Navigation Links
IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
Date:8/27/2007

d 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 Phase 3 trial conducted by Children's Oncology Group as adequate for their assessment of L-MTP-PE, which may cause delays in review, may result in the regulatory authorities requiring the Company to conduct additional clinical trials, or may result in a determination by the regulatory authorities that the data does not support marketing approval, whether regulatory authorities will approve L-MTP-PE within the time frame expected by the Company or at all, and whether the Company will be able to manufacture and commercialize L-MTP-PE even if it is approved by regulatory authorities. Other risks affecting the Company and its drug development programs include whether the Company or any of its collaborators will be able to develop pharmaceutical products using the technologies of the Company, whether clinical trial results to date are predictive of results of any future clinical trials, risks associated with completing clinical trials of product candidates, risks involved in the regulatory approval process for the Company's product candidates, the possibility that clinical testing may reveal undesirable
'/>"/>
SOURCE IDM Pharma, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

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:4/27/2015)... April 27, 2015   Aratana Therapeutics, Inc ... company focused on the licensing, development and commercialization ... provided commentary on clinical study data involving ADXS31-164 ... session at the American Association for Cancer Research ... a novel Lm -LLO immunotherapy developed by ...
(Date:4/27/2015)... Mass., April 27, 2015  Haemonetics Corporation (NYSE: ... fourth quarter fiscal 2015 of $226.5 million, down ... in the quarter. The Company reported a fourth ... $0.06 per share.  Adjusted net income, exclusive of ... was $24.5 million, up 1%, and adjusted earnings ...
(Date:4/27/2015)... McKinney, Texas (PRWEB) April 27, 2015 ... products for use in applications such as animal ... fat and oil reduction in wastewater treatment plants ... be an exhibitor at the Texas Commission on ... May 5-6 in Austin, Texas. , The company ...
(Date:4/27/2015)... tru Shrimp™ Systems announced today that ... University for the exclusive worldwide rights to commercialize Tidal ... The license agreement for the patented technology, developed by ... such as China, Taiwan, France, Germany, Italy, Spain, the ... had inquires from all over the world for our ...
Breaking Biology Technology:Aratana Therapeutics Comments on ADXS31-164 (AT-014) Study Data Presented During Poster Session at the American Association for Cancer Research (AACR) Annual Meeting 2015 2Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 2Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 3Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 4Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 5Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 6Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 7Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 8Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 9Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 10Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 11Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 12Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 13Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 14Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 15Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 16Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 17Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 18Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 19Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 20Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 21Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 22Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 23Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 24Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 25Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 26Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 27Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 28Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 29Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 30Haemonetics Reports 4th Quarter Fiscal 2015 Revenue of $226 Million and Adjusted EPS of $0.47; Full Year Revenue of $910 Million and Adjusted EPS of $1.85; Provides Fiscal 2016 Guidance 31DryLet to Showcase Multiple Products at Texas Commission on Environmental Quality Trade Fair and Conference May 5-6 in Austin, Texas 2tru Shrimp™ Systems Acquires Global Patent for Tidal Basin™ Shrimp Production 2
... MabVax Therapeutics, Inc., a privately held clinical stage ... antibody based therapies to address the unmet medical need ... the Phase 2 portion of the Small Business Innovation ... under the agency,s Streamlined Non-competing Award Procedures (SNAP). The ...
... Bacterin International Holdings, Inc. ("Bacterin") (NYSE Amex: ... filed its 2010 Annual Report on SEC Form 10-K ... charges in the fourth quarter results ended  December 31, ... million from the financial results reported by the Company ...
... 2011 On April 12, at the Hilton San Francisco ... Marrone Bio Innovations (MBI), will address Agriculture ... debating the topic of ,Feeding a Growing Global Population,. The ... impact while producing enough food to feed a projected world ...
Cached Biology Technology:MabVax Therapeutics Receives $1.8 Million in a Phase 2 Small Business Innovation Research Program Award From the National Cancer Institute 2MabVax Therapeutics Receives $1.8 Million in a Phase 2 Small Business Innovation Research Program Award From the National Cancer Institute 3Bacterin International Updates Fourth Quarter and Full Year 2010 Financial Results 2Bacterin International Updates Fourth Quarter and Full Year 2010 Financial Results 3Pam Marrone to Speak at Ag 2.0 Conference 2
(Date:4/20/2015)... 2015 The announcement comes as ... Records Management (GRM), Ireland,s foremost records ... Having built up an impressive track record of clients within ... within the records management sector in Dubai ... GCC staffbase and employ a further eight staff members at ...
(Date:4/13/2015)... a leading cloud-based consumer engagement platform that provides trusted ... communities around health and wellness, announced today the launching ... The ... vehicle to receive validated health information from consumers. ... will allow higi,s trusted partners, on a user opt-in ...
(Date:4/2/2015)... In the current eight ... the strongest competitors, showing outstanding performance in recognition ... is capable of a throughput of 5.000.000 fingerprints ... be ten times faster than most competitors and ...      (Photo: http://photos.prnewswire.com/prnh/20150402/738673-a ) , ...
Breaking Biology News(10 mins):Glenbeigh Records Management Wins Contract With Dubai Islamic Bank 2Glenbeigh Records Management Wins Contract With Dubai Islamic Bank 3higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 2higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 3DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 2DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 3
... Exotic bacteria that do not rely on oxygen may have ... early atmosphere, according to a theory that UChicago researcher Albert ... volcanic crater in Siberia. He has found that bacteria ... a surprising twist that scientists must take into account as ...
... WASHINGTON, April 26, 2011 The American Chemical Society ... " Global Challenges/Chemistry Solutions " podcast series showcasing ... friendly production of a key ingredient used to make ... and accompanying website focus on a new way to ...
... Group announced today that four individuals, representing Chile, Mexico ... in Marine Conservation. The 2011 Pew Marine ... dolphin populations, measure the economic and ecological tradeoffs of ... scientific foundation for the establishment of marine protected areas ...
Cached Biology News:Cold case: Siberian hot springs reveal ancient ecology 2Cold case: Siberian hot springs reveal ancient ecology 3Pew announces 2011 recipients of distinguished marine conservation fellowship 2
Wellpro 96 an automated liquid handling system for 96-well plates that quickly and accurately prepares large quantities of serial dilutions. The Wellpro also performs plate to plate transfers using ...
... Once a macromolecular structure has been determined, ... to a widely diverse audience of scientists, ... printed literature and dissemination over the Internet, ... personal web pages. Printed literature has the ...
ma. plate stack height 70mm...
Buckets for tube holder inserts...
Biology Products: