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

rther confirm the overall survival benefit of L-MTP-PE in osteosarcoma and provide evidence for approvability."

The Company will continue working with the cooperative groups and investigative sites involved in the study to collect vital status (information on whether the subjects remain alive or have died) on patients who participated in the Phase 3 clinical trial and for whom complete data were not available at the time of filing of the NDA in October 2006. When the additional follow up data have been collected, the Company will analyze the data and expects to submit an amendment to the NDA to the FDA by the first quarter of 2008. In addition to collecting supplemental Phase 3 data, the Company will address the other points raised in the FDA action letter.

"While we believe the evidence demonstrating the overall survival benefit of L-MTP-PE exists, we commend IDM Pharma for their continued investment in and commitment to working with investigators to collect the most recent data available," said Matthew Alsante, executive director, Sarcoma Foundation of America. "As the survival in children with osteosarcoma has not improved in the last twenty years, gaining approval of investigational agents with demonstrated improvement in survival is critical."

Conference Call Details

The Company will be holding a conference call on Monday, August 27, 2007 at 4:30 p.m. ET. A webcast of the call will be accessible through the Company's website at http://www.idm-pharma.com. A replay of the call will be available on the website for 30 days.

Dial-In Information:

U.S. Dial-In: (800) 289-0529

International Dial-In: 913-981-5523

Passcode (both U.S. and International): 4467870

About the mifamurtide (L-MTP-PE) NDA

The L-MTP-PE NDA includes efficacy and safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received L-MTP-PE, and from 115 pati
'/>"/>

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:8/3/2015)... Mass. , Aug. 3, 2015  Merck KGaA, ... for innovative and top-quality high-tech products in the healthcare, ... with the US-based company Nano-C, their development and launch ... of organic photovoltaics (OPV). Merck KGaA, Darmstadt, ... in the growing OPV sector. Novel derivatives: ...
(Date:8/3/2015)... According to a new market ... Asia to Witness Highest Growth ... cell culture market was valued at US$ 586.1 Mn in ... of 29.1% to account for US$ 2,717.6 Mn by ... 3D cell culture refers to a ...
(Date:7/31/2015)... 2015 China Cord Blood Corporation (NYSE: CO) ... leading provider of cord blood collection, laboratory testing, hematopoietic ... announced that the Company has filed its Annual Report ... Commission. The filed Form 20-F includes audited financial statements ... Form 20-F can be accessed by visiting the U.S. ...
(Date:7/30/2015)... Dallas, TX, USA (PRWEB) , ... July 30, ... ... nano and microsystems, has appointed Francois Vieillard as Sales & Marketing Director. ... executive positions, Francois Vieillard will be responsible for reinforcing Tronics’ business development activities ...
Breaking Biology Technology:Merck KGaA, Darmstadt, Germany, and Nano-C Present Enhanced Materials for Organic Photovoltaics 2Merck KGaA, Darmstadt, Germany, and Nano-C Present Enhanced Materials for Organic Photovoltaics 3Merck KGaA, Darmstadt, Germany, and Nano-C Present Enhanced Materials for Organic Photovoltaics 4Global 3D Cell Culture Market Will Reach US$ 2,717.6 Million by 2020: Persistence Market Research 2Global 3D Cell Culture Market Will Reach US$ 2,717.6 Million by 2020: Persistence Market Research 3Global 3D Cell Culture Market Will Reach US$ 2,717.6 Million by 2020: Persistence Market Research 4China Cord Blood Corporation Files Its Annual Report on Form 20-F 2Tronics appoints Francois Vieillard as Sales and Marketing Director 2
... research center. The facility would be built between University ... Madison, Wis. Wisconsin should hold on to its ... million in public and private funding for a new research ... Doyle said on Wednesday. , ,He also called for ...
... have been transformed into specific cells of the body. Courtesy ... Madison, Wis. The answer to reversing the ... may lie in stem-cell treatment, according to the ongoing research ... Life Sciences and Venture Conference held Wednesday at Monona ...
... Bureau of Labor and Statistics projections: by 2006 two employees ... 2008, there will be a national shortage of ten million ... job loss, and when off-shoring is becoming de rigueur, these ... common arguments I hear refuting BLS statistics, along with my ...
Cached Biology Technology:Wisconsin governor calls for $750 million investment in life sciences 2Wisconsin governor calls for $750 million investment in life sciences 3Wisconsin governor calls for $750 million investment in life sciences 4Wisconsin governor calls for $750 million investment in life sciences 5UW-Madison puts heart and mind into stem cells 2UW-Madison puts heart and mind into stem cells 3Talent shortage? Cmon. 2
(Date:8/3/2015)... Aug. 3, 2015 Synaptics, Inc. (Nasdaq: ... today announced that members of the executive management team ... Crest Global Technology Leadership Forum on Tuesday, August 11, ... be held at the Sonnenalp Resort in ... may include forward-looking information. An audio webcast of the ...
(Date:7/31/2015)... de julio de 2015 La 10 th ... por medio de BGI del 22 al 25 de octubre de ... Este año, la conferencia celebra su décimo aniversario. Desde ... en una de las reuniones anuales más influyentes del mundo ... reuniones más dinámicas, entusiastas y mejores a nivel científico. ...
(Date:7/27/2015)... JOSE, Calif. , July 27, 2015 /PRNewswire/ ... developer of human interface solutions, today announced that ... ® touchscreen solution for its stylish smartwatch. ... for its proven reliability, low power and highly ... a wet finger. Huawei designers also required a ...
Breaking Biology News(10 mins):La 10th International Conference on Genomics (ICG-10) se llevará a cabo en octubre 2La 10th International Conference on Genomics (ICG-10) se llevará a cabo en octubre 3Synaptics Touchscreen Solution Powers New Huawei Watch 2Synaptics Touchscreen Solution Powers New Huawei Watch 3
... key building block of life, actin is one of the ... First discovered in muscle cells more than 70 years ... that works by linking itself in chains to form filaments. ... contraction. So it came as a surprise when ...
... August 2011, researchers from the U.S. Department of Agriculture ... puzzle in Kennewick, Wash. Since Kennewick lies within a ... apple-growing region, an annual survey of fruit trees is ... to look for any invading insects. This time the ...
... boats, many invasive species are now covering our shorelines and ... a study published in Ecology Letters , Northeastern University ... some invasive species to survive in their new environments and ... Once invasive species arrive in their new location, ...
Cached Biology News:UT MD Anderson scientists uncover the nuclear life of actin 2UT MD Anderson scientists uncover the nuclear life of actin 3Genetic analysis saves major apple-producing region of Washington state 2Invasive species: Understanding the threat before it's too late 2
...
... Molecular Probes is pleased to ... for the ultrasensitive detection of primary ... at Indiana University, the ATTO-TAG reagents ... o-phthaldialdehyde (OPA), naphthalene-2,3-dicarboxaldehyde (NDA) and anthracene-2,3-dicarboxaldehyde, ...
... Molecular Probes is pleased to ... for the ultrasensitive detection of primary ... at Indiana University, the ATTO-TAG reagents ... o-phthaldialdehyde (OPA), naphthalene-2,3-dicarboxaldehyde (NDA) and anthracene-2,3-dicarboxaldehyde, ...
...
Biology Products: