DOCSLIB.ORG

Biosimilar Product Differences Will Affect US Uptake, Amgen Predicts

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Biosimilar Product Differences Will Affect US Uptake, Amgen Predicts 28 April 2017 No. 3851 Scripscrip.pharmamedtechbi.com Pharma intelligence | informa However, the US is poised for potentially significant growth in the biosimilar category in the coming year. There currently are at least six 351(k) applications and at least one resubmitted application pending with FDA. The report’s discussion of delivery de- vice, packaging and product dosing con- siderations as market drivers is particularly timely in the context of FDA’s recently re- leased draft guidance on interchangeabil- ity, which suggested that such differences from a reference product could present a hurdle to achieving an interchangeability determination. “While the biosimilar market continues to develop, we expect that the next year will bring another strong phase of growth and market maturity for biosimilars,” Amgen’s Shutterstock: spaxiax Shutterstock: Duane Barnes, vice president and general manager of US Value and Access, said in the report’s opening message. “We anticipate Biosimilar Product Differences Will additional regulatory and legal activity sur- rounding these agents across a range of Affect US Uptake, Amgen Predicts therapeutic areas.” Differences in product characteristics should be considered in formulary decisions, Amgen INDICATION BREADTH says in annual trends report that puts its biosimilars in a strong competitive light while The report discusses the FDA approval path- also bolstering the position of its reference biologics. way for 351(k) applications, evolution of the US biosimilar market, and patient and phy- SUE SUTTER [email protected] sician perceptions of the product category. It also identifies manufacturer, product iosimilar product considerations such The document marks Amgen’s fourth re- and operational considerations that pay- as delivery device, dosing and pack- port on biosimilar trends, but the first since ers and other formulary decision-makers Baging that differ from the reference the company received FDA approval last should take into account when evaluating a product may affect uptake of the follow-on September of its own biosimilar, Amjevita biosimilar and considering appropriate cov- agents in the nascent US market, a new Am- (adalimumab-atto), which references AbbVie erage criteria (see box). gen Inc. report states. Inc.’s TNF-inhibitor Humira (adalimumab). The document reiterates a point raised While a biosimilar must have no clinically The US biosimilars market is still young, in Amgen’s earlier reports regarding supply meaningful efficacy or safety differences with just four approved products. Only two chain reliability and avoiding the potential from the reference product, nonclinical dif- of these – Sandoz Inc.’s Zarxio (filgrastim- for drug shortages when making formulary and prescribing decisions about a biosimi- ferences could have implications for payers, sndz) and Celltrion Inc.’s Inflectra (infliximab- lar. It emphasizes the importance of biologic integrated delivery networks, healthcare dyyb) – have launched; commercialization manufacturing experience. providers and patients, the “2017 Trends in of Amjevita and Sandoz’s Erelzi (etanercept- Biosimilars Report” states. szzs) have been delayed by patent litigation. CONTINUED ON PAGE 8 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Market Intelligence Research & Development Company Focus Can cholesterol drug sponsors make New active substance launches UniQure gives up on Glybera, but not the case for statin intolerance? (p11) declined again in 2016 (p14) gene therapies (p18) IN THIS ISSUE from the editor [email protected] If a company is still assuming the value of its drug is to stretch the length of significant profitable service almost entirely tied up in the IP around its active ingre- a drug can deliver. For example, while a biologic may dient, it is probably over-zealous in its interpretation of technically be exposed to biosimilar competition, bar- the IP protection bargain between society and innova- riers to adoption are likely to be posed by peripheral tive pharma. At its extreme, this bargain entails generic elements such as the delivery device in which the origi- competition being held at bay for a limited number of nator product is packaged (see cover story). “Beyond the years of premium pricing – to generate funds to plow pill” factors can