Navigation Links
Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
Date:2/5/2008

RICHMOND, Va., Feb. 5 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM) CEO Geoffrey Allan issued the following statement today following the White House FY09 Budget and Food and Drug Administration statements on developing an approval pathway for follow-on biologics:

"Insmed is very pleased to see that the White House recognizes the importance of establishing a follow-on biologics approval pathway to deliver safe and more affordable medicines to Americans.

"We are also pleased by news of the Food and Drug Administration's preparation of a proposal to assist the Congress in moving forward with legislation to establish an approval pathway for follow-on biologics.

"We hope that the attention this important issue has received from both the White House and FDA will move Congress to adopt follow-on biologics legislation so patients can receive safe and affordable access to generic versions of these life-saving biotech drugs."

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs. Insmed has a state-of-the- art, FDA-approved biologic commercial manufacturing facility in Boulder, Colorado and a Corporate office in Richmond, Virginia. For more information, please visit http://www.insmed.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results
'/>"/>

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

Page: 1 2

Related biology technology :

1. 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
2. Insmed to Appeal Delisting Notification From Nasdaq
3. Insmed Awarded $2.1 Million by Muscular Dystrophy Association
4. Insmed Appoints Dennis M. Lanfear to Board Of Directors
5. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
6. FDA Issues Approvable Letter for LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
7. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
8. CCPM Issues Statement on FDAs GIVE Initiative
9. Symmetry Medical Discloses Accounting Issues at Sheffield, UK Operating Unit and Possible Restatement
10. CalbaTech Issues Update; Beginning Training for Adult Stem Cell Collections in Atlanta
11. HHS Issues First Department-Wide Report on Personalized Health Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2013)... Bellingham, WA (PRWEB) May 24, 2013 ... researchers, engineers, and industry suppliers will present technologies ... life at the annual SPIE Optics and ... August. Organized by SPIE, the international society ... the largest international, multidisciplinary optical sciences and technology ...
(Date:5/24/2013)... Many factors impact tissues targeting such ... transporters at the blood-tissue barrier. Even when tissue disposition ... in the tissue rather than the total tissue concentration. ... required to guide lead optimization, predict in vivo activity ... that may impact the likely human clinical dose. , ...
(Date:5/23/2013)... stopped breathing, his collapsed bronchus blocking the crucial flow ... watched helplessly, just praying that somehow the dire predictions ... had a good chance of not leaving the hospital ... Kaiba. "At that point, we were desperate. Anything that ... it." , They found hope at the University of ...
(Date:5/23/2013)... Patheon Inc ., a leading provider of ... industry, will host a complimentary webinar on “Cleaning Validation: ... June 4, 2013 at 11 a.m. Eastern Standard Time. ... with regulations for cleaning validation. Many companies have ... little evaluation of risk. Some companies have chosen ...
Breaking Biology Technology:See What’s in Earth’s Future ? and Out in Space Now ? at SPIE Optics and Photonics 2See What’s in Earth’s Future ? and Out in Space Now ? at SPIE Optics and Photonics 3See What’s in Earth’s Future ? and Out in Space Now ? at SPIE Optics and Photonics 4DMPK for Targeted Tissue Delivery: Solutions for the Most Challenging Part of Outsourcing, New Life Science Webinar Hosted by Xtalks 2Baby's life saved with groundbreaking 3-D printed device that restored his breathing 2Baby's life saved with groundbreaking 3-D printed device that restored his breathing 3Patheon to Present on “Cleaning Validation: Science, Risk and Novel Approaches to Testing” 2
... Biomarker Identification ... and ADME/Tox Applications, LINCOLN, R.I., ... into a worldwide,exclusive license and technology purchase agreement with Corning,Incorporated ... cell lines. Corning paid MultiCell a license fee, and ...
... of Unsaturated Fatty Acids in ... Cardiovascular ... AMRN ) today announced that it has initiated a cardiovascular,development ... acids in cardiovascular disease. Amarin plans to utilize,its extensive know-how ...
... Fourth Fourth Fiscal Fiscal ($ in millions) ... ... $364 $212 $2,807 $1,793 Soybean seed and traits ... Cotton seed and traits 58 52 319 ...
Cached Biology Technology:MultiCell Technologies Signs Worldwide Exclusive License Agreement With Corning Incorporated 2MultiCell Technologies Signs Worldwide Exclusive License Agreement With Corning Incorporated 3Amarin Announces Initiation of Cardiovascular Development Strategy 2Amarin Announces Initiation of Cardiovascular Development Strategy 3Amarin Announces Initiation of Cardiovascular Development Strategy 4Amarin Announces Initiation of Cardiovascular Development Strategy 5Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 2Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 3Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 4Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 5Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 6Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 7Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 8Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 9Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 10Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 11Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 12Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 13Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 14Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 15Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 16Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 17Monsanto Sees Record Sales in Fiscal Year 2007; Seeds and Traits Business Contributes to Strong Fourth Quarter and Year-End Results 18
(Date:5/22/2013)... a novel technique that can detect molecular variants in ... one of the most important, though time-consuming, processes in ... in Nature , post-doctoral researcher David Patterson, Professor ... the Center for Free-Electron Laser Science (CFEL) in Hamburg, ... fields to identify molecular variants apart, and to determine ...
(Date:5/22/2013)... 3 fatty acids in fish oil have long been ... the American Heart Association currently recommends eating at least ... rich in omega 3s. However, the mechanism behind this ... study, scientists led by Jason R. Carter of Michigan ... evidence that fish oil might specifically counteract the detrimental ...
(Date:5/22/2013)... and human health effects from disposal of millions ... scientists to recommend stronger government policies to encourage ... materials. That,s the conclusion of a new paper ... Technology . , Oladele A. Ogunseitan and colleagues ... for powering everything from smart phones to components ...
Breaking Biology News(10 mins):Detecting mirror molecules 2Detecting mirror molecules 3Fish oil may help the heart beat mental stress 2
... A new discovery about selective serotonin reuptake inhibitors ... treat mental health disorders like depression and anxiety, have ... published in the August 2010 issue of GENETICS ... identify secondary drug targets or pathways affected by SSRIs. ...
... Solitary snails in search of a mate put off parenthood as ... But when Physa acuta snails smell predators, they don,t ... parenthood much sooner than their calm counterparts, says a new study ... Durham, NC. "They can,t wait for a mate indefinitely ...
... Buck Institute for Age Research have successfully used human ... with Parkinson,s Disease (PD). The research, which validates ... developed, can be used to manufacture the type of ... way for the use of iPSC,s in various biomedical ...
Cached Biology News:SSRIs may pack more punch at the cellular level than believed 2Scared snails opt for single parenthood rather than wait for a mate 2Scientists successfully use human induced pluripotent stem cells to treat Parkinson's in rodents 2
Mouse monoclonal antibody raised against a full length recombinant SLC25A11. NCBI Entrez Gene ID = SLC25A11...
... raised against a partial recombinant ... TOPORS (NP_005793, 98 a.a. ... protein with GST tag. ... NM_005802 Protein ...
Mouse monoclonal antibody raised against a full length recombinant SNAPC5. NCBI Entrez Gene ID = SNAPC5...
... antibody raised against a partial recombinant NFKBIB. ... ~ 145 a.a) partial recombinant protein with GST ... Accession: BC015528 ... OMIM: 604495, GeneID: ...
Biology Products: