Navigation Links
IDM Pharma Announces Updated Data From Mifamurtide (L-MTP-PE) Compassionate Access Program
Date:5/15/2008

l survival and quality of life benefits for patients treated with L-MTP-PE continue to be supported through physician experience and we remain committed to advancing L- MTP-PE through the European and U.S. regulatory processes to bring this important treatment to market."

Update on L-MTP-PE Regulatory Status

In January 2008 the Company announced that following presentation of data at an oral explanation hearing before the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, the CHMP determined in a non-binding opinion that L-MTP-PE suggested a possible clinical benefit in terms of survival and granted the Company a clock stop, or time extension. The clock stop allows the Company additional time to respond to all the remaining questions regarding the marketing authorization application for L-MTP-PE (MAA). The CHMP has requested clarification of the existing data in order to gain assurance about the quality of the data before drawing any final conclusions from the data presented. In addition, the Company is required to address a number of remaining questions relating to chemistry, manufacturing and controls (CMC) and the Company expects to provide responses and data regarding these issues to the CHMP in advance of its meeting scheduled for June 23-26, although the CHMP may have additional questions or require additional information regarding these issues. In April, the European regulatory authorities conducted an inspection of the Children's Oncology Group (COG) to assess the quality of the overall survival data from the 2006 confirmatory database included in our applications for regulatory approval, and to review Good Clinical Practices compliance of COG in terms of patient randomization and stratification, overall survival data collection, and study monitoring. The Company supported the COG in this effort.

The Company expects to receive a final opinion from the CHMP in the third quarter and a final decision fro
'/>"/>

SOURCE IDM Pharma, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Poniard Pharmaceuticals Licenses Kinase Inhibitors From The Scripps Research Institute
2. Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
3. Alseres Pharmaceuticals Announces 12 Month Interim Results from the Phase I/IIa Cethrin(R) Clinical Trial in Acute Spinal Cord Injury
4. Alpharma Presents Data Addressing Abuse Liability Features, Safety and Efficacy on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) at the American Pain Society Annual Scientific Session
5. Vion Pharmaceuticals Announces Initiation of Clinical Trial of Cloretazine(R) (VNP40101M) in Combination with Cytarabine
6. Arena Pharmaceuticals, Inc. Announces Initiation of Phase 1 Clinical Trial of Drug Candidate Under Partnership with Taisho Pharmaceutical Co., Ltd.
7. Poniard Pharmaceuticals Completes Enrollment of Phase 2 Picoplatin Trial in Colorectal Cancer
8. Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update
9. Alseres Pharmaceuticals Enters Agreement to Amend Cethrin(R) License to Lower Milestone Payments and Royalty Rates
10. Champions Biotechnology and Concordia Pharmaceuticals Complete Service Agreement and Begin Preclinical Evaluation of Oncology Drugs
11. Diplomat Specialty Pharmacy Develops and Launches Best-In-Class Electronic Navigator (eNAV(TM)) Patient Care System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... July 25, 2014 /PRNewswire-iReach/ -- ScriptPro, of ... Powers Lake, Wisconsin , announce ... distribution and co-marketing agreement allowing ScriptPro to bring ... the United States . ScriptPro ... and workflow systems to retail and ambulatory pharmacies. ...
(Date:7/25/2014)... GrowBLOX Sciences, Inc. (OTCQB: GBLX) is pleased to announce the ... LLC, an Illinois limited liability company ... medical marijuana licenses in the state of Illinois ... 20% equity interest in LaurelCo, LLC in exchange for licenses ... well as all technology related to the machines and to ...
(Date:7/25/2014)... , July 25, 2014  Acsis Inc., ... protection and serialization solutions, has recently posted an ... that addresses current and future needs for companies, ... the old supply chain model no longer work ... technology, including the growth of mobile technology, machine ...
Breaking Medicine Technology:ScriptPro and TCGRx Integrate Pharmacy Automation Technologies 2ScriptPro and TCGRx Integrate Pharmacy Automation Technologies 3GrowBLOX Sciences, Inc. Partners with LaurelCo, LLC to Obtain Licenses to Cultivate and Dispense Medical Marijuana in Illinois 2GrowBLOX Sciences, Inc. Partners with LaurelCo, LLC to Obtain Licenses to Cultivate and Dispense Medical Marijuana in Illinois 3Acsis Addresses Questions on the Modern Supply Chain 2
... MASI ) announced today that it will release fourth ... 31, 2011, after the market closes on February 14, 2012. The ... PT (4:30 p.m. ET) and will be hosted by Joe Kiani, ... Vice President and Chief Financial Officer. A live webcast ...
... BEACH, Fla., Jan. 26, 2012 China Nuvo Solar ... name change to SurgLine International, Inc. has been completed ... under the new OTC ticker symbol: SGLN, effective tomorrow, ... owned operating subsidiary of SGLN. Thomas Toland, ...
Cached Medicine Technology:Masimo to Report Fourth Quarter and Full Year 2011 Financial Results After Market Close on February 14, 2012 2Masimo to Report Fourth Quarter and Full Year 2011 Financial Results After Market Close on February 14, 2012 3China Nuvo Solar Energy, Inc. Completes Name Change to SurgLine International, Inc. 2
(Date:7/26/2014)... The birth control safety center at DrugNews.net is ... legal information on the site. A federal panel recently ... pending for July alleging side effects from the device*. ... popular prescription drugs and medical devices. By giving patients ... all in one place, they can see if others ...
(Date:7/25/2014)... (PRWEB) July 26, 2014 PersonalInjurySolicitorsIreland, ... legal help to people who have suffered from ... launch of both their new company, and a ... on the new website explained, http://www.personalinjurysolicitorsireland.com/personal-injury-claims , ... The focus of the company is always on ...
(Date:7/25/2014)... (PRWEB) July 26, 2014 2014 ... Scanning Confocal Microscope Industry” is a professional ... Scanning Confocal Microscope market. The report provides ... Laser Scanning Confocal Microscope definition, classification, application, ... overview. This research covers international market analysis, including ...
(Date:7/25/2014)... (PRWEB) July 26, 2014 According ... Monitoring Market by Product (vibration monitoring, thermography, ultrasound ... signature analysis), Component, Application and Geography - Global ... the machine health monitoring market is expected to ... 2014 to 2020. , Browse 117 market data ...
(Date:7/25/2014)... York, New York (PRWEB) July 25, 2014 ... dismissal and summary judgment in two DePuy Pinnacle hip ... paving the way for the claims to go before ... reports. In an opinion rendered on July 18th, U.S. ... Texas, ruled that the two Plaintiffs’ claims may proceed ...
Breaking Medicine News(10 mins):Health News:DrugNews Adds Latest Court Updates on Mirena IUD Lawsuits 2Health News:PersonalInjurySolicitorsIreland.com Announces the Launch of their New Company and Website 2Health News:Laser Scanning Confocal Microscope Market: 2014 Global, China Manufacturing Bases Analysis Now at DeepResearchReports.com 2Health News:Laser Scanning Confocal Microscope Market: 2014 Global, China Manufacturing Bases Analysis Now at DeepResearchReports.com 3Health News:Laser Scanning Confocal Microscope Market: 2014 Global, China Manufacturing Bases Analysis Now at DeepResearchReports.com 4Health News:Machine Health Monitoring Market by Product, Component & Application Worth $2.50 Billion by 2020 - New Report by MarketsandMarkets 2Health News:Machine Health Monitoring Market by Product, Component & Application Worth $2.50 Billion by 2020 - New Report by MarketsandMarkets 3Health News:Machine Health Monitoring Market by Product, Component & Application Worth $2.50 Billion by 2020 - New Report by MarketsandMarkets 4Health News:First Federal DePuy Pinnacle Hip Lawsuits Headed for Trial, As Judge Denies Defense Motions For Dismissal, Summary Judgment, Bernstein Liebhard LLP Reports 2Health News:First Federal DePuy Pinnacle Hip Lawsuits Headed for Trial, As Judge Denies Defense Motions For Dismissal, Summary Judgment, Bernstein Liebhard LLP Reports 3Health News:First Federal DePuy Pinnacle Hip Lawsuits Headed for Trial, As Judge Denies Defense Motions For Dismissal, Summary Judgment, Bernstein Liebhard LLP Reports 4
... Inc. (Nasdaq: TRBN ) announced today that executives ... Needham Life Sciences Conference to be held at the New ... co-founder and senior vice president of research and development, and ... scheduled to present on Wednesday, June 10 at 2:00 pm ...
... , , FRANKLIN, Mass., June 4 ... on innovative cardiac and vascular medical device-based technologies, today announced ... of Directors. Dr. Brenner, currently Senior Vice President at ... Magazine, who did not seek re-election. , , Dr. ...
... more dangerous as it travels from country to country , ... to be some encouraging news in the ongoing H1N1 swine ... samples of the virus from points around the globe are ... , "We have tested isolates from a wide geographic area, ...
... Cambrex Corporation (NYSE: CBM ) announced today that ... ("NYSE") informing the Company that it is in compliance with ... the Company on April 14, 2009, the Company had failed ... market capitalization over a consecutive 30-day period and total shareholders, ...
... ... Successfully Encourage Adoption of Healthcare Information Technology , ... Stamford, CT (PRWEB) June 4, 2009 -- IVANS, ... a recent survey that showed healthcare providers believe in the importance of reform, but ...
... St. Jude Children,s Research Hospital(R) celebrated its 7th annual FedEx/St. ... Thalia Mottola on May 16th, at the InterContinental Hotel ... popular Univision show El Gordo y La Flaca ... for their commitment to children,s causes and for their contributions ...
Cached Medicine News:Health News:Trubion to Present at the 8th Annual Needham Life Sciences Conference 2Health News:PLC Systems Announces Appointment of Louis Brenner, M.D. to Board of Directors 2Health News:Global Testing Shows No Variation in Swine Flu Virus 2Health News:Global Testing Shows No Variation in Swine Flu Virus 3Health News:Global Testing Shows No Variation in Swine Flu Virus 4Health News:Global Testing Shows No Variation in Swine Flu Virus 5Health News:Global Testing Shows No Variation in Swine Flu Virus 6Health News:Global Testing Shows No Variation in Swine Flu Virus 7Health News:Global Testing Shows No Variation in Swine Flu Virus 8Health News:Global Testing Shows No Variation in Swine Flu Virus 9Health News:Global Testing Shows No Variation in Swine Flu Virus 10Health News:Global Testing Shows No Variation in Swine Flu Virus 11Health News:Providers Believe Healthcare Reform Will Increase Their Costs, According to IVANS Survey 2Health News:Providers Believe Healthcare Reform Will Increase Their Costs, According to IVANS Survey 3Health News:Photos: Tommy & Thalia Mottola Honored at 7th Annual FedEx/St. Jude Angels & Stars Gala 2Health News:Photos: Tommy & Thalia Mottola Honored at 7th Annual FedEx/St. Jude Angels & Stars Gala 3
... minimal cervical spine manipulation. Prevent dental and ... Cost effective alternative to X-ray. Light-guided intubation ... soft tissues in the neck. This technique ... the trachea relative to the esophagus. A ...
Bivona® stylets are manufactured of malleable stainless steel wire. The length can be adjusted by sliding the attached silicone stopper. The Blue Line® tracheal tube introducer (bougie) is de...
... Aaron manufactures two groups of flexible lighting ... and non-sterile in three different sizes 5", ... shaft portion of the light). These lights ... light is needed., ,The second group ...
... manufactures two groups of flexible lighting products. ... non-sterile in three different sizes 5", 10", ... portion of the light). These lights are ... is needed., ,The second group of ...
Medicine Products: