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:8/28/2014)... --  SunTrust Robinson Humphrey (STRH) today announced ... equity research team in biotechnology and oilfield services.  ... research demonstrates our commitment to providing our valued ... investment decision making," said Biff Woodruff , ... make significant investments in differentiated content at a ...
(Date:8/28/2014)... 2014 A new market research ... is available from Strategic Consulting, Inc., the leading ... Microbiology Market Review, Fourth Edition: Global Review of ... tracks and compares microbiology test volumes, market values ... and Asia, and forecasts future volumes and market ...
(Date:8/27/2014)... 27, 2014 Varian Medical Systems today ... current Salt Lake City manufacturing facility and allow for ... to ultimately create 1,000 new full time jobs in ... “Utah is home to hardworking people with immense engineering ... with Varian’s success in the manufacturing of our state-of-the-art ...
(Date:8/27/2014)... Aug. 27, 2014   MSC , a healthcare ... today announced the appointment of Mary Beth Loesch ... 28 years of experience preparing companies for rapid growth ... Executive Vice President of Corporate Development and Healthcare. In ... business , as well as corporate strategy and marketing. ...
Breaking Biology Technology:SunTrust Robinson Humphrey Expands Equity Research in Healthcare and Energy 2SunTrust Robinson Humphrey Expands Equity Research in Healthcare and Energy 32 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 22 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 3Varian Medical Systems Groundbreaking on Facility Expansion Triggers Influx of New Jobs to Salt Lake 2Varian Medical Systems Groundbreaking on Facility Expansion Triggers Influx of New Jobs to Salt Lake 3MSC names Mary Beth Loesch President and CEO 2
... ROI Opportunity for Consumers in Shortest Period of ... examines the potential investment in targeted therapies that ... new report released today by the Deloitte Center ... adoption of personalized medicine to produce a positive ...
... Technology and consulting firm, Fadel Partners Inc., a certified ... over year revenue growth of 13% for 2008, and ... The company,s report stands in contrast to analyst estimates ... the U.S. IT services industry overall, as the economic ...
... Allow Development of Accurate Blood Test for Common Genetic ... Artemis Health Inc., a privately-held company dedicated to ... that it has acquired a co-exclusive worldwide license from ... prenatal diagnostic tests based on pioneering research from the ...
Cached Biology Technology:Adoption of Personalized Medicine May Yield Significant ROI; Time to Achieve Benefit Varies Among U.S. Health Care Stakeholders, According to Deloitte Report 2Adoption of Personalized Medicine May Yield Significant ROI; Time to Achieve Benefit Varies Among U.S. Health Care Stakeholders, According to Deloitte Report 3Adoption of Personalized Medicine May Yield Significant ROI; Time to Achieve Benefit Varies Among U.S. Health Care Stakeholders, According to Deloitte Report 4Fadel Partners Announces 13% Growth Despite IT Services Industry Downtrend 2Artemis Health Licenses Prenatal Cell-Free DNA Analysis Technology from Stanford University 2Artemis Health Licenses Prenatal Cell-Free DNA Analysis Technology from Stanford University 3
(Date:8/29/2014)... such as the prolific bloomer Emiliania huxleyi , ... discovered. The finding contradicts the common view that ... on scarce supplies of thiamine in the ocean to ... about the ocean," says CIFAR Senior Fellow Alexandra ... paper with CIFAR fellows John Archibald (Dalhousie ...
(Date:8/29/2014)... them, fold them: modern materials that are light, flexible ... artificial skin or electronic paper. , Making such concepts ... a new way of working with copper nanowires and ... , Previous success in the field of ultra-lightweight "aerogel ... gold and silver nanowires. , By turning instead ...
(Date:8/28/2014)... app called TX Invasives is now available from the ... Texas at Austin for identifying harmful non-native plant, insect ... in the United States cause about $137 billion in ... crops, clog waterways, kill native plants and more. , ... for reporting where invasive species occur, we,re more likely ...
Breaking Biology News(10 mins):Not all phytoplankton in the ocean need to take their vitamins 2Not all phytoplankton in the ocean need to take their vitamins 3Copper shines as flexible conductor 2Mobile app makes ID of harmful plants, insects in Texas a snap 2
... communities and the growth of sedimentary rock at Mammoth ... surprising discovery about the geological record of life and ... of sedimentary rock are dated, and how scientists might ... found microbes change the rate at which calcium carbonate ...
... Titled Assessment of Climate Change for the Baltic Sea Basin ... survey of past and possible future climate change in the ... in northern and mid-Europe. One of the key findings is ... by up to five degrees Celsius from now to 2100. ...
... oceans, lakes and even wet soil, diatoms are unicellular ... Curiously, these tiny phytoplankton could be harboring the next ... cell walls by laying down submicron-sized lines of silica, ... semiconductor industrysilicon. If we can genetically control that process, ...
Cached Biology News:Hot springs microbes hold key to dating sedimentary rocks, researchers say 2Climate change in the Baltic Sea basin -- past, present and future 2Climate change in the Baltic Sea basin -- past, present and future 3In diatom, scientists find genes that may level engineering hurdle 2
... Lambda Protein Phosphatase ( ... protein phosphatase with activity ... and tyrosine residues. It ... product of the ORF221 ...
... a high performance spectral scanning multimode ... With the advanced SkanIt Software it ... drug discovery assay development. Varioskan provides ... time-resolved fluorescence and photometric assays and ...
... refrigerated cold traps offers a choice of ... solvents or high volatility solvents. Ideal to ... evaporators. Also used for maintaining vapor-free gas ... in electron microscopes. Can be used as ...
96 Well Plate UB, RE bottom; consistent medium binding affinity for hydrophobic complexes and proteins....
Biology Products: