Navigation Links
IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)
Date:9/26/2008

eceived feedback from the CHMP that there are no major objections remaining related to chemistry, manufacturing and controls (CMC)."

Mr. Walbert continued, "While we have satisfactorily addressed issues related to the positive benefit/risk assessment reached at the oral explanation meeting with the CHMP in January 2008, we have been invited by the CHMP to meet with SAG-O and CHMP in November to address certain open issues arising from the assessment by the Rapporteur and Co-Rapporteur. We welcome the opportunity to present to both the SAG-O and CHMP to complete the L-MTP-PE MAA review and we remain confident that L-MTP-PE provides a significant overall survival benefit for osteosarcoma patients and meets an important unmet treatment need."

With the final CHMP opinion now anticipated in November, IDM Pharma expects a final decision from the European Commission in the first quarter of 2009. If approved for Marketing Authorization by the European Commission, L-MTP-PE will be the first treatment in more than 20 years approved for patients with osteosarcoma.

In January 2008, the Company announced that, following presentation of data at an oral explanation hearing, 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 to allow IDM Pharma additional time to respond to questions regarding the MAA. At that time, the CHMP 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 was required to address a number of remaining questions relating to CMC.

In April 2008, the European regulatory authorities conducted an inspection of the COG to assess the quality of the overall survival data from the 2006 confirmatory database included in the Company's applications for regulatory approval, and to review GCP c
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. Quark Pharmaceuticals Announces First RNAi Drug Candidate Having a Novel, Proprietary Structure Covered by Quark Intellectual Property
2. Lotus Pharmaceuticals, Inc.s New Drug Laevo-Bambutero Begins Evaluation for Clinical Trials
3. VIA Pharmaceuticals Completes Patient Visits in Phase 2 Acute Coronary Syndrome (ACS) Trial
4. QuatRx Pharmaceuticals Announces Additional Data From Phase 3 Study for Ophena(TM) (Ospemifene Tablets) Showing Improvements in Clinical Symptoms of Vulvovaginal Atrophy
5. PharmAthene Presents Data for Protexia(R) and Valortim(R) at 2008 BARDA Industry Conference / PHEMCE Stakeholders Workshop
6. Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
7. Oramed Pharmaceuticals Commences Phase 2A Trials of its Oral Insulin Capsule on Type 1 Diabetics
8. Enobia Pharma Appoints Industry Veterans with Commercial and Manufacturing Expertise to Expand Senior Management Team
9. Vion Pharmaceuticals Enters into Agreement to Conduct a Phase I/II Clinical Trial of Cloretazine(R) in Combination with Induction Therapy in Poor Prognosis AML Patients
10. Enobia Pharma Receives FDA Orphan Drug Designation for Hypophosphatasia Product Candidate ENB-0040
11. Pharmasset to Present at the UBS Global Life Sciences Conference on Wednesday, September 24th
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014  Commonwealth Cornerstone Group (CCG) today announced the completion ... Tuesday to help fund the expansion and consolidation of healthcare ... Sharon . PHN is the largest ... . It is the largest employer in Sharon,s ... on staff. Currently, PHN Sharon offers scattered services ...
(Date:12/24/2014)...  The International Trade Commission (ITC) issued its final decision ... In a notice issued on December 23, the ITC ruled ... its humidifier was invalid. BMC President, James ... very excited with the ITC,s decision in this case. This ... since the very beginning on the key patents in the ...
(Date:12/24/2014)... YORK and LONDON , ... global orthopedic industry are expected to grow at an ... in terms of value and volume. Hip, knee and ... developed world while in emerging economies they have a ... rates are challenging the use of composites. Non-metallic orthopedic ...
Breaking Medicine Technology:Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 2Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 3ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 3
... STAAR Surgical Company (NASDAQ: STAA ), a ... products, today reported financial results for the first quarter ... 8% to $14.8 million over the first quarter of ... and ICL) sales.  The Company achieved its first quarter ...
... 3, 2011 Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ ) ... Total revenues for the quarter ended March ... the first quarter of 2010.  Total revenues included net product ... for the first quarter of 2011 was $21.8 million, or ...
Cached Medicine Technology:STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 2STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 3STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 4STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 5STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 6STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 7STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 8STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 9STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 10STAAR Surgical Reports First Quarterly Profit from Continuing Operations Since 2000 11Jazz Pharmaceuticals Announces First Quarter 2011 Financial Results 2Jazz Pharmaceuticals Announces First Quarter 2011 Financial Results 3Jazz Pharmaceuticals Announces First Quarter 2011 Financial Results 4Jazz Pharmaceuticals Announces First Quarter 2011 Financial Results 5Jazz Pharmaceuticals Announces First Quarter 2011 Financial Results 6Jazz Pharmaceuticals Announces First Quarter 2011 Financial Results 7
(Date:12/24/2014)... 2014 Dr. Vu Ho, a Dallas ... his practice and med-spa with the addition of new ... of cosmetic treatments and services. , “Silk Peel is ... says Dr. Ho. “As a result it can address ... sun spots, discolorations or blemishes.” , Similar to microdermabrasion, ...
(Date:12/24/2014)... TX (PRWEB) December 25, 2014 The ... to 2023” focuses on the current treatment landscape, unmet ... cancer market. Stivarga is a drug which is used ... drug is orally administered and is also prescribed to ... drug which is FDA approved is a multi-kinase inhibitor ...
(Date:12/24/2014)... (HealthDay News) -- The holidays can be a challenge for ... certain foods and drinks. "This is the season in ... of migraine," Dr. David Dodick, chair of the American Migraine ... "It,s important to think through food and beverage choices, to ... Dodick, a professor of neurology at the Mayo Clinic in ...
(Date:12/24/2014)... 24, 2014 (HealthDay News) -- Researchers say they have ... develop into eggs and sperm. While this had ... the first time that these types of cells -- ... using human stem cells, according to the team at ... of primordial germ cells is one of the earliest ...
(Date:12/24/2014)... 2014 Gluten, a protein found predominately ... have an intolerance to gluten, causing side effects that ... headaches, joint pain and fatigue. For this reason, Diet ... that deliver safe and fast weight loss while teaching ... gluten allergy reaction. These gluten free diet plans combine ...
Breaking Medicine News(10 mins):Health News:Dr. Vu Ho Expands Facial Plastic Surgery Practice to Include New Skin Care Treatment 2Health News:Stivarga Colorectal Cancer Treatment Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:Stivarga Colorectal Cancer Treatment Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3Health News:Expert Offers Tips for Preventing Holiday Migraines 2Health News:Diet Doc Adds Gluten Free Diet Plans to Their Stable of Specialized Weight Loss Programs 2Health News:Diet Doc Adds Gluten Free Diet Plans to Their Stable of Specialized Weight Loss Programs 3
... ... and Ethan Nadelmann, PhD, JD, is Keynote Speaker on the Failed War on Drugs ... Las Vegas, NV (PRWEB) September ... founder of the Drug Policy Alliance advocating for drug reform in the United States as ...
... U.S. reports unusually high flu activity, most of it swine ... officials said Friday that additional trials of the H1N1 swine ... a strong immune response in healthy adults. , The findings ... that found that a single dose of the vaccine creates ...
... , WINSTON-SALEM, N.C., Sept. 11 Sales of ... three years after the FDA approved the drug an estimated three ... advertising and lobbying for government mandates. A recent marketing study ... professor of marketing at Wake Forest University, and several colleagues conducted ...
... , TERRE HAUTE, Ind., Sept. 11 Indiana State University,s ... environmental health sciences professors using the campus as her classroom. , ... year at the school, is teaching the course titled "Communicable and Chronic ... to learn about various types of pathogens - the biological agents that ...
... , , , WASHINGTON, ... Civil Rights and Elections (AMT), a coalition of major national Islamic organizations, ... health care reform. , , DATE: Tuesday, September 15, ... Hill, Washington, D. C. , , TIME: 10 AM-1 ...
... , SEATTLE, Sept. 11 The following ... the synthesis blog, winner of the 2008 Weblog award for ... , It,s true that the devil is in the details, ... about the outcome you,re trying to create, then whatever you,re doing, however ...
Cached Medicine News:Health News:Healthcare Legal Issues Take the Stage at PAINWeek 2009 2Health News:Healthcare Legal Issues Take the Stage at PAINWeek 2009 3Health News:Swine Flu Trials Continue to Point to 1-Dose Vaccine 2Health News:Swine Flu Trials Continue to Point to 1-Dose Vaccine 3Health News:HPV Vaccine Study Shows Why Few Women Getting Shots 2Health News:Professor Uses H1N1 as a Teaching Tool 2Health News:Professor Uses H1N1 as a Teaching Tool 3Health News:Muslim Coalition to Host D.C. Hearing on Health Care Reform 2
... Tissue Sectioning System has maintained the reputation ... Researchers from around the globe have relied ... fresh and fresh fixed tissue sectioning needs ... the Vibratome Automatic Tissue Sectioning Systems, the ...
Replacement bulb for Vibratome light system....
Injector blades come ten to an injector and allow for the easy replacement of Vibratome cutting blades....
Vibratome Specimen Adhesive is a special formulation developed by a major adhesive manufacturer for applications such as tissue mounting. The advantage of this adhesive is that it has a strong holdi...
Medicine Products: