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- OSI Pharmaceuticals, Inc. Q1 2009 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions Your first question comes from Geoffrey Meacham with J.P. Morgan Terry Bivens - J.P. Morgan This is Terry in for Jeff. My first question is on Tarceva. When we are modeling out the...
- Earnings calls 2009-04-29
Additional Resources
- Genentech, OSI Pharmaceuticals target approval for Tarceva. (Life Sciences).(cancer drug)(Brief Article)
- GENENTECH INC. and OSI Pharmaceuticals Inc. saw their stocks climb last week after the Food and Drug Administration FDA awarded fast-track review status to cancer drug Tarceva (erlotinib, OSI-774). Tarceva is expected to compete with AstraZeneca GENENTECH INC. and OSI Pharmaceuticals Inc. saw...
- Research articles 2002-05-20
- OSI Pharmaceuticals Announces Acceptance of a Tarceva® Supplemental New Drug Application in Pancreatic Cancer for Review by the U.S. Food and Drug Administration; Tarceva's sNDA is Granted Priority Review Designation by the FDA
- MELVILLE, N.Y. -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the U.S. Food and Drug Administration FDA has accepted for filing and review the supplemental New Drug Application sNDA for use of TarcevaR erlotinib plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not...
- Research articles 2005-07-06
- FDA Advisory Panel Recommends Tarceva® Approval for Pancreatic Cancer; Committee Supports New Indication for EGFR Inhibitor Tarceva
- MELVILLE, NY & SAN FRANCISCO -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc. (NYSE: DNA) announced today that the Oncologic Drug Advisory Committee ODAC appointed by the U.S. Food and Drug Administration FDA voted 10 to 3 in favor of recommending approval of TarcevaR erlotinib in combination with gemcitabine...
- Research articles 2005-09-14
- Genentech and OSI Pharmaceuticals Initiate Phase IIIB Clinical Trial of Tarceva in Advanced Non-Small Cell Lung Cancer
- SOUTH SAN FRANCISCO, Calif. & MELVILLE, N.Y. -- Genentech, Inc. (NYSE: DNA) and OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today the initiation of a Phase IIIB clinical study of the investigational therapy TarcevaTM erlotinib HCl in patients with second- and third-line non-small cell lung cancer NSCLC who have previously received...
- Research articles 2004-09-10
- FDA Approves Tarceva® in Combination with Gemcitabine Chemotherapy for Treatment of Locally Advanced, Inoperable or Metastatic Pancreatic Cancer; Tarceva Now Approved for Advanced Non-Small Cell Lung Cancer and Pancreatic Cancer
- MELVILLE, N.Y. and SOUTH SAN FRANCISCO, Calif. -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc. (NYSE: DNA) announced today that the U.S. Food and Drug Administration FDA approved TarcevaR erlotinib in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous...
- Research articles 2005-11-02
- FDA Approves Tarceva-TM- For Patients with Advanced Non-Small Cell Lung Cancer; Only Targeted EGFR Therapy Shown to Improve Survival in Advanced Non-Small Cell Lung Cancer
- MELVILLE, N.Y. & SOUTH SAN FRANCISCO, Calif. -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) and Genentech, Inc. (NYSE: DNA) announced today that the U.S. Food and Drug Administration FDA has approved, after priority review, TarcevaTM erlotinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer NSCLC...
- Research articles 2004-11-19
- OSI: Tarceva Approved as Maintenance Treatment for Lung Cancer
- Finally OSI Pharmaceuticals OSIP has reported its expected results from the SATURN study, which confirm that immediate treatment with Tarceva after initial chemotherapy delays the progression of advanced lung cancer and helps patients live longer. Advanced lung cancer has yet to find a satisfactory treatment. It still frustrates oncologists and...
- External links 2009-07-14
- Pivotal Phase III Tarceva Study Published in the New England Journal of Medicine Showed Survival Improvement in Advanced Non-Small Cell Lung Cancer
- MELVILLE, N.Y. & SOUTH SAN FRANCISCO, Calif. -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) and Genentech, Inc. (NYSE: DNA) announced today that The New England Journal of Medicine published results from the pivotal Phase III study showing TarcevaR erlotinib improved survival in patients with advanced non-small cell lung cancer NSCLC. The...
- Research articles 2005-07-13
- OSI Pharmaceuticals and Genentech Announce Filing of a Supplemental New Drug Application to the FDA for Tarceva -TM- in Pancreatic Cancer
- MELVILLE, N.Y. & SOUTH SAN FRANCISCO, Calif. -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc. (NYSE: DNA) announced today that OSI submitted a supplemental New Drug Application sNDA with the U.S. Food and Drug Administration FDA for use of TarcevaTM erlotinib plus gemcitabine chemotherapy for the treatment of advanced...
- Research articles 2005-05-02
- OSI Pharmaceuticals and Genentech Enter into Co-Promotion and Manufacturing Agreements For Tarceva
- MELVILLE, N.Y. & SOUTH SAN FRANCISCO, Calif. -- OSI Pharmaceuticals, Inc. (Nasdaq:OSIP) and Genentech, Inc. (NYSE:DNA) today announced the companies have entered into two agreements detailing the roles of the two parties with respect to promotion, marketing and manufacturing responsibilities for the investigational drug TarcevaTM erlotinib HCl once it is...
- Research articles 2004-06-16
- In the Interests of Patients, Roche Will Consider all Options Following CHMP Opinion on Tarceva in Pancreatic Cancer.
- BASEL, Switzerland, July 28 /PRNewswire/ -- Roche announced today that its cancer medicine Tarceva erlotinib has received a negative opinion from the European Committee for Medicinal Products for Human Use CHMP for use in combination with gem BASEL, Switzerland, July 28 /PRNewswire/...
- Research articles 2006-07-28
- OSI Pharmaceuticals Seeks to Strengthen Tarceva Patent by Filing Re-Issue Application with the U.S. Patent and Trademark Office
- MELVILLE, N.Y. -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that it has filed with the U.S. Patent and Trademark Office an application to reissue its composition of matter patent for Tarceva([R]) erlotinib, U.S. Patent No. 5,747,498 (the '498 patent), in order to correct certain errors relating to the claiming...
- Research articles 2008-02-27
- OSI Pharmaceuticals Announces Pivotal Phase III Tarceva® Study Published in the Journal of Clinical Oncology Showed Survival Improvement in Patients with Pancreatic Cancer
- MELVILLE, N.Y. -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that results published yesterday in the Journal of Clinical Oncology show that adding Tarceva([R]) erlotinib to gemcitabine chemotherapy significantly improves survival when administered as first-line therapy to patients with advanced pancreatic cancer. Data from this study, conducted by the National...
- Research articles 2007-04-25
- OSI Pharmaceuticals Announces That Roche Has Received Negative CHMP Opinion in European Union on Tarceva® in Pancreatic Cancer
- MELVILLE, N.Y. -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that Roche, its international partner for TarcevaR erlotinib, received a negative opinion from the European Committee for Medicinal Products for Human Use CHMP, regarding approval of Tarceva in combination with gemcitabine chemotherapy as first-line, once-daily, oral therapy for locally advanced,...
- Research articles 2006-07-28
- Tarceva approved for pancreatic cancer and Discovery Laboratories to present at SG Cowen 6th annual Global Health Care Conference.
- M2 PRESSWIRE-3 November 2005-US Financial Network: Tarceva approved for pancreatic cancer and Discovery Laboratories to present at SG Cowen 6th annual Global Health Care ConferenceC1994-2005 M2 COMMUNICATIONS LTD RDATE:03112005 City of Industry, CA - Biotechnology industry news provided by Financial...
- Research articles 2005-11-03
- OSI Pharmaceuticals Summarizes Data Presented on Tarceva® at the 12th World Congress on Lung Cancer Meeting
- MELVILLE, N.Y. -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) today provided a summary of selected data from over 58 studies involving the Company's lead product, Tarceva([R]), presented during the 12th World Congress on Lung Cancer WCLC held September 2-6 in Seoul, Korea. Tarceva is currently approved in the United States as...
- Research articles 2007-09-07
- OSI Pharmaceuticals Announces Tarceva® to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for Use in Pancreatic Cancer
- MELVILLE, N.Y. -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the Oncologic Drugs Advisory Committee ODAC panel will review at its September 13, 2005 meeting the use of TarcevaR erlotinib plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment....
- Research articles 2005-08-08
- FDA grants Melville-based OSI's Tarceva orphan-drug status
- Tarceva, an anti-cancer drug under development by OSI Pharmaceuticals Inc. (Nasdaq: OSIP), has been granted orphan-drug status by the Food and Drug Administration for patients with the most common form of brain cancer, malignant glioma.
- Research articles 2003-08-15
- Ambit Biosciences Publishes Data Identifying Drug Candidates That Counter Resistance to Gleevec, IRESSA and TARCEVA; Kinase Profiling Data Published in the Proceedings of the National Academy of Sciences
- SAN DIEGO -- Ambit Biosciences today announced that a study utilizing its novel kinase profiling technology revealed several existing clinical drug candidates that bind to and inhibit various mutations responsible for the development of resistance to the leading targeted cancer drugs GleevecR, IRESSAR and TARCEVATM. The study was published in...
- Research articles 2005-07-26
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