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July 2019 New Drugs
July 2019 Learn more New drugs Drug name Therapeutic category Indication(s) Launch information Manufacturer(s) AirDuo® Digihaler™ Treatment of asthma in patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately (fluticasone Corticosteroid/ long-acting beta controlled on a long term asthma control medication such as TBD propionate/salmeterol) agonist (LABA) an inhaled corticosteroid or whose disease warrants initiation Teva of treatment with both an inhaled corticosteroid and LABA Accrufer® (ferric maltol) Iron replacement Treatment of iron deficiency in adults TBD Shield Therapeutics ® Anticoagulant in patients undergoing percutaneous coronary Angiomax RTU (bivalrudin) intervention, including patients with heparin-induced Direct thrombin inhibitor TBD MAIA Pharmaceuticals thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome Baqsimi™ (glucagon) Treatment of severe hypoglycemia in patients with diabetes nasal powder Glucagon analog July 28, 2019 ages 4 years and above Eli Lilly Cuvitru (immune globulin subcutaneous [human], 20% Replacement therapy for primary humoral immunodeficiency solution) 10 mg/50 mL Immunoglobulin July 2, 2019 subcutaneous injection in adult and pediatric patients two years of age and older Baxalta 1 RxHighlights July 2019 Drug name Therapeutic category Indication(s) Launch information Manufacturer(s) Drizalma Sprinkle™ (duloxetine) Treatment of major depressive disorder in adults; generalized Serotonin and norepinephrine anxiety disorder in adults and pediatric -
Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer
The new england journal of medicine Original Article Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer Karim Fizazi, M.D., Neal Shore, M.D., Teuvo L. Tammela, M.D., Ph.D., Albertas Ulys, M.D., Egils Vjaters, M.D., Sergey Polyakov, M.D., Mindaugas Jievaltas, M.D., Murilo Luz, M.D., Boris Alekseev, M.D., Iris Kuss, M.D., Christian Kappeler, Ph.D., Amir Snapir, M.D., Ph.D., Toni Sarapohja, M.Sc., and Matthew R. Smith, M.D., Ph.D., for the ARAMIS Investigators* ABSTRACT BACKGROUND Darolutamide is a structurally unique androgen-receptor antagonist that is under de- From Institut Gustave Roussy, Université velopment for the treatment of prostate cancer. We evaluated the efficacy of darolu- Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, tamide for delaying metastasis and death in men with nonmetastatic, castration- SC (N.S.); Tampere University Hospital resistant prostate cancer. and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, METHODS Espoo (A.S., T.S.) — all in Finland; Na- tional Cancer Institute, Vilnius (A.U.), We conducted a randomized, double-blind, placebo-controlled, phase 3 trial involving and Medical Academy, Lithuanian Uni- men with nonmetastatic, castration-resistant prostate cancer and a prostate-specific versity of Health Sciences, Kaunas (M.J.) antigen doubling time of 10 months or less. Patients were randomly assigned in a 2:1 — both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); ratio to receive darolutamide (600 mg [two 300-mg tablets] twice daily) or placebo N.N. Alexandrov National Cancer Center while continuing androgen-deprivation therapy. -
Product Monograph Crestor
PRODUCT MONOGRAPH Pr CRESTOR® rosuvastatin calcium Tablets, 5, 10, 20 and 40 mg LIPID METABOLISM REGULATOR AstraZeneca Canada Inc. Date of Revision: May 14, 2020 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca Control No: 235939 CRESTOR® is a registered trademark of the AstraZeneca group of companies. Licensed from Shionogi & Co. Ltd. Osaka, Japan. COPYRIGHT 2003 – 2020 ASTRAZENECA CANADA INC. Page 1 of 46 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION......................................................3 SUMMARY PRODUCT INFORMATION ..............................................................3 INDICATIONS AND CLINICAL USE....................................................................3 CONTRAINDICATIONS ........................................................................................4 WARNINGS AND PRECAUTIONS .......................................................................5 ADVERSE REACTIONS ...................................................................................... 10 DRUG INTERACTIONS....................................................................................... 16 DOSAGE AND ADMINISTRATION.................................................................... 22 OVERDOSAGE..................................................................................................... 25 ACTION AND CLINICAL PHARMACOLOGY................................................... 25 STORAGE AND STABILITY............................................................................... 27 DOSAGE -
Driving Performance and Delivering New Growth Opportunities
Driving Performance and Delivering New Growth Opportunities /////////// Capital Markets Day London, December 5, 2018 Stefan Oelrich Head of Pharmaceuticals Joerg Moeller Head of Pharmaceuticals R&D Disclaimer Cautionary Statements Regarding Forward-Looking Information This presentation contains forward-looking statements. A forward-looking statement is any statement that does not relate to historical facts and events, but rather reflects Bayer’s current beliefs, expectations and assumptions regarding the future. This applies, in particular, to statements in this presentation on revenue growth, including product introductions and peak sales potential, synergies, especially in relation to the acquisition and integration of Monsanto Company, portfolio adjustments, cost reduction, financial targets and earnings, cash flow generation, deleveraging and other similar statements relating to future performance, including with respect to the markets in which Bayer is active. Although the forward-looking statements contained in this presentation are based upon what Bayer’s management believes are reasonable assumptions, they necessarily involve known and unknown risks and uncertainties that could cause actual results and future events to differ materially from those anticipated in such statements. Forward- looking statements are not guarantees of future performance and undue reliance should not be placed on them. Bayer undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. For more information on factors that could cause actual results and future events to differ from those anticipated in forward looking statements, please refer to the factors discussed in Bayer’s public reports which are available on the Bayer website at https://www.investor.bayer.com/en/reports/annual-reports/overview/, including in the Annual Report 2017 under the caption “Report on Future Perspectives and on Opportunities and Risks”. -
Androgen Receptor Targeted Agents for Castration Resistant Prostate Cancer: a Review of Clinical Effectiveness and Cost- Effectiveness
CADTH RAPID RESPONSE REPORT: SUMMARY WITH CRITICAL APPRAISAL Androgen Receptor Targeted Agents for Castration Resistant Prostate Cancer: A Review of Clinical Effectiveness and Cost- Effectiveness Service Line: Rapid Response Service Version: 1.0 Publication Date: June 6, 2019 Report Length: 30 Pages Authors: Khai Tran, Suzanne McCormack Cite As: Androgen Receptor Targeted Agents for Castration Resistant Prostate Cancer: A Review of Clinical Effectiveness and Cost-Effectiveness. Ottawa: CADTH; 2019 Jun. (CADTH rapid response report: summary with critical appraisal). ISSN: 1922-8147 (online) Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. -
Multi-Discipline Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 212099Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA 212099 Multi-disciplinary Review and Evaluation Darolutamide/NUBEQA NDA/BLA Multi-Disciplinary Review and Evaluation Application Type NDA Application Number(s) 212099 Priority or Standard Priority Submit Date(s) February 26, 2019 Received Date(s) February 26. 2019 PDUFA Goal Date August 26, 2019 Division/Office Division of Oncology Products 1/Office of Hematology & Oncology Products Review Completion Date Established/Proper Name Darolutamide (Proposed) Trade Name Nubeqa Pharmacologic Class Androgen receptor inhibitor Code name 427492003 | Hormone refractory prostate cancer (disorder) Applicant Bayer Doseage form 300 mg tablets Applicant proposed Dosing NUBEQA 600 mg, (two 300 mg tablets) administered orally Regimen twice daily. Swallow tablets whole. Take NUBEQA with food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Applicant Proposed NUBEQA is an androgen receptor inhibitor indicated for the Indication(s)/Population(s) treatment of patients with non-metastatic castration-resistant prostate cancer. Applicant Proposed Non-metastatic castration resistant prostate cancer (nmCRPC) SNOMED CT Indication Disease Term for each Proposed Indication Recommendation on Regular approval Regulatory Action Recommended -
CHMP Agenda of the 11-14 November 2019 Meeting
11 November 2019 EMA/CHMP/606044/2019 Inspections, Human Medicines Pharmacovigilance and Committees Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 11-14 November 2019 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 11 November 2019, 13:00 – 19:30, room 1C 12 November 2019, 08:30 – 19:30, room 1C 13 November 2019, 08:30 – 19:30, room 1C 14 November 2019, 08:30 – 16:00, room 1C Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on-going procedures for which a final decision has not yet been adopted. -
February 13–15, 2020 Moscone West Building | San Francisco, California
gucasym.org #GU20 IN PURSUIT OF PATIENT-CENTERED CARE PROCEEDINGS FEBRUARY 13–15, 2020 MOSCONE WEST BUILDING | SAN FRANCISCO, CALIFORNIA COSPONSORED BY 2020 Genitourinary Cancers Symposium Proceedings Guide to Abstracts Penile Cancer 1 Prostate Cancer—Advanced 3 Prostate Cancer—Localized 69 Testicular Cancer 96 Urethral Cancer 106 Urothelial Carcinoma 109 Renal Cell Cancer 151 The abstracts contained within are published as an online supplement to Journal of Clinical Oncology (JCO) and carry JCO citations. The format for citation of abstracts is as follows: J Clin Oncol 38, 2020 (suppl 6; abstr 1). Editor: Michael A. Carducci, MD The 2020 Genitourinary Cancers Symposium Proceedings (ISBN 978-0-9996799-9-9) is published by the American Society of Clinical Oncology. Requests for permission to reprint abstracts should be directed to [email protected]. Editorial correspondence should be directed to [email protected]. Copyright © 2020 American Society of Clinical Oncology. All rights reserved. No part of this publication may be reproduced or transmitted in any form orby any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without written permission by the Society. The abstracts contained within are copyrighted to Journal of Clinical Oncology and are reprinted within the Proceedings with Permissions. The American Society of Clinical Oncology assumes no responsibility for errors or omissions in this publication. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration or administration, or contraindications. It is the responsibility of the treating physician or other health care professional, relying on independent experience and knowledge of the patient, to determine drug, disease, and the best treatment for the patient. -
Bayer AG Stock Exchange: Frankfurt Stock Exchange • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 103,824
Access to Medicine Index 2021 – Company report cards BAY RANK SCORE . Bayer AG Stock Exchange: Frankfurt Stock Exchange • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 103,824 PERFORMANCE IN THE 2021 INDEX How score was achieved 13th place. Bayer has an average performance. It delivers a Governance of Access 3.55 strong approach to filing its new products for registration, Research & Development 1.01 but has a small-sized R&D priority pipeline and no structured process for access planning. Its approach to governance and Product Delivery 3.03 compliance is average. 0 1 2 3 4 5 Average Leader Governance of Access: 8th place. Bayer has an average per- formance in this area. It implements an access-to-medicine strategy with a business rationale and discloses outcomes of some of its access-to-medicine activities. The company has some compliance controls in place, but lacks evidence of a continuous system to monitor compliance across its activities. Product Delivery: 11th place. Bayer has an average perfor- mance in this area. It has filed to register the majority of Research & Development: 17th place. Bayer falls to the lower its new products in the majority of high-burden countries. ranks in R&D. The company features a small-sized R&D prior- The company has access strategies for some of its products ity pipeline compared to peers and does not have a structured and for some countries in scope and is able to provide evi- process to develop access plans during R&D. A few of its late- dence of how patient reach has been increased through the stage R&D projects are covered by access plans . -
Genomic Pro Ling in Ctdna Revealing Complicated Resistance
Genomic Proling in ctDNA Revealing Complicated Resistance Mechanism of Olaparib and Abiraterone as Salvage Therapy in Prostate Cancer: A Case Report Fang Yuan Chongqing University Nan Liu Chongqing University Hong Luo Chongqing University XiaoTian Zhang BGI MingZhen Yang Army Medical University Hong Zhou ( [email protected] ) Chongqing University https://orcid.org/0000-0003-2526-8153 Case Report Keywords: mCRPC, Olaparib, PALB2 Posted Date: July 9th, 2020 DOI: https://doi.org/10.21203/rs.3.rs-38627/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/12 Abstract Background: PARP inhibitor, e.g. Olaparib, displayed superior clinical effect in metastatic castration prostate cancer (mCRPC) patients with deleterious mutations of DNA damage repair genes (DDR) as reported recently. Besides, for mCRPC patients without DDR alterations, a combination of Olaparib and abiraterone may achieve an acceptable clinical outcome as indicated by researches. However, these previous clinical studies involved patients strictly following inclusion criteria. In real-world situations, where the situation of patients is more complicated, the ecacy of salvage treatment of Olaparib with or without abiraterone-prednisone remains to be unclear. Case presentation: The present case displayed a 61-year-old man who was initially diagnosed with metastatic hormone-sensitive prostate cancer(mHSPC) and proceeding into mCRPC after several kinds of standard therapies. Surprisingly, the patient had a well TPSA response and remission of symptoms for four months by taking Olaparib combined with abiraterone-prednisone, basing on androgen-deprivation therapy (ADT). The resistance of Olaparib was occurred with slowly increasing serum TPSA level again. -
OUH Formulary Approved for Use in Breast Surgery
Oxford University Hospitals NHS Foundation Trust Formulary FORMULARY (Y): the medicine can be used as per its licence. RESTRICTED FORMULARY (R): the medicine can be used as per the agreed restriction. NON-FORMULARY (NF): the medicine is not on the formulary and should not be used unless exceptional approval has been obtained from MMTC. UNLICENSED MEDICINE – RESTRICTED FORMULARY (UNR): the medicine is unlicensed and can be used as per the agreed restriction. SPECIAL MEDICINE – RESTRICTED FORMULARY (SR): the medicine is a “special” (unlicensed) and can be used as per the agreed restriction. EXTEMPORANEOUS PREPARATION – RESTRICTED FORMULARY (EXTR): the extemporaneous preparation (unlicensed) can be prepared and used as per the agreed restriction. UNLICENSED MEDICINE – NON-FORMULARY (UNNF): the medicine is unlicensed and is not on the formulary. It should not be used unless exceptional approval has been obtained from MMTC. SPECIAL MEDICINE – NON-FORMULARY (SNF): the medicine is a “special” (unlicensed) and is not on the formulary. It should not be used unless exceptional approval has been obtained from MMTC. EXTEMPORANEOUS PREPARATION – NON-FORMULARY (EXTNF): the extemporaneous preparation (unlicensed) cannot be prepared and used unless exceptional approval has been obtained from MMTC. CLINICAL TRIALS (C): the medicine is clinical trial material and is not for clinical use. NICE TECHNOLOGY APPRAISAL (NICETA): the medicine has received a positive appraisal from NICE. It will be available on the formulary from the day the Technology Appraisal is published. Prescribers who wish to treat patients who meet NICE criteria, will have access to these medicines from this date. However, these medicines will not be part of routine practice until a NICE TA Implementation Plan has been presented and approved by MMTC (when the drug will be given a Restricted formulary status). -
Orange Book Cumulative Supplement 08 August 2019
CUMULATIVE SUPPLEMENT 8 AUGUST 2019 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 39th EDITION Department of Health and Human Services Food and Drug Administration Office of Medical Products and Tobacco Center for Drug Evaluation and Research Office of Generic Drugs Office of Generic Drug Policy 2019 Prepared By Food and Drug Administration Office of Medical Products and Tobacco Center for Drug Evaluation and Research Office of Generic Drugs Office of Generic Drug Policy APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 39th EDITION Cumulative Supplement 8 August 2019 CONTENTS PAGE 1.0 INTRODUCTION ......................................................................................................................................... v 1.1 How to use the Cumulative Supplement ............................................................................................ v 1.2 Cumulative Supplement Content ...................................................................................................... vi 1.3 Applicant Name Changes ................................................................................................................ vii 1.4 Levothyroxine Sodium....................................................................................................................... ix 1.5 Availability of the Edition .................................................................................................................... x 1.6 Report of Counts for the Prescription Drug Product List ..................................................................