Navigation Links
Insmed Incorporated Provides Corporate Update
Date:1/20/2012

MONMOUTH JUNCTION, N.J., Jan. 20, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease.  Insmed continues to engage in discussions with FDA regarding the clinical hold placed on ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections.

The clinical holds placed on the ARIKACE programs in NTM and CF were based on an initial review by FDA of the results reported by Insmed of a long-term rat inhalation carcinogenicity study of ARIKACE.

FDA previously requested that Insmed conduct a phase 2 clinical trial of ARIKACE in adult patients with NTM to provide proof-of-concept efficacy and safety data before proceeding with a phase 3 clinical trial.  As part of its on-going assessment of the appropriate path forward for the ARIKACE program, including the phase 2 trial of ARIKACE in NTM patients, the Company is continuing communication with FDA regarding the CF clinical hold.

Insmed also announced that it will move ahead with the 9-month dog inhalation toxicity study of ARIKACE as previously requested by FDA to determine if the findings of the rat inhalation carcinogenicity study are observed in a non-rodent model.

"We are pleased that FDA has lifted the clinical hold on the ARIKACE development program in NTM," said Timothy Whitten, President and CEO of Insmed.  "Insmed continues to work closely with regulatory authorities regarding the development program for ARIKACE.  We are initiating the work required to begin the 9-month dog study during the second quarter and are continuing our dialogue with FDA regarding the CF clinical program."

Insmed also announced that IPLEX® inventory has now been fully depleted.  At present,
'/>"/>

SOURCE Insmed Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Insmed to Host 2011 Third Quarter Earnings Conference Call
2. Insmed to Present at 2011 Wedbush Securities Life Sciences Management Access Conference
3. Andrea Drucker Joins Insmed as General Counsel
4. Insmed Announces FDA Clearance of IND for Pivotal Phase 3 Trial of ARIKACEā„¢ in Nontuberculous Mycobacteria Indication
5. Insmed Announces Fourth Quarter and Full-Year 2010 Financial Results
6. Insmed to Host Second Quarter 2009 Conference Call
7. Insmed Announces Addition to the Russell 3000(R) Index
8. Insmed Announces Results of IPLEX(TM) Phase II Trial in Myotonic Muscular Dystrophy
9. Insmed CEO Resigns Due to Health Concerns
10. Insmed Announces First Quarter 2009 Financial Results
11. Insmed Regains NASDAQ Compliance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/18/2014)... Aug. 18, 2014 /PRNewswire/ - SQI Diagnostics Inc. (TSX-V: SQD), ... technologies and products for advanced microarray diagnostics, today announced ... August 22 at 2:00 pm ET.  ... provide a brief review of SQI,s recent commercialization progress ... diagnostics industry veteran recently appointed to the Board of ...
(Date:8/18/2014)...   Sterne, Kessler, Goldstein & Fox P.L.L.C. , ... DC , announced today that it has filed ... with the U.S. Patent and Trademark Office (USPTO) on ... Inc. (Nasdaq: BRLI).  These IPR petitions aim to nullify ... Inc. These patents have been asserted against GeneDx in ...
(Date:8/18/2014)... (PRWEB) August 18, 2014 Global HIV ... pharma report announced by Reportstack. The rate of HIV infection ... on a declining note at a positive rