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

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:10/22/2014)... , Oct. 22, 2014 Research ... the "Global DNA Diagnostics Market (Product types, ... Share, Global Trends, Company Profiles, Demand, Insights, Analysis, ... 2020" report to their offering. ... (products, applications, techniques, end users and Geography) Global ...
(Date:10/22/2014)... The Americas Inorganic Refrigerants Market report defines and ... analysis and forecast of revenue. , Browse through ... report, to get an idea of the in-depth ... the segmentation in the Americas inorganic refrigerants market, ... , http://www.micromarketmonitor.com/market/americas-inorganic-refrigerants-4191654241.html , Inorganic refrigerants ...
(Date:10/22/2014)... Shimadzu Scientific Instruments introduces its Open Solution ... pain management and clinical markets. The software increases the ... allowing users to highlight and review results that are ... analysts to filter results by group or based on ... the need to sift through analytes of no interest. ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 WriteResult, ... services – has been working with a team of ... New Haven Farms Community Farming Collaborative to provide electronic ... solution. The study, which started in May, aims ... that provides participants weekly exposure to and participation in ...
Breaking Biology Technology:Global DNA Diagnostics Market (Product types, Application, Technology, End User and Geography) - Forecast to 2020 2Global DNA Diagnostics Market (Product types, Application, Technology, End User and Geography) - Forecast to 2020 3The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 2The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 3Shimadzu Releases QuantAnalytics Open Access LCMS Software Package for Clinical Applications 2myPROpad™ Topic of Panel Discussion at the Yale Food Systems Symposium 2myPROpad™ Topic of Panel Discussion at the Yale Food Systems Symposium 3
... U.S. Department of Energys Brookhaven National Laboratory have developed ... and micrometer-sized particles. The method, based on designed DNA ... to manipulate the structure and therefore the properties ... be of interest to industry. For example, such fine-tuning ...
... 12 BioReliance Corporation, a,leading contract services ... contracted with Gentronix to offer their,GreenScreen HC ... of BioReliance,s portfolio of,genotoxicity screening services. GreenScreen ... pharmaceutical companies to test for genotoxic potential,earlier ...
... Inc. (Nasdaq:,PPDI) today announced Daniel G. Darazsdi has ... position on October 1. Mr. Darazsdi, 47, ... a $34 billion diversified technology and manufacturing,leader, where ... CFO of finance,transformation and operations. Over the years ...
Cached Biology Technology:New DNA-based technique for assembly of nano- and micro-sized particles 2BioReliance Launches Next-Generation Genotoxicity Screening Service 2PPD Names Daniel Darazsdi as Chief Financial Officer 2PPD Names Daniel Darazsdi as Chief Financial Officer 3
(Date:10/16/2014)... can be cultivated efficiently, they are anything but ... by monoculture cultivation is becoming increasingly evident. Despite ... form and are regarded as the sole possibility ... quite wrongfully, finds Bernhard Schmid, an ecology professor ... novel form of agriculture and forestry. After all, ...
(Date:10/15/2014)... the pandemic risk from strains of influenza virus increases ... ourselves to become complacent that the most substantial threats ... , Influenza pandemics arise when a new virus strain ... immunity – spreads in the human population. There have ... the worst of which – the 1918 Spanish Flu ...
(Date:10/15/2014)... NXT-ID, Inc. (NASDAQ: NXTD and NXTDW) ... growing mobile commerce market releases photos and video of the recent ... October 13 th . Gino Pereira , ... angel investor Mr. Chad A. Verdi rang the bell.  ... his investors and employees "for their work and dedication in bringing ...
Breaking Biology News(10 mins):Plant communities produce greater yield than monocultures 2Plant communities produce greater yield than monocultures 3Scientists 'must not become complacent' when assessing pandemic threat from flu viruses 2Photo Release: NXT-ID Inc. Rings Opening Bell of the NASDAQ Stock Market October 13th 2Photo Release: NXT-ID Inc. Rings Opening Bell of the NASDAQ Stock Market October 13th 3
... entire lives as parasites on birds, it is difficult ... the University of Gothenburg, Sweden, reveals. Researcher Daniel ... world and investigated how host birds, migration patterns affect ... very small eyes, chewing lice are, by and large, ...
... temperature of the food we eat affect the intensity of ... new study by Dr. Gary Pickering and colleagues from Brock ... temperature of foods and drinks have an effect on the ... but not sweetness. Their work is published online in Springer,s ...
... first in a series of annual literature reviews ... was recently released by Society of Interventional Radiology ... expanding, and it has become increasingly difficult for ... volume of literature required to remain current," said ...
Cached Biology News:Hitch-hiking with birds for life 2To get the full flavor, you need the right temperature 2'Updates in Interventional Radiology' accents emerging trends, practice growth 2
Request Info...
... Panomer 9 oligodeoxynucleotides ... are labeled at the ... proprietary Alexa Fluor dyes ... for assessing microarray spot ...
Topoisomerase I, isolated from wheat germ, is an enzyme capable of removing negative supercoils from covalently closed circular DNA (1)....
DEAD (Asp-Glu-Ala-Asp) box polypeptide 5...
Biology Products: