Navigation Links
Neurochem reports results for fourth quarter and fiscal year 2007 and important advances on corporate objectives
Date:2/20/2008

tration (FDA), the amount would no longer be refundable and would be amortized as earned revenue.

In December 2007, the Company received an acknowledgement from the FDA that Neurochem's response to the approvable letter received in July 2007 for the New Drug Application (NDA) for eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis is a complete, Class 2 response. The PDUFA (Prescription Drug User Fee Act) goal date by which the FDA is expected to render a decision is April 2, 2008. In the second approvable letter (July 2007), the FDA indicated that an additional efficacy trial will be necessary before the FDA could approve the investigational product candidate. The approvable letter also states that additional submissions, filed by Neurochem as part of its response to this approvable letter, may address issues raised in this letter. The FDA has indicated that additional submissions could persuade the agency to eliminate the requirement for an additional trial. The FDA also asked for additional information, including further pharmacokinetic studies, and again acknowledged that a QT clinical study should be submitted as part of a Phase IV (post-approval) commitment.

Neurochem has also submitted for marketing approval eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis in the European Union and Switzerland. In December 2007, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a negative opinion recommending refusal of the marketing authorization application (MAA) for eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis in the European Union and concluded that another study would be needed to demonstrate eprodisate's (KIACTA(TM)) effectiveness. The Company requested a re-examination of the opinion by CHMP. As provided by the European regulations, the Company requested that the CHMP consult a Scientific Advisory Group in connection with the re-examination.
'/>"/>

SOURCE NEUROCHEM INC.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

Related medicine news :

1. Neurochem to present at 2008 BIO CEO & Investor Conference - Presentation will be Web cast live
2. Neurochem appoints Mr. Gary Schmid as CEO of new nutraceutical business
3. Neurochem to present at JPMorgan Healthcare Conference
4. Neurochem announces European opinion for Eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis
5. Neurochem announces eprodisate (KIACTA(TM)) receives acknowledgement of complete response and is granted Class 2 review
6. Neurochem announces departure of Dr. Philippe Calais, President, Global Business
7. Neurochem reports results for third quarter of fiscal 2007
8. Emageon Reports Fourth Quarter and 2007 Financial Results
9. Cyberonics Reports Operating Profit for Third Quarter FY08 and Announces Share Repurchase Program
10. Platinum Underwriters Holdings, Ltd. Reports Record Fourth Quarter and Year Ended December 31, 2007 Financial Results
11. Onyx Pharmaceuticals Reports Fourth Quarter and Twelve-Month 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... MIDDLEBURY, CT (PRWEB) July 11, 2014 ... announced today the launch of the Timex Performance Network, ... product information, training plans, athlete testimonials, seasonal news and ... Performance Network will capitalize on the legacy of the ... online destination for runners and endurance athletes nationwide. The ...
(Date:7/11/2014)... 11, 2014 (HealthDay News) -- Polio is history in ... like Afghanistan, Nigeria and Pakistan. Giving vaccinated children an ... immunity and help eradicate the highly infectious disease, a ... highly effective, immunity wanes as early as a year ... infected and contribute to the spread of the disease, ...
(Date:7/11/2014)... AngelWeddingDress is now providing worldwide clients with ... ”. When it comes to buying summer wedding dresses ... the unlimited stock of beautiful wedding gowns. Recently, the ... summer wedding gowns. , The company’s current promotion ... pace with the newest fashion trends. The top experts ...
(Date:7/11/2014)... Alliance Labs announced that they will be featured ... Jr, airing later this year 2014, via Discovery Channel. ... Innovations will explore DocuSol® Kids, a mini-enema containing a ... base designed to give adolescents general constipation relief. Viewers ... hyperosmotic laxative by drawing water into the bowel from ...
(Date:7/11/2014)... July 11, 2014 Anterior Cruciate Ligament ... but the type of material used to create a ... the game, say researchers presenting their work today at ... Sports Medicine ( AOSSM ). , “Our ... allografts (tissue harvested from a donor) fail more frequently ...
Breaking Medicine News(10 mins):Health News:Timex Announces Launch of Timex Performance Network 2Health News:Researchers Assess New Way to Boost Polio Immunity 2Health News:AngelWeddingDress Will Continuously Unveil More Summer Wedding Dresses for Loyal Clients 2Health News:Alliance Labs & DocuSol® to be Featured in Upcoming Episode of Innovations 2Health News:ACL Reconstructions May Last Longer With Autografts 2
... cases from two severely disabled children. These cases were mainly ... negligent medical advice. //One such is that of Alexia Harriton, ... that her family doctor had not informed her mother about ... is that of a five-year-old Keeden Waller who was born ...
... The Australian Medical Association announced today that six doctors ... the implementation of new rosters,//which they contend could harm ... doctors are simply expressing displeasure over the new working ... the resignation of the doctors was effective from this ...
... the doctors of the Royal College of Physicians it was ... //It was found that about 73% of the doctors were ... dying where it states that the doctors should be given ... the terminally ill person. But the physicians of the ...
... Office workers are at an increased risk of being affected ... hours on their computer.// DVT is a condition that gives ... the heat or the lung with often fatal consequences. ,This ... e-thrombosis. The condition came to light after it emerged that ...
... take place on June 18 has been advanced to ... the advancement but the centre is against the advancement ... the death of about 1,000 to 2,000 lives every ... children in Muslim-dominated areas are dying. About 5.2 million ...
... from Uttar Pradesh has disproved the claims of health authorities ... been reported in the state. ,This is reported ... (NPSP) issued here this month. ,Some of the ... by the state but also by international agencies like UNICEF, ...
Cached Medicine News:Health News:Fresh Polio Cases Reported In Uttar Pradesh 2
(Date:1/15/2014)... 2014  Novation, the leading health care supply chain expertise, ... reseller (VAR) national contracts that expand its portfolio to ... lower costs. These include manufacturer product and service agreements, ... and ongoing IT consulting support. New ...
(Date:1/15/2014)... DUBLIN , January 15, 2014 Shire plc ... waived the Office of Fair Trading (OFT) approval condition to the ... Incorporated (NASDAQ: VPHM).   As a result of the ... Shire expects to complete the tender offer on January 24, 2014 ...
(Date:1/15/2014)...  Manufacturers, suppliers and distributors of innovative medical-related products ... most important business assets, intellectual property (IP). ... Because of the highly-competitive nature of the Medical ... most litigious industry sectors of cases involving IP ...
Breaking Medicine Technology:New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3Intellectual Property Insurance for Medical-related Products and Services 2
... Incorporated (NASDAQ: VPHM ) today announced the ... ILNS) to its clinical stage drug candidate, OX1, being ... rare, hereditary, progressive neurodegenerative disease. OX1, ... molecule that has potent anti-oxidant properties that can protect ...
... KIRKLAND, Wash., Sept. 29, 2011 Cardiac Dimensions®, Inc. ... Mark approval for a newly enhanced version of its ... heart failure patients suffering from functional mitral regurgitation (FMR). ... initiate a commercial launch of the enhanced device in ...
Cached Medicine Technology:ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 2ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 3ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 4Cardiac Dimensions® Receives CE Mark Approval for Enhanced CARILLON® Mitral Contour System™ 2Cardiac Dimensions® Receives CE Mark Approval for Enhanced CARILLON® Mitral Contour System™ 3
... Advanced diagnostic capabilities combined with ease of ... product in its class. Ideal for office ... complete system for Uroflowmetry, cystometry, leak point ... configurations are available which make the OM-5 ...
... with ease of use make the OM-5 ... Ideal for office or hospital-based urodynamics, the ... cystometry, leak point pressure, or urethral pressure ... make the OM-5 flexible enough to meet ...
... with ease of use make the OM-5 ... Ideal for office or hospital-based urodynamics, the ... cystometry, leak point pressure, or urethral pressure ... make the OM-5 flexible enough to meet ...
... capabilities combined with ease of use make ... its class. Ideal for office or hospital-based ... for Uroflowmetry, cystometry, leak point pressure, or ... available which make the OM-5 flexible enough ...
Medicine Products: