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:12/17/2014)... (PRWEB) December 17, 2014 Gene ... that it has entered into a technology access ... (ADM) to apply DNA2.0’s proprietary protein engineering technology, ... process. , “We are extremely excited that the ... platform. This proprietary bioengineering technology has now ...
(Date:12/17/2014)... SOUTH SAN FRANCISCO, Calif. , Dec. 17, ... positive results of a Phase 2 study evaluating ... for the treatment of patients with severe, chronic ... the current standard of care, including topical steroids ... endpoint was percent change in Visual Analog Scale ...
(Date:12/15/2014)...  GlassesOff Inc. (OTCBB: GLSO) announced today the appointment ... director of the Company,s Board of Directors. ... its CEO until its acquisition by Stanley Black ... Recognized as the inventor of the first Wi-Fi-based Active ... -based RFID solutions focused on improving operational efficiency, safety ...
(Date:12/13/2014)... (PRWEB) December 12, 2014 Clarassance, a ... announced its new name: Therabron Therapeutics , Inc. ... and bronchioles (a type of structure in the lungs ... company’s mission to develop novel protein therapeutics for the ... directors decided to change the name to mark the ...
Breaking Biology Technology:ADM and DNA2.0 Enter Into Protein Engineering Technology Access and Service Agreement 2Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 2Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 3Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 4AeroScout Founder Joins GlassesOff's Board of Directors 2AeroScout Founder Joins GlassesOff's Board of Directors 3Maryland-based Biotech Company's Path Forward in Treating Respiratory Diseases Sparks Name Change 2
... Jan. 31 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc.,("Oncolytics") (TSX:ONC, ... criteria to proceed to full enrolment in its ... of REOLYSIN(R) in patients with,various sarcomas that have ... trial protocol, to proceed to full enrolment of ...
... blueprint of all life, giving instruction and function to ... beings. Now Northwestern University researchers report they have used ... build a three-dimensional structure out of gold, a lifeless ... the researchers built two common but very different crystalline ...
... 19.8% Revenue Growth -, PRINCETON, N.J., Jan. 30 ... fourth quarter ended December 31, 2007,of $0.78 per diluted ... $0.06 per share gain from the sale of its ... $0.72 per diluted share in the,fourth quarter, representing 21.8% ...
Cached Biology Technology:Oncolytics Biotech Inc. Proceeds to Full Enrolment in U.S. Phase II Sarcoma Clinical Trial 2Oncolytics Biotech Inc. Proceeds to Full Enrolment in U.S. Phase II Sarcoma Clinical Trial 3DNA is blueprint, contractor and construction worker for new structures 2DNA is blueprint, contractor and construction worker for new structures 3Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 2Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 3Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 4Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 5Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 6Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 7Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 8Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 9Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 10Covance Reports Full-Year 2007 Revenue Growth Of 15.4% and Seventh Consecutive Year of EPS Growth in Excess of 20% 11
(Date:12/3/2014)... 2, 2014 As part of our commitment ... is pleased to announce the release of a new ... collect the workforce data that they need. ... left by existing readers. Many such devices have serious ... modern technology. Older models force users to navigate numerous ...
(Date:11/21/2014)... JOSE, Calif. , Nov. 20, 2014   ... global leader in microcontroller (MCU) and touch technology solutions, ... digital temperature sensors with the widest V cc ... delivers higher temperature accuracy and faster I 2 C ... registers and serial EEPROM memory making them ideal for ...
(Date:11/15/2014)... NEW YORK , Nov. 13, 2014  While we ... of technology Doctor McCoy used in "Star Trek" to gain ... and tools designed to work with smartphones and tablets for ... corners of the healthcare world. This may seem a tad ... are ready to adopt some of these technological opportunities into ...
Breaking Biology News(10 mins):Inception Technologies to Release New Biometric Reader 2Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 2Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 3Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 4Americans May Be Ready for a Brave New World of Healthcare 2Americans May Be Ready for a Brave New World of Healthcare 3Americans May Be Ready for a Brave New World of Healthcare 4
... using a novel technique to better understand mineral growth ... Ridge National Laboratory are improving predictions of mineral reactions ... oil pipes clear to sequestering radium. The mineral ... generally, but also because it is the dominant scale-forming ...
... SUNY Downstate Medical Center,s growth into a major center ... awarded SUNY Downstate a four-year challenge grant of $220,000 ... causes, treatment, and prevention of blinding diseases. Douglas R. ... principal investigator. RPB is the world,s leading voluntary organization ...
... one of the most common neurological diseases, more than 4,000 ... decoded over the next five years in a study led ... and several collaborating institutions. Daniel Lowenstein, MD , ... been attempted for identifying the genetic causes of epilepsy, and ...
Cached Biology News:Metadynamics technique offers insight into mineral growth and dissolution 2SUNY Downstate receives grant from research to prevent blindness 2UCSF shares $25-million grant to find epilepsy genes 2UCSF shares $25-million grant to find epilepsy genes 3
... system, 220-240 V, is used for nucleic acid ... slab gel format. The system includes the modular ... separating nucleic acids with single base-pair resolution and ... and bonded inner glass plate, outer glass plate, ...
... PowerPac HV high-voltage power supply, with temperature probe, ... of 5,000 V, 500 mA, and 400 W. ... temperature between 0 and 90 degrees C during ... transfer. Power cord and instructions are provided. Dimensions ...
... cooling coil, Trans-Blot cell, provides ... high-intensity, and extended electrophoretic transfer ... Trans-Blot cell. Use of the ... to an external water recirculator, ...
... By incorporating a wide range of next-generation ... sets a new standard for flexible laboratory ... handling including pipetting, dilution, dispensing, and ... thats as powerful and flexible as it ...
Biology Products: