Navigation Links
MedImmune Submits Biologics License Application to FDA for Motavizumab
Date:2/4/2008

GAITHERSBURG, Md., Feb. 4 /PRNewswire/ -- MedImmune announced today it submitted to the U.S. Food & Drug Administration (FDA) on January 30 a Biologics License Application (BLA) for motavizumab, an investigational monoclonal antibody (MAb) derived from recombinant DNA technology. The motavizumab BLA is supported by clinical trial data from more than 6,000 patients in which safety and efficacy in prevention of serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients were evaluated.

"We are pleased to submit this BLA for motavizumab, which we believe represents another tool in the fight against RSV. This marks a significant milestone for this molecule and further reinforces MedImmune's commitment to developing anti-RSV biologics for the underserved pediatric patient population," said Linda J. Peters, senior vice president, regulatory affairs.

Motavizumab was studied in an active-controlled Phase 3 trial against the standard of care in pediatric patients at high risk of serious RSV disease. Primary and secondary endpoints of the study included incidence of RSV hospitalizations and RSV-specific medically attended outpatient lower respiratory tract infections. Rates of adverse events, serious adverse events and study drug discontinuations were balanced between treatment groups. The most frequently observed reactions versus the active comparator were cutaneous reactions (overall).

"Beyond the findings of the various investigational trials for motavizumab, we believe this molecule will help reinforce the positive role that MAbs play in RSV prevention within the current clinical body of evidence. It also reinforces our position as a leader in RSV prevention," said Genevieve Losonsky, M.D., vice president, clinical development, infectious disease.

RSV is a leading cause of viral respiratory infection among infants. Each year, up to an estimated 125,000 infants in the United States are hospitalized with sev
'/>"/>

SOURCE MedImmune
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related biology technology :

1. MedImmune Broadens Focus of Venture Capital Fund to Include New Therapeutic Areas
2. MedImmune Announces Seven Key Promotions and New Hires
3. AstraZeneca Bolsters Its Worldwide Biologics Division Through Integration of Cambridge Antibody Technology Into MedImmune
4. MedImmune to Present RSV Surveillance and Cost-Effectiveness Data at American Academy of Pediatrics National Conference & Exhibition
5. MedImmune Recognized by Local Volunteer Organization for Its Employees Exceptional Commitment to Community Service within Montgomery County
6. MedImmune Celebrates Opening of New Pilot Lab at Gaithersburg Headquarters
7. MedImmune Licenses Reverse Genetics Technology to Novartis for Use in Influenza Vaccine Development and Production
8. Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkins Lymphoma
9. Exelixis Submits XL139 Diligence Report to Bristol-Myers Squibb
10. Angiotech Submits 510(K) To FDA For Its Innovative 5-FU CVC
11. Cephalon Submits Supplemental New Drug Application for FENTORA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... IL (PRWEB) May 23, 2013 Bed bugs ... against the pests is still ongoing, a report from kmov.com ... more for the bed bug treatment. Meanwhile, to be of ... apartment from the costly bed bug exterminator service. ... stated that AHA has so far spent $35,000 ...
(Date:5/23/2013)... Newmarket, NH (PRWEB) May 23, 2013 Ralph ... all of their emergency management products and emergency survival ... , This announcement was made at the quarterly executive ... meeting with a moment of silence for the Oklahoma tornado ... executives that the quality of their emergency kits is paramount. ...
(Date:5/22/2013)... 2013 Industry leaders from around ... the Oak Ridge National Laboratory’s Biosurveillance Symposium ... at the Hilton Alexandria Mark Center. Held in ... conference on June 18 - 19. , ... American Elements, Applied Research Associates, ARA, AttaGene, Battelle, ...
(Date:5/22/2013)... (PRWEB) May 22, 2013 The ... Annual Disruptive Innovations to Advance Clinical Trials conference taking ... Hotel in Boston, MA. , Disruptive thinkers from ... and more share bold approaches to reduce expensive infrastructure, ... “Disruptive innovation needs to be big, or novel, or ...
Breaking Biology Technology:Bed Bug Exterminator Service Could Cost AHA $250K, My Cleaning Products Gives Tips How to Save Apartments from Costly Bed Bug Treatment 2PHI Emergency Management on Announces Father's Day Specials All Emergency Survival Kits 2Biodetection Technologies 2013 and Oak Ridge National Lab’s Biosurveillance Symposium to Bring Together Leading Organizations in Alexandria, VA from June 17-19, 2013 2Biodetection Technologies 2013 and Oak Ridge National Lab’s Biosurveillance Symposium to Bring Together Leading Organizations in Alexandria, VA from June 17-19, 2013 3Biodetection Technologies 2013 and Oak Ridge National Lab’s Biosurveillance Symposium to Bring Together Leading Organizations in Alexandria, VA from June 17-19, 2013 4Biodetection Technologies 2013 and Oak Ridge National Lab’s Biosurveillance Symposium to Bring Together Leading Organizations in Alexandria, VA from June 17-19, 2013 5Disruptive Innovation Hits Clinical Trials, Dedicated Event Launches 2
... 11:00 am EASTERN, DUBLIN, Ireland, July 15 ... and manufacturer of diagnostic products,for the point-of-care and clinical ... of fiscal year 2008 on Tuesday,July 22, 2008. The ... Tuesday, July 22, 2008, at 11:00am EDT (4:00pm BST) ...
... of Group Purchasing Organizations Hosted,by Trane -, ... Society of,Healthcare Engineering (ASHE) offers professional learning opportunities,for ... is no exception. Added,to the roster for the ... of,indoor comfort systems and comprehensive facility solutions., ...
... SHANGHAI, China, July 15 /Xinhua-PRNewswire-FirstCall/ --,China-Biotics, Inc. ... leading Chinese firm specializing in the manufacture,research, ... announced the appointment of American Stock Transfer ... agent and registrar, effective August 15, 2008.,AST, ...
Cached Biology Technology:Trinity Biotech plc to Announce Second Quarter 2008 Financial Results on July 22, 2008 2Healthcare Facility Managers Learn to Optimize Surgical Suites at 2008 ASHE Annual Conference 2Healthcare Facility Managers Learn to Optimize Surgical Suites at 2008 ASHE Annual Conference 3China-Biotics, Inc. Announces Appointment of New Transfer Agent Effective August 15, 2008 2
(Date:5/23/2013)... cancer patients unnecessarily undergo surgery or harsh treatments ... slow-growing and aggressive forms of the disease. Researchers ... Medical Institutes are developing technology that allows patients ... relatively mild treatments or take drastic measures. , ... an associate professor of biomedical engineering at Case ...
(Date:5/23/2013)... history museums of the world are billions of animal ... flowers, mushrooms and grasses, all stacked, stored and preserved ... diverse collections could be critical to understanding how the ... growing human footprint if only the information were ... life with the help of a team from the ...
(Date:5/23/2013)... age when microbial pathogens are growing increasingly resistant to ... team of Wisconsin scientists has synthesized a potent new ... cause staph infections. , Writing online in the ... led by University of Wisconsin-Madison chemistry Professor Helen Blackwell ... behavior of Staphylococcus aureus , a bacterium at ...
Breaking Biology News(10 mins):Using big data to identify prostate cancers and best treatments 2Using big data to identify prostate cancers and best treatments 3CU-Boulder helps tap crowds to digitize museum records of bugs and plants 2CU-Boulder helps tap crowds to digitize museum records of bugs and plants 3CU-Boulder helps tap crowds to digitize museum records of bugs and plants 4University of Wisconsin chemists find new compounds to curb staph infection 2
... team from Rollins College in Florida and the University of ... coral-killing pathogen that causes white pox disease of Caribbean elkhorn ... coral was listed for protection under the United States Endangered ... The team,s findings have just been published in the peer-reviewed ...
... -- in particular, dog fecal material -- may constitute the ... air, says a new University of Colorado Boulder study. ... cities in the experiment, two cities had significant quantities of ... the most likely source. "We found unexpectedly high ...
... helpful even life-saving to have a warning sign before ... few nanometers in size, having a sign that,s easy to read ... molecular design by University of Pennsylvania and Duke University bioengineers and ... color change. The study was conducted by ...
Cached Biology News:Human pathogen killing corals in the Florida Keys 2Human pathogen killing corals in the Florida Keys 3New CU-Boulder study reveals bacteria from dog feces in outdoor air of urbanized air 2New CU-Boulder study reveals bacteria from dog feces in outdoor air of urbanized air 3Penn molecular scientists develop color-changing stress sensor 2Penn molecular scientists develop color-changing stress sensor 3