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:11/24/2009)...RNewswire-FirstCall/--GenomicHealth,Inc.(Nasdaq: G...xecutiveChairman,willpresentatthe21stAnnualPiperJa...cember1,2009at10:00a.m.ET. ,, Toaccessthelivean...ttheInvestorRelationssectionofGenomicHealth,swebsi...ecttothewebsiteatleast15minutespriortothebeginning...
(Date:11/23/2009)...n a provocative new study, a University of Utah sc...s the major cause of global warming cannot be st...ociety builds the equivalent of one new nuclear po...here will be any substantial near-term departure f...de emission rates," says the new paper by Tim Garr...
(Date:11/23/2009)...swire-FirstCall/-YMBioSciencesInc.(NYSEAmex: YMI ;...identifiesandadvancesadiverseportfolioofpromisingc...todayreportedthatCytopia(ASX:CYT)hascommencedenrol...lly-administeredJAK1/JAK2inhibitor.Thetrialisbeing...altomergeCytopiaintoYMhasbeenpreviouslyannouncedan...
(Date:11/23/2009)...PRNewswire/--Frost&Sullivan,theGrowthPartnersh...ngleadershipandinnovationThursday,November19,2009a...eldinSanAntonio,Texas. ,, (Logo: http://www.new...ealthcareInnovationAwardsaregiventocompaniesthatha...gementofhealthcare.Suchcompanieshaveshownsuccessat...
Breaking Biology Technology:Genomic Health to Present at Piper Jaffray Health Care Conference 2Is global warming unstoppable? 2Is global warming unstoppable? 3Is global warming unstoppable? 4YM BIOSCIENCES REPORTS FIRST PATIENT IN PHASE I/II TRIAL OF JAK1/JAK2 INHIBITOR, CYT387 ENROLLED BY CYTOPIA 2YM BIOSCIENCES REPORTS FIRST PATIENT IN PHASE I/II TRIAL OF JAK1/JAK2 INHIBITOR, CYT387 ENROLLED BY CYTOPIA 3YM BIOSCIENCES REPORTS FIRST PATIENT IN PHASE I/II TRIAL OF JAK1/JAK2 INHIBITOR, CYT387 ENROLLED BY CYTOPIA 4Excellence in Healthcare Innovation Recognized by Frost & Sullivan 2Excellence in Healthcare Innovation Recognized by Frost & Sullivan 3
...e per capita income, retain more college graduates...options, the state announced Thursday a commitment...laureate degree programs. , ,The announcement, mad...art of the state,s strategy to play catch up in te...ees. Seven programs have been selected to receive ...
...ogy business, especially manufacturers and printer...Applied Technology Centers now under construction ... and at Waukesha County Technical College . , ,Bo...ea employers, especially in the area of workforce ...has received approval to move ahead with the Cente...
...a Madison software developer, achieved its 68th co...e months of 2006, thanks largely to a 125 percent ...d message transfer management products. , ,Citing ...ide actual sales numbers for MOVEit, but said Stan...rcent in 2005. The company employs less than 25 pe...
Other Biology Technology:State commits $500,000 to boost bachelor's degrees 2Applied Technology Centers to aid printing and manufacturing 2Applied Technology Centers to aid printing and manufacturing 3
(Date:11/23/2009)...s that a common oral bacterium may exacerbate auto...al, "Unique Lipids from a Common Human Bacterium R...hancing Autoimmunity," appears in the December 200... Multiple sclerosis (MS), a disease where the imm...cts nearly 1 in 700 people in the United States. ...
(Date:11/23/2009)... the highest resolution images of peptides attachi...nderstanding how biomolecules manipulate the growt...ent for kidney stones using biomolecules. , The ...ion of the journal Proceedings of the National Ac... with mineral surfaces by accelerating, switching ...
(Date:11/23/2009)...ire microbiologist Louis Tisa has received two gra...the actinorhizal plants, widespread woody plants w...ated soils. , The United States Department of A...ecular, cellular and biomedical sciences, $399,000... bacteria Frankia and Casuarina, an actinorhizal p...
Breaking Biology News(10 mins):Factors from common human bacteria may trigger multiple sclerosis 2Scientists watch as peptides control crystal growth with 'switches, throttles and brakes' 2Scientists watch as peptides control crystal growth with 'switches, throttles and brakes' 3UNH prof. receives nearly $500,000 to research environmentally significant plants 2Pitt researchers harness carbon nanomaterials for drug delivery systems oxygen sensors 54668 1Pitt researchers harness carbon nanomaterials for drug delivery systems oxygen sensors 54668 2A New Marketplace for Doctors DoctorFinders com 3A Free Market Solutions for Health Care 54667 1A New Marketplace for Doctors DoctorFinders com 3A Free Market Solutions for Health Care 54667 2Employee Benefits Industry Organizes to Protect Flexible Spending Accounts From Elimination or Contribution Limits 54665 1Employee Benefits Industry Organizes to Protect Flexible Spending Accounts From Elimination or Contribution Limits 54665 2Employee Benefits Industry Organizes to Protect Flexible Spending Accounts From Elimination or Contribution Limits 54665 3
... new mechanistic description of how tumor cells mi...of tumor metastasis. This new understanding holds ...is therapies. , Scientists know that tumor cells ...derstand the details of how this deadly migration ... Cancer Cell, EPFL Professor Melody Swartz and pos...
...ered how female cells are able to choose randomly ...e is always lucky. , Human males have both a X and.... This means that in an early stage in the develop... silence one of those two X chromosomes. This proc...rocess are related to serious genetic diseases. ...
... survey sponsored by CancerCare, a national nonpro...y (76 percent) of women surveyed said they know at...ain unaware of the important recent progress made ...ent) women ages 50-65 have heard of new therapies ...ss and information that women can use toward bette...
Other Biology News:Migration alert -- How tumor cells home in on the lymphatic system 2Physicist cracks women's random but always lucky choice of X chromosome 2Women well informed about breast cancer, yet lacking knowledge about current treatments 2
...easy-to-use operating environment for simplified i...gration with regulatory compliance requirements. C...e-analysis, custom reports, and data management in...utions assistant bar provides easy navigation betw...
Corning Resuable Pp Vial Rack, Non-Sterile, 50 Positions, Self Locking Design from Sigma-Aldrich
Corning Cryo Vial Rack, PC, Holds 30 Self-Standing Vials, Non-Sterile from Sigma-Aldrich
Benchtop Laminar Hood (Universal Hood) from Terra Universal, Inc.
Biology Products: