Navigation Links
FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
Date:9/20/2007

Study Data Demonstrated Improved Progression-free Survival with Campath

CAMBRIDGE, Mass. and WAYNE, N.J., Sept. 20 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) and Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for Campath(R) (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath was initially approved in 2001 under accelerated approval regulations and the FDA has determined that the study results submitted in the sBLA fulfill the post- marketing commitment to verify clinical benefit. A label expansion is under consideration in Europe.

"Campath is clearly an important single agent for the first-line treatment of CLL," said Peter Hillmen, MB, ChB, of the Leeds General Infirmary, Leeds, United Kingdom, and the lead investigator of the pivotal study comparing Campath against chlorambucil. "We are excited to be entering an era where our improved understanding of CLL, coupled with more advanced laboratory tests and targeted therapy options like Campath, have dramatically changed the first- line treatment approach for this type of leukemia."

Campath works in an entirely different way than chemotherapy, and is the first and only monoclonal antibody approved by the FDA for the treatment of B- CLL.

"The data that supported this label expa
'/>"/>

SOURCE Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. UW-Madison approves new research institute
2. FDA approves GEs heart-imaging technology
3. Senate approves bill to expand stem cell funding
4. FDA approves advanced digital mammography system
5. Building commission approves Institutes for Discovery
6. UW Board of Regents approves $134 million medical research facility
7. FDA approves Bone Cares Hectorol for treatment of kidney disease
8. New Microarray Labeling Kit for Preparing cDNA Probes
9. Antibodies for Studying NMDA Receptor Protein Expression and Synapse-Specific Immunolabeling
10. aRNA Synthesis and Labeling for Array Analysis
11. Amino Allyl Labeling for Array Analysis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2014)... 2014 Deep Research Report on Global and ... study on the current state of the Nano Silver ... a basic overview of the industry, including definitions, applications ... domestic market analysis are provided with a focus on ... A comparison between the international and Chinese situation is ...
(Date:7/11/2014)... WEST PALM BEACH, Fla. , July 11, 2014 ... wide variety of high-quality peptides that are used solely ... online. To honor two successful years in business, Maxim ... Performance LLC, has just launched a new and updated ... addition, the research blog section has been updated with ...
(Date:7/11/2014)... DUBLIN , July 11, 2014 ... "International Transfection Technology Market - Global Industry Analysis, ... report to their offering. ... to introduce nucleic acids (either DNA or RNA) into ... therapy, mutation of cancer cells and protein metabolism by ...
(Date:7/11/2014)... 2014 EPFL and the University of  ... of John P. Donoghue . The American neuroscientist ... . The new Wyss Center for ... Geneva , has named as its director ... P. Donoghue , founder of Brown University,s Institute for ...
Breaking Biology Technology:2014 Nano Silver Industry in Global and China Regions Development Proposals Analysis Available at DeepResearchReports.com 22014 Nano Silver Industry in Global and China Regions Development Proposals Analysis Available at DeepResearchReports.com 3Maxim Peptide Celebrates Second Anniversary Online with an Updated Website and Special Deals Section 2International Transfection Technology Market - Industry Analysis, Size, Share, Growth, Trends and Forecast to 2019 2John P. Donoghue is Taking the Lead at the Wyss Center and is Appointed Professor at EPFL and University of Geneva 2John P. Donoghue is Taking the Lead at the Wyss Center and is Appointed Professor at EPFL and University of Geneva 3
... Institute of Standards and Technology (NIST) may have ... of computer memory now under development. The work, ... University (GMU), aims to optimize nanowire-based charge-trapping memory ... computers and cell phones that can operate for ...
... DIEGO, May 25, 2011 Anadys Pharmaceuticals, Inc. (Nasdaq: ... for the treatment of hepatitis C, announced today that it ... ANA773, the Company,s oral immuno-modulator that acts via the TLR-7 ... Annual Meeting in Chicago, IL.  The data from the completed ...
... 2011 WaferGen Biosystems, Inc. (OTCBB:WGBS), a leading ... it has entered into definitive agreements with three ... LLC, Deerfield Management and Merlin Nexus, and certain ... $30.4 million private placement financing of equity and ...
Cached Biology Technology:NIST 'nanowire' measurements could improve computer memory 2Anadys Highlights ANA773 Data to be Presented at ASCO 2Anadys Highlights ANA773 Data to be Presented at ASCO 3Anadys Highlights ANA773 Data to be Presented at ASCO 4WaferGen Announces $30 Million Financing 2WaferGen Announces $30 Million Financing 3WaferGen Announces $30 Million Financing 4
(Date:7/10/2014)... , June 30, 2014  Aware, Inc. (NASDAQ: ... software and services, previously announced on June 26, 2014 ... cash dividend of $1.75 per share, or approximately $40 ... of July 10, 2014 and a payment date of ... NASDAQ that it had set an ex-dividend date for ...
(Date:7/10/2014)... SHELTON, Conn. , July 2, 2014 NXT-ID, Inc., ... market, reports that CEO Mr. Gino Pereira was ... radio show in Tampa Florida . Mr. ... radio host Cedric Harris and how the Wocket™ ... secure alternative.  Cedric Harris tells ...
(Date:7/10/2014)... 2014 According to a new ... Control Systems Market Global Forecast, Market Share, Size, Growth ... Access Control systems market was valued at USD 15,406.1 ... a CAGR of 12.6% from 2014 to 2019, to ... 2019. Browse the full Electronic Access Control ...
Breaking Biology News(10 mins):NASDAQ Sets Ex-Dividend Date for Aware, Inc.'s Special Cash Dividend of $1.75 Per Share 2Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 2Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 3Security and Your Money: Tampa Bay Radio Host Cedric Harris Talks to NXT-ID CEO Mr. Gino Pereira about the Wocket Smart Wallet 4Electronic Access Control Systems Market is Expected to Reach USD 31.2 Billion Globally in 2019: Transparency Market Research 2Electronic Access Control Systems Market is Expected to Reach USD 31.2 Billion Globally in 2019: Transparency Market Research 3Electronic Access Control Systems Market is Expected to Reach USD 31.2 Billion Globally in 2019: Transparency Market Research 4Electronic Access Control Systems Market is Expected to Reach USD 31.2 Billion Globally in 2019: Transparency Market Research 5
... The California Institute for Regenerative Medicine (CIRM) has awarded ... associate professor at Sanford-Burnham Medical Research Institute (Sanford-Burnham). Chen,s ... part of CIRM,s Basic Biology IV awards program, which ... stem cells and how to work with them. This ...
... study tissue engineering and test new drugs often need ... They can do this by prodding the cells into ... the desired direction with acoustic waves, electric fields, or ... can position individual cells with a high level of ...
... , WEST LAFAYETTE, Ind. Researchers have created a new ... be used in drug-delivery patches powered by fermentation., The micropump ... water is added and the patch is placed on the ... yeast and sugar to ferment, generating a small amount of ...
Cached Biology News:California's stem cell agency boosts heart disease research at Sanford-Burnham 2Body heat, fermentation drive new drug-delivery 'micropump' 2
Mouse Collagen IV...
The Captivate Disposable Sample Chamber is designed for use with the Captivate magnetic yoke assembly (C-24700) and can be used with our Captivate ferrofluid conjugates (C-21473 C-21474 C-21476) or ...
Sheep Serum US Origin...
Human PDGF, CF...
Biology Products: