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:7/30/2014)... 30, 2014   Wyle has been ... Lifecycle Mission Support Services (FILMSS) contract awarded by ... the terms of the contract, Wyle will provide ... Field, Calif. In particular, Wyle will provide program ... projects on the International Space Station and collaborative ...
(Date:7/30/2014)... 30, 2014 Yuma Regional Cancer ... complementary therapies brings comprehensive cancer care to Yuma, ... Regional Cancer Center has officially opened. A Mayo ... includes services such as open, semi-private and private ... Cancer Society Resource Center, hematology, rehabilitation center, a ...
(Date:7/30/2014)... July 30, 2014  AtheroNova Inc. (OTCBB: AHRO), ... development of compounds to safely regress atherosclerotic plaque ... that its partner, CardioNova, has accomplished first dosing ... with AtheroNova,s lead compound, AHRO-001.  This Phase 1b ... Phase 1 safety trial completed in February 2014, ...
(Date:7/30/2014)... Adding to their already extensive selection of ... – Buy 2 of any Weighing Boats or Dishes ... technicians looking for durable and reliable weighing products to ... applications including weighing liquids, solid, or granulated samples. ... hexagonal, square, aluminum weighing, and standard boats. Aluminum weighing ...
Breaking Biology Technology:Wyle Wins NASA's Fully Integrated Lifecycle Mission Support Services Contract 2Sate-of-the-Art Yuma Regional Cancer Center Officially Opens 2AtheroNova Announces Milestone with Initiation of Phase 1b Clinical Trial of AHRO-001 2AtheroNova Announces Milestone with Initiation of Phase 1b Clinical Trial of AHRO-001 3AtheroNova Announces Milestone with Initiation of Phase 1b Clinical Trial of AHRO-001 4Weighing Boat Promotion Now Available at Pipette.com, Major Pipette Distributor 2
... AMSTERDAM, November 30 Biopharmaceutical company Kiadis,Pharma ... in its,multinational registration clinical trial with ATIR(TM). The study ... after one,year following an allogeneic stem cell transplantation with ... an allogeneic,stem cell transplantation but without having a matched ...
... , ... Yongxin Pharmaceuticals, Inc. (OTC Bulletin Board: CYXN; ,China Yongxin,Pharmaceuticals, ... pharmaceuticals in Northeastern China, today announced it has,completed preparation ... , The Chinese government recently ...
... NOVATO, Calif., Nov. 30 BioMarin Pharmaceutical Inc. (Nasdaq: ... Drug Administration (FDA) has granted orphan drug designation for ... Lambert Eaton Myasthenic Syndrome (LEMS). 3,4-DAP has previously ... in October 2009, the Committee for Medicinal Products for ...
Cached Biology Technology:Kiadis Pharma Announces Enrollment of First Patients in a Multinational Registration Study for ATIR(TM) 2China Yongxin Pharmaceuticals Inc. to Distribute Medicines on the Essential Drug List 2China Yongxin Pharmaceuticals Inc. to Distribute Medicines on the Essential Drug List 3FDA Grants Orphan Drug Designation for 3,4-DAP for LEMS 2FDA Grants Orphan Drug Designation for 3,4-DAP for LEMS 3FDA Grants Orphan Drug Designation for 3,4-DAP for LEMS 4
(Date:7/30/2014)... humans figured out how to create colors, nature had ... wings of many different hues, for example. Now scientists ... environmentally friendly way to make colored plastics. Their paper ... of materials rather than dyes, to produce color ... , N. Asger Mortensen, Anders Kristensen and colleagues point ...
(Date:7/30/2014)... professor from Wayne State University,s College of Engineering ... Science Foundation for the project, "Nanoparticle-directed synthesis of ... Science Foundation, nanotechnology is the creation and utilization ... properties and functions. A major bottleneck in scaling ... that connect different functional materials into one device. ...
(Date:7/30/2014)... therapies for spinal cord injury (SCI), traumatic brain injury ... great deal has been learned over the past 30 ... factors that regulate axon growth, but this large body ... therapeutics. Prof. Lemmon and his team from University of ... root causes, but a consensus is emerging that one ...
Breaking Biology News(10 mins):NSF grant to Wayne State supports new concept for manufacturing nanoscale devices 2
... Eucalyptus trees - or gum trees as they are know - ... system and depositing it their leaves and branches., Scientists from CSIRO ... Nature Communications . "The eucalypt acts as a hydraulic ... and draw up water containing the gold. As the gold is ...
... prominence as research reagents in modern biological science labs, ... lot can differ significantly from the next, in terms ... loss of countless hours of research, to say nothing ... antigen is a substance that stimulates the production of ...
... Clemson University scientists are working to determine how ... for neurological disorders like Tuberous Sclerosis Complex (TSC). ... growth of tumors in the brain and other vital ... and cognitive impairment that may arise from the abnormal ...
Cached Biology News:There's gold in them thar trees 2The hitchhiker antigen: Cause for concern? 2Clemson University study points to possible treatment for brain disorders 2
Rabbit Anti-Human Secretory Carrier Membrane Protein 2 (SCAMP2 Polyclonal AntibodyOther Sub-Family: not assigned-Other Applications: Western Blot...
Parathyroid Hormone Receptor 2 [PTHR2]...
... a proprietary high-performance desalting resin, exclusive to ... characteristics compared to other commercially available resins. ... of protein can be processed, providing exceptional ... salts and other small molecules ( ...
... member of the caudal-related homeobox family, is ... proliferation and differentiation in intestinal epithelial cells. ... cells towards the phenotype of differentiated villus ... of the phenotype. Clone CDX2-88 reacts with ...
Biology Products: