Journal of Managed Care & Specialty Pharmacy®
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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 -
Pertuzumab and Trastuzumab: the Rationale Way to Synergy
Anais da Academia Brasileira de Ciências (2016) 88(1 Suppl.): 565-577 (Annals of the Brazilian Academy of Sciences) Printed version ISSN 0001-3765 / Online version ISSN 1678-2690 http://dx.doi.org/10.1590/0001-3765201620150178 www.scielo.br/aabc Pertuzumab and trastuzumab: the rationale way to synergy SANDRINE RICHARD1, FRÉDÉRIC SELLE1, JEAN-PIERRE LOTZ1,2, AHMED KHALIL1, JOSEPH GLIGOROV1,2 and DANIELE G. SOARES1 1Medical Oncology Department, APREC (Alliance Pour la Recherche En Cancérologie), Tenon Hospital (Hôpitaux Universitaires de l’Est-Parisien, AP-HP), rue de la Chine, 75020 Paris, France 2Institut Universitaire de Cancérologie Université Pierre et Marie Curie (IUC-UPMC Univ Paris 06), Sorbonne Universités, 4 place Jussieu, 75005 Paris, France Manuscript received on March 13, 2015; accepted for publication on May 5, 2015 ABSTRACT It has now been 15 years since the HER2-targeted monoclonal antibody trastuzumab was introduced in clinical and revolutionized the treatment of HER2-positive breast cancer patients. Despite this achievement, most patients with HER2-positive metastatic breast cancer still show progression of their disease, highlighting the need for new therapies. The continuous interest in novel targeted agents led to the development of pertuzumab, the first in a new class of agents, the HER dimerization inhibitors. Pertuzumab is a novel recombinant humanized antibody directed against extracellular domain II of HER2 protein that is required for the heterodimerization of HER2 with other HER receptors, leading to the activation of downstream signalling pathways. Pertuzumab combined with trastuzumab plus docetaxel was approved for the first-line treatment of patients with HER2-positive metastatic breast cancer and is currently used as a standard of care in this indication. -
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 -
Pharmacy Prior Authorization Criteria
Central California Alliance for Health Pharmacy Prior Authorization Criteria March 2020 Notice of Nondiscrimination and Accessibility Discrimination is Against the Law Central California Alliance for Health (the Alliance) complies with Federal civil rights and nondiscrimination laws to make sure all members have access to its programs and services. This means that the Alliance does not exclude or treat members differently because of race, color, national origin, age, disability, or sex. The Alliance provides services, at no cost, to help members communicate with us. • Members with a disability can ask for: ○ A trained sign language interpreter, and ○ Written information in large print, audio, easy to use electronic formats and other formats. • Members whose primary language is not English can ask for: ○ A trained language interpreter, and ○ Information written in a language they can understand. If you need these services, contact the Alliance Member Services Department at 1-800-700-3874 or if you believe that the Alliance did not provide these services or treated you differently because of race, color, national origin, age, disability, or sex, you can file a grievance in any of these ways: Phone: 1-800-700-3874 ext. 5816 Website: https://www.ccah-alliance.org/Complaints.html Fax: 1-831-430-5579 Email: [email protected] Mail: Grievance Department 1600 Green Hills Road, Suite 101 Scotts Valley, CA 95066 If you need help filing a grievance, our Member Service Representatives and Grievance Coordinators can help you. Contact the Alliance Member Services Department at 1-800-700-3874 or Grievance Department at 1-800-700-3874, ext. -
WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT (51) International Patent Classification: (71) Applicant: JUNO THERAPEUTICS, INC. [US/US]; 400 A 61K 35/1 7 (20 15.0 1) A 61P 35/00 (2006 .0 1) Dexter Ave. N., Suite 1200, Seattle, WA 98109 (US). (21) International Application Number: (72) Inventor: ALBERTSON, Tina; 400 Dexter Ave. N., Suite PCT/US2018/035755 1200, Seattle, WA 98109 (US). (22) International Filing Date: (74) Agent: AHN, Sejin et al; Morrison & Foerster LLP, 1253 1 0 1 June 2018 (01 .06.2018) High Bluff Drive, Suite 100, San Diego, CA 92130-2040 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/5 14,774 02 June 2017 (02.06.2017) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/5 15,530 05 June 2017 (05.06.2017) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/521,366 16 June 2017 (16.06.2017) u s HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/527,000 29 June 2017 (29.06.2017) u s KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 62/549,938 24 August 2017 (24.08.2017) u s MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/580,425 0 1 November 2017 (01 .11.2017) u s OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 62/593,871 0 1 December 2017 (01 .12.2017) u s SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/596,764 08 December 2017 (08.12.2017) u s TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
Pharmacokinetics and Exposure-Response Relationship of Teprotumumab Frst 3 Months, Unless Determined to Be Medically Necessary
Clinical Pharmacokinetics https://doi.org/10.1007/s40262-021-01003-3 ORIGINAL RESEARCH ARTICLE Pharmacokinetics and Exposure‑Response Relationship of Teprotumumab, an Insulin‑Like Growth Factor‑1 Receptor‑Blocking Antibody, in Thyroid Eye Disease Yan Xin1 · Fengyan Xu2 · Yuying Gao2 · Nivedita Bhatt1 · Jason Chamberlain1 · Saba Sile1 · Suzy Hammel1 · Robert J. Holt1 · Srini Ramanathan1 Accepted: 10 February 2021 © The Author(s) 2021 Abstract Background and Objective Thyroid eye disease (TED) is characterized by infammation/expansion of orbital tissues, prop- tosis, and diplopia. Teprotumumab is the frst US Food and Drug Administration-approved therapy for TED, administered as an initial intravenous infusion of 10 mg/kg followed by 20 mg/kg every 3 weeks for an additional seven infusions. The objec- tive of this article is to discuss the pharmacokinetics and exposure-response profle for teprotumumab in patients with TED. Methods A population pharmacokinetic analysis was performed to characterize pharmacokinetics and select dosing in patients with TED. Exposure-response was evaluated for efcacy (proptosis response, clinical activity score categorical response, and diplopia response) and safety (hyperglycemia, muscle spasms, and hearing impairment) parameters. Results Teprotumumab pharmacokinetics was linear in patients with TED, with low systemic clearance (0.334 L/day), low volume of distribution (3.9 and 4.2 L for the central and peripheral compartment, respectively), and a long elimination half- life (19.9 days). The approved dosing regimen provided > 20 µg/mL for > 90% insulin-like growth factor 1 receptor saturation throughout the dosing interval. Model-predicted mean (± standard deviation) steady-state area under the concentration-time curve, peak, and trough concentrations in patients with TED were 131 (± 30.9) mg∙h/mL, 643 (± 130) µg/mL, and 157 (± 50.6) µg/mL, respectively. -
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 -
Refractory Early T-Cell Precursor Acute Lymphoblastic Leukemia
Zurich Open Repository and Archive University of Zurich Main Library Strickhofstrasse 39 CH-8057 Zurich www.zora.uzh.ch Year: 2019 Venetoclax and Bortezomib in Relapsed/Refractory Early T-Cell Precursor Acute Lymphoblastic Leukemia La Starza, Roberta ; Cambò, Benedetta ; Pierini, Antonio ; Bornhauser, Beat ; Montanaro, Anna ; Bourquin, Jean-Pierre ; Mecucci, Cristina ; Roti, Giovanni DOI: https://doi.org/10.1200/PO.19.00172 Posted at the Zurich Open Repository and Archive, University of Zurich ZORA URL: https://doi.org/10.5167/uzh-198023 Journal Article Published Version The following work is licensed under a Creative Commons: Attribution 4.0 International (CC BY 4.0) License. Originally published at: La Starza, Roberta; Cambò, Benedetta; Pierini, Antonio; Bornhauser, Beat; Montanaro, Anna; Bourquin, Jean-Pierre; Mecucci, Cristina; Roti, Giovanni (2019). Venetoclax and Bortezomib in Relapsed/Refrac- tory Early T-Cell Precursor Acute Lymphoblastic Leukemia. JCO precision oncology, 3:PO.19.00172. DOI: https://doi.org/10.1200/PO.19.00172 case report Venetoclax and Bortezomib in Relapsed/ Refractory Early T-Cell Precursor Acute Lymphoblastic Leukemia Roberta La Starza, MD, PhD1; Benedetta Cambo,` MD2; Antonio Pierini, MD, PhD1; Beat Bornhauser, PhD3; Anna Montanaro2; Jean-Pierre Bourquin, MD, PhD3; Cristina Mecucci, MD, PhD1; and Giovanni Roti, MD, PhD2 INTRODUCTION CD2, CD4, CD8, and CD1a and positive for human Although in the past three decades we welcomed the leukocyte antigen (HLA-DR), CD38, CD117, CD33, advent of targeted therapies in -
DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
Press Release
Press Release Daiichi Sankyo and AstraZeneca Announce Global Development and Commercialization Collaboration for Daiichi Sankyo’s HER2 Targeting Antibody Drug Conjugate [Fam-] Trastuzumab Deruxtecan (DS-8201) Collaboration combines Daiichi Sankyo’s scientific and technological excellence with AstraZeneca’s global experience and resources in oncology to accelerate and expand the potential of [fam-] trastuzumab deruxtecan as monotherapy and combination therapy across a spectrum of HER2 expressing cancers AstraZeneca to pay Daiichi Sankyo up to $6.90 billion in total consideration, including $1.35 billion upfront payment and up to an additional $5.55 billion contingent upon achievement of future regulatory and sales milestones as well as other contingencies Companies to share equally development and commercialization costs as well as profits worldwide from [fam-] trastuzumab deruxtecan with Daiichi Sankyo maintaining exclusive rights in Japan Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates; AstraZeneca is expected to book sales in all other markets worldwide, including China, Australia, Canada and Russia Tokyo, Munich and Basking Ridge, NJ – (March 28, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into a global development and commercialization agreement with AstraZeneca for Daiichi Sankyo’s lead antibody drug conjugate (ADC), [fam-] trastuzumab deruxtecan (DS-8201), currently in pivotal development for multiple HER2 expressing cancers including breast and gastric cancer, and additional development in non-small cell lung and colorectal cancer. Daiichi Sankyo and AstraZeneca will jointly develop and commercialize [fam-] trastuzumab deruxtecan as a monotherapy or a combination therapy worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. -
Eros, Storge, Phileo, and Agape
Eros, Storge, Phileo, and Agape INTRODUCTION II. Storge Love is ambiguous in the English language. A. This is natural affection—family, kin, the There is “Strawberry Shortcake Love.” We love humblest of loves. We love each other simply cats, dogs, and ice cream. This is trite and with- because we are of the family. B. It is negative in Romans 1:31 and 2 Timothy out depth or permanence. There is “Aunt Minnie 3:3, used regarding homosexuals. Love” which is reserved for “special” people C. It is used in withdrawal in 2 Timothy 3:14, 15. who are sweet and lovable. Sometimes it is con- Withdrawal is not excommunication, put- descending. There is “Bowling Team Love” for ting one out of the church. It is what it says, “buddies” in a reciprocal way. Moderns do not withdrawal of fellowship. zero in on “Tough Love.” So there is a Greek word study. However, the III. Phileo Bible is not learned in a seminary; it is learned A. This is tender affection and brotherly love. out on the street with people in local work. (Philadelphia is the city of “brotherly love.”) Footnotes will not preach. Also, the Bible must B. However, sometimes we make too clear a not be reduced to word studies. You can get so distinction between phileo and agape. Be care- ful. There are surprises. Read Titus 2:3, 4; far out on a limb looking at a leaf you forget the Romans 12:9, 10; 1 Corinthians 16:22; He- tree. Word studies can be helpful, but they can brews 13:1; John 16:27; and 1 Peter 1:22. -
Fam-Trastuzumab Deruxtecan-Nxki Submitted by Daiichi
Dan Liang, PharmD Associate Director, Medical Information & Education Daiichi Sankyo, Inc. 211 Mount Airy Road Basking Ridge, NJ 07920 Phone: 908-992-7054 Email: [email protected] Date of request: July 9, 2020 NCCN Panel: Colon Cancer and Rectal Cancer On behalf of Daiichi Sankyo, Inc. and AstraZeneca Pharmaceuticals LP, I respectfully request the NCCN Guideline Panel for Colon and Rectal Cancers to review data from the clinical study1 in support of fam-trastuzumab deruxtecan-nxki, also known as T-DXd, as a monotherapy option for the treatment of patients with HER2-positive unresectable and/or metastatic colorectal cancer. Specific Changes: We respectfully ask the NCCN panel to consider the following: • COL-D1 through COL-D6 and REC-F1 through REC-F6, “Continuum of Care - Systemic Therapy for Advanced or Metastatic Disease” o Add “Fam-trastuzumab deruxtecan-nxki (HER2-positive and RAS and BRAF WT)” to the following: . COL-D1 and REC-F1: “Patient not appropriate for intensive therapy” . COL-D2 and REC-F2: “Previous oxaliplatin-based therapy without irinotecan” . COL-D3 and REC-F3: “Previous irinotecan-based therapy without oxaliplatin” . COL-D4 and REC-F4: “Previous treatment with oxaliplatin and irinotecan” . COL-D5 and REC-F5: “Previous therapy without irinotecan or oxaliplatin” . COL-D6 and REC-F6: “FOLFOX or CAPEOX or (FOLFOX or CAPEOX) + bevacizumab” • COL-D11 and REC-F11, “Systemic Therapy for Advanced or Metastatic Disease – Chemotherapy Regimens” o Add “Fam-trastuzumab deruxtecan-nxki 6.4 mg/kg IV on Day 1, cycled every 21 days” with a footnote: “fam-trastuzumab deruxtecan-nxki is approved for metastatic HER2-positive breast cancer at a different dose of 5.4 mg/kg IV on Day 1, cycled every 21 days” FDA Clearance: ENHERTU (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.