become even more important in bind- back into novel drug development – and then being ing payers to an out-of-patent branded product if the unleashed to flood the market with the same medicine originator harnesses real-world evidence to ‘accessorize’ at a fraction of the price. This frees up patient spending its offering and demonstrate how patient outcomes dollars and the cycle begins again. associated with the drug are influenced by numerous In fact, the multiple facets of digital health technol- non-pharmacological factors, from delivery devices ogy and the increasing complexity of many therapies and physician education to adherence, monitoring (from biologicals to combinations to respiratory medi- and medical support apps. Now more than ever, patent cines packaged in proprietary inhaler devices) promise expiry need not be a cliff-edge for pharma. LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Mike Ward Christopher Keeling Paul Wilkinson SUBSCRIPTIONS DESIGN SUPERVISOR Scrip Daniel Frere Gayle Rembold Furbert EDITORS IN CHIEF Vibha Sharma EDITORIAL OFFICE Eleanor Malone (Europe) Joanne Shorthouse Christchurch Court Denise Peterson (US) Sten Stovall 10-15 Newgate Street Ian Haydock (Asia) Sukaina Virji London, EC1A 7AZ CUSTOMER SERVICES EXECUTIVE EDITORS US Tel: +44 (0)20 7017 5540 COMMERCIAL Michael Cipriano or (US) Toll Free: 1 800 997 3892 Alexandra Shimmings (Europe) Derrick Gingery Email: clientservices@ Mary Jo Laffler (US) Joseph Haas pharmamedtechbi.com Emily Hayes POLICY AND REGULATORY Mandy Jackson TO SUBSCRIBE, VISIT Maureen Kenny (Europe) Cathy Kelly scrip.pharmamedtechbi.com Nielsen Hobbs (US) Jessica Merrill TO ADVERTISE, CONTACT Brenda Sandburg [email protected] EUROPE Bridget Silverman Lubna Ahmed Sue Sutter Neena Brizmohun Francesca Bruce ASIA John Davis Ying Huang Lucie Ellis Anju Ghangurde All stock images in this publication John Hodgson Jung Won Shin courtesy of www.shutterstock.com Ian Schofield Brian Yang unless otherwise stated Scrip is published by Informa UK Limited. ©Informa UK Ltd 2017: All rights reserved. ISSN 0143 7690. 2 | Scrip intelligence | 28 April 2017 © Informa UK Ltd 2017 NAS Launches Declined In 2016 Amgen’s study supports LDL- Emicizumab’s lowering Next Big 20Challenge 7 11 16 exclusive online content inside: COVER / Biosimilar Product Differences Will Affect US Uptake, Biomunex CEO On Earlier Deals For Cancer Drugs Amgen Predicts http://bit.ly/2pcLp8S Biomunex CEO Pierre Emmanuel Gerard discusses the 4 Veliparib Phase III Failures Strike Blow To AbbVie’s company’s founding, its pipeline of innovative bispecific Oncology Strategy antibodies being developed for oncological indications, and the partnering potential for these compounds. 5 Teva’s AirDuo Authorized Generic Priced At A 70% Discount To Advair Newron CEO On Xadago & Upcoming Pipeline 6 Rebates, Pricing Pressure Weigh On J&J’s 1Q Pharma Sales Milestones http://bit.ly/2on4Ts9 7 Roche’s Emicizumab Progresses Against Hemophilia’s Next Newron CEO Stefan Weber joins Scrip to discuss the company’s Big Challenge recently approved Parkinson’s therapy Xadago (safinamide), as well as development timelines for Newron’s other pipeline 9 High Profile Combo Answer To Late-Stage NASH Programs? candidates. 10 AbbVie Next-Gen Combo To Target Hard-To-Cure Noxxon CEO Talks Partnering Strategy & Cancer HCV Patients Combos http://bit.ly/2pXpdQJ 10 OncoMed Trying To Regroup After Cancer Failures Aram Mangasarian, CEO of Noxxon Pharma, a biotech company focused on cancer therapies targeting the tumor 11 Can Cholesterol Drug Sponsors Make The Case For microenvironment, discusses partnering options and his Statin Intolerance? strategy for how Noxxon can compete in the busy immuno- oncology space. 14 New Active Substance Launches Declined Again In 2016 18 UniQure Gives Up On Glybera, But Not Gene Therapies India Pricing Authority Chief Says List Is No Attempt To Vilify Industry 20 Immune-Focused Discovery Firm Alpine Goes Public http://bit.ly/2oDIh1H The chair of India’s National Pharmaceutical Pricing Authority 21 Valeant Gives Siliq Competitive Price In Crowded has tried to clear the air around the regulator’s recent public Psoriasis Market notice that lists over 600 products suspected of having flouted price caps, telling Scrip the chances of error around the data 22 Pipeline Watch used to verify compliance is low, though at least half a dozen companies on the list indicate they have complied with the regulator’s norms. 23 Multispecific Approach Could Improve I-O Side Effect Profile, Says Numab Forward Pharma Faces Uphill Struggle Appealing 23 Appointments Biogen’s Tecfidera PTAB Win http://bit.ly/2oZAzTp Forward Pharma is suspending all FP187 development pending the outcome of its legal interference appeal against Biogen – but analysts see little prospect of it overturning last month’s decision that effectively allows Biogen’s dimethyl fumarate-based drug Tecfidera to stay on the market with @scripnews /scripintelligence its own patent. /scripintelligence /scripintelligence scrip.pharmamedtechbi.com 28 April 2017 | Scrip intelligence | 3 RESEARCH & DEVELOPMENT Veliparib Phase III Failures Strike Blow To AbbVie’s Oncology Strategy STEN STOVALL
Load more

Recommended publications
  • Precision Medicine for Human Cancers with Notch Signaling Dysregulation (Review)
    INTERNATIONAL JOURNAL OF MOleCular meDICine 45: 279-297, 2020 Precision medicine for human cancers with Notch signaling dysregulation (Review) MASUKO KATOH1 and MASARU KATOH2 1M & M PrecMed, Tokyo 113-0033; 2Department of Omics Network, National Cancer Center, Tokyo 104-0045, Japan Received September 16, 2019; Accepted November 20, 2019 DOI: 10.3892/ijmm.2019.4418 Abstract. NOTCH1, NOTCH2, NOTCH3 and NOTCH4 are conjugate (ADC) Rova-T, and DLL3-targeting chimeric antigen transmembrane receptors that transduce juxtacrine signals of receptor‑modified T cells (CAR‑Ts), AMG 119, are promising the delta-like canonical Notch ligand (DLL)1, DLL3, DLL4, anti-cancer therapeutics, as are other ADCs or CAR-Ts targeting jagged canonical Notch ligand (JAG)1 and JAG2. Canonical tumor necrosis factor receptor superfamily member 17, Notch signaling activates the transcription of BMI1 proto-onco- CD19, CD22, CD30, CD79B, CD205, Claudin 18.2, fibro- gene polycomb ring finger, cyclin D1, CD44, cyclin dependent blast growth factor receptor (FGFR)2, FGFR3, receptor-type kinase inhibitor 1A, hes family bHLH transcription factor 1, tyrosine-protein kinase FLT3, HER2, hepatocyte growth factor hes related family bHLH transcription factor with YRPW receptor, NECTIN4, inactive tyrosine-protein kinase 7, inac- motif 1, MYC, NOTCH3, RE1 silencing transcription factor and tive tyrosine-protein kinase transmembrane receptor ROR1 transcription factor 7 in a cellular context-dependent manner, and tumor-associated calcium signal transducer 2. ADCs and while non-canonical Notch signaling activates NF-κB and Rac CAR-Ts could alter the therapeutic framework for refractory family small GTPase 1. Notch signaling is aberrantly activated cancers, especially diffuse-type gastric cancer, ovarian cancer in breast cancer, non-small-cell lung cancer and hematological and pancreatic cancer with peritoneal dissemination.
    [Show full text]
  • (AAV1-LPLS447X) Gene Therapy for Lipoprotein Lipase Deficiency
    Gene Therapy (2013) 20, 361–369 & 2013 Macmillan Publishers Limited All rights reserved 0969-7128/13 www.nature.com/gt ORIGINAL ARTICLE Efficacy and long-term safety of alipogene tiparvovec (AAV1-LPLS447X) gene therapy for lipoprotein lipase deficiency: an open-label trial D Gaudet1,2,JMe´ thot1,2,SDe´ry1, D Brisson1,2, C Essiembre1, G Tremblay1, K Tremblay1,2, J de Wal3, J Twisk3, N van den Bulk3, V Sier-Ferreira3 and S van Deventer3 We describe the 2-year follow-up of an open-label trial (CT-AMT-011–01) of AAV1-LPLS447X gene therapy for lipoprotein lipase (LPL) deficiency (LPLD), an orphan disease associated with chylomicronemia, severe hypertriglyceridemia, metabolic complications and potentially life-threatening pancreatitis. The LPLS447X gene variant, in an adeno-associated viral vector of serotype 1 (alipogene tiparvovec), was administered to 14 adult LPLD patients with a prior history of pancreatitis. Primary objectives were to assess the long-term safety of alipogene tiparvovec and achieve a X40% reduction in fasting median plasma triglyceride (TG) at 3–12 weeks compared with baseline. Cohorts 1 (n ¼ 2) and 2 (n ¼ 4) received 3 Â 1011 gc kg À 1, and cohort 3 (n ¼ 8) received 1 Â 1012 gc kg À 1. Cohorts 2 and 3 also received immunosuppressants from the time of alipogene tiparvovec administration and continued for 12 weeks. Alipogene tiparvovec was well tolerated, without emerging safety concerns for 2 years. Half of the patients demonstrated a X40% reduction in fasting TG between 3 and 12 weeks. TG subsequently returned to baseline, although sustained LPLS447X expression and long-term changes in TG-rich lipoprotein characteristics were noted independently of the effect on fasting plasma TG.
    [Show full text]
  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
    [Show full text]
  • Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
    Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany).
    [Show full text]
  • 2017 Immuno-Oncology Medicines in Development
    2017 Immuno-Oncology Medicines in Development Adoptive Cell Therapies Drug Name Organization Indication Development Phase ACTR087 + rituximab Unum Therapeutics B-cell lymphoma Phase I (antibody-coupled T-cell receptor Cambridge, MA www.unumrx.com immunotherapy + rituximab) AFP TCR Adaptimmune liver Phase I (T-cell receptor cell therapy) Philadelphia, PA www.adaptimmune.com anti-BCMA CAR-T cell therapy Juno Therapeutics multiple myeloma Phase I Seattle, WA www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 "armored" CAR-T Juno Therapeutics recurrent/relapsed chronic Phase I cell therapy Seattle, WA lymphocytic leukemia (CLL) www.junotherapeutics.com Memorial Sloan Kettering New York, NY anti-CD19 CAR-T cell therapy Intrexon B-cell malignancies Phase I Germantown, MD www.dna.com ZIOPHARM Oncology www.ziopharm.com Boston, MA anti-CD19 CAR-T cell therapy Kite Pharma hematological malignancies Phase I (second generation) Santa Monica, CA www.kitepharma.com National Cancer Institute Bethesda, MD Medicines in Development: Immuno-Oncology 1 Adoptive Cell Therapies Drug Name Organization Indication Development Phase anti-CEA CAR-T therapy Sorrento Therapeutics liver metastases Phase I San Diego, CA www.sorrentotherapeutics.com TNK Therapeutics San Diego, CA anti-PSMA CAR-T cell therapy TNK Therapeutics cancer Phase I San Diego, CA www.sorrentotherapeutics.com Sorrento Therapeutics San Diego, CA ATA520 Atara Biotherapeutics multiple myeloma, Phase I (WT1-specific T lymphocyte South San Francisco, CA plasma cell leukemia www.atarabio.com
    [Show full text]
  • 2019 ESC/EAS Guidelines for the Management of Dyslipidaemias
    Atherosclerosis 290 (2019) 140–205 Contents lists available at ScienceDirect Atherosclerosis journal homepage: www.elsevier.com/locate/atherosclerosis 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid ☆ T modification to reduce cardiovascular risk ∗ ∗∗ Authors/Task Force Members (François Macha, ,2, Colin Baigentb, ,2, ∗∗∗ Alberico L. Catapanoc, ,1,2, Konstantinos C. Koskinasd, Manuela Casulae,f,1, Lina Badimong, M. John Chapmanh,i,cm,1, Guy G. De Backerj, Victoria Delgadok, Brian A. Ferencel, Ian M. Grahamm, Alison Hallidayn, Ulf Landmessero,p,q, Borislava Mihaylovar,s, Terje R. Pedersent, Gabriele Riccardiu,1, Dimitrios J. Richterv, Marc S. Sabatinew, Marja-Riitta Taskinenx,1, Lale Tokgozogluy,1, Olov Wiklundz), ESC National Cardiac Societies (Djamaleddine Nibouchean, Parounak H. Zelveianao, Peter Siostrzonekap, Ruslan Najafovaq, Philippe van de Bornear, Belma Pojskicas, Arman Postadzhiyanat, Lambros Kyprisau, Jindřich Špinarav, Mogens Lytken Larsenaw, Hesham Salah Eldinax, Margus Viigimaaay, Timo E. Strandbergaz, Jean Ferrièresba, Rusudan Agladzebb, Ulrich Laufsbc, Loukianos Rallidisbd, László Bajnokbe, Thorbjörn Gudjónssonbf, Vincent Maherbg, Yaakov Henkinbh, Michele Massimo Guliziabi, Aisulu Mussagaliyevabj, Gani Bajraktaribk, Alina Kerimkulovabl, Gustavs Latkovskisbm, Omar Hamouibn, Rimvydas Slapikasbo, Laurent Visserbp, Philip Dinglibq, Victoria Ivanovbr, Aneta Boskovicbs, Mbarek Nazzibt, Frank Visserenbu, Irena Mitevskabv, Kjetil Retterstølbw, Piotr Jankowskibx, Ricardo Fontes-Carvalhoby, Dan Gaitabz, Marat Ezhovca,
    [Show full text]
  • Small Dense Low-Density Lipoprotein: Biomarker Or Potential Drug Target?
    Published online: 02.10.2019 THIEME 92 SmallReview Dense Article Low-Density Lipoprotein Samanta Small Dense Low-Density Lipoprotein: Biomarker or Potential Drug Target? Basabdatta Samanta1 1Department of Biochemistry, Burdwan Medical College, West Address for correspondence Basabdatta Samanta, MBBS, MD, Bengal, India DNB, Department of Biochemistry, Burdwan Medical College, Burdwan 713104, West Bengal, India (e-mail: [email protected]). Ann Natl Acad Med Sci (India) 2019;55:92–97 Abstract Ischemic heart disease is currently an epidemic affecting individuals worldwide. Increased incidence along with earlier onset of disease has led to the constant search for biomarkers that will help in earlier identification and treatment of at risk individuals. Small dense low-density lipoprotein (sdLDL) is the atherogenic subtype of low-densi- ty lipoprotein (LDL). It is smaller in size and higher in density in comparison to other LDL subtypes. Higher levels of sdLDL have been found to be associated with increased incidence of ischemic heart disease and adverse outcomes. Properties including decreased resistance to oxidative stress and prolonged residence time in the circula- tion account for its increased atherogenic potential. Hence intervention approaches targeting sdLDL directly in at risk individuals may be beneficial. Genetic, lifestyle, and environmental factors affect sdLDL levels. But the main deter- mining factor is the level of triglycerides (TGs). Higher TG levels are associated with higher levels of very low density lipoprotein (VLDL) 1 and sdLDL. Various drugs Keywords have been used for targeting sdLDL with varying outcomes; drugs tried out include ► ischemic heart disease statins, fibrates, niacin, cholesterol ester transfer protein inhibitors and sodium-glu- ► small dense low - cose co-transporter-2 inhibitors.
    [Show full text]
  • Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark
    A Service of Leibniz-Informationszentrum econstor Wirtschaft Leibniz Information Centre Make Your Publications Visible. zbw for Economics Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas Working Paper Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark ZEW Discussion Papers, No. 10-062 Provided in Cooperation with: ZEW - Leibniz Centre for European Economic Research Suggested Citation: Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas (2010) : Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark, ZEW Discussion Papers, No. 10-062, Zentrum für Europäische Wirtschaftsforschung (ZEW), Mannheim This Version is available at: http://hdl.handle.net/10419/41440 Standard-Nutzungsbedingungen: Terms of use: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Documents in EconStor may be saved and copied for your Zwecken und zum Privatgebrauch gespeichert und kopiert werden. personal and scholarly purposes. Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle You are not to copy documents for public or commercial Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich purposes, to exhibit the documents publicly, to make them machen, vertreiben oder anderweitig nutzen. publicly available on the internet, or to distribute or otherwise use the documents in public. Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten, If the documents have been made available under an Open gelten abweichend von diesen Nutzungsbedingungen die in der dort Content Licence (especially Creative Commons Licences), you genannten Lizenz gewährten Nutzungsrechte. may exercise further usage rights as specified in the indicated licence. www.econstor.eu Dis cus si on Paper No. 10-062 Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark Ulrich Kaiser, Susan J.
    [Show full text]
  • The Two Tontti Tudiul Lui Hi Ha Unit
    THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int .
    [Show full text]
  • LAI Expert Consensus Statement
    st st 8 Supplement to Journal of The Association of Physicians of India ■ Published on 1 of Every Month 1 November, 2020 Lipid Association of India Expert Consensus Statement on Management of Dyslipidemia in Indians 2020: Part III Expert Consensus Panel: Raman Puri, Chairman1, Vimal Mehta, Co-Chair2, SS Iyengar, Co-Chair3, SN Narasingan, Co-Chair4, P Barton Duell5, GB Sattur6, Krishnaswami Vijayaraghavan7, JC Mohan8, SK Wangnoo9, Jamshed Dalal10, D Prabhakar11, Rajeev Agarwal12, Manish Bansal13, Jamal Yusuf2, Saibal Mukhopadhyay2, Sadanand Shetty14, Prabhash Chand Manoria15, Avishkar Sabharwal16, Akshayaya Pradhan17, Rahul Mehrotra18, Sundeep Mishra19, Sonika Puri20, A Muruganathan21, Abdul Hamid Zargar22, Rashida Melinkari Patanwala23, Soumitra Kumar24, Neil Bardoloi25, KK Pareek26, Aditya Kapoor27, Ashu Rastogi28, Devaki R Nair29, Altamash Shaikh30, Chandra Mani Adhikari31, Muhammad Shoaib Momen Majumder32, Dheeraj Kapoor33, Madhur Yadav34, MR Mubarak35, AK Pancholia36, Rakesh Kumar Sahay37, Rashmi Nanda38, Nathan D Wong39 Introduction proposed by Lipid Association of India regarding various interventions based (LAI),8 identification and application on scientific evidence. The section on ndia is in the middle of an epidemic of lipid markers like lipoprotein (a) low LDL-C levels sums the evidence to Iof atherosclerotic cardiovascular [Lp(a)] and apolipoprotein B (apo the present date and gives justification disease (ASCVD) which is showing B) for risk stratification and control for lower proposed LDL-C goals. Since no signs of abating.1,2
    [Show full text]
  • Gastrointestinal Cancer Tumor Panel
    POST-TEST Gastrointestinal Cancer Tumor Panel: Clinical Investigators Provide Their Perspectives on Current Cases and Clinical Issues in the Management of Colorectal, Gastric and Pancreatic Cancer THE CORRECT ANSWER IS INDICATED WITH YELLOW HIGHLIGHTING. 1. The Phase III TML trial evaluating 5. The results from the Phase III bevacizumab beyond disease progression RECOURSE trial of TAS-102 for patients for patients with metastatic colorectal with metastatic colorectal cancer cancer demonstrated a statistically refractory to standard therapies demon- significant improvement in overall strated a statistically significant improve- survival (OS) with bevacizumab beyond ment in ___________ with TAS-102/best progression compared to chemotherapy supportive care compared to placebo/ alone. best supportive care. a. True a. OS b. False b. Progression-free survival c. Both a and b 2. Similar to those with other agents in d. Neither a nor b the same class, the adverse events of note that were associated with the VEGF 6. Results from the Phase II RECAP trial inhibitor ramucirumab on the RAISE trial of capecitabine in combination with include ___________. ___________ or placebo as second-line a. Bleeding/hemorrhage therapy for patients with metastatic b. Hypertension pancreatic cancer indicated improved c. Proteinuria OS with that agent in a subgroup of d. Both a and b patients with high C-reactive protein levels. e. All of the above a. Ruxolitinib 3. The ongoing Phase III JACOB trial is b. Brivanib evaluating chemotherapy/trastuzumab c. Nanoparticle albumin-bound (nab) with or without ___________ as first-line paclitaxel therapy for patients with HER2-positive metastatic gastric or gastroesophageal- 7.
    [Show full text]
  • High Delta-Like Ligand 4 Expression Correlates with a Poor Clinical
    Journal of Cancer 2019, Vol. 10 3172 Ivyspring International Publisher Journal of Cancer 2019; 10(14): 3172-3178. doi: 10.7150/jca.30257 Research Paper High delta-like ligand 4 expression correlates with a poor clinical outcome in gastric cancer Youjin Kim1,2*, Sun-ju Byeon3,4*, Joonyoung Hur1, Kangkook Lee1, Dongin Kim5, Jin-Hyung Ahn5, Sang Hoon Lee5, Weon-Kyoo You5, Seung Tae Kim1, Se Hoon Park1, Won Ki Kang1, Kyoung-Mee Kim3, Jeeyun Lee1 1. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea 2. Division of Hematology-Oncology, Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea 3. Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea 4. Department of Pathology, Hallym University Dongtan Sacred Heart Hospital, Korea 5. ABL Bio, Korea *Equal contributing authors Corresponding authors: Jeeyun Lee, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351 (Korea). Tel. +82 2 3410 1779; Fax +82 2 3410 1754; Email: [email protected] and Kyoung-Mee Kim, MD, Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351 (Korea). Tel. +82 2 3410 2807; Fax +82 2 3410 1754; Email: [email protected] © Ivyspring International Publisher. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) license (https://creativecommons.org/licenses/by-nc/4.0/).
    [Show full text]