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

0

GOOD

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:11/5/2009)...5 DSM Pharmaceutical Products toda...nce with Galenix, Saint Jean D,Illac, France, wher...acturing partner for Galenix commercial products o...borate on business development opportunities co-ma...on the strength of Galenix in drug product develop...
(Date:11/5/2009)... Nov. 5 ThermoGenesis Co...tive products for processing and storing adult ste...ter of fiscal 2010. ,, For the quarter ended Se... $5.2 million, a 15 percent increase over revenues...The Company said the key contributors to the growt...
(Date:11/5/2009)...Newswire-FirstCall/ -- Transgenomic, Inc. (OTC Bul...ts for the quarter ended September 30, 2009. The C...bles that follow. ,, Third Quarter 2009 ,,....01 per share for the third quarter of 2009 as com... for the third quarter of 2008. ,, Net sales w...
(Date:11/5/2009)... 5 Cepheid (Nasdaq: CPH...eaking at the following investor conferences, and ... Credit Suisse Healthcare Conferenc...ber, 2009 at 10 a.m. Mountain Time, ...nd, Tuesday, 1 December, 2009 at 1...
Breaking Biology Technology:DSM Pharmaceutical Products Forms Manufacturing Alliance With Galenix 2DSM Pharmaceutical Products Forms Manufacturing Alliance With Galenix 3ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 2ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 3ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 4ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 5ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 6ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 7ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line 8Transgenomic, Inc. Reports Third Quarter 2009 Results 2Transgenomic, Inc. Reports Third Quarter 2009 Results 3Transgenomic, Inc. Reports Third Quarter 2009 Results 4Transgenomic, Inc. Reports Third Quarter 2009 Results 5Transgenomic, Inc. Reports Third Quarter 2009 Results 6Transgenomic, Inc. Reports Third Quarter 2009 Results 7Cepheid to Webcast Upcoming Financial Presentations 2
...ay, Apple,s Steve Jobs announced the new iPhone ...ut whenever you have something new come onto the m...Plus, you can,t compare Apples to oranges. In this...torola RAZRs, Nokias , Samsung , and all the ot...CNBC , Herb Greenberg, was very skeptical in sayin...
...Wis. - In a letter to members of Wisconsin,s Cong...to vote to lift president Bush,s restrictions on...ell Research Enhancement Act of 2007. , ,The Hous...asure on Jan. 11. , ,Doyle, who has supported prev... said the bill, also known as HR 3, would lift cur...
...Wis. - Responding to a lawsuit filed by Digene C...iolated a patent covering a single and rare type o...inue to develop products to detect high-risk infec...nfringing on claims of a U.S. patent - number 5,64...ted in Gaithersburg, Md., filed the suit in U.S. ...
Other Biology Technology:The Apple iPhone: A call to competitors 2The Apple iPhone: A call to competitors 3The Apple iPhone: A call to competitors 4Third Wave responds to Digene patent lawsuit 2
(Date:11/9/2009)... , Large blooms of tiny marine plants called phyt...eft exposed by the recent and rapid melting of ice...la. This remarkable colonisation is having a benef...back phytoplankton sinks to the sea-bed where it c.... , Reporting this week in the journal Global ...
(Date:11/9/2009)... , Cold Spring Harbor, N.Y. Oncologists have had...man cancers have mutations that disable a protein ...3 masterminds several cancer-fighting operations w...essively and often cannot be treated. , These t...suggests a new study from Cold Spring Harbor Labor...
(Date:11/9/2009)... , Rice University evolutionary biologists David ...hat high cooperation and low conflict between comp...g thing its "organismality," whether that thing is...Some of the traits scientists use to describe an o...in the same species, may not be necessary to achie...
Breaking Biology News(10 mins):Antarctica glacier retreat creates new carbon dioxide store 2CSHL study shows that some malignant tumors can be shut down after all 2CSHL study shows that some malignant tumors can be shut down after all 3What is the meaning of 'one'? 2What is the meaning of 'one'? 3livethesource 28TM 29 Hosts Company Launch Event While Supporting The Brent Shapiro Foundations Annual Sober Night Out 57392 1livethesource 28TM 29 Hosts Company Launch Event While Supporting The Brent Shapiro Foundations Annual Sober Night Out 57392 2livethesource 28TM 29 Hosts Company Launch Event While Supporting The Brent Shapiro Foundations Annual Sober Night Out 57392 3Pesky fruit flies learn from experienced females 3A Study 9954 1Pesky fruit flies learn from experienced females 3A Study 9954 2Chloride found at levels that can harm aquatic life in urban streams of the Northern US 9949 1Chloride found at levels that can harm aquatic life in urban streams of the Northern US 9949 2
...demy of Sciences (NAS) will honor 13 individuals w...hievements in the areas of biology, chemistry, sol...leontology, social sciences, and psychology. , T...I MEDAL a medal and a prize of $20,000 as well as...ent,s choosing, awarded every three years to honor...
...spital announced today that it has been named an A...y (ASMBS) Bariatric Surgery Center of Excellence. ...izes surgical programs with a demonstrated track r... , This distinction recognizes the expertise of ...mitment to quality programs and services, says Rob...
...LEASE , From and for the heart, My Dear Valent...Chemistry , Wishing your Valentine good heart he...nsider the food some people love to hate, and hand...-shaped box of chocolates. Researchers in Connecti...ing broccoli may protect against heart disease. Th...
Other Biology News:Academy honors 13 for major contributions to science 2Academy honors 13 for major contributions to science 3Academy honors 13 for major contributions to science 4Academy honors 13 for major contributions to science 5Pennsylvania Hospital recognized for excellence in bariatric surgery 2American Chemical Society's Weekly PressPac -- Jan. 16, 2008 2American Chemical Society's Weekly PressPac -- Jan. 16, 2008 3American Chemical Society's Weekly PressPac -- Jan. 16, 2008 4American Chemical Society's Weekly PressPac -- Jan. 16, 2008 5American Chemical Society's Weekly PressPac -- Jan. 16, 2008 6American Chemical Society's Weekly PressPac -- Jan. 16, 2008 7American Chemical Society's Weekly PressPac -- Jan. 16, 2008 8American Chemical Society's Weekly PressPac -- Jan. 16, 2008 9
Invitrogen Magnetic Stand from Invitrogen
H2A.X Phosphorylation Assay Kit (Flow Cytometry) from Upstate
H2A.X Phosphorylation Assay Kit (Chemiluminescence Detection) from Upstate
...fusion system. For real-time or pre-programmed liq..., electrochemistry, or general liquid-handling res...with 10 millisecond accuracy Run experiments auto...for accuracy and flexibility Turnkey perfusion sy...
Biology Products: