International Nonproprietary Names for Pharmaceutical Substances (INN)
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( 12 ) Patent Application Publication ( 10 ) Pub . No .: US 2020/0121788 A1
US 20200121788A1 IN (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No .: US 2020/0121788 A1 MASSIMINI et al. (43 ) Pub . Date : Apr. 23 , 2020 ( 54 ) ABITUZUMAB FOR THE TREATMENT OF A61K 31/44 (2006.01 ) COLORECTAL CANCER A61P 35/00 (2006.01 ) (52 ) U.S. Cl. ( 71) Applicant: Merck Patent GmbH , Darmstadt (DE ) CPC ... A61K 39/39558 (2013.01 ) ; CO7K 16/2848 ( 2013.01 ) ; CO7K 16/2863 ( 2013.01 ) ; CO7K ( 72 ) Inventors: Giorgio MASSIMINI, Darmstadt (DE ) ; 16/22 (2013.01 ) ; A61K 31/4745 ( 2013.01 ) ; Ilhan Celik , Zwingenberg (DE ) ; Josef A61K 31/513 ( 2013.01 ) ; A61K 2039/505 Straub , Seeheim - Jugenheim (DE ) ; Rolf ( 2013.01) ; A61K 31/519 ( 2013.01 ) ; A61K Bruns, Darmstadt ( DE ) 33/243 (2019.01 ) ; A6IK 38/179 ( 2013.01) ; A61K 31/44 ( 2013.01) ; A61P 35/00 ( 2018.01 ) ; ( 73 ) Assignee: Merck Patent GmbH , Darmstadt (DE ) CO7K 2317/76 ( 2013.01) ; A61K 31/7072 ( 21 ) Appl. No .: 16 /657,828 ( 2013.01) ( 22 ) Filed : Oct. 18 , 2019 (57 ) ABSTRACT Methods of treatment of colorectal cancer can include the Related U.S. Application Data administration of the anti - alpha - v integrin (receptor ) anti (60 ) Provisional application No. 62 / 748,114 , filed on Oct. body Abituzumab . Preferably , the methods of treating col 19 , 2018 . orectal cancer can include treating Stage II - IV colorectal cancer, metastatic colorectal cancer , left - sided colorectal Publication Classification cancer and /or left- sided metastatic colorectal cancer, involv ( 51) Int. Ci. ing the administration of said Abituzumab to patients in need A61K 39/395 ( 2006.01 ) thereof. Abituzumab is also useful for the manufacture of a COZK 16/28 ( 2006.01 ) medicament for treating colorectal cancer , preferably col COOK 16/22 ( 2006.01 ) orectal cancer as defined herein . -
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. -
LGM-Pharma-Regulatory-1527671011
Pipeline Products List Specialty Portfolio Updated Q2 2018 Updated Q2 2018 See below list of newly approved API’s, samples are readily available for your R&D requirements: Inhalation Ophthalmic Transdermal Sublingual Abaloparatide Defibrotide Sodium Liraglutide Rituximab Abciximab Deforolimus Lixisenatide Rivastigmine Aclidinium Bromide Azelastine HCl Agomelatine Alprazolam Abemaciclib Delafloxacin Lumacaftor Rivastigmine Hydrogen Tartrate Beclomethasone Dipropionate Azithromycin Amlodipine Aripiprazole Acalabrutinib Denosumab Matuzumab Rizatriptan Benzoate Budesonide Besifloxacin HCl Apomorphine Eletriptan HBr Aclidinium Bromide Desmopressin Acetate Meloxicam Rocuronium Bromide Adalimumab Difluprednate Memantine Hydrochloride Rolapitant Flunisolide Bimatoprost Clonidine Epinephrine Aflibercept Dinoprost Tromethamine Micafungin Romidepsin Fluticasone Furoate Brimonidine Tartrate Dextromethorphan Ergotamine Tartrate Agomelatine Dolasetron Mesylate Mitomycin C Romosozumab Fluticasone Propionate Bromfenac Sodium Diclofenac Levocetrizine DiHCl Albiglutide Donepezil Hydrochloride Mometasone Furoate Rotigotine Formoterol Fumarate Cyclosporine Donepezil Meclizine Alectinib Dorzolamide Hydrochloride Montelukast Sodium Rucaparib Iloprost Dexamethasone Valerate Estradiol Melatonin Alemtuzumab Doxercalciferol Moxifloxacin Hydrochloride Sacubitril Alirocumab Doxorubicin Hydrochloride Mycophenolate Mofetil Salmeterol Xinafoate Indacaterol Maleate Difluprednate Fingolimod Meloxicam Amphotericin B Dulaglutide Naldemedine Secukinumab Levalbuterol Dorzolamide -
Abstract Book – Oral Sessions
Sunday, June 21, 2015 12:00 p.m. - 1:15 p.m. Latin American Psychopharmacology Update: INNOVATIVE TREATMENTS IN PSYCHIATRY INNOVATIVE TREATMENTS IN PSYCHIATRY Flavio Kapczinski, The University of Texas Health Science Center at Houston Overall Abstract In this panel, we will propose innovative treatments in psychiatry and recent literature findings will be summarized. The effective pharmacological treatment of psychiatric diseases and development of new therapeutic entities has been a long-standing challenge. Despite the complexity and heterogeneity of psychiatric disorders, basic and clinical research studies and technological advancements in genomics, biomarkers, and imaging have begun to elucidate the pathophysiology of etiological complexity of psychiatric diseases and to identify efficacious new agents (Tcheremissine et al. 2014). Many psychiatric illnesses are associated with neuronal atrophy, characterized by loss of synaptic connections, increase of inflammatory markers like TNF-α and DAMPS (damage-associate molecular patterns,- cell free (ccf) DNA, heat shock proteins HSP70, HSP90, and HSP60, and cytochrome C), decrease of neurotrophic factors, increase of oxidative stress, mitochondrial dysfunction and apoptosis (Fries et al., 2012; Pfaffenseller et al., 2014). Also, neurocognitive impairment and poor psychosocial functioning has been related to a psychiatric disease. Therefore, trying to discover new therapeutic targets that act in these pathways can help to develop new treatment or improve the treatment of these serious diseases. -
2 Total Pharmaceutical Sales
OECD Health Statistics 2021 Definitions, Sources and Methods Total pharmaceutical sales Total sales of pharmaceutical products on the domestic market, in total and by selected Anatomical Therapeutic Chemical (ATC) classification groups, based on retail prices (which means the final price paid by the customer). The ATC codes below are based on the 2021 version of the ATC Index. All alterations implemented from January 2021 are available on the WHO Collaborating Centre for Drug Statistics Methodology website at http://www.whocc.no/atc/lists_of_new_atc_ddds_and_altera/alterations_in_atc_ddd/. Note: There are at least three possible sources of under-reporting of drug sales in different countries: 1) sales data may only cover those drugs that are reimbursed by public insurance schemes; 2) they may be based on ex-factory or wholesale prices rather than retail prices; and 3) sales data may exclude drug consumption in hospitals. Data for the following countries under-estimate pharmaceutical sales reported in this section because of one of these limitations: Australia, Austria, France, Germany, Greece, Japan, Luxembourg, the Netherlands, the Slovak Republic (before 2016) and Spain. (For further information, see the country-specific information below). Please also note that depending on the allocation of pharmaceutical products with more than one use, differences in reporting of specific drugs may occur across countries, thereby affecting the relative size of specific ATC groups. Data should reflect total sales for each drug category, based on -
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. -
Andrew Lai Thesis
TOWARDS THE DEVELOPMENT OF NOVEL BISPECIFIC ANTIBODIES TO INHIBIT KEY CELL SURFACE RECEPTORS INTEGRAL FOR THE GROWTH AND MIGRATION OF TUMOUR CELLS Andrew Lai Bachelor of Science, UNSW 2008 Master of Biotechnology, QUT 2010 Bachelor of Applied Science (Hons), QUT 2012 Submitted for the degree of Doctor of Philosophy Institute of Health and Biomedical Innovation Faculty of Health Queensland University of Technology 2016 Keywords Breast cancer, extracellular matrix, insulin-like growth factor, metastasis, migration, therapeutics, phage display, single chain variable fragments, vitronectin Towards the development of novel bispecific antibodies to inhibit key cell surface receptors integral for the growth and migration of tumour cells i Abstract Metastatic breast cancer, or breast cancer which has spread from the primary tumour to distal secondary sites, remains a major killer of women today. Researchers have observed that the relationship between tumour cells and its surrounding environment plays an important role in cancer progression. One such interaction is between the Insulin-like growth factor (IGF) system and the integrin system, which has been demonstrated to be involved in cancer cell metabolic activity and migration. Therefore, the aim of this project was to translate this knowledge into the generation of bispecific antibody fragments (BsAb) targeting both systems, in order to disrupt their roles in cancer growth and metastasis. To screen for IGF-1R and αv integrin binding ScFv, a phage display enrichment procedure using the Tomlinson ScFv libraries was conducted. After the panning cycles, 192 clones were screened for binding using ELISA, of which 16 were selected for sequencing. Analysis of the results revealed 1 IGF-R and 3 αv integrin unique binding ScFv, which were all subsequently expressed in a bacterial expression system. -
Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products. -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
Geisinger Lewistown Hospital Published: March 25, 2019
Geisinger Lewistown Hospital Published: March 25, 2019 DESCRIPTION CHARGE Fine needle aspiration; without imaging guidance $ 607.00 Fine needle aspiration; without imaging guidance $ 286.00 Fine needle aspiration; with imaging guidance $ 2,218.00 Fine needle aspiration; with imaging guidance $ 1,691.00 Placement of soft tissue localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous, including imaging guidance; first lesion $ 1,979.00 Placement of soft tissue localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous, including imaging guidance; each $ 1,385.00 additional lesion (List separately in addition to code for primary procedure) Incision and drainage of abscess (eg, carbuncle, suppurative hidradenitis, cutaneous or subcutaneous abscess, cyst, furuncle, or paronychia); simple or single $ 657.00 Incision and drainage of abscess (eg, carbuncle, suppurative hidradenitis, cutaneous or subcutaneous abscess, cyst, furuncle, or paronychia); complicated or $ 986.00 multiple Incision and drainage of pilonidal cyst; simple $ 657.00 Incision and drainage of pilonidal cyst; complicated $ 3,726.00 Incision and removal of foreign body, subcutaneous tissues; simple $ 1,694.00 Incision and removal of foreign body, subcutaneous tissues; complicated $ 4,710.00 Incision and drainage of hematoma, seroma or fluid collection $ 3,470.00 Puncture aspiration of abscess, hematoma, bulla, or cyst $ 1,272.00 Puncture aspiration of abscess, hematoma, bulla, or cyst $ 657.00 Incision -
ENTRESTO (Sacubitril and Valsartan) Is a Combination of a Neprilysin Inhibitor and an Angiotensin II Receptor Blocker
HIGHLIGHTS OF PRESCRIBING INFORMATION • Adjust adult doses every 2 to 4 weeks and pediatric doses every 2 weeks These highlights do not include all the information needed to use to the target maintenance dose, as tolerated by the patient. (2.2, 2.3) ENTRESTO safely and effectively. See full prescribing information for • Reduce starting dose to half the usually recommended starting dosage for: ENTRESTO. – patients not currently taking an ACE inhibitor or ARB or previously ENTRESTO® (sacubitril and valsartan) tablets, for oral use taking a low dose of these agents (2.5) Initial U.S. Approval: 2015 – patients with severe renal impairment (2.6) – patients with moderate hepatic impairment (2.7) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. ----------------------DOSAGE FORMS AND STRENGTHS-------------------- • When pregnancy is detected, discontinue ENTRESTO as soon as • Film-coated tablets: 24/26 mg; 49/51 mg; 97/103 mg (3) possible. (5.1) --------------------------------CONTRAINDICATIONS---------------------------- • Drugs that act directly on the renin-angiotensin system can cause • Hypersensitivity to any component. (4) injury and death to the developing fetus. (5.1) • History of angioedema related to previous ACEi or ARB therapy. (4) • ----------------------------RECENT MAJOR CHANGES------------------------- Concomitant use with ACE inhibitors. (4, 7.1) • • Indications and Usage, Adult Heart Failure (1.1) 2/2021 Concomitant use with aliskiren in patients with diabetes. (4, 7.1) ----------------------------INDICATIONS AND USAGE-------------------------- ------------------------WARNINGS AND PRECAUTIONS---------------------- ENTRESTO is indicated: • Observe for signs and symptoms of angioedema and hypotension. (5.2, 5.3) • to reduce the risk of cardiovascular death and hospitalization for heart • Monitor renal function and potassium in susceptible patients. -
Emerging Role of Tumor Cell Plasticity in Modifying Therapeutic Response
Signal Transduction and Targeted Therapy www.nature.com/sigtrans REVIEW ARTICLE OPEN Emerging role of tumor cell plasticity in modifying therapeutic response Siyuan Qin1, Jingwen Jiang1,YiLu 2,3, Edouard C. Nice4, Canhua Huang1,5, Jian Zhang2,3 and Weifeng He6,7 Resistance to cancer therapy is a major barrier to cancer management. Conventional views have proposed that acquisition of resistance may result from genetic mutations. However, accumulating evidence implicates a key role of non-mutational resistance mechanisms underlying drug tolerance, the latter of which is the focus that will be discussed here. Such non-mutational processes are largely driven by tumor cell plasticity, which renders tumor cells insusceptible to the drug-targeted pathway, thereby facilitating the tumor cell survival and growth. The concept of tumor cell plasticity highlights the significance of re-activation of developmental programs that are closely correlated with epithelial–mesenchymal transition, acquisition properties of cancer stem cells, and trans- differentiation potential during drug exposure. From observations in various cancers, this concept provides an opportunity for investigating the nature of anticancer drug resistance. Over the years, our understanding of the emerging role of phenotype switching in modifying therapeutic response has considerably increased. This expanded knowledge of tumor cell plasticity contributes to developing novel therapeutic strategies or combination therapy regimens using available anticancer drugs, which are likely to