Navigation Links
IDM Pharma Names Dr. Jeffrey W. Sherman Chief Medical Officer and Senior Vice President of Research and Development
Date:8/27/2007

Company's belief that the supplemental data to be submitted in the amended NDA will overcome the need for additional trials, the review of the submissions for marketing approval of L-MTP-PE by the FDA and the EMEA, and the Company's goal of making L-MTP-PE available to patients as quickly as possible. Actual results may differ materially from the forward-looking statements due to a number of important factors, including, but not limited to, the possibility that the Company may not be able to collect, analyze and submit additional data in an amendment to the NDA for L-MTP-PE by the first quarter of 2008, if at all, the possibility that such data will not support the benefit of L-MTP-PE in the treatment of non-metastatic osteosarcoma, will not allow a more robust analysis of L-MTP-PE, will not continue to support its overall survival benefit in osteosarcoma, and may not provide substantial evidence for the potential regulatory approval of L-MTP-PE, the timing of the FDA's and EMEA's review of the submissions for marketing approval of L-MTP-PE, the ability of the Company to respond to questions raised by the FDA and EMEA in a satisfactory manner, the time needed to respond to any issues raised by the FDA and EMEA with regard to regulatory submissions for L-MTP-PE, although the FDA is not bound by the decision of any advisory panel, the possible negative impact that the opinion of the FDA's Oncologic Drugs Advisory Committee that the results of the Company's Phase 3 trial do not provide substantial evidence of effectiveness of L-MTP-PE in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy would have upon the determination by the FDA whether to approve the marketing application for L- MTP-PE, which would have a material and adverse affect on IDM's business, the possibility that regulatory authorities may not consider preclinical and early clinical development work conducted by Ciba-Geigy and efficacy data from the Ph
'/>"/>
SOURCE IDM Pharma, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Analyzing Trace-Level Impurities of a Pharmaceutical Intermediate Using an LCQ Deca Ion Trap Mass Spectrometer and the Mass Frontier Software Package
2. Rapid SNP Genotyping of the Pharmacogenomically Important Allele CYP2D6*4 Using Real-Time qPCR on the DNA Engine Opticon 2 System
3. Development of a sensitive enzyme fragment complementation assay for cyclic adenosine 3, 5 monophosphate and its validation for pharmacological screening at G protein-coupled receptors
4. Practical Applications of HyperDSC in a Pharmaceutical Laboratory
5. World Class Life Science and Pharmaceutical Companies Leverage DoveBid s Global Reach for Asset Management and Disposition
6. Germantown drug company hires pharma veteran James Davidson as COO
7. Deltanoid Pharmaceuticals begins phase II osteoporosis study
8. New angel capital centered on GenTel agreement with big pharma
9. The deconstruction of Big Pharma
10. Big pharma seeks Wisconsin biotech partnerships
11. Doing the pharmaceutical tango
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... Dec. 19, 2014  Roche (SIX: RO, ROG; OTCQX: ... Inc. (Bina), a privately held company based in ... Bina provides a big data platform for centralized ... data. Bina,s proprietary on-market Genomic Management Solution, Bina-GMS ... to perform fast and scalable analyses to maximize ...
(Date:12/19/2014)... 2014 Decision Resources Group finds that the ... 12 percent compound annual growth rate through 2023. This ... and the increasing adoption of dental implants. Growing aesthetic ... also spur demand for dental biomaterials because they can ... treatments. Other key findings from Decision Resources ...
(Date:12/19/2014)... 18, 2014 BioPlus Specialty ... specialty pharmacies, has an expanded team of Regional ... consultants for prescriber offices in their regions, with ... “We have a variety of Regional Pharmaceutical Care ... specializing in hepatitis C help prescribers understand all ...
(Date:12/19/2014)... MA (PRWEB) December 18, 2014 LayerBio ... for ophthalmology and wound care. The National Eye Institute ... awarded LayerBio a Phase I SBIR grant to develop ... Cataracts are the most common cause of vision loss ... of blindness worldwide. According to Dr. Ken Mandell, LayerBio’s ...
Breaking Biology Technology:Roche acquires Bina Technologies and enters the genomic informatics market 2Roche acquires Bina Technologies and enters the genomic informatics market 3Latin American Dental Biomaterial Market Will Expand at a 12 Percent Annual Growth Rate Through 2023 2Latin American Dental Biomaterial Market Will Expand at a 12 Percent Annual Growth Rate Through 2023 3BioPlus Specialty Pharmacy Expands ‘Regional Pharmaceutical Care Liaison’ Team 2BioPlus Specialty Pharmacy Expands ‘Regional Pharmaceutical Care Liaison’ Team 3LayerBio Awarded NIH Grant to Develop a Drug Delivery Device for Cataract Surgery 2
... LONDON, January 23, 2012 Representatives of ... new regulatory landscape as well as provide the feedback ... th   Annual Cool Chain Logistics Europe, ... Basel, Switzerland. Over 400 attendees including senior ...
... (NYSE: DGX ), the world,s leading provider ... the U.S. Food and Drug Administration (FDA) has granted ... STRATIFY JCV ™ Antibody ELISA testing service. STRATIFY ... market authorized for the qualitative detection of antibodies to ...
... 2012  Waters Corporation (WAT:NYSE) and Ireland,s National ... announced today the availability of the world,s first ... Chromatography ® (UPLC®). Developed by Professor Pauline ... GlycoBase 3+ Database is the first-of-its-kind ...
Cached Biology Technology:Quest Diagnostics STRATIFY JCV™ First FDA Market Authorized Antibody-based Blood Test to Help Stratify PML Risk in Multiple Sclerosis Patients 2Quest Diagnostics STRATIFY JCV™ First FDA Market Authorized Antibody-based Blood Test to Help Stratify PML Risk in Multiple Sclerosis Patients 3Waters and NIBRT Complete Work on World's First UPLC Glycan Database 2Waters and NIBRT Complete Work on World's First UPLC Glycan Database 3
(Date:12/10/2014)...  Valencell, a leader in performance biometric data sensor ... from its licensees for highly accurate, clinically validated biometric ... coming from fitness and health sectors, but first responders/military ... is only as useful as the biometric data it ... in long-term mass consumer adoption of wearable products," said ...
(Date:12/10/2014)... December 9, 2014   ... Platform   Jifflenow, ... scheduling solutions for business-to-business (B2B) events, today announced ... in mobile near-field communication (NFC), Bluetooth low energy ... (Logo: http://photos.prnewswire.com/prnh/20140612/691055) , Jifflenow will integrate ...
(Date:12/3/2014)...   Marvin Test Solutions , a trusted ... military, aerospace, and manufacturing organizations, today announced the ... TS-900 PXI semiconductor test platform . The TS-960 ... to customers at a fraction of the footprint ... "Our semiconductor customers asked for ...
Breaking Biology News(10 mins):Wearable Technology Products Demand Highly Accurate Biometric Technology 2Jifflenow And ITN International Bring Cutting-Edge Badge Scanning Technology To B2B Events 2Jifflenow And ITN International Bring Cutting-Edge Badge Scanning Technology To B2B Events 3Marvin Test Solutions Brings New Capabilities to PXI-Based Semiconductor Test with TS-960 2Marvin Test Solutions Brings New Capabilities to PXI-Based Semiconductor Test with TS-960 3
... Lugano-CH, Brussels- BE, 2 May 2013 -- An important ... precisely how much measurement variation influences gene expression profiles ... first time, which gene expression measurements may benefit from ... at the 5th IMPAKT Breast Cancer Conference in Brussels, ...
... healthy people have been bombarded by stories in the media ... vitamin D levels, and urging high doses of supplements to ... to diabetes. But new research from Johns Hopkins finds ... the top of the range suggested by the Institute of ...
... PLOS, the Public Library of Science, today is launching ... use of scientific research, published through Open Access, which ... society. Major sponsors include the Wellcome Trust and Google. ... applied or remixed scientific research to innovate and make ...
Cached Biology News:Study reveals magnitude of variation in gene expression measurements within breast cancers 2Study reveals magnitude of variation in gene expression measurements within breast cancers 3Vitamin D: More may not be better 2PLOS announces Accelerating Science Award Program 2