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:10/22/2014)... (PRWEB) October 22, 2014 Currently ... Sartorius, A & D Weighing, Rice Lake, and ... Semi-Micro Balance . The Sartorius CPA Semi-Micro Balance ... affordable high-quality, precise, and user-friendly laboratory balance. , ... laboratory equipment, their laboratory balances are well known ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 According ... Market by Service Type (Consulting, Integration, Deployment & ... by Deployment Model (Public, Private, Others (Hybrid & ... MarketsandMarkets, defines and segments the Cloud Professional Services ... and forecasting of revenues. It also identifies the ...
(Date:10/22/2014)... 22, 2014 Nuvilex, Inc. (OTCQB: NVLX) – ... people worldwide are living with diabetes, with  that number ... The global market for diabetes treatments is approximately $500 ... worldwide died from pancreatic cancer.  Pancreatic cancer is the ... in the United States , and ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 The ... (Medication Dispensing Systems, Packaging and Labeling Systems, Table-top ... Automation) - Global Forecasts & Trends to 2019” ... and opportunities in North America, Europe, Asia-Pacific, and ... 101 market tables and 30 figures spread through ...
Breaking Biology Technology:Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 2Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 3Cloud Professional Services Market by Public, Private, Hybrid & Community Expected to Reach $34.41 Billion by 2019 - New Report by MarketsandMarkets 2Cloud Professional Services Market by Public, Private, Hybrid & Community Expected to Reach $34.41 Billion by 2019 - New Report by MarketsandMarkets 3Cloud Professional Services Market by Public, Private, Hybrid & Community Expected to Reach $34.41 Billion by 2019 - New Report by MarketsandMarkets 4Cloud Professional Services Market by Public, Private, Hybrid & Community Expected to Reach $34.41 Billion by 2019 - New Report by MarketsandMarkets 5Nuvilex Brief Analyst Report: Thinking Outside the Box by BrokerBank Securities, Inc. 2Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 2Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 3Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 4
... has announced the formation of a Medical Advisory Council ... (MiCK) assay for apoptosis , a new assay designed ... patients. DiaTech has introduced this technology for individual patient ... companies in validating new drugs that may be more ...
... 2011  Rhythm announced today that Lex Van der Ploeg, ... Dr. Van der Ploeg brings to Rhythm more than ... diseases, and other therapeutic areas. "Lex has ... metabolic pathways we are targeting with our ghrelin and ...
... mystery of prematurely dead cell phone and laptop batteries may ... energy grid according to Drexel researcher Dr. Yury Gogotsi. In ... Science , Gogotsi, who is the head of the ... of performance measurement for energy storage devices that are as ...
Cached Biology Technology:DiaTech Life Sciences Announces Medical Advisory Board 2DiaTech Life Sciences Announces Medical Advisory Board 3Rhythm Names Lex Van der Ploeg Chief Scientific Officer 2Drexel expert: Efficiency metrics for energy storage devices need standardization 2
(Date:10/25/2014)... , Oct. 22, 2014 This report covers ... relatively new space in heavy pursuit of research due ... to miRNAs compared to other RNA components. miRNA,s non-coding ... a novel candidate for use as a biomarker for ... miRNA-based microarrays and diagnostics for the advancement in therapeutic ...
(Date:10/22/2014)... , Oct. 20, 2014 The Nano-Bio ... States Air Force Research Laboratory (AFRL), has chosen a ... (AzCIM) at the University of Arizona College of Medicine ... funding.  The AzCIM project,s goal is to assess different ... collect different volumes of sweat under a variety of ...
(Date:10/18/2014)... 2014 Psychological stress and stress-related psychiatric disorders are ... but the molecular mechanisms underlying this relation ... to the development of targeted preventive strategies ... devastating diseases. This work is presented at ... Berlin., Now an international group of researchers ...
Breaking Biology News(10 mins):MicroRNA: An Insight to miRNA-based microarrays, diagnostics and therapeutics Overview, Cambridge Healthtech Advisors 2Nano-Bio Manufacturing Consortium Selects Project Proposed by Arizona Center for Integrative Medicine to Optimize Human Performance Monitoring Techniques 2Nano-Bio Manufacturing Consortium Selects Project Proposed by Arizona Center for Integrative Medicine to Optimize Human Performance Monitoring Techniques 3Researchers find why depression and aging linked to increased disease risk 2
... from an observational study by researchers at the University ... 65 and 80 years of age who received treatment ... than men who did not receive treatment. The study ... the Journal of the American Medical Association. , Thanks ...
... possible new cancer drug suggests that it may prove ... chemotherapeutic drugs. , Dr David Huang, Dr Andrew Roberts, ... research divisions have been assessing the potential of a ... company, Abbott. , Under normal circumstances, human ...
... to light is missing in humans, researchers have discovered. , ... amphibians have two versions of this photoreceptor, mammals, including humans, ... Public Library of Science journal PLoS Biology ?reveal how our ... other vertebrates and fits with the suggestion that early mammals ...
Cached Biology News:Older men treated for early prostate cancer live longer than those who are not 2Hope for a more effective and less toxic cancer drug 2Does missing gene point to nocturnal existence for early mammals? 2
Reacts with the 80 kDa fragment of the M-chain of human merosin....
ICAD / DFF45 (NT) Affinity Purified Polyclonal Antibody...
... polyclonal to ZFP91 ( Abpromise ... Antigen: Synthetic peptide derived ... human ZFP91. (Note: the amino ... Entrez Gene ID: ...
AANAT [Arylalkylamine N-acetyltransferase; EC 2.3.1.87]...
Biology Products: