TAG Mail – 17 Dec 2020
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Stanford Chem-H Presentation (PDF)
KiNativ® In situ kinase profiling Stanford University ChEM-H confidential @KiNativPlatform Principle of the KiNativ platform • ATP (or ADP) acyl phosphate binds to, and covalently modifies Lysine residues in the active site • Thus, ATP acyl phosphate with a desthiobiotin tag can be used capture and quantitate kinases in a complex lysate Acyl phosphate Desthiobiotin tag ATP 2 ATP acyl phosphate probe covalently modifies kinase in the active site Lysine 2 Lysine 1 3 ATP acyl phosphate probe covalently modifies kinase in the active site Lysine 2 Lysine 1 4 Samples trypsinized, probe-labeled peptides captured with streptavidin, and analyzed by targeted LC-MS2 Identification Quantitation Explicit determination of peptide Integration of signal from MS2 sequence and probe modification site fragment ions from MS2 spectrum 5 Comprehensive Coverage of Protein and Lipid Kinases Protein kinases Atypical kinases Green: Kinases detected on KiNativ Red: Kinases not detected on KiNativ ~80% of known protein and atypical kinases identified on the platform http://www.kinativ.com/coverage/protein-lipid.html 6 Profiling compound(s) on the KiNativ platform Control sample – add probe Sample: Lysate derived from any cell line or tissue from ANY species Treated sample – add inhibitor followed by probe Inhibited kinase Green: Kinases Blue: Probe Gray: Non-kinases Red: Inhibitor 7 Profiling compound(s) on the KiNativ platform Control sample – add probe MS signalMS Sample: Lysate derived from any cell line or tissue from ANY species Treated sample – add inhibitor -
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 -
PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects
International Journal of Molecular Sciences Review PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects Rosalin Mishra , Hima Patel, Samar Alanazi , Mary Kate Kilroy and Joan T. Garrett * Department of Pharmaceutical Sciences, College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267-0514, USA; [email protected] (R.M.); [email protected] (H.P.); [email protected] (S.A.); [email protected] (M.K.K.) * Correspondence: [email protected]; Tel.: +1-513-558-0741; Fax: +1-513-558-4372 Abstract: The phospatidylinositol-3 kinase (PI3K) pathway is a crucial intracellular signaling pathway which is mutated or amplified in a wide variety of cancers including breast, gastric, ovarian, colorectal, prostate, glioblastoma and endometrial cancers. PI3K signaling plays an important role in cancer cell survival, angiogenesis and metastasis, making it a promising therapeutic target. There are several ongoing and completed clinical trials involving PI3K inhibitors (pan, isoform-specific and dual PI3K/mTOR) with the goal to find efficient PI3K inhibitors that could overcome resistance to current therapies. This review focuses on the current landscape of various PI3K inhibitors either as monotherapy or in combination therapies and the treatment outcomes involved in various phases of clinical trials in different cancer types. There is a discussion of the drug-related toxicities, challenges associated with these PI3K inhibitors and the adverse events leading to treatment failure. In addition, novel PI3K drugs that have potential to be translated in the clinic are highlighted. Keywords: cancer; PIK3CA; resistance; PI3K inhibitors Citation: Mishra, R.; Patel, H.; Alanazi, S.; Kilroy, M.K.; Garrett, J.T. -
European Iron Club 7
EUROPEAN IRON CLUB 7 - 10 MEETING IN April INNSBRUCK 2016 Programme Kein Eisen unter der Oberfläche Novartis Pharma GmbH Stella-Klein-Loew-Weg 17 | 1020 Wien www.novartispharma.at | +43 1 866 57-0 Erstellungsdatum 02/2016 | AT1602436490 CONTENTS Welcome 6 Committees 7 Masterclass in Iron Therapies 8 Thursday, 7 April 2016 European Iron Club Annual Meeting 10 Friday, 8 April 2016 European Iron Club Annual Meeting 20 Saturday, 9 April 2016 Scientific Programme 31 Kein Eisen Sunday, 10 April 2016 Innsbruck city map 34 unter der General Information 35 Exhibitors & Sponsors 40 Oberfläche Drug labels 41 Notes 42 Novartis Pharma GmbH 3 Stella-Klein-Loew-Weg 17 | 1020 Wien www.novartispharma.at | +43 1 866 57-0 Erstellungsdatum 02/2016 | AT1602436490 CONGRESS INFORMATION DATES CONGRESS ORGANISER Masterclass in Iron Therapies PCO TYROL CONGRESS Thursday, 7 April, 2016 MMag. Ina Kähler Mechthild Walter European Iron Club Annual Rennweg 3 Meeting 6020 Innsbruck Friday, 8 April – Saturday, 9 April, Austria 2016 T: +43 (0) 512 575600 F: +43 (0) 512 575607 Non HFE Hemochromatosis E: [email protected] Registry Meeting I: www.pco-tyrolcongress.at Sunday, 10 April, 2016 Meeting of Patient Organisations Sunday, 10 April, 2016 EXHIBITION MANAGEMENT AND SPONSORING VENUE (THU - SAT) S12! STUDIO12 GMBH CONGRESS INNSBRUCK Ralph Kerschbaumer Rennweg 3 Kaiser Josef Straße 9 6020 Innsbruck 6020 Innsbruck Austria Austria www.cmi.at T: +43 (0) 512 890438 F: +43 (0) 512 890438 15 E: [email protected] I: www.studio12.co.at VENUE (SUN) AUSTRIA TREND HOTEL Rennweg 12a -
Emergency Use Authorization (EUA) for Sotrovimab 500 Mg Center for Drug Evaluation and Research (CDER) Review
Emergency Use Authorization (EUA) for Sotrovimab 500 mg Center for Drug Evaluation and Research (CDER) Review Identifying Information Application Type EUA (EUA or Pre-EUA) If EUA, designate whether pre-event or intra-event EUA request. EUA Application EUA 000100 Number(s) Sponsor (entity EUA Sponsor requesting EUA or GlaxoSmithKline Research & Development Limited pre-EUA 980 Great West Road consideration), point Brentford Middlesex, TW8 9GS of contact, address, UK phone number, fax number, email GSK US Point of Contact address Debra H. Lake, M.S. Sr. Director Global Regulatory Affairs GlaxoSmithKline 5 Moore Drive PO Box 13398 Research Triangle Park, NC 27709-3398 (b) (6) Email: Phone Manufacturer, if GlaxoSmithKline, Parma. different from Sponsor Submission Date(s) Part 1: March 24, 2021 Part 2: March 29, 2021 Receipt Date(s) Part 1: March 24, 2021 Part 2: March 29, 2021 OND Division / Office Division of Antivirals /Office of Infectious Disease 1 Reference ID: 4802027 Product in the No Strategic National Stockpile (SNS) Distributor, if other (b) (4) than Sponsor I. EUA Determination/Declaration On February 4, 2020, the Secretary of Health and Human Services determined pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States (US) citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. -
How I Treat Myelofibrosis
From www.bloodjournal.org by guest on October 7, 2014. For personal use only. Prepublished online September 16, 2014; doi:10.1182/blood-2014-07-575373 How I treat myelofibrosis Francisco Cervantes Information about reproducing this article in parts or in its entirety may be found online at: http://www.bloodjournal.org/site/misc/rights.xhtml#repub_requests Information about ordering reprints may be found online at: http://www.bloodjournal.org/site/misc/rights.xhtml#reprints Information about subscriptions and ASH membership may be found online at: http://www.bloodjournal.org/site/subscriptions/index.xhtml Advance online articles have been peer reviewed and accepted for publication but have not yet appeared in the paper journal (edited, typeset versions may be posted when available prior to final publication). Advance online articles are citable and establish publication priority; they are indexed by PubMed from initial publication. Citations to Advance online articles must include digital object identifier (DOIs) and date of initial publication. Blood (print ISSN 0006-4971, online ISSN 1528-0020), is published weekly by the American Society of Hematology, 2021 L St, NW, Suite 900, Washington DC 20036. Copyright 2011 by The American Society of Hematology; all rights reserved. From www.bloodjournal.org by guest on October 7, 2014. For personal use only. Blood First Edition Paper, prepublished online September 16, 2014; DOI 10.1182/blood-2014-07-575373 How I treat myelofibrosis By Francisco Cervantes, MD, PhD, Hematology Department, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain Correspondence: Francisco Cervantes, MD, Hematology Department, Hospital Clínic, Villarroel 170, 08036 Barcelona, Spain. Phone: +34 932275428. -
NG198 Evidence Review E1
1 2 Research recommendations for review question: For people with mild to 3 moderate acne vulgaris what are the most effective treatment options? 4 Research question - physical modalities 5 What is the effectiveness of physical modalities (such as light devices) in the treatment of 6 acne vulgaris or persistent acne vulgaris-related scarring? 7 Why this is important 8 Physical treatments for acne are popular with people because they have the benefit of 9 treating a local area without systemic effects. They can be used in people with co-morbidities 10 or side effects where other treatments are unsuitable. They are currently available in the 11 private sector but there is no standardisation of treatment modalities or duration. Many 12 different physical therapies have been described for acne including: 13 • Comedone extraction 14 • Phototherapy – including UVB, intense pulsed light, blue and red light 15 • Photochemical therapy (e.g. photodynamic therapy) 16 • Laser 17 • Photopneumatic therapy (e.g. intense pulsed light + vacuum) 18 • Photothermal therapy (eg gold nanoparticles +light or laser) 19 Physical treatments are also used for acne scarring. These include: 20 • Punch excision 21 • CO2 laser 22 • Dermabrasion 23 • Radiofrequency (e.g. fractional microneedling, bipolar) 24 Further research is required to determine the most effective physical treatments for acne and 25 acne scarring. This could open the way to wider availability in the NHS. 26 Table 26: Research recommendation rationale Research question What is the effectiveness of physical modalities (such as light devices) in the treatment of acne vulgaris or persistent acne vulgaris-related scarring? Why is this needed Importance to ‘patients’ or the Physical treatments for acne are popular with people because population they have the benefit of treating a local area without systemic effects. -
Mark Taylor; [email protected]; (317) 276-5795 (Media) Kevin Hern; Hern Kevin [email protected]; (317) 277-1838 (Investors)
January 29, 2021 Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 U.S.A. +1.317.276.2000 www.lilly.com For Release: Immediately Refer to: Mark Taylor; [email protected]; (317) 276-5795 (Media) Kevin Hern; [email protected]; (317) 277-1838 (Investors) Lilly Reports Strong Fourth-Quarter and Full-Year 2020 Financial Results • Revenue in the fourth quarter of 2020 increased 22 percent, driven by volume growth of 24 percent. Excluding bamlanivimab revenue of $871 million, fourth-quarter 2020 revenue grew 7 percent. • Full-year 2020 revenue increased 10 percent, driven by volume growth of 15 percent. Excluding bamlanivimab, full-year 2020 revenue grew 6 percent, driven by volume growth of 11 percent. • Key growth products launched since 2014, consisting of Trulicity, Verzenio, Taltz, Tyvyt, Olumiant, Jardiance, Emgality, Cyramza, Retevmo, Baqsimi and Basaglar contributed nearly 12 percentage points of revenue growth and represented approximately 48 percent of total revenue in the fourth quarter of 2020, or 55 percent of total revenue excluding bamlanivimab. • Fourth-quarter 2020 operating expenses increased 3 percent, driven by higher research and development investments, including expenses of $265 million to develop COVID-19 therapies. • Notable pipeline events included Emergency Use Authorizations from the FDA for both bamlanivimab and baricitinib for the treatment of COVID-19, as well as positive data readouts for donanemab for Alzheimer's disease, tirzepatide for type 2 diabetes and LOXO-305 for cancer. • Fourth-quarter 2020 earnings per share (EPS) increased to $2.32 on a reported basis and $2.75 on a non- GAAP basis. Full year 2020 EPS decreased to $6.79 on a reported basis and increased to $7.93 on a non- GAAP basis. -
June 2021 Therapeutic Research Center (TRC) Is the Leading Advisory Service on Drug Therapy and Medication Management
June 2021 Therapeutic Research Center (TRC) is the leading advisory service on drug therapy and medication management. Every month over 400,000 prescribers, pharmacists, and pharmacy technicians rely on our unbiased, evidence-based clinical recommendations to help them improve medication use, prevent medication errors, and improve patient care and outcomes. We also have one of the most extensive CE/CME course offerings in the industry. Our accredited continuing education and continuing medical education courses are trusted and relied on by hundreds of thousands of pharmacists, technicians, and prescribers every month. Therapeutic Research Center does not receive commercial support and does not accept any advertising. It is completely independent and is supported entirely by subscriptions. Credit is reported to CPE Monitor, AAFP, and CE Broker as appropriate. Accreditation Information: Therapeutic Research Center is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing education for physicians. Pharmacist’s Letter / Therapeutic Research Center is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Therapeutic Research Center / Prescriber’s Letter is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number:080517. Select Therapeutic Research Center courses are also acceptable for American Academy of Family Physicians (AAFP) Prescribed credit, American Osteopathic Association (AOA) credit, and American College of Emergency Physicians (ACEP) Category I Credit. Please refer to the detailed accreditation statements available online for each course. Get started at TherapeuticResearchCenter.com. Log in to access your course list or purchase a course or subscription. For additional assistance, please call 209-472-2240 and we’ll be happy to help you. -
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. -
JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors
Drugs https://doi.org/10.1007/s40265-020-01261-8 CURRENT OPINION JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors Miguel Nogueira1 · Luis Puig2 · Tiago Torres1,3 © Springer Nature Switzerland AG 2020 Abstract Despite advances in the treatment of psoriasis, there is an unmet need for efective and safe oral treatments. The Janus Kinase– Signal Transducer and Activator of Transcription (JAK–STAT) pathway plays a signifcant role in intracellular signalling of cytokines of numerous cellular processes, important in both normal and pathological states of immune-mediated infamma- tory diseases. Particularly in psoriasis, where the interleukin (IL)-23/IL-17 axis is currently considered the crucial pathogenic pathway, blocking the JAK–STAT pathway with small molecules would be expected to be clinically efective. However, relative non-specifcity and low therapeutic index of the available JAK inhibitors have delayed their integration into the therapeutic armamentarium of psoriasis. Current research appears to be focused on Tyrosine kinase 2 (TYK2), the frst described member of the JAK family. Data from the Phase II trial of BMS-986165—a selective TYK2 inhibitor—in psoriasis have been published and clinical results are encouraging, with a large Phase III programme ongoing. Further, the selective TYK2 inhibitor PF-06826647 is being tested in moderate-to-severe psoriasis in a Phase II clinical trial. Brepocitinib, a potent TYK2/JAK1 inhibitor, is also being evaluated, as both oral and topical treatment. Results of studies with TYK2 inhibitors will be important in assessing the clinical efcacy and safety of these drugs and their place in the therapeutic armamentarium of psoriasis. -
Phase I Trial of the PARP Inhibitor Olaparib and AKT Inhibitor Capivasertib in Patients with BRCA1/2- and Non–BRCA1/2-Mutant Cancers
Published OnlineFirst June 12, 2020; DOI: 10.1158/2159-8290.CD-20-0163 RESEARCH ARTICLE Phase I Trial of the PARP Inhibitor Olaparib and AKT Inhibitor Capivasertib in Patients with BRCA1/2- and Non–BRCA1/2-Mutant Cancers Timothy A. Yap1,2, Rebecca Kristeleit3, Vasiliki Michalarea1, Stephen J. Pettitt4,5, Joline S.J. Lim1, Suzanne Carreira2, Desamparados Roda1,2, Rowan Miller3, Ruth Riisnaes2, Susana Miranda2, Ines Figueiredo2, Daniel Nava Rodrigues2, Sarah Ward1,2, Ruth Matthews1,2, Mona Parmar1,2, Alison Turner1,2, Nina Tunariu1, Neha Chopra1,4, Heidrun Gevensleben2, Nicholas C. Turner1,4, Ruth Ruddle2, Florence I. Raynaud2, Shaun Decordova2, Karen E. Swales2, Laura Finneran2, Emma Hall2, Paul Rugman6, Justin P.O. Lindemann6, Andrew Foxley6, Christopher J. Lord4,5, Udai Banerji1,2, Ruth Plummer7, Bristi Basu8, Juanita S. Lopez1,2, Yvette Drew7, and Johann S. de Bono1,2 Downloaded from cancerdiscovery.aacrjournals.org on September 30, 2021. © 2020 American Association for Cancer Research. Published OnlineFirst June 12, 2020; DOI: 10.1158/2159-8290.CD-20-0163 ABSTRACT Preclinical studies have demonstrated synergy between PARP and PI3K/AKT path- way inhibitors in BRCA1 and BRCA2 (BRCA1/2)–deficient andBRCA1/2 -proficient tumors. We conducted an investigator-initiated phase I trial utilizing a prospective intrapatient dose- escalation design to assess two schedules of capivasertib (AKT inhibitor) with olaparib (PARP inhibi- tor) in 64 patients with advanced solid tumors. Dose expansions enrolled germline BRCA1/2-mutant tumors, or BRCA1/2 wild-type cancers harboring somatic DNA damage response (DDR) or PI3K–AKT pathway alterations. The combination was well tolerated. Recommended phase II doses for the two schedules were: olaparib 300 mg twice a day with either capivasertib 400 mg twice a day 4 days on, 3 days off, or capivasertib 640 mg twice a day 2 days on, 5 days off.