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The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances" WHO/EMP/RHT/TSN/2018.1
INN Working Document 19.450 04/02/2019 Addendum1 to "The use of stems in the selection of International Nonproprietary names (INN) for pharmaceutical substances" WHO/EMP/RHT/TSN/2018.1 Programme on International Nonproprietary Names (INN) Technologies Standards and Norms (TSN) Regulation of Medicines and other health technologies (RHT) World Health Organization, Geneva © World Health Organization 2019 - All rights reserved. The contents of this document may not be reviewed, abstracted, quoted, referenced, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means, without explicit prior authorization of the WHO INN Programme. This document contains the collective views of the INN Expert Group and does not necessarily represent the decisions or the stated policy of the World Health Organization. Addendum1 to "The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances" - WHO/EMP/RHT/TSN/2018.1 1 This addendum is a cumulative list of all new stems selected by the INN Expert Group since the publication of "The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances" 2018. ------------------------------------------------------------------------------------------------------------ -calcet/-calcet- calcium-sensing receptors (CaSR) agonists cinacalcet (88), etelcalcetide (112), evocalcet (113), tecalcet (87), upacicalcet (118) ------------------------------------------------------------------------------------------------------------ -
What Are the Costs and Benefits of Patent Systems?
CENTRE FOR GOVERNANCE OF KNOWLEDGE AND DEVELOPMENT WORKING PAPER: OCTOBER 2008 What are the costs and benefits of patent systems? Hazel V J Moir This paper can be downloaded without charge from http://cgkd.anu.edu.au/menus/workingpapers.php Citation for non-commercial purposes is encouraged by the author Correspondence to: [email protected] Dr Hazel Moir Program Visitor Centre for Governance of Knowledge and Development Regulatory Institutions Network (RegNet) College of Asia and the Pacific The Australian National University Canberra ACT 0200 AUSTRALIA © Moir 2008 (citation for non-commercial purposes is encouraged) . What are the costs and benefits of patent systems?* Hazel V J Moir Program Visitor, Centre for Governance of Knowledge and Development Regulatory Institutions Network, College of Asia and the Pacific The Australian National University ABSTRACT There do not appear to be any cost-benefit assessments of the impact of patent systems, nor any data that can be used to directly assess the economic impact of patent systems. Discussions of patent policy therefore tend to be theoretical, and any evidence used is anecdotal rather than scientifically based. A wider search shows, however, that there is substantial empirical material on the costs and benefits of patent systems published in a very diverse range of journals and working papers. While these do not allow a full assessment of the economic impact of patent systems, they do provide useful evidence on many aspects of the impact of patent systems. This evidence is drawn together in this summary overview. The objective is to assist in a move towards an evidence-based discussion of patents as a central issue in innovation policy. -
Obseva SA Reports Consistent Long-Term Findings from Phase 2B EDELWEISS Trial of Linzagolix for Endometriosis-Associated Pain
ObsEva SA Reports Consistent Long-Term Findings from Phase 2b EDELWEISS trial of Linzagolix for Endometriosis-Associated Pain Geneva, Switzerland and Boston, MA – May 3, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical- stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today reported follow-up results from the Phase 2b EDELWEISS clinical trial of its oral gonadotropin releasing hormone (GnRH) receptor antagonist, linzagolix, for the treatment of endometriosis-associated pelvic pain. These new data include 28-week extension study treatment (52 weeks of continuous treatment), as well as the 24-week post treatment follow-up (PTFU) results for patients who did not enter the extension study after completing the initial 24-week treatment period. "We are pleased to report long-term data from the EDELWEISS trial of linzagolix, which show that in patients treated with linzagolix for 52 weeks, pelvic pain response rates are maintained with the 75mg or the 200mg dose. Bone mineral density remains within safe limits. Patients that were followed for 6 months after treatment completion continue to experience pain control, and showed BMD increase,” said Ernest Loumaye, Co-Founder and Chief Executive Officer of ObsEva. “These data further support the long term therapeutic potential of linzagolix and support the currently starting Phase 3 program for the endometriosis indication, as we anticipate initial Phase 3 clinical results later this year from the trial in uterine fibroids.” Overall Pelvic Pain reduction sustained long-term After 52 weeks of treatment, responder rates for Overall Pelvic Pain (OPP)— defined as the proportion of patients experiencing an OPP score reduction >30% from baseline using a verbal rating scale— were 69% for the 75mg once daily dose and 82% for the 200mg/100mg once daily dose. -
EC313-A Tissue Selective SPRM Reduces the Growth and Proliferation of Uterine Fbroids in a Human Uterine Fbroid Tissue Xenograft Model Hareesh B
www.nature.com/scientificreports OPEN EC313-a tissue selective SPRM reduces the growth and proliferation of uterine fbroids in a human uterine fbroid tissue xenograft model Hareesh B. Nair1*, Bindu Santhamma1, Kalarickal V. Dileep2, Peter Binkley3, Kirk Acosta1, Kam Y. J. Zhang 2, Robert Schenken3 & Klaus Nickisch1 Uterine fbroids (UFs) are associated with irregular or excessive uterine bleeding, pelvic pain or pressure, or infertility. Ovarian steroid hormones support the growth and maintenance of UFs. Ulipristal acetate (UPA) a selective progesterone receptor (PR) modulator (SPRM) reduce the size of UFs, inhibit ovulation and lead to amenorrhea. Recent liver toxicity concerns with UPA, diminished enthusiasm for its use and reinstate the critical need for a safe, efcacious SPRM to treat UFs. In the current study, we evaluated the efcacy of new SPRM, EC313, for the treatment for UFs using a NOD-SCID mouse model. EC313 treatment resulted in a dose-dependent reduction in the fbroid xenograft weight (p < 0.01). Estradiol (E2) induced proliferation was blocked signifcantly in EC313-treated xenograft fbroids (p < 0.0001). Uterine weight was reduced by EC313 treatment compared to UPA treatment. ER and PR were reduced in EC313-treated groups compared to controls (p < 0.001) and UPA treatments (p < 0.01). UF specifc desmin and collagen were markedly reduced with EC313 treatment. The partial PR agonism and no signs of unopposed estrogenicity makes EC313 a candidate for the long-term treatment for UFs. Docking studies have provided a structure based explanation for the SPRM activity of EC313. Te unmet need for medical management of uterine fbroids (UFs) has led to the discovery of various novel agents in recent years. -
Obseva's Linzagolix Blooms but Safety Questions Remain
December 09, 2019 Obseva’s linzagolix blooms but safety questions remain Joanne Fagg Obseva is further behind the competition in uterine fibroids but the company’s gonadotropin-releasing hormone (GnRH) antagonist linzagolix could have the edge clinically. Results from the phase III Primrose 2 trial showed a placebo-adjusted 65% response rate for a high dose of linzagolix in combination with hormonal add- back therapy (ABT), putting it in the same league as Abbvie’s Orilissa, and slightly better than Myovant’s Relugolix, cross-trial caveats notwithstanding. The pull for linzagolix is a low dose option without ABT; ABT is needed to counteract the menopause-like symptoms associated with GnRH inhibition but has side effects of its own and is not advised in patients with high BMI, diabetes and cardiovascular disease. The company described a 27% placebo adjusted response rate for the low dose as “clinically relevant”, saying it could open up linzagolix as a first-line treatment. One potential hurdle is safety: bone loss points to greater levels than with competing projects, though Obseva claims that patient demographics could explain this. A second pivotal study, Primrose 1, will need to confirm this profile for a filing to occur next year. Tiny Obseva has its work cut out to catch up in this space, however. Cross-trial comparison of GnRH inhibitors in uterine fibroids Linzagolix Orilissa Relugolix (Obseva) (Abbvie) (Myovant) Elaris Elaris Liberty Primrose 2 Liberty 2 UF-1 UF-2 1 100mg daily 200mg 300mg 300mg 40mg 40mg w/o daily* bid* bid* daily* daily* ABT Placebo- adjusted 27% 65% 60% 66% 55% 57% response rate Placebo- adjusted bone - - - - -2.50% -0.45% mineral 1.81% 0.55% 0.55% 0.41% density change *Doses with ABT; bid=twice daily. -
Obseva Needs More to Beat Abbvie in Endometriosis
June 19, 2018 Obseva needs more to beat Abbvie in endometriosis Madeleine Armstrong Obseva, lagging behind its bigger rival Abbvie in the oral gonadotrophin-releasing hormone antagonist space, has a clear mission. The smaller company’s candidate, linzagolix, will need to show best-in-class efficacy if it is to have a chance of competing with Abbvie’s elagolix, which could hit the market this year in its first indication, endometriosis-associated pain. Obseva believes that it has gone some way to proving linzagolix’s superiority with data from the small phase IIb Edelweiss trial in the same disorder, and investors sent the group’s stock up 23% yesterday in response. But a look at how the results stack up against data from elagolix’s pivotal trials suggests some cause for concern (see table below). Of course, cross-trial comparisons should always be treated with caution, and this one is particularly fraught with difficulty, as the studies used different endpoints. But on the most similar measure, response on non- menstrual pain, linzagolix appears to fall short, particularly at the highest dose used, 200mg. Cross-trial comparison of linzagolix and elagolix Placebo 50mg 75mg 100mg 150mg 200mg Linzagolix/OBE2109: Edelweiss (phase IIb, NCT02778399) Response rate (primary endpoint)* 35% 49% 62% 56% - 56% P value - 0.155 0.003 0.039 - 0.034 Response rate, nonmenstrual pain 37% 46% 59% 62% - 48% P value - 0.38 0.017 0.022 - 0.297 Elagolix: Elaris EM-I, Elaris EM-II (phase III, NCT01620528, NCT01931670) Response rate, nonmenstrual pain 37% - - - 50%** 55-58%** *Response defined as reduction of ≥30% in combined menstrual and non-menstrual pelvic pain at week 12; **p<0.003; Source: Company presentations; NEJM paper. -
Patent Protection Through Patent Insurance in India: a Research Framework [1] Dr
ISSN (Online) 2394-2320 International Journal of Engineering Research in Computer Science and Engineering (IJERCSE) Vol 5, Issue 2, February 2018 Patent protection through Patent Insurance in India: A research framework [1] Dr. Surabhi Goyal [1] Faculty, Army Institute of Management & Technology, Greater Noida Abstract - In today’s world of competitiveness and innovation, leading the world technologically is very important. Many economies have identified that patent protection is a very crucial strategic decision to lead in a technological industry. Patent insurance is one of the tools to support this thought. In this conceptual research paper, a trail has been to find the possibility of acceptance of patent insurance as a financial tool for securing the patents from infringements in India. Also, a conceptual framework is also framed in the form of suggestive measures to support the importance of such concept in Indian context. Keywords: --- Patent insurance, litigation, competitiveness, technology, patent protection, infringement This paper will discuss the possibility of acceptance of INTRODUCTION patent insurance in India. It will also discuss the obstacles and suggestive measures to be taken by the companies A patent is an exclusive right granted by a country to the and government for the implementation of this concept. owner of an invention to make, use, to manufacture and to market the invention, provided it satisfies certain OBJECTIVES OF THE STUDY conditions stipulated by law. Exclusivity of rights implies that no one else can make, use, manufacture or market the In today’s business scenario, risk management is a key inventions without the consent of patent holder. As soon focus area, and insurance is the only effective protection as the patent gets expired, it passes into the public available for a product portfolio. -
Insurance Patents: Indian Scenario
Journal of Intellectual Property Rights Vol 17, March 2012, pp 152-156 Insurance Patents: Indian Scenario Rahul Sinha† Life Insurance Corporation of India, Mahrajganj Branch, Uttar Pradesh 273 303, India Received 5 August 2011, revised 8 December 2011 The importance of intellectual property is well recognized in various industries but the Indian insurance industry has not yet opened its door to intellectual property. Whereas insurance companies world-wide are patenting various aspects of insurance products, the Indian insurance industry finds excuse in the argument that the Patents Act in India does not allow insurance products to be patented. The paper explores various forms of intellectual property, with special emphasis on patents, which can be used to protect insurance methods and products. It attempts to undo the misconceptions about patenting insurance products and suggests by example, that insurance products can be protected under computer programs category. Keywords: Intellectual property, insurance patent, insurance industry, computer program Insurance is a contract that pledges payment of an intellectual property can do in promoting competition, amount on the happening of the event insured against. else some kind of protection would definitely have The Indian insurance industry dates back to ancient been sought for by insurance companies to protect times and finds mention in the writings of Manu their innovative products. IRDA being a regulator, the (Manusmrithi), Yagnavalkya (Dharmasastra) and responsibility to encourage the insurers to build Kautilya (Arthasastra).1 These ancient texts describe innovative products and effectively protect them, pooling of resources that could be re-distributed in squarely falls on its shoulders. Innovation is a key times of calamities, such as fire, floods, epidemics component in insurance market, be it through and famine. -
Manejo De La Paciente Con Miomas Uterinos Y Deseo Reproductivo Guía De Práctica Clínica Basada En La Evidencia Versión Corregida
MANEJO DE LA PACIENTE CON MIOMAS UTERINOS Y DESEO REPRODUCTIVO GUÍA DE PRÁCTICA CLÍNICA BASADA EN LA EVIDENCIA VERSIÓN CORREGIDA Patrocinado por: ÍNDICE Documento de aclaraciones ........................................................................... 5 Introducción ..................................................................................................... 5 Justificación, objetivos y alcance de la guía ................................................ 7 Justificación ................................................................................................. 7 Objetivos ....................................................................................................... 8 Alcance .......................................................................................................... 8 Síntesis de la evidencia e interpretación de las recomendaciones ......... 10 Algoritmos diagnóstico-terapéuticos .......................................................... 25 1. Diagnóstico de los miomas en pacientes con deseo genésico ............ 29 1.1.- Miomas con componente intracavitario.............................................. 30 1.1.1 Rendimiento diagnóstico de la ecografía transvaginal (2D y 3D) .....30 1.1.2 Rendimiento diagnóstico de la histerosonografía ....................... 32 1.1.3 Rendimiento diagnóstico de la histeroscopia frente a la histología ... 34 1.1.4 Rendimiento diagnóstico de la RNM frente a la histología ......... 35 1.2.- Miomas sin componente intracavitario .............................................. -
D Rug U Tilization R Eview B Oard
Wednesday, January 13, 2021 No live meeting scheduled for January. January 2021 will be a packet only meeting. Review Board Review Oklahoma Health Care Authority (OHCA) 4345 N. Lincoln Blvd. Oklahoma City, OK 73105 Drug Utilization The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review (DUR) Board Members FROM: Michyla Adams, Pharm.D. SUBJECT: Packet Contents for DUR Board Meeting – January 13, 2021 NOTE: No live January meeting. January 2021 is a packet only meeting. Enclosed are the following items related to the January meeting. Material is arranged in order of the agenda. Approval of DUR Board Meeting Minutes – Appendix A Update on Medication Coverage Authorization Unit/SoonerCare Opioid Initiative Update – Appendix B Annual Review of Gonadotropin Releasing Hormone (GnRH) Medications and 30-Day Notice to Prior Authorize Fensolvi® (Leuprolide Acetate) and Oriahnn™ (Elagolix/Estradiol/Norethindrone and Elagolix) – Appendix C Annual Review of Antihyperlipidemics and 30-Day Notice to Prior Authorize Nexletol® (Bempedoic Acid) and Nexlizet™ (Bempedoic Acid/Ezetimibe) – Appendix D Annual Review of Glaucoma Medications and 30-Day Notice to Prior Authorize Durysta™ (Bimatoprost Implant) – Appendix E Annual Review of Antiviral Medications – Appendix F Annual Review of Korlym® (Mifepristone) – Appendix G Annual Review of Turalio® (Pexidartinib) – Appendix H Annual Review of Inrebic® (Fedratinib) and Elzonris® (Tagraxofusp-erzs) – Appendix I 30-Day Notice to Prior Authorize Imcivree™ (Setmelanotide) – Appendix J U.S. Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) Updates – Appendix K Future Business ORI-4403 • P.O. BOX 26901 • OKLAHOMA CITY, OKLAHOMA 73126-0901 • (405) 271-9039 • FAX: (405) 271-2615 Oklahoma Health Care Authority Drug Utilization Review Board (DUR Board) Packet – January 13, 2021 No live January meeting. -
WO 2020/0951S3 A1 14 May 2020 (14.05.2020) I 4 P Cl I P C T
(12) INTERNATIONAL APPLICATION PI;BLISHED I. NDER THE PATENT COOPERATION TREATY (PCT) (19) World intellectual Propertv Organraation llIIlIIlllIlIlllIlIllIllIllIIIIIIIIIIIIIIIIIIIIIIllIlIlIlIllIlllIIllIlIIllllIIIIIIIIIIIIIIIIIII International Bureau (10) International Publication Number (43) International Publication Date WO 2020/0951S3 A1 14 May 2020 (14.05.2020) I 4 P Cl I P C T (51) International Patent Classification: MC. MK, MT. M., NO, PL, PT, RO, RS. SE. SI. SK. SM, A6JK3J/4166 (2006.01) A6/K&/5/t)6 (200G 01) TR). OAPI (BF, BJ, CF, CG, CI. CYI. GA, GN, GQ. GW. AGJK39/00(2006 01) C07K/6/28 (2006 01) KM,:vIL. MR, NE. SN, TD, TG) A6JP35/00(200G 01) AGJK38/68 (2019 Ol) Published: (21) International Application tiumber: »iili nrternatinrral seair 6 repurt 14rt 2113&i PCT/IB2019/059459 m Alar/ and &ilnte, the mternat»rrral app/icramn as fihrl (22) International Filing Date: crmiamerl en/«i rrr grevscale a&irl is rivrnhihiefur d«ii nlrrarl 04 November 2019 (04,11.2019) /rum P) TES"/;ST'OPE (25) Filing Langurrge: Enghsh (26) Public&stion Language: Enghsh (30) Priority Data: (&2/755.944 05 Not en&ber 2018105.11 20)8) US (i2/882.424 02 Auknrst 2019 (02 08.2019) US (71) Applicants: PFIZER INC. [US/L S], 233 East 42nd Street. Neve York. Ncw York 10017 (US). MERCK PATENT GMBH [DE/DE], Frankfurter Strasse 250, G4293 Dmm- stadi (DE) NEKTAR THERAPEUTICS [US/US]. 435 Nlission Ba) Boulmard South. Suite 100. San Francis- co, California 94158 (US). ASTELLAS PHARMA INC. f JP/JP], 2-5-1. Nihonbashi-Honcho, Chuo-Ku, Tokv o (JP) (72) Inventors: BOSHOFF, Christoffel Hendrik; c/o PFIZER INC, 235 East 42nd Street Neu York. -
Concept of Patent Insurance: Part 2 3-JUNE-2013
Concept of Patent Insurance: Part 2 3-JUNE-2013 From Our Website For Readers: In the preceding newsletter a generous attempt was made to www.hariani.co.in enlighten readers on the concept and types of patent insurance available at present. This write-up will throw some light on the existence of patent insurance globally. Supreme Court Backs The Right To Education Act 1. Universal Approach towards Patent Insurance Practical difficulties in slow evolution of patent insurance globally are as under: 1. Low level of indemnity, perhaps 200,000 Euros in large countries where costs Your View are highly variable. 2. Lack of awareness of insurance and low level of appreciation of patent utility. Please feel free to 3. Inadequate understanding of the limitation of a patent grant and the need to comment on this be able to litigate to enforce. newsletter. You can 4. Poor experiences in the past with conflict between insured and insurer. send us an email at 5. Bad press reports from professional bodies such as CIPA Restricted scope of [email protected] policies. 6. Low indemnity. 7. Need for complex and expensive evaluation of risk for insurers. 8. Burdensome restrictions and exclusions. 2. Global obstacles in pursuance of insurance on patents. Conventionally the Patent Litigation insurance has not been so successful in most of the economies which was backed by few reasons leaving such imperative insurance in a predicament for e.g.: High level of premium (for example averaging 20-50,000 Euros annually). Lack of statutes and amendments required for implementation of patent insurance.