Navigation Links
Neurochem announces European opinion for Eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis
Date:12/14/2007

ECUBLENS, Switzerland, Dec. 14 /PRNewswire-FirstCall/ - Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX: NRM), announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a negative opinion recommending refusal of the marketing authorization application (MAA) for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis and concluding that another study would be needed to demonstrate eprodisate's (KIACTA(TM)) effectiveness. The Company is currently reviewing all of its options in view of this opinion, including the option of requesting a re-examination of the opinion by CHMP. As provided by the European regulations, the Company may request that the CHMP consult a Scientific Advisory Group (SAG) in connection with the re-examination. The deadline for filing any such request is within fifteen days of receipt of notification of the opinion.

"We are naturally disappointed with this opinion for KIACTA(TM) as we are acutely aware of the needs of AA amyloidosis patients who have no specific therapy presently available," said Dr. Francesco Bellini, Neurochem Inc.'s Chairman, President and CEO. "In view of the clinical benefit KIACTA(TM) has shown on the kidney function of patients, we are considering making a request for re-examination of the opinion which could lead to a decision as early as the second quarter of 2008. We look forward to further productive interactions with the EMEA," he concluded.

U.S. New Drug Application (NDA)

In the U.S., Neurochem Inc. received an acknowledgement from the Food and Drug Administration (FDA) that the Company's response to th
'/>"/>

SOURCE NEUROCHEM INC.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Neurochem reports results for third quarter of fiscal 2007
2. Neurochem announces departure of Dr. Philippe Calais, President, Global Business
3. Neurochem announces eprodisate (KIACTA(TM)) receives acknowledgement of complete response and is granted Class 2 review
4. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
5. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
6. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
7. HEI, Inc. Announces Sale of RFID Division Assets
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
9. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
10. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
11. Brooke Franchise Corporation Announces Selected July Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/2/2015)... Prussia, PA (PRWEB) June 02, 2015 ... Outsourcing solutions for health plans in the Medicare Advantage, ... participation as a sponsor and exhibitor at AHIP’s Institute ... America’s Health Insurance Plans. The conference will be held ... exhibition booth, #1303, will offer opportunities for attendees to ...
(Date:6/2/2015)... Dallas, TX, USA (PRWEB) June 02, 2015 ... and microsystems, is deploying its growth strategy to benefit ... on BioMEMS: “In Yole Développement’s May 2015 Status of ... market will grow sharply and reach $6.6B in 2020,” ... at Yole Développement . , The analyst adds ...
(Date:6/2/2015)... MedPro Healthcare Staffing, the leading provider of temporary ... the worldwide release of the MedPro Top Jobs app, ... find best jobs that fit their needs. , According ... 10 job seekers report they’re likely to use a ... Top Jobs app gives its users 24/7 mobile access ...
(Date:6/2/2015)... June 02, 2015 Claflin Medical ... has announced the acquisition of RSI Equipment, ... effective May 29th, 2015. , With CME’s recent merger ... latest acquisition joins three premier organizations which specialize in ... and healthcare facilities. By combining forces, they now cover ...
(Date:6/2/2015)... (PRWEB) June 02, 2015 MAP Health ... and revenue cycle management for addiction treatment facilities, announced ... Vice President of Marketing. Mr. Smith will be responsible ... the awareness and visibility of MAP’s core message, products ... was the Marketing Manager at Cottonwood Financial in Irving, ...
Breaking Medicine News(10 mins):Health News:TMG Health to Sponsor and Exhibit at AHIP’s Institute 2015 2Health News:Tronics Aims to Benefit from Major Growth of Sensors and Related Technologies for Healthcare Applications 2Health News:MedPro Healthcare Staffing Launches New MedPro Top Jobs App To Facilitate Job Search For Healthcare Professionals 2Health News:Claflin Medical Equipment (CME) Announces Acquisition of RSI Equipment, Inc. 2Health News:Jared Smith Joins MAP Health Management, LLC, as Vice President of Marketing 2
... understanding of the evolution and spread of viruses like H5N1, ... a consortium, where all// information about the avian influenza will ... on Sharing Avian Influenza Data (GISAID) was announced in ... that was signed by 70 scientists and health officials. Dr. ...
... a vaccine against pneumococcal disease will be introduced for the ... 50 babies and small children a year and prevnt// illness ... national childhood immunisation programme. all babies will be vaccinated against ... months,from Sept.4. Apart from that, in a catch-up programme, infants ...
... analytical capabilities of high-tech laboratory tools, like computers, their ... they have// developed a second generation "lab on a ... first time rapidly and reliably sequences all mitochondrial DNA, ... Diagnostics. Mitochondria which are the energy-producing organelles in cells, ...
... tools such as computers with greater analytical capacities are ... generation "lab on a silicon chip" called the MitoChip ... mitochondrial DNA quickly and reliably. Their report will be ... Molecular Diagnostics. ,The mitochondria have their own ...
... a coordinated global plan, especially in developing countries to ... HIV/AIDS-related cases. ,57 countries, mostly in sub-Saharan ... facing acute shortage. Over 4 million workers are needed ... Train, Retain’ is an essential part of its effort ...
... latest example of growing online interaction between Britain and ... hour for online tuition on various subjects from teachers ... have been receiving such one-to-one tuition using Internet telephony ... employs teachers who work in shifts. ,While ...
Cached Medicine News:Health News:Global avian flu database 2Health News:Global avian flu database 3Health News:Global avian flu database 4Health News:Immunisation programme to include vaccine against Pneumococcal disease 2Health News:High -tech Mitochondrial DNA Sequencing Tool Updated 2Health News:High -tech Mitochondrial DNA Sequencing Tool Updated 3Health News:High -tech Mitochondrial DNA Sequencing Tool Updated 4Health News:MitoChip v2.0 – the new Mitochondrial DNA sequencing too 2Health News:MitoChip v2.0 – the new Mitochondrial DNA sequencing too 3Health News:MitoChip v2.0 – the new Mitochondrial DNA sequencing too 4Health News:British Pupils Opt for Online Tuition from India 2
(Date:6/2/2015)... , June 2, 2015 ... and segments the concerned market with analysis and ... $261.8 million in 2014, and is estimated to ... of 19.3% from 2014 to 2019. ... Simulation Market for an analysis of industry trends ...
(Date:6/2/2015)... , June 2, 2015 BioDelivery Sciences International, Inc. ... the presentation by Dr. Mark A. Sirgo , President ... 2:30 PM Eastern time. Jefferies 2015 Global Healthcare ... Hyatt, New York City , NY ... accessed at www.bdsi.com .  For those who are not ...
(Date:6/2/2015)... -- Only a quarter of physicians who prescribe opioids say ... them to, according to new survey results released by ... and myCME , Haymarket Medical Education,s global medical ... director of BUSM,s Safe and Competent Opioid Prescribing ... a critical need for provider education addressing this issue. ...
Breaking Medicine Technology:North America Mannequin-Based Simulation Market is Expected to Reach $632.5 Million by 2019, at a CAGR of 19.3% From 2014 to 2019 2North America Mannequin-Based Simulation Market is Expected to Reach $632.5 Million by 2019, at a CAGR of 19.3% From 2014 to 2019 3BioDelivery Sciences to Present at the Jefferies 2015 Healthcare Conference - Schedule Change 2BioDelivery Sciences to Present at the Jefferies 2015 Healthcare Conference - Schedule Change 3Survey Results Show Few Doctors Are Very Confident Managing Patients on Opioids 2
... ... Jolla-, ... /PRNewswire-,FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD ), a,biopharmaceutical company ... organization, today announced,that an agreement has been executed licensing classes of ...
... The Quigley,Corporation (Nasdaq: QGLY ) announced positive ... subsidiary, Quigley Pharma Inc., which was,conducted in chickens ... The compound was administered to chicks that had ... from the study indicated,that QR448(a) is efficacious against ...
Cached Medicine Technology:Poniard Pharmaceuticals Licenses Kinase Inhibitors From The Scripps Research Institute 2Poniard Pharmaceuticals Licenses Kinase Inhibitors From The Scripps Research Institute 3Poniard Pharmaceuticals Licenses Kinase Inhibitors From The Scripps Research Institute 4Quigley Announces Successful Poultry Study of Chickens With Infectious Bronchitis; Plans to Approach the Poultry Industry for Potential Commercialization 2Quigley Announces Successful Poultry Study of Chickens With Infectious Bronchitis; Plans to Approach the Poultry Industry for Potential Commercialization 3Quigley Announces Successful Poultry Study of Chickens With Infectious Bronchitis; Plans to Approach the Poultry Industry for Potential Commercialization 4Quigley Announces Successful Poultry Study of Chickens With Infectious Bronchitis; Plans to Approach the Poultry Industry for Potential Commercialization 5
... is a new product number, ... product number. If showing no ... the old Sigma-Aldrich number (Z37,160-2) ... assistance. Color: colour-coded ...
... These 3mL PYREX volumetric pipets ... tolerances in accordance with ASTM ... pipet is individually serialized and ... Identification and Capacity, traceable to ...
... disposable lever action skin stapler ... that is designed to provide ... work from your normal vantage ... available in four configurations: 35 ...
... Reference Series 2000 Pipette is a synonym ... compact and robust design, and superior operating ... to operate the measuring stroke and blow-out ... features:Eppendorf "pipette/tip" system ensures utmost accuracy and ...
Medicine Products: