Valeant Pharmaceuticals' remofovir mesylate, an improved adefovir prodrug for targeted and tolerable treatment of hepatitis B - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
Chronic viral hepatitis: B is for billions However, the development of the first two antivirals, GSK's Zeffix (lamivudine) and Gilead's Hepsera (adefovir dipivoxil) has led to considerable growth in the market, with these two drugs experiencing a compound annual growth rate (CAGR) of 80-90% between 1999 and 2004.- The majority of drugs undergoing clinical development belong to the nucleoside or nucleotide...
Chronic hepatitis B and- C: a chronic lack of effective treatment - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
BioPortfolio Limited 8 Summary 9 Key metrics 10 CHAPTER 2 NATURE OF THE HIV/HBV COINFECTED POPULATION 16 Introduction 16 Prognosis of HIV/HBV co-infection 17 HBV genotypes 19 HIV/HBV co-morbid population: estimates of prevalence 20 Case study: regional variation in Italy 23 Drivers and resistors to increasing HIV/HBV co-infection 24 Increased ‘high risk’ activity 25 CHAPTER 3 DIAGNOSTIC AND...
BioPortfolio Limited Hepatitis B and C - The Chinese Way?
BioPortfolio Limited Both GSK and Gilead are obvious candidates and in light of similar challenges between HBV/HCV and HIV, Datamonitor expects increased portfolio synergies for the management of chronic viral conditions; 10 Summary 11 Key metrics 12 CHAPTER 2 MARKET SEGMENTATION & DEFINITION 29 Strategic scope and focus 29 Market definition 30 Hepatitis B 30 Disease definition 30 Epidemiology 34...
Approved Products_2004.xls 194 Jul- 02 Aranes p hyperglycosylated erythropoietin Chemotherapy- induced anemia Amgen 195 Jul- 02 X yrem Sodium oxybate oral solution Cataplexy associated with narcolepsy Orphan Medical 196 Au g- 02 Prestara Prasterone Lupus Genelabs 197 Se p- 02 Hepsera Adefovir dipivoxil Chronic Hepatitus B Gilead 198 Nov- 02 Mitoz ytrex Generic mitomycin Disseminated...
author: Reijer
Approved Products_2004.xls page 4
author: Reijer
Database A A - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.
Database H H - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.
http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
../2002/21-449_Hepsera_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Hepsera (Adefovir Dipivoxil) Tablets Company:--Gilead Sciences, Inc
author: USERNAME
Pharmaceutical Research and Manufacturers of America - Gilead Sciences Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes emtricitabine (FTC) none / none treatment of HIV disease Gilead Sciences Foster City, CA Phase I/II 3 months-17 years - Hepsera none / ...
Pharmaceutical Research and Manufacturers of America - Hepatitis B Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes ACH-126,443 none / ACH-126,443 Hepatitis B Achillion Pharmaceuticals New Haven, CT Phase II - Beta-L-Fd4C none / none Hepatitis B HIV Infection...
Approved Biotechnology Drugs, 2000 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Milestones 2003 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Approved Biotechnology Drugs, 2002 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
CDER 2002 Report to the Nation; Drug Review Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2002 Table of Contents Adobe Acrobat version of this document 1 Drug Review Index Mission Highlights New Drug Review List of priority new drugs List of new molecular entities List of orphan new drugs New Drug Review Statistics Priority new drug statistics...
author: OLIVERN
NMEs Approved in CY 2002 NMEs Approved in Calendar Year 2002 - NDA Number Generic Name Trade Name Dosage Form Applicant *Classification Approval Date 21-232 Nitisinone Orfadin Capsule Swedish Orphan -- 1PV 01-18-2002 21-286 Olmesartan Medoxomil Benicar Tablet Sankyo- 1S 04-25-2002 21-344 Fulvestrant Faslodex Injection AstraZeneca 1S 04-25-2002 21-272 Treprostinil Sodium Remodulin Injection United...
author: Susan Daugherty
Prescription and OTC Drug Product List 9/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ...
BIO Editors &Reporters 03LIVE page 58
author: Elinor
V:\DAVDP\CSO\HOLLOMAN\NDAS\NDA 21449 REPSUR ADV HBV\LETTERS\AP LT\ R with ATTACHED LABELING 09-20-2002.doc Kraus: Please refer to your new drug application (NDA) dated March 20, 2002, received March 21, 2002, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for HEPSERA ™ (adefovir dipivoxil) 10 mg Tabletsadefovir dipivoxil 10 mg patients rolled over from the pivotal...
author: Marsha Holloman
V:\DAVDP\CSO\HOLLOMAN\NDAS\NDA 21449 REPSUR ADV HBV\LETTERS\AP LT\ R with ATTACHED LABELING 09-20-2002.doc page 1
author: Marsha Holloman
http://www.phrma.org/newmedicines/resources/2003-01-30.102.pdf Holmer President and CEO PhRMA 2 N E W D R U G A P P R O V A L S I N 2002 0 500 1000 1500 2000 2500 3000 3500 4000 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 NUMBER OF CLINICAL TRIALS OF NEW MEDICINES 3 N E W D R U G A P P R O V A L S I N 2002 New Drug Approvals in 2002 NDA FDA Review Foreign Product ompany Indication/ Use Received Approved Time...
http://www.phrma.org/newmedicines/resources/2003-01-30.102.pdf page 13
