Navigation Links
Insmed Selected to Complete Congressional Questionnaire Regarding the Potential Establishment of a Follow-On Biologics Regulatory Pathway
Date:4/10/2008

RICHMOND, Va., April 10 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced receipt of a letter and questionnaire from the Chairman and Ranking Member of the U.S. House of Representatives' Subcommittee on Health on the possible development of legislation to establish a Follow-On Biologics (FOBs) regulatory pathway.

Sent to approximately 30 stakeholders in the biotechnology industry, healthcare and patient communities, the letter notes that the " ... Members of the Subcommittee on Health are committed to this issue" and has requested Insmed's input "to better evaluate the merits, benefits, and costs of a biosimilars bill ... " Included in the letter for response are six pages of questions covering a range of related issues, including science, potential economic impact, incentives, and innovation.

Insmed intends to submit responses to the Subcommittee in advance of the April 22, 2008 deadline.

"We are very pleased that Insmed has been selected by the Subcommittee for input on this important issue," said Geoffrey Allan, Ph.D., CEO of Insmed. "We are pleased to be at the forefront of this critical healthcare initiative, look forward to submitting our thoughts and welcome the Member's commitment to adopt legislation so patients can readily receive affordable access to life-saving biotechnology drugs."

Insmed is currently developing a portfolio of FOBs and intends to initiate clinical trials for its first two FOBs in 2008, both of whose brand sales represent over $3 billion in current sales worldwide. Members of Insmed's skilled biologics team have worked on the development of over 50 therapeutic proteins. Their focused protein-based drug development backgrounds, coupled with the Company's FDA-approved protein manufacturing facility, and clinical and regulatory expertise, positions Insmed, upon the establishment of a regulatory pathway, to be an initial entrant
'/>"/>

SOURCE Insmed Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Insmed Appoints Dennis M. Lanfear to Board Of Directors
2. Insmed Awarded $2.1 Million by Muscular Dystrophy Association
3. Insmed to Appeal Delisting Notification From Nasdaq
4. Insmed President Interviewed for Follow-On Biologics Podcast: Insmed Inc. President Steve Glover Discusses Safe and Effective Biologic Therapies and Reduced Costs with The American Magazine
5. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
6. Insmed to Host Fourth Quarter and Full-Year 2007 Conference Call
7. Insmed Announces Listing Transfer from Nasdaq Global Market to Nasdaq Capital Market
8. Insmed Announces Fourth Quarter and Full-Year 2007 Financial Results
9. Insmed Announces Additional Information in Compliance With NASDAQ Rules
10. Biomaxx Systems Inc. Selected as Technical Consultant By Southern Cross Agricultural Developments
11. Solazyme, Inc. Selected by AlwaysOn as a GoingGreen 100 Top Private Company Award Winner
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2014)... (PRWEB) July 13, 2014 2014 Deep ... is a professional and in-depth study on the current ... China. , The report provides a basic overview of ... Global market analysis and Chinese domestic market analysis are ... competitive landscape of the market. A comparison between the ...
(Date:7/12/2014)... July 12, 2014 This ... reagents used in the life science industry. ... life science reagents market towards remarkable growth. ... and providers of life science reagents. , ... http://www.transparencymarketresearch.com/life-sciences-reagents-analytical-reagents.html . , The global life ...
(Date:7/11/2014)... 2014 /PRNewswire-iReach/ -- Maxim Peptide, a website that features ... solely in scientific experiments, is currently celebrating its second ... Maxim Peptide, which was created by the founders of ... updated website that now features a special deals section. ... with fascinating articles about peptide research, including a new ...
(Date:7/11/2014)... , Not for release, publication or ... any jurisdiction where to do so would constitute a violation ... plc ("Shire" or the "Company") (LSE: SHP, NASDAQ: ... it has held a meeting with representatives of AbbVie. ... prior agreement or approval of AbbVie. A further ...
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 3Transparency Market Research: Life Science Reagents Market- PCR Reagent Kits, Cell and Tissue Culture, Flow Cytometry, Electrophoresis and Chromatography 2Transparency Market Research: Life Science Reagents Market- PCR Reagent Kits, Cell and Tissue Culture, Flow Cytometry, Electrophoresis and Chromatography 3Maxim Peptide Celebrates Second Anniversary Online with an Updated Website and Special Deals Section 2Shire plc - Statement re: Media Speculation 2
... Minds, Establishes New Company to Commercialize ... Novel Technology from UC ... investment,firm specializing in early stage university business ventures, has,established RF ... technology invented at UC Davis., The newly formed RF ...
... TAIAN CITY, Shandong, China, June 30 /Xinhua-PRNewswire-FirstCall/ --,China ... or "the,Company"), one of the leading plasma-based pharmaceutical ... announced that the Company,received the approval from the ... new plasma collection station in Pu Bei County, ...
... Cellumen, Inc., the Cellular,Systems Biology Company, announced today ... Center for Toxicology Research (NCTR), a,research center of ... Cellumen will use its proprietary CellCiphr(R) toxicity risk,assessment ... toxicity,compounds including both failed and marketed drugs for ...
Cached Biology Technology:Allied Minds Launches Novel Disinfectant/Disinfestant Technology Start-up With UC Davis 2China Biologic Products Announces Approval for Setting Up a New Plasma Collection Station in Pu Bei County, Guangxi Province 2China Biologic Products Announces Approval for Setting Up a New Plasma Collection Station in Pu Bei County, Guangxi Province 3Cellumen to Collaborate With the NCTR of the FDA to Apply Cellular Systems Biology (CSB(TM)) to Predictive Toxicology 2
(Date:7/11/2014)... Wildlife Conservation Society shows that no-take zones in ... such as lobster, conch, and fish recover from ... areas. , The reporttitled "Review of the Benefits ... literature from no-take areas around the world. The ... recognized expert in marine protected areas and fisheries ...
(Date:7/11/2014)... July 11, 2014--Researchers at the Department of Energy,s ... 100 awards, presented by R&D Magazine in recognition ... "These awards recognize the tremendous value of our ... "Research and development at the National Labs continues ... and pursue the scientific and technological innovations necessary ...
(Date:7/11/2014)... South Wales, Australia when NASA,s Aqua satellite passed overhead ... 11 (12:35 p.m. local time/11:35 p.m. EDT on July ... (NSW), the Moderate Resolution Imaging Spectroradiometer (MODIS) aboard captured ... smoke (light brown) from various fires. Actively burning areas, ... , The New South Wales, Australia Government website "NSW ...
Breaking Biology News(10 mins):Belize's lobster, conch, and fish populations rebuild in no-take zones 2ORNL wins eight R&D 100s 2ORNL wins eight R&D 100s 3ORNL wins eight R&D 100s 4
... Health has named researchers at Baylor College of Medicine ... and only recipients of the inaugural Quantum Grant for ... and blood vessels for the treatment of stroke. , ... Institute of Biomedical Imaging and Bioengineering (NIBIB), part of ...
... two candidate vaccines that may eventually be used together ... are published in the December 15 issue of The ... S. Graham, MD, PhD, and colleagues from the National ... the Fred Hutchinson Cancer Research Center in Seattle, and ...
... heart muscle ?even though it was grown in the ... the goal of creating replacement parts for damaged human ... just a spoonful of loose heart cells. , This ... in growing bioengineered heart muscle, or BEHM, with organized ...
Cached Biology News:First Quantum Grant to fund stem cell repair of damage from stroke 2Progress made in HIV vaccine development 2A new approach to growing heart muscle 2A new approach to growing heart muscle 3A new approach to growing heart muscle 4
Cord blood endothelial progenitor cells, For immunohistochemistry (IHC) Cell Chip with Human Umbilical Cord Blood Progenitor Cells...
Umbilical cord blood CD14+ Monocytes, For immunohistochemistry (IHC) Cell Chip with Human Umbilical Cord Blood Monocytes, B Cells and NK Cells...
Human peripheral blood basophils, For immunohistochemistry (IHC) Cell Chip with Human Peripheral Blood Granulocytes...
Umbilical cord blood CD19+ B cells, For immunohistochemistry (IHC) Cell Chip with Human Umbilical Cord Blood Monocytes, B Cells and NK Cells...
Biology Products: