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Genentech: Investor Relations - Financials - 2001 Third Quarter Report
Home Contact Us Site Index Search [ Investors -- Financials -- Quarterly Reports -- 2002 First Quarter Report ] Investors Home Calendar of Events Contacts Corporate Governance E-Delivery of Annual Report E-Mail Alerts Fact Sheet FAQs Financials Annual Reports Quarterly Reports--- Earnings Releases GAAP vs Non-GAAP Reconciliation Other Income, Net Historical Product Sales 11-Year...
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Genentech: Investor Relations - Financials - 2001 Second Quarter Report
Home Contact Us Site Index Search [ Investors -- Financials -- Quarterly Reports -- 2001 Second Quarter Report ] Investors Home Calendar of Events Contacts Corporate Governance E-Delivery of Annual Report E-Mail Alerts Fact Sheet FAQs Financials Annual Reports Quarterly Reports--- Earnings Releases GAAP vs Non-GAAP Reconciliation Other Income, Net Historical Product Sales 11-Year...
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Genentech: Investor Relations - Financials - 2001 Third Quarter Report
Home Contact Us Site Index Search [ Investors -- Financials -- Quarterly Reports -- 2001 Third Quarter Report ] Investors Home Calendar of Events Contacts Corporate Governance E-Delivery of Annual Report E-Mail Alerts Fact Sheet FAQs Financials Annual Reports Quarterly Reports--- Earnings Releases GAAP vs Non-GAAP Reconciliation Other Income, Net Historical Product Sales 11-Year...
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LeadDiscovery - Emerging Drug Discovery Targets June 26th 2004
- - - - 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...
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Sitaxentan as an effective treatment of pulmonary arterial hypertension
- - - - 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...
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Btech News -TRACLEER WILL NOT EXPAND INTO TREATMENT OF CONGESTIVE HEART FAILURE
- - - - BioNews BioWeb Companies Products BioReports - - - - - - TRACLEER WILL NOT EXPAND INTO TREATMENT OF CONGESTIVE HEART FAILURE Actelion (Swiss: ATLN) and Genentech's (NYSE: DNA) Tracleer (bosentan) has failed to meet primary endpoints of the phase III ENABLE trial.
Tracleer is not sold in general drugstores; Actelion has hired 4 specialty pharmacies...
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Remodulin Approvable For Pulmonary Hypertension
- - - - BioNews BioWeb Companies Products BioReports - - - - - - Remodulin Approvable For Pulmonary Hypertension United Therapeutics (NASDAQ: UTHR) has received an approvable letter for Remodulin (treprostinil sodium) injection.
Upon approval, Remodulin will compete with GlaxoSmithKline's (NYSE: GSK) Flolan (epoprostenol) and Actelion (Swiss: ATLN) and Genentech's (NYSE: DNA) ...
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Results From The American College of Cardiology Meeting
- - - - BioNews BioWeb Companies Products BioReports - - - - - Results From The American College of Cardiology Meeting The 51st Annual Scientific Session of the American College of Cardiology concluded today in Atlanta, Georgia.
Disappointing data and subgroup analyses from Actelion (Swiss: ATLN) and Genentech's (NYSE: DNA) phase III ENABLE trial for Tracleer (bosentan)...
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Tracleer Efficacious in Children for treatment of pulmonary arterial hypertension (PAH)
- - - - BioNews BioWeb Companies Products BioReports - - - - - Tracleer Efficacious in Children for treatment of pulmonary arterial hypertension (PAH) Actelion (Swiss: ATLN) announced yesterday that Tracleer (bosentan) has demonstrated evidence of utility in the treatment of pulmonary arterial hypertension (PAH) in children under the age of 15.
Further clinical trials are ongoing...
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Biotech Tracker news - Sitaxsentan May Stack Up Well Against Other Pulmonary Arterial Hypertension Treatments
- - - - BioNews BioWeb Companies Products BioReports - - - - - - Sitaxsentan May Stack Up Well Against Other Pulmonary Arterial Hypertension Treatments-- October 21, 2002.
The adverse effect profile was predictable and manageable.- Overall, including data from the sitaxsentan program that includes a maximum of 55 weeks follow-up, the greatest benefit/risk ratio appeared to favor...
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BioPortfolio Limited
dacarbazine 66 Screening 68 Treatment variations by country 69 CHAPTER 5 PIPELINE PRODUCTS 71 Unmet needs 71 Low efficacy/high toxicity 71 Lack of significant developments 72 Need for earlier diagnosis 72 Need for increased public awareness 73 Future importance of genetic profiling 73 Key clinical trials 74 Vaccines 75 Melacine 77 M-Vax 80 Canvaxin 83 Oncophage (HSPPC-96) 85 GMK 87...
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Approved Products_2004.xls
LIST OF APPROVED BIOTECHNOLOBY PRODUCTS (Page 1: product 1- 50) Biotechnology companies have already commercialized a great number of drugs.
147 Oct- 00 CroFab Antivenom (antibodies to venom) Rattlesnake bites Protherics pic 148 Oct- 00 Ovidrel Chorio gonadotropin alfa for injection infertility Serono Laboratories 149 Oct- 00 Solarze H yaluronan trandermal delivery Acute keratosis...

author: Reijer
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Approved Products_2004.xls page 4


author: Reijer
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United Therapuetics
- About Pulmonary Arterial Hypertension United Therapeutics’s lead product, Remodulin, was approved by the FDA on May 21, 2002 as a continuous subcutaneous infusion for the treatment of the life-threatening disease pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.
The non-selective endothelin receptor...
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ENCYSIVE PHARMACEUTICALS
- BACK To Headlines...
Research agreement revenue was approximately $1.5 million in 2004 as compared to $3.0 million in 2003 due to the conclusion in June of 2004 of research payments in our agreement with Schering-Plough.
Bosentan (Tracleer®), the only approved oral product for pulmonary arterial hypertension, increased the 6MW by 29.5 meters, while patients on...
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ENCYSIVE PHARMACEUTICALS
A 50 mg dose of Thelin improved 6MW by 24.2 meters, and bosentan (Tracleer®), currently the only approved oral agent for treating PAH, improved 6MW by 29.5 meters.
There were five clinical worsening events in the 100 mg patient group, seven events in the 50 mg group, 15 events in the bosentan group, and 13 for placebo.
Liver function abnormalities ...
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Haberman Associates: The Millennium/COR merger
The Millennium/COR merger and the future of cardiovascular drug development Allan B.
Millennium sees the merger with COR as a move toward becoming a major developer and marketer of novel drugs, rather than a research boutique that licenses drugs to Big Pharma companies.- If successful, it would join the ranks of such "Big Biotech" companies as Amgen, Biogen, Immunex, Chiron,...
author: Allan B. Haberman
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Database B
B - 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.
See Amevive ® (2076)- B-Amylin (1678) B-Cell Lymphoma Autologous Vaccine (2691).
Product development terminated!
Product...
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Database T
T - 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 To purchase documents on-line click on -link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
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ENCYSIVE PHARMACEUTICALS
- Protocol: FPH06 Title: A Double-Blind Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients with Pulmonary Arterial Hypertension Who Have Failed Bosentan Therapy Purpose: The purpose of this study is to evaluate the safety and efficacy of sitaxsentan sodium in patients with PAH who have failed treatment with standard dose bosentan (Tracleer™),...
author: MENTUS [ www.mentus.com ]
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http://www.unither.com/Files/2003AnnualReport.pdf
Medicines for Life ® United Therapeutics Corporation 2003 Annual Report Corporate Profile Subcutaneous Remodulin ® for PAH Arginine Supplements CardioPAL ® and Decipher ® Recorder Services CardioPAL ® AI* Intravenous Remodulin for PAH* OvaRex ® for Ovarian Cancer* Intermittent Remodulin ® for CLI* UT- 231B for Hepatitis C* BrevaRex ® for...

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Office of Drug Safety: Patient Labeling and Risk Communitation
Food and Drug Administration • Center for Drug Evaluation and Research Office of Drug Safety Search Patient Labeling and Risk Communication FDA-Approved Patient Labeling Patient Package Inserts.- For some prescription medicines, FDA approves special patient materials to instruct patients about the safe use of the product
-Medication Guides are available for these products:...
author: PhillipsJ
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Cardiovascular and Renal Drugs Advisory Committee Meetings
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER < a href="http://www.fda.gov/cder/regulatory/default.htm" onMouseOut="MM_startTimeout();" onMouseOver="MM_showMenu(window.mm_menu_0718112003_0,0,33,null,'Sm_Button_Regulatory_Off');"> - Search - Cardiovascular and Renal Drugs Advisory Committee Meetings List of Tentative Meeting Dates for All CDER...
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http://www.fda.gov/cder/orange/appendix_a.txt
2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...

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2002 Warning Letters and Untitled Letters to Pharmaceutical Companies
Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 2002 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
The letters are arranged in chronological order by month.- Click on the month to view the letters in Adobe...
author: STAUFFERP
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