Navigation Links
Celsense, Inc Files FDA & EMEA Regulatory Submissions
Date:10/12/2009

FDA accepts Drug Master File and EMEA receives Active Substance Master File for Cell Sense in vivo imaging agent

Pittsburgh, PA (Vocus) October 12, 2009 -- Celsense, Inc. announced today it has reached a critical milestone in the push to market for its lead in vivo imaging reagent, Cell Sense CS-1000 (Cell Sense).

Celsense filed a Drug Master File (a “DMF”) with CBER earlier this year which the Agency has now accepted. An FDA Drug Master File provides key information about the quality of components, materials and manufacturing processes involved in producing medical devices and human drugs, including related products such as imaging reagents like Cell Sense. The main objective of a DMF is to support the filing and obtaining of Investigational New Drug Applications (INDs) by investigators incorporating the use of Cell Sense in their clinical trial.

Additionally, Celsense last week submitted an Active Substance Master File (ASMF) with the European Medicines Agency (EMEA) serving the same function within the European regulatory framework and assisting European investigators in similar fashion.

“Having these regulatory filings available for investigators to reference in their clinical testing applications is critical to the rapid and widespread adoption of our in vivo imaging reagents,” said Charlie O’Hanlon, company President and CEO.

Indeed, the company announced earlier this year that the company was one of the recipients on a 4-year $1.95M grant from the National Institutes of Health intended to fund the first studies to evaluate

Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Pan-American Life Insurance Group Plans to Complete Coverage in Central America With Entry Into Costa Rica; Company Files Request for Authorization
2. Profiles International Finds High Employee Utilization is One Key to Maximizing Productivity
3. Reportlinker Adds H1N1 (Swine Influenza) Market Assessment (Latest Data, Company Profiles, Implications for Immunoassays and Molecular Assays) Report
4. Texas Doctor Files Case Pro Se in U.S. Supreme Court Against Insurance Giant on Integrity and Unethical Practices
5. Innovative Medical Technology Companies From Around the World Selected to Present Profiles to Industry Leaders & Financiers at AdvaMed 2009
6. Warner Chilcott Files New Lawsuit for Infringement of LOESTRIN(R) 24 FE and FEMCON(R) FE Patents
7. GENova files patent for new breast cancer treatment
8. Longevinex(R) Files Lawsuit Against ResveratrolBenefits.com, for False and Misleading Statements
9. US Farms, Inc. Files Trademark Application for Aloe365
10. Genova files patent for new prostate cancer treatment
11. Sun Pharmaceutical Files HSR Application for Taro Tender Offer
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Celsense, Inc Files FDA & EMEA Regulatory Submissions
(Date:4/18/2014)... of your worst memories? How did it make you ... a negative personal experience, such as how sad you ... emotional distress, especially when you can,t stop thinking about ... thinking about the context of the memories, rather than ... way to alleviate the negative effects of these memories, ...
(Date:4/18/2014)... ― A new study in the American Journal ... Google searches reveals a recurring pattern that could be ... Investigators from San Diego State University, the Santa Fe ... "healthy" Google searches (searches that included the term healthy ... the U.S. from 2005 to 2012. They found that ...
(Date:4/17/2014)... of chronic inflammation in benign prostate tissue was ... this association was found even in those with ... study published in Cancer Epidemiology, Biomarkers & ... for Cancer Research. , An analysis of prostate ... placebo arm of the Prostate Cancer Prevention Trial ...
(Date:4/17/2014)... that could be used to provide relief from ... made the discovery when researching how pain occurs ... , Dr Marzia Malcangio said: "We have been ... our findings could help chemotherapy patients who suffer ... effect of some chemotherapy drugs (such as vincristine) ...
(Date:4/17/2014)... Experimental Biology and Medicine a multidisciplinary ... Paul Kenis in the Institute of Genomic Biology ... Illinois Urbana-Champaign describe their recent work on subcellular ... of cell functions including energy metabolism, signaling, and ... regulating normal cellular behavior, redox status has been ...
Breaking Medicine News(10 mins):Health News:New study suggests a better way to deal with bad memories 2Health News:New study suggests a better way to deal with bad memories 3Health News:New research shows people are thinking about their health early in the week 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 3Health News:New pain relief targets discovered 2Health News:Live cell imaging reveals distinct alterations of subcellular glutathione potentials 2
... determining factor, study finds , , TUESDAY, Jan. 22 (HealthDay ... for fast-moving prostate cancer can save lives, but the ... serious medical problems, a new study shows. , "The ... is a difference in outcome, depending on the gentleman,s ...
... pounds than dieting and exercise do, study shows , , ... gastric lap-band surgery isn,t only for the most obese; it ... , Still, the surgery is extremely expensive and carries risks. ... need alternative ways to shed pounds, said study author John ...
... MENTOR, Ohio, Jan. 22 STERIS Corporation,(NYSE: STE ... authorized a,regular quarterly dividend in the amount of $0.06 ... to shareholders of record at the close,of business on ... of STERIS Corporation is to provide a healthier today ...
... of Navarra PhD in chemistry researcher, Esther Vicente, has ... Her thesis, defended at the Faculty of Sciences in ... describes the synthesis and characterisation of 65 derivatives of ... number of antimalalarial and antituberculosis pharmaceutical drugs currently on ...
... January 22, 2007, Weinheim, DE: Wiley-Blackwell, the scientific, ... Wiley & Sons, Inc., published a comprehensive resource ... function. , Proteins are essential components of all ... and function of each cell and, ultimately, the ...
... how to manipulate the immune system to increase its ... , Published in the current edition of Viral ... new and more effective vaccines against diseases like influenza ... , The study suggests that scientists can boost the ...
Cached Medicine News:Health News:Hormone Therapy Only Helps Some Older Men With Prostate Cancer 2Health News:Gastric Lap-Band Surgery Can Send Diabetes Into Remission 2Health News:Gastric Lap-Band Surgery Can Send Diabetes Into Remission 3Health News:STERIS Corporation Declares Regular Quarterly Dividend 2Health News:STERIS Corporation Declares Regular Quarterly Dividend 3Health News:Research discovers new compounds active against tuberculosis and malaria 2Health News:'The Handbook of Proteins' 2
(Date:1/15/2014)... Jan. 15, 2014  Manufacturers, suppliers and distributors of ... to protect their most important business assets, intellectual ... ) Because of the highly-competitive nature ... one of the most litigious industry sectors of ...
(Date:1/15/2014)... Medical is very pleased to announce the appointment of Mr. ... Officer.  Mark was promoted from his current role of Chief ... facilities in Massachusetts , Mississippi ... in 2012 with 20+ years of broad-based operations, sales, engineering ...
(Date:1/15/2014)... Therapeutics, Inc. (Nasdaq: ECTE ) ("Echo"), a ... a non-invasive, wireless continuous glucose monitoring system, today announced ... Interim CEO of Echo Therapeutics, will present at "TEN", ... Mr. Doman will make a corporate presentation ...
Breaking Medicine Technology:Intellectual Property Insurance for Medical-related Products and Services 2Tegra Medical Appoints New Chief Executive Officer 2Tegra Medical Appoints New Chief Executive Officer 3Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference 2Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference 3
... PRINCETON, N.J. , June 14 Covance Inc. (NYSE: ... Company,s 30th Annual Growth Stock Conference on Wednesday, June 16, 2010 ... the presentation at www.covance.com .  In order to register and download any ... , , ...
... June 14 MultiCell Technologies, Inc. (OTC Bulletin Board: MCET) ... Cheshire, England to manage its planned Phase IIb clinical trial ... candidate for treatment of primary multiple sclerosis-related fatigue (PMSF). , ... In an earlier Phase IIa study, MCT-125 ...
Cached Medicine Technology:MultiCell Hires Clinical Research Organization to Manage MCT-125 Phase IIb Clinical Trial 2MultiCell Hires Clinical Research Organization to Manage MCT-125 Phase IIb Clinical Trial 3MultiCell Hires Clinical Research Organization to Manage MCT-125 Phase IIb Clinical Trial 4
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: