Navigation Links
IDM Pharma Reports Third Quarter 2007 Financial Results
Date:11/8/2007

patients with metastatic osteosarcoma treated in earlier Phase 2 studies. The biological effects and safety of L-MTP-PE are further supported by data from 7 other Phase 1 and 2 clinical studies performed under IND, in which an additional 197 patients received at least one dose of L-MTP-PE.

L-MTP-PE was granted orphan drug status in the United States in 2001. The NDA for L-MTP-PE was submitted to the U.S. Food and Drug Administration (FDA) in October 2006 and was accepted for review in December 2006.

The FDA's Oncologic Drugs Advisory Committee, or ODAC, met in May 2007 and voted 12 to 2 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. In July 2007, following a meeting with the FDA, the Company announced plans to collect, analyze and submit additional data for L-MTP-PE to the FDA, in an amendment to the NDA, by the first quarter of 2008. In August 2007 the FDA, considering ODAC's recommendation, issued a not approvable letter to the Company after completing the review of the NDA for L-MTP-PE. In this letter, the FDA requested data from additional clinical trials to demonstrate the benefit of L-MTP-PE, as well as information or clarification with respect to other sections of the NDA.

IDM Pharma also is seeking marketing approval from the European Medicines Agency (EMEA) for the use of L-MTP-PE, or MEPACT as it is known in Europe. L-MTP-PE was granted orphan drug status in Europe in 2004. The Marketing Authorization Application (MAA) for L-MTP-PE was submitted to the EMEA and accepted for review in November 2006. The EMEA application is currently under review and the Company continues to work closely with the regulatory body by providing as much additional data as possible and responding to ongoing inquiries from reviewers. The Company expects that the Committee for Human Medicina
'/>"/>

SOURCE IDM Pharma, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine news :

1. Anemia and tropical diseases; Is pharmacogenomics ready for the clinic?
2. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
3. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
4. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
5. The Pharma & Life Sciences Best Practice Database: an Industry Resource for Successful Techniques and Performance Benchmarks for Reaching the Top
6. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
8. National Pharmaceutical Council Announces New Strategic Focus, Search for New Leadership
9. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
11. Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to EUSA Pharma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/2/2015)... As one of only 30 Illinois ... and Health Achievement and Recognition Program (SHARP) certification, ... by the Illinois Department of Labor to host this ... SHARP certification by the Occupational Safety and Health Administration’s ... continued to meet or exceed all of the necessary ...
(Date:5/2/2015)... Vancouver fencing company, QS Fencing, has recently announced that its ... related to their questions on railings and gates. Many people ... and patios. While that seems like an easy task, there ... rolls up their sleeve to start working. One of the ... gate that matches it. , Instead of spending hours worrying ...
(Date:5/2/2015)... ProText Kinetic 2 is a set of typography ... X. ProText Kinetic 2 features 40 animation presets ... X . Easily create interactive text videos without having ... Kinetic 2. , Using ProText Kinetic is as easy as ... presets in the FCPX timeline. Playback the default animation ...
(Date:5/2/2015)... 2015 We are pleased to announce ... Center as one of the Top Workplaces of 2015. ... addiction treatment field for their ethics and standards of ... to continue their educational efforts. The Delray Recovery Center ... forgetting their purpose – to help individuals heal from ...
(Date:5/2/2015)... On Tuesday April 7th, the patient ... to celebrate improvements in patient care. In 2014 the ... had zero acquired ventilator associated infections, zero central line ... was also recently named a Top Performer by the ... credited the teamwork of staff from all departments involved ...
Breaking Medicine News(10 mins):Health News:Essentra Specialty Tapes is Selected to Host Gov. Rauner and the Workers' Memorial Day Celebration 2Health News:Essentra Specialty Tapes is Selected to Host Gov. Rauner and the Workers' Memorial Day Celebration 3Health News:Professional Staff at QS Fencing Company Now Provides Advice on Railings and Gates 2Health News:Pixel Film Studios Announced the Release of Protext Kinetic 2 for FPCX. 2Health News:The Delray Recovery Center Named 2015 Top Workplace 2Health News:East Liverpool City Hospital Celebrates Patient Care Improvements 2
... going blind and not know it. Silently, without symptoms, Glaucoma ... ,January is Glaucoma Awareness Month, and the American Academy ... urges everyone to get a complete eye exam, especially if ... ,* African-Americans older than 40 ,* Hispanics ,* People with ...
... long been associated with an increased risk of injury ... says a recent study// by a University of Missouri, Columbia. ... Vinson, professor of community and family medicine, found that patients ... injured. However, patients who reported better sleep quality in the ...
... New research published in the Jan. 10 issue of ... University chemists// and North Carolina State University toxicologists, finds ... ,This research was based on the ... buckyball-containing amino acids. "Our results confirm that repetitive ...
... new software-based approach to detect osteoporosis while doing routine ... width of a part of the patient`s lower jaw. ... at the University’s School of Dentistry adapted the ‘active ... of Imaging Sciences and use it to automatically detect ...
... younger someone starts drinking alcoholic beverages, the more likely ... to relieve stress when older, a large new study ... among persons who started drinking at 14 or younger ... drinking are already higher than those of other drinkers,” ...
... undergone a hip replacement surgery and is resting comfortably//. ... the Mayo Clinic in Rochester, Minnesota said on its ... of the current president. His surgery came two days ... of former president Gerald Ford, who died Dec 26 ...
Cached Medicine News:Health News:Glaucoma: Silently Stealing Sight from Millions 2Health News:A Study Explores the Medical Potentials of Bucky Amino Acids 2Health News:Youngest Drinkers Likelier to Use Alcohol for Stress Relief as Adults 2
(Date:5/1/2015)... REDWOOD CITY, Calif. , May 1, 2015  AcelRx ... company focused on the development and commercialization of innovative ... today announced that Timothy E. Morris , chief ... events.  Details of the events are as follows: ... Tuesday, May 5 Location:  The Omni Berkshire Place, ...
(Date:4/30/2015)... ON , April 30, 2015 /PRNewswire/ - ... specialty pharmaceutical company with a focus on Omega-3 ... announced its operational highlights and financial results for ... dollar amounts referenced herein are in Canadian dollars ... 2014 have been significant, with the right strategic ...
(Date:4/30/2015)... SUNNYVALE, Calif. , April 30, 2015 /PRNewswire/ ... that it has signed an agreement with MIM ... for the TomoTherapy ® and CyberKnife ® ... both Accuray and MIM technology. This is Accuray,s ... to the development of the first iPad-based treatment ...
Breaking Medicine Technology:AcelRx Pharmaceuticals to Participate at Upcoming Investor Conferences in May 2Pivotal Therapeutics Announces 2014 Financial Results 2Pivotal Therapeutics Announces 2014 Financial Results 3Pivotal Therapeutics Announces 2014 Financial Results 4Pivotal Therapeutics Announces 2014 Financial Results 5Pivotal Therapeutics Announces 2014 Financial Results 6Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 2Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 3
... , , ... SILVER SPRING, Md. , Jan. 18 The ... a counterfeit and potentially harmful version of Alli 60 mg ... ) , Preliminary laboratory tests conducted by GlaxoSmithKline (GSK) -- ...
... , Kidney Care Partners, Members Provide Dialysis Equipment, ... Access to Life-Saving Treatment , PORT-AU-PRINCE, Haiti ... an earthquake that has devastated this Caribbean country, ... of millions of dollars as well as dialysis equipment, medications, ...
Cached Medicine Technology:FDA Warns Consumers about Counterfeit Alli 2FDA Warns Consumers about Counterfeit Alli 3U.S. Kidney Dialysis Community Responds to Haiti's Emergency Plea for Life-Saving Dialysis Care 2U.S. Kidney Dialysis Community Responds to Haiti's Emergency Plea for Life-Saving Dialysis Care 3
Finstruments 96 well washer and Cellwasher. Multi-function with touch programmable display....
... plus simple operation especially ... efficient washing of cells. ... with minimum loss of ... membrane bound labels and ...
The Finstrip 4 is an effective and reliable microplate washer offering high performance, simplicity and ease of use....
... PW 384 has set a standard for ... plates. The instrument not only processes all ... washing to further boost wash performance. This ... short wash times as no transport steps ...
Medicine Products: