, Curitiba - PR Av. Prof. Moraes Rego, 1235 – Campus Universitário CEP: 80010-909 Bairro - Engenho do Meio CHEFE DE GABINETE Telefone/Fax: (0XX-41) 3322-4411 Recife - PE - CEP: 50670-920 Josefina Sales de Oliveira RIO GRANDE DO SUL Tel/Fax:(0XX-81) 3453-8145 e 3271-1223 Chefe: Vera Lúcia de Seixas Grimberg Piauí DIRETORIA DE ARTICULAÇÃO E INFORMAÇÃO TECNOLÓGICA Rua Sete de Setembro, 515 – 5º andar - Centro Av. João XXIII, n° 865 Marco Antônio Lima Porto Alegre - RS - CEP: 90010-190 Espaço Cidadania Telefone/Fax.: (0XX-51) 3226-6909 e 3226-6422 Teresina - PI - CEP: 64049-010 PROCURADORIA GERAL SÃO PAULO Tel.:(0XX-86) 3235-9616/3218-1838 Mauro Sodré Maia Chefe: Maria dos Anjos Marques Buso Fax:(0XX-86) 3218-1838 DIRETORIA DE PATENTES Rua Tabapuã, 41 - 4º andar - Itaim-Bibi Rio Grande do Norte Carlos Pazos Rodrigues São Paulo - SP - CEP: 04533-010 SECRETÁRIA DO DESENVOLVIMENTO ECONÔMICO – DIRETORIA DE MARCAS Telefone/Fax: