MM&M Takes a Detailed Look at Key Products in the Pipeline
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A Phase II Study of the Novel Proteasome Inhibitor Bortezomib In
Memorial Sloan-Kettering Cance r Center IRB Protocol IRB#: 05-103 A(14) A Phase II Study of the Novel Proteas ome Inhibitor Bortezomib in Combination with Rituximab, Cyclophosphamide and Prednisone in Patients with Relapsed/Refractory I Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL) MSKCC THERAPEUTIC/DIAGNOSTIC PROTOCOL Principal Investigator: John Gerecitano, M.D., Ph.D. Co-Principal Carol Portlock, M.D. Investigator(s): IFormerly: A Phase I/II Study of the Nove l Proteasome Inhibitor Bortezomib in Combinati on with Rituximab, Cyclophosphamide and Prednisone in Patients with Relapsed/Refractory Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL) Amended: 07/25/12 Memorial Sloan-Kettering Cance r Center IRB Protocol IRB#: 05-103 A(14) Investigator(s): Paul Hamlin, M.D. Commack, NY Steven B. Horwitz, M.D. Philip Schulman, M.D. Alison Moskowitz, M.D. Stuart Lichtman, M.D Craig H. Moskowitz, M.D. Stefan Berger, M.D. Ariela Noy, M.D. Julie Fasano, M.D. M. Lia Palomba, M.D., Ph.D. John Fiore, M.D. Jonathan Schatz, M.D. Steven Sugarman, M.D David Straus, M.D. Frank Y. Tsai, M.D. Andrew D. Zelenetz, M.D., Ph.D. Matthew Matasar, M.D Rockville Center, NY Mark L. Heaney, M.D., Ph.D. Pamela Drullinksy, M.D Nicole Lamanna, M.D. Arlyn Apollo, M.D. Zoe Goldberg, M.D. Radiology Kenneth Ng, M.D. Otilia Dumitrescu, M.D. Tiffany Troso-Sandoval, M.D. Andrei Holodny, M.D. Sleepy Hollow, NY Nuclear Medicine Philip Caron, M.D. Heiko Schoder, M.D. Michelle Boyar, M.D. -
Endothelin System and Therapeutic Application of Endothelin Receptor
xperim ACCESS Freely available online & E en OPEN l ta a l ic P in h l a C r m f o a c l a o n l o r g u y o J Journal of ISSN: 2161-1459 Clinical & Experimental Pharmacology Research Article Endothelin System and Therapeutic Application of Endothelin Receptor Antagonists Abebe Basazn Mekuria, Zemene Demelash Kifle*, Mohammedbrhan Abdelwuhab Department of Pharmacology, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia ABSTRACT Endothelin is a 21 amino acid molecule endogenous potent vasoconstrictor peptide. Endothelin is synthesized in vascular endothelial and smooth muscle cells, as well as in neural, renal, pulmonic, and inflammatory cells. It acts through a seven transmembrane endothelin receptor A (ETA) and endothelin receptor B (ETB) receptors belongs to G protein-coupled rhodopsin-type receptor superfamily. This peptide involved in pathogenesis of cardiovascular disorder like (heart failure, arterial hypertension, myocardial infraction and atherosclerosis), renal failure, pulmonary arterial hypertension and it also involved in pathogenesis of cancer. Potentially endothelin receptor antagonist helps the treatment of the above disorder. Currently, there are a lot of trails both per-clinical and clinical on endothelin antagonist for various cardiovascular, pulmonary and cancer disorder. Some are approved by FAD for the treatment. These agents are including both selective and non-selective endothelin receptor antagonist (ETA/B). Currently, Bosentan, Ambrisentan, and Macitentan approved -
Tyrosine Kinase Inhibitors and Modifications of Thyroid Function Tests
European Journal of Endocrinology (2009) 160 331–336 ISSN 0804-4643 REVIEW Tyrosine kinase inhibitors and modifications of thyroid function tests: a review Fre´de´ric Illouz1,2, Sandrine Laboureau-Soares1,Se´verine Dubois1, Vincent Rohmer1,2,3,4 and Patrice Rodien1,2,3,4 1CHU d’Angers, De´partement d’Endocrinologie Diabe´tologie Nutrition, Angers Cedex 09 F-49933, France, 2Centre de Re´fe´rence des Pathologies de la Re´ceptivite´ Hormonale, CHU d’Angers, Angers Cedex 09 F-49933, France, 3INSERM, U694, Angers Cedex 09 F-49933, France and 4Universite´ d’Angers, Angers Cedex 09 F-49933, France (Correspondence should be addressed to F Illouz; Email: [email protected]) Abstract Tyrosine kinase inhibitors (TKI) belong to new molecular multi-targeted therapies that are approved for the treatment of haematological and solid tumours. They interact with a large variety of protein tyrosine kinases involved in oncogenesis. In 2005, the first case of hypothyroidism was described and since then, some data have been published and have confirmed that TKI can affect the thyroid function tests (TFT). This review analyses the present clinical and fundamental findings about the effects of TKI on the thyroid function. Various hypotheses have been proposed to explain the effect of TKI on the thyroid function but those are mainly based on clinical observations. Moreover, it appears that TKI could alter the thyroid hormone regulation by mechanisms that are specific to each molecule. The present propositions for the management of TKI-induced hypothyroidism suggest that we assess the TFT of the patients regularly before and during the treatment by TKI. -
(12) United States Patent (10) Patent No.: US 8,580,814 B2 Adelman Et Al
USOO858O814B2 (12) United States Patent (10) Patent No.: US 8,580,814 B2 Adelman et al. (45) Date of Patent: *Nov. 12, 2013 (54) METHODS OF USING 5,528,823. A 6/1996 Rudy, Jr. et al. (+)-1,4-DIHYDRO-7-(3S4S)-3-METHOXY-4- 3.43wk A E. E. St.Ola tala (METHYLAMINO)-1-PYRROLIDINYL-4- 6,171,857 B1 1/2001 Hendrickson OXO-1-(2-THIAZOLYL)-1.8- 6,291643 B1 9/2001 Zou et al. NAPHTHYRIDNE-3-CARBOXYLIC ACID 6,570,002 B1 5/2003 Hardwicket al. FORTREATMENT OF CANCER 6,641,810 B2 11/2003 Gold 6,641,833 B2 * 1 1/2003 Dang ............................ 424/426 (75) Inventors: Daniel CAdelman, Redwood City, CA 6,696,4836,670,144 B2B1 12/20032/2004 CraigSingh et al. (US); Jeffrey A. Silverman, 6,723,734 B2 4/2004 Kim et al. Burlingame, CA (US) 7,211,562 B2 5/2007 Rosen et al. 7.989,468 B2 * 8/2011 Adelman et al. .............. 514,300 (73) Assignee: Sunesis Pharmaceuticals, Inc., South 3.9. A. S. idaran-Ghera Gh et al.1 San Francisco, CA (US) 2003/0232334 A1* 12/2003 Morris et al. ..................... 435/6 c - r 2004/0106605 A1 6/2004 Carboni et al. .... 514/226.8 (*) Notice: Subject to any disclaimer, the term of this 2004/0132825 A1* 7/2004 Bacopoulos et al. ......... 514/575 patent is extended or adjusted under 35 2005/0203120 A1 9, 2005 Adelman et al. U.S.C. 154(b) by 201 days. 2005/0215583 A1 9, 2005 Arkin et al. 2006, OO25437 A1 2/2006 Adelman et al. -
Application Withdrawal Assessment Report for Luveniq
Committee for Medicinal Products for Human Use (CHMP) Assessment report Luveniq voclosporin Procedure No.: EMEA/H/C/002069//0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 5 1.1. Submission of the dossier.................................................................................... 5 1.2. Steps taken for the assessment of the product ....................................................... 6 2. Scientific discussion ................................................................................ 7 2.1. Introduction ...................................................................................................... 7 2.2. Quality aspects .................................................................................................. 8 2.2.1. Introduction ................................................................................................... 8 2.2.2. Active Substance............................................................................................. 8 2.2.3. Finished Medicinal Product ............................................................................. -
(12) Patent Application Publication (10) Pub. No.: US 2004/0116357 A1 Fushimi Et Al
US 2004O116357A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0116357 A1 Fushimi et al. (43) Pub. Date: Jun. 17, 2004 (54) GLUCOPYRANOSYLOXYPYRAZOLE DERVATIVES AND MEDICINAL USE THEREOF (I) (76) Inventors: Nobuhiko Fushimi, Matsumoto-shi (JP); Hideki Fujikura, Matsumoto-shi (JP); Toshihiro Nishimura, Minamiazumi-gun (JP); Kenji Katsuno, Kamiina-gun (JP); Masayuki Isaji, Shiojiri-shi (JP) Correspondence Address: SUGHRUE MION, PLLC 2100 PENNSYLVANIAAVENUE, N.W. SUTE 800 WASHINGTON, DC 20037 (US) (21) Appl. No.: 10/469,140 (22) PCT Filed: Feb. 26, 2002 (86) PCT No.: PCT/JP02/01708 wherein R', R and R represent a hydrogen atom or a (30) Foreign Application Priority Data halogen atom; R" represents a lower alkyl group or a halo(lower alkyl) group; and R represents a hydrogen atom, Feb. 27, 2001 (JP)...................................... 2001-053085 a lower alkyl group, a lower alkoxy group, a lower alkylthio group, etc., a pharmaceutically acceptable Salt thereof or a Publication Classification prodrug thereof., which exert an excellent inhibitory activity (51) Int. Cl. ................................................ A61K 31/7056 in human SGLT2, and therefore are useful as drugs for the (52) U.S. Cl. ............................................. 514/23: 536/17.4 prevention or treatment of a disease associated with hyper glycemia Such as diabetes, diabetic complications or obesity, (57) ABSTRACT pharmaceutically acceptable Salts thereof or prodrugs The present invention provides glucopyranosyloxypyrazole thereof, production intermediates thereof and pharmaceuti derivatives represented by the general formula: cal uses thereof. US 2004/0116357 A1 Jun. 17, 2004 GLUCOPYRANOSYLOXYPYRAZOLE 0005. In recent years, development of new type antidia DERVATIVES AND MEDICINAL USE THEREOF betic agents has been progressing, which promote urinary glucose excretion and lower blood glucose level by prevent TECHNICAL FIELD ing excess glucose reabsorption at the kidney (J. -
Benlysta® (Belimumab)
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2021 P 1227-6 Program Prior Authorization/Notification Medication Benlysta® (belimumab)* *This program applies to the subcutaneous formulation of belimumab P&T Approval Date 9/2017, 9/2018, 9/2019, 9/2020, 2/2021, 7/2021 Effective Date 10/1/2021; Oxford only: 10/1/2021 1. Background: Benlysta® is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy and adult patients with active lupus nephritis who are receiving standard therapy. Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics. Use of Benlysta is not recommended in these situations. 2. Coverage Criteria: A. Systemic Lupus Erythematosus 1. Initial Authorization a. Benlysta will be approved based on all of the following criteria: (1) Diagnosis of systemic lupus erythematosus -AND- (2) Laboratory testing has documented the presence of autoantibodies [e.g., ANA, Anti-dsDNA, Anti-Sm, Anti-Ro/SSA, Anti-La/SSB] -AND- (3) Patient is currently receiving standard immunosuppressive therapy [e.g., hydroxychloroquine, chloroquine, prednisone, azathioprine, methotrexate] -AND- (4) Patient does not have severe active central nervous system lupus -AND- (5) Patient is not receiving Benlysta in combination with either of the following: (a) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Kineret (anakinra)] © 2021 UnitedHealthcare Services, Inc. 1 (b) Lupkynis (voclosporin) Authorization will be issued for 12 months. -
Research in Your Backyard Developing Cures, Creating Jobs
Research in Your Backyard Developing Cures, Creating Jobs PHARMACEUTICAL CLINICAL TRIALS IN ILLINOIS Dots show locations of clinical trials in the state. Executive Summary This report shows that biopharmaceutical research com- Quite often, biopharmaceutical companies hire local panies continue to be vitally important to the economy research institutions to conduct the tests and in Illinois, and patient health in Illinois, despite the recession. they help to bolster local economies in communities all over the state, including Chicago, Decatur, Joliet, Peoria, At a time when the state still faces significant economic Quincy, Rock Island, Rockford and Springfield. challenges, biopharmaceutical research companies are conducting or have conducted more than 4,300 clinical For patients, the trials offer another potential therapeutic trials of new medicines in collaboration with the state’s option. Clinical tests may provide a new avenue of care for clinical research centers, university medical schools and some chronic disease sufferers who are still searching for hospitals. Of the more than 4,300 clinical trials, 2,334 the medicines that are best for them. More than 470 of the target or have targeted the nation’s six most debilitating trials underway in Illinois are still recruiting patients. chronic diseases—asthma, cancer, diabetes, heart dis- ease, mental illnesses and stroke. Participants in clinical trials can: What are Clinical Trials? • Play an active role in their health care. • Gain access to new research treatments before they In the development of new medicines, clinical trials are are widely available. conducted to prove therapeutic safety and effectiveness and compile the evidence needed for the Food and Drug • Obtain expert medical care at leading health care Administration to approve treatments. -
Comment Letter
July 23, 2008 Subject: Follow-up on July 22 Meeting Dr. Sirri et al.: I thank you for meeting with Ken Salomon, John Welborn and me yesterday afternoon to discuss Reg SHO, naked short selling and the SEC's recent emergency order. As a follow-up, I want to emphasize the following points: 1. OSTK continues to believe that it is critical that the SEC extend the pre-borrow requirement of the emergency order to the entire market, not just the 19 select companies. OSTK requests that the SEC promptly undertake swift rulemaking so that this protection applies fairly across the market. 2. OSTK continues to support the prompt and full elimination of the option market maker exception, an exception that swallows up the good intentions of Reg SHO. During yesterday's meeting, we discussed the relationship between the markets for equities and their corresponding derivatives (including listed options). You stated that options market makers enjoy an exception from the Reg SHO requirement that they locate and/or deliver shares when hedging against options positions. I am not sure that I would read Reg SHO to say that. However, under your theory, if an options market maker sells a put with a 6- month expiration, then that same market maker has the legal right to naked short and fail to deliver an equivalent amount of the underlying equity (leaving the option market maker "delta neutral”) for six months. This exception is unnecessary and open to abuse/manipulation, particularly with the married puts that often occur in Reg SHO threshold securities. -
204569Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204569Orig1s000 MEDICAL REVIEW(S) Cross Discipline Team Leader Review 3. CMC/Device Dr. Khairuzzaman found the drug product portion of the NDA to be acceptable, and without need for phase 4 commitments. Dr. Sapru’s review stated that with the exception of a pending issue concerning the control of potential genotoxic impurity (b) (4) the NDA was approvable in terms of drug substance. Dr. Suarez found that the NDA was acceptable from a biopharmaceutics perspective. The Office of Compliance issuance of an acceptable recommendation for drug substance manufacturing and testing facilities was pending at the time of this review. 4. Nonclinical Pharmacology/Toxicology Dr. Richard Siarey completed the primary nonclinical review, and Dr. Lois Freed completed a supervisory memo. Dr. Siarey’s overall conclusion was that from a nonclinical perspective, approval of the suvorexant NDA was recommended. However, he found evidence that catapelxy was observed in dogs exposed to MK-4305 (suvorexant) near Tmax, although he concluded that additional information could have been gained by studying the drug in an experimental model that has been used for diagnosing cataplexy in dogs. Dr. Siarey suggested that since cataplexy occurred in dogs near Tmax, a time at which if used for insomnia patients would ordinarily be in bed, safety concern for humans was reduced. Dr. Siarey also found that the neurobehavioral assessment in the pre- and post-natal developmental study was not complete, as the passive avoidance tests was performed too early in development, while learning/acquisition tests and retention/memory tests were not conducted. -
Supplementary Information
Supplementary Information Network-based Drug Repurposing for Novel Coronavirus 2019-nCoV Yadi Zhou1,#, Yuan Hou1,#, Jiayu Shen1, Yin Huang1, William Martin1, Feixiong Cheng1-3,* 1Genomic Medicine Institute, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA 2Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH 44195, USA 3Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA #Equal contribution *Correspondence to: Feixiong Cheng, PhD Lerner Research Institute Cleveland Clinic Tel: +1-216-444-7654; Fax: +1-216-636-0009 Email: [email protected] Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. Supplementary Table S2. Protein sequence identities across 5 protein regions in 15 coronaviruses. Supplementary Table S3. HCoV-associated host proteins with references. Supplementary Table S4. Repurposable drugs predicted by network-based approaches. Supplementary Table S5. Network proximity results for 2,938 drugs against pan-human coronavirus (CoV) and individual CoVs. Supplementary Table S6. Network-predicted drug combinations for all the drug pairs from the top 16 high-confidence repurposable drugs. 1 Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. GenBank ID Coronavirus Identity % Host Location discovered MN908947 2019-nCoV[Wuhan-Hu-1] 100 Human China MN938384 2019-nCoV[HKU-SZ-002a] 99.99 Human China MN975262 -
Anti-Infectives Industry Over the Next 5 Years and Beyond
Bridging the innovation gap... New Drug Futures: Products that could change the pharma market to 2013 and beyond Over 70 pipeline prospects This new major and insightful 450 page in 8 major therapy areas analysis evaluates, compares and contrasts the are analysed in this report prospects for the development compounds that could revolutionise the pharmaceutical Anti-infectives industry over the next 5 years and beyond. Cardiovascular CNS The report provides: Gastrointestinal Detailed background and market context for Metabolic each therapy area covered: Musculoskeletal Addressable patient population Oncology Current treatments Sales drivers Respiratory Sales breakers Future treatments Market dynamics – winners and losers Key drug launches by 2013 Unique sales forecasts by major product to 2013 Over 70 key products assessed Unique evaluation scores for key areas such as novelty of mechanism, clinical data and competition Critical and detailed appraisal of each product‟s research and development Extensive pipeline listings, putting the profiled products into their competitive context The search – and need – for new products has never been greater and what’s in the development pipeline has never generated more interest. That is why this analysis is so important! GLOBAL PHARMA MARKET IN CONTEXT THE Are there too many prophets of doom ready to write-off the research-based pharma industry in the future? Too few novel There is plenty on which to base such anxiety. The research-based industry products and an must achieve a fair price in the face of greater cost control, while the aggressive generic burden of regulation is setting the bar high for successful product sector are taking introduction.