Navigation Links
Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles
Date:12/21/2009

EXTON, Pa., Dec. 21 /PRNewswire-FirstCall/ -- Fibrocell Science, Inc. (OTC Bulletin Board: FCSC) announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to the Biologics License Application (BLA) for azficel-T, an autologous cell therapy for the treatment of moderate to severe nasolabial fold wrinkles in adults. A Complete Response letter is issued by the FDA's Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and additional data are needed prior to approval. The Complete Response letter requested that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls (CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred during the BLA review period, as well as revised policies and procedures regarding shipping practices, and proposed labeling.

"We are pleased with the review and will work closely with the FDA to complete the histopathology study and provide all of the requested data as quickly as possible," said Declan Daly, Fibrocell Science, Inc. interim chief executive officer.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (OTC Bulletin Board: FCSC) is a biotechnology company focused on the development of regenerative cell therapy for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com.

Forward Looking Statements

All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, without limitation, the ability of the Company to complete the histopathology study and provide to the FDA the requested data on a timely basis. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company's control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2008, as updated in "Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company's public filings with the SEC.

SOURCE Fibrocell Science, Inc.


'/>"/>
SOURCE Fibrocell Science, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles
2. Isolagen, Inc. Reorganizes as Fibrocell Science, Inc.
3. California Life Science, Business, and Economic Development Experts Discuss Californias Bioscience Future
4. FRC: NIH Stem Cell Guidelines Reflect Poor Science, Ignore Real Hope for Patients
5. Seahorse Bioscience, Inc. Acquires BioProcessors Corp.
6. Bert W. OMalley, M.D., Recipient of the 2008 National Medal for Science, Joins Bionovos Scientific Advisory Board
7. For creating new field of science, Texas chemist wins international prize
8. Todd R. Nelson Named Chief Executive Officer of eBioscience, Inc.
9. Repligen Receives Second Research Grant from the Muscular Dystrophy Association to Support Friedreichs Ataxia Preclinical Development Program
10. Vivakor Receives $5 Million Licensing and Purchase Agreement for Nutraceutical Products
11. Sangart, Inc. Receives European Orphan Drug Designation for the Use of MP4CO in Patients With Sickle Cell Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... , June 27, 2016 /PRNewswire/ - BIOREM Inc. (TSX-V: BRM) ... advised by its major shareholders, Clean Technology Fund I, ... United States based venture capital funds which ... Biorem (on a fully diluted, as converted basis), that ... of their entire equity holdings in Biorem to TUS ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... will join the faculty of the University of North Carolina Kenan-Flagler Business ... strategy and entrepreneurship at UNC Kenan-Flagler, with a focus on the school’s international ...
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of commercial spectrophotometers ... 5000 and the 6000i models are higher end machines that use the more unconventional ... spectrophotometer’s light beam from the bottom of the cuvette holder. , FireflySci has ...
(Date:6/23/2016)... TORONTO , June 23, 2016 /PRNewswire/ - ... Ontario biotechnology company, Propellon ... the development and commercialization of a portfolio of ... cancers. Epigenetic targets such as WDR5 represent an ... contribute significantly in precision medicine for cancer patients. ...
Breaking Biology Technology:
(Date:5/3/2016)... , May 3, 2016  Neurotechnology, a provider ... MegaMatcher Automated Biometric Identification System (ABIS) , ... multi-biometric projects. MegaMatcher ABIS can process multiple complex ... any combination of fingerprint, face or iris biometrics. ... SDK and MegaMatcher Accelerator , which ...
(Date:4/26/2016)... India and LONDON ... Infosys Finacle, part of EdgeVerve Systems, a product ... and Onegini today announced a partnership to integrate ... solutions.      (Logo: http://photos.prnewswire.com/prnh/20151104/283829LOGO ... to provide their customers enhanced security to access ...
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
Breaking Biology News(10 mins):