Q1 2021 Presentation
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The Hexavalent Dtap/IPV/Hib/Hepb Combination Vaccine: Information for Healthcare Practitioners About the Neonatal Selective
The hexavalent DTaP/IPV/Hib/HepB combination vaccine Information for healthcare practitioners about the neonatal selective immunisation programme for babies at risk of hepatitis B The Hexavalent DTaP/IPV/Hib/HepB combination vaccine: Information for Healthcare Practitioners (selective programme) About Public Health England Public Health England exists to protect and improve the nation’s health and wellbeing, and reduce health inequalities. We do this through world-leading science, research, knowledge and intelligence, advocacy, partnerships and the delivery of specialist public health services. We are an executive agency of the Department of Health and Social Care, and a distinct delivery organisation with operational autonomy. We provide government, local government, the NHS, Parliament, industry and the public with evidence-based professional, scientific and delivery expertise and support. Public Health England Wellington House 133-155 Waterloo Road London SE1 8UG Tel: 020 7654 8000 www.gov.uk/phe Twitter: @PHE_uk Facebook: www.facebook.com/PublicHealthEngland For queries relating to this document, please contact: [email protected] © Crown copyright 2020 You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence v3.0. To view this licence, visit OGL. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. First published November 2017 This updated version published February -
Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution. -
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2021 FORUM REPORT COVID-19 in Africa one year on: Impact and Prospects MO IBRAHIM FOUNDATION 2021 FORUM REPORT COVID-19 in Africa one year on: Impact and Prospects MO IBRAHIM FOUNDATION Foreword by Mo Ibrahim Notwithstanding these measures, on current projections Founder and Chair of the Mo Ibrahim Africa might not be adequately covered before 2023. Foundation (MIF) Vaccinating Africa is an urgent matter of global security and all the generous commitments made by Africa’s partners must now be delivered. Looking ahead - and inevitably there will be future pandemics - Africa needs to significantly enhance its Over a year ago, the emergence and the spread of COVID-19 homegrown vaccine manufacturing capacity. shook the world and changed life as we knew it. Planes were Africa’s progress towards its development agendas was off grounded, borders were closed, cities were shut down and course even before COVID-19 hit and recent events have people were told to stay at home. Other regions were hit created new setbacks for human development. With very earlier and harder, but Africa has not been spared from the limited access to remote learning, Africa’s youth missed out pandemic and its impact. on seven months of schooling. Women and girls especially The 2021 Ibrahim Forum Report provides a comprehensive are facing increased vulnerabilities, including rising gender- analysis of this impact from the perspectives of health, based violence. society, politics, and economics. Informed by the latest data, The strong economic and social impacts of the pandemic it sets out the challenges exposed by the pandemic and the are likely to create new triggers for instability and insecurity. -
Revised 6/29/2020 GEORGIA MEDICAID FEE-FOR-SERVICE
GEORGIA MEDICAID FEE-FOR-SERVICE BIOLOGIC IMMUNOMODULATORS PA SUMMARY Preferred Non-Preferred Arcalyst (rilonacept) Actemra subcutaneous (tocilizumab) Benlysta subcutaneous (belimumab) Cimzia (certolizumab) Enbrel (etanercept) Cosentyx (secukinumab) Humira (adalimumab) Dupixent (dupilumab) Ilaris (canakinumab) Fasenra Pen (benralizumab autoinjector)Kevzara Xeljanz (tofacitinib) (sarilumab) Xeljanz XR (tofacitinib extended-release) Kineret (anakinra) Nucala Pen (mepolizumab autoinjector) Olumiant (baricitinib) Orencia subcutaneous (abatacept) Otezla (apremilast) Rinvoq (upadacitinib) Siliq (brodalumab) Simponi (golimumab) Stelara (ustekinumab) Skyrizi (risankizumab) Taltz (ixekizumab) Tremfya (guselkumab) The drug names above include all available oral or subcutaneous formulations under the same primary name. LENGTH OF AUTHORIZATION: Varies NOTES: ▪ All preferred and non-preferred products require prior authorization. Intravenous (IV) formulations of the biologic immunomodulators are not covered under Pharmacy Services. ▪ The criteria details below are for the outpatient pharmacy program. If a medication is being administered in a physician’s office or clinic, then the medication must be billed through the DCH physician services program and not the outpatient pharmacy program. Information regarding the physician services program is located at www.mmis.georgia.gov. PA CRITERIA: Actemra Subcutaneous ❖ Approvable for members 2 years of age or older with a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis -
UNICEF Pentavalent-Hexa 2021+ Pre-Tender Industry Consultation
UNICEF Pentavalent-Hexa 2021+ Pre-Tender Industry Consultation 19th SEPTEMBER 2019 1 Presentation Outline 1. Context ▪ Gavi Board decision ▪ Hexa strategic alignment ▪ Value Based Assessment 2. Demand scenarios and assumptions 3. Pentavalent Tender: ▪ Objectives ▪ Scope ▪ Duration ▪ Modality 4. Summary of feedback and response to questionnaire 5. Timelines 1. CONTEXT Gavi Board decision Hexa strategic alignment Value Based Assessment 3 Gavi Board November 2018 – Decisions IPV Post-2020 DTP booster VIS 2018 VIS 2018 + Hexavalent as immunisation option • Approved support for D, T & P vaccines (Td, DTwP, pentavalent) to be used as booster doses beginning in 2021 • Approved support for inactivated poliovirus vaccine (IPV), with country financing arrangements subject to alignment with the final parameter setting for Gavi 5.0 at the June 2019 Board meeting* • Approved in principle support of wP-Hexavalent vaccine, subject to a vaccine being licenced, recommended for use by WHO, WHO pre-qualified and that market attributes support the successful implementation of Hexavalent The development of capacity for standalone IPV remains the main priority for Gavi Alliance as part of the effort to eradicate polio All Gavi Board decisions are “subject to the availability of funding for the 2021-2025 period and alignment with the final parameter setting for Gavi 5.0 at the June 2019 Board meeting.” *Gavi's Board approved IPV co-financing arrangements post-2020 in its June 2019 session 4 Conditions to open a funding window for Hexavalent Condition 1: Hexavalent vaccines that are candidates for Gavi support should achieve IPV immunogenicity targets as per WHO’s SAGE recommendations. Condition 2: Hexavalent vaccines are priced in line with value-based principles. -
Fasenra, INN-Benralizumab
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Fasenra 30 mg solution for injection in pre-filled syringe Fasenra 30 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe Each pre-filled syringe contains 30 mg benralizumab* in 1 mL. Pre-filled pen Each pre-filled pen contains 30 mg benralizumab* in 1 mL. *Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection) Solution for injection in pre-filled pen (injection) (Fasenra Pen) Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see section 5.1). 4.2 Posology and method of administration Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma. After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. -
Access to Medicine Index Scoping Report & Stakeholder Review
THE APPROACH TAKEN TO Access To Medicine Index ESTABLISH THE ACCESS TO MEDICINE INDEX Scoping Report & FRAMEWORK Background Research The Access To Medicine Index project Stakeholder Review builds on a large body of work published on this issue in recent years. Innovest has February 2007 collected and reviewed the latest academic, industry, and other third-party reports on access to medicines (ATMs) and related issues. Report prepared by The Innovest Healthcare Team: Veronique Menou, Adam Savitz and Katharine Preston. ATMs Questionnaire A questionnaire was designed to help Access To Medicine Index Framework identify the key issues to be included in an evaluation of healthcare companies’ ATMs strategies and performance based 20% Access to Medicines Management on the background research. The questionnaire was delivered to over 200 20% Research & Development into Neglected Diseases leading ATMs experts around the globe. This key stakeholder group included academics, consultants, investors, 18% Equitable Pricing government representatives, and non- governmental organizations (NGOs). 15% Patents & Licensing Stakeholder Roundtables 10% Policy Influence & Lobbying Stakeholder roundtables were held in London and New York to discuss and debate the questionnaire results and 7% Drug Donations refine ATMs indicators. Each stakeholder roundtable included 5% Philanthropic Activities representatives from the stakeholder groups, who shared their expertise and 5% Ethical Promotion & Marketing Activities continued to provide input during the Access To Medicine Index building This table includes the eight most relevant criteria, ranked in order of importance, as indicated by the percentage weighting. This criteria will be used to evaluate each pharmaceutical company’s performance during the CONTINUED ON NEXT PAGE… benchmarking phase. -
W W W .Bio Visio N .Co M New Products Added in 2020
New products added in 2020 Please find below a list of all the products added to our portfolio in the year 2020. Assay Kits Product Name Cat. No. Size Product Name Cat. No. Size N-Acetylcysteine Assay Kit (F) K2044 100 assays Human GAPDH Activity Assay Kit II K2047 100 assays Adeno-Associated Virus qPCR Quantification Kit K1473 100 Rxns Human GAPDH Inhibitor Screening Kit (C) K2043 100 assays 20 Preps, Adenovirus Purification Kit K1459 Hydroxyurea Colorimetric Assay Kit K2046 100 assays 100 Preps Iodide Colorimetric Assay Kit K2037 100 assays Aldehyde Dehydrogenase 2 Inhibitor Screening Kit (F) K2011 100 assays Laccase Activity Assay Kit (C) K2038 100 assays Aldehyde Dehydrogenase 3A1 Inhibitor Screening Kit (F) K2060 100 assays 20 Preps, Lentivirus and Retrovirus Purification Kit K1458 Alkaline Phosphatase Staining Kit K2035 50 assays 100 Preps Alpha-Mannosidase Activity Assay Kit (F) K2041 100 assays Instant Lentivirus Detection Card K1470 10 tests, 20 tests Beta-Mannosidase Activity Assay Kit (F) K2045 100 assays Lentivirus qPCR Quantification Kit K1471 100 Rxns 50 Preps, Buccal Swab DNA Purification Kit K1466 Maleimide Activated KLH-Peptide Conjugation Kit K2039 5 columns 250 Preps Methionine Adenosyltransferase Activity Assay Kit (C) K2033 100 assays CD38 Activity Assay Kit (F) K2042 100 assays miRNA Extraction Kit K1456 50 Preps EZCell™ CFDA SE Cell Tracer Kit K2057 200 assays MMP-13 Inhibitor Screening Kit (F) K2067 100 assays Choline Oxidase Activity Assay Kit (F) K2052 100 assays Mycoplasma PCR Detection Kit K1476 100 Rxns Coronavirus -
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Antibodies to Watch in a Pandemic Dr. Janice M. Reichert, Executive Director, The Antibody Society August 27, 2020 (updated slides) Agenda • US or EU approvals in 2020 • Granted as of late July 2020 • Anticipated by the end of 2020 • Overview of antibody-based COVID-19 interventions in development • Repurposed antibody-based therapeutics that treat symptoms • Newly developed anti-SARS-CoV-2 antibodies • Q&A 2 Number of first approvals for mAbs 10 12 14 16 18 20 Annual first approvals in either the US or EU or US the either in approvals first Annual 0 2 4 6 8 *Estimate based on the number actually approved and those in review as of July 15, with assumption of approval on the first c first the on of approval assumption 15, with as July of review in those and approved actually number the on based *Estimate Tables of approved mAbs and antibodies in review available at at mAbs ofand available in antibodies approved review Tables 1997 98 99 2000 01 02 03 Year of first US or EU approval or EU US of first Year 04 05 06 https://www.antibodysociety.org/resources/approved 07 08 09 10 11 12 13 14 15 Non-cancer Cancer 16 - antibodies/ 17 ycl 18 e. 19 2020* First approvals US or EU in 2020 • Teprotumumab (Tepezza): anti-IGF-1R mAb for thyroid eye disease • FDA approved on January 21 • Eptinezumab (Vyepti): anti-CGRP IgG1 for migraine prevention • FDA approved on February 21 • Isatuximab (Sarclisa): anti-CD38 IgG1 for multiple myeloma • FDA approved on March 2, also approved in the EU on June 2 • Sacituzumab govitecan (Trodelvy): anti-TROP-2 ADC for triple-neg. -
2020 Health for Humanity Report
2020 Health for Humanity Report Progress in Sustainability Contents | Message from Our CEO | Our Approach | United in Defeating COVID-19 | Better Health for All | Responsible Business Practices | Reporting Hub Contents Message from Our Chairman and CEO 3 2020 Year in Brief 4 Our Recognitions 5 Our Approach 6 Health for Humanity Strategy & Goals 9 Sustainability Governance 13 Sustainability Priorities 14 United in Defeating COVID-19 15 Caring for Patients 17 Supporting the Front Lines of Care 24 Protecting Employees 25 Supply Chain Resilience 28 Better Health for All 30 Innovation 31 Global Public Health Strategy 35 Access & Affordability 45 Strengthening Health Systems 48 Responsible Business Practices 52 Ethics & Values 53 Our People 60 Product Quality & Safety 74 Environmental Health 79 Responsible Supply Base 90 ABOVE: During the COVID-19 pandemic, Report overview community healthcare workers in Peru Reporting Hub 98 This Report details the progress of the Johnson & Johnson Family traveled door-to-door to reach children with ESG Summary 98 of Companies in sustainability. It is also our primary source of VERMOX Chewable tablets for treatment of Performance Data 98 annual disclosure on environmental, social and governance intestinal worms. The medicine is donated GRI Content Index 98 (ESG) performance and should be reviewed in conjunction by Johnson & Johnson and implemented GRI Culture of Health for Business Framework 98 with disclosures on the ESG Policies & Positions page. Data by INMED Partnerships for Children. SASB Index 98 in this Report cover the period between January 1, 2020, and Photo by INMED Partnerships for Children. TCFD 98 December 31, 2020, unless otherwise noted. -
2020 Hospital Regulatory Update
2020 Hospital Regulatory Update BY TERI BEDARD, BA, RT(R)(T), CPC he Hospital Outpatient Prospective finalized CF. To determine this payment rate, ASCs to be approximately $4.96 billion, an Payment System (OPPS) is one of the CMS utilized data released in the inpatient increase of approximately $230 million from T Medicare payment systems that prospective payment system (IPPS) final rule CY 2019 payments. applies to facility-based settings, which for FY 2020, which had a 3 percent increase CMS finalized to continue applying a wage include, hospitals, ambulatory surgical for inpatient services, slightly lower than index of 1.000 for frontier state hospitals centers (ASCs), critical access hospitals proposed, and minus 0.4 percent for the (Montana, Wyoming, North Dakota, South (CAHs) and excepted off-campus provid- multifactor productivity (MFP) adjustment. Dakota, and Nevada), this policy has been in er-based departments. As indicated in the CY Due to wage index changes, a budget place since CY 2011. This ensures that lower 2019 OPPS final rule, the overarching goal of neutrality factor of 0.9981 was also applied population states are not “penalized” for the Centers for Medicare & Medicaid Services for CY 2020. reimbursement due to the low number of (CMS) is “to make payments for all services CMS is maintaining the rural adjustment people per square mile when compared to under the OPPS more consistent with those of factor of 7.1 percent to OPPS payments to other states. CMS also finalized for CY 2020 a prospective payment system and less like certain rural sole community hospitals to continue additional payments to cancer those of a per-service fee schedule, which pays (SCHs), including essential access commu- hospitals. -
Changes in Serum Micrornas After Anti-IL-5 Biological Treatment of Severe Asthma
International Journal of Molecular Sciences Article Changes in Serum MicroRNAs after Anti-IL-5 Biological Treatment of Severe Asthma Manuel J. Rial 1,2, José A. Cañas 2,3 , José M. Rodrigo-Muñoz 2,3 , Marcela Valverde-Monge 1 , Beatriz Sastre 2,3 , Joaquín Sastre 1,3 and Victoria del Pozo 2,3,* 1 Allergy Unit, Hospital Universitario Fundación Jiménez Díaz, 28040 Madrid, Spain; [email protected] (M.J.R.); [email protected] (M.V.-M.); [email protected] (J.S.) 2 Department of Immunology, IIS-Fundación Jiménez Díaz, 28040 Madrid, Spain; [email protected] (J.A.C.); [email protected] (J.M.R.-M.); [email protected] (B.S.) 3 CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, 28029 Madrid, Spain * Correspondence: [email protected]; Tel.: +34-9155-048-91 Abstract: There is currently enough evidence to think that miRNAs play a role in several key points in asthma, including diagnosis, severity of the disease, and response to treatment. Cells release different types of lipid double-membrane vesicles into the extracellular microenvironment, including exosomes, which function as very important elements in intercellular communication. They are capable of distributing genetic material, mRNA, mitochondrial DNA, and microRNAs (miRNAs). Serum miRNA screening was performed in order to analyze possible changes in serum miRNAs in 10 patients treated with reslizumab and 6 patients with mepolizumab after 8 weeks of treatment. The expression of miR-338-3p was altered after treatment (p < 0.05), although no significant differences between reslizumab and mepolizumab were found. Bioinformatic analysis showed that miR-338-3p regulates important pathways in asthma, such as the MAPK and TGF-β signaling pathways and the Citation: Rial, M.J.; Cañas, J.A.; biosynthesis/degradation of glucans (p < 0.05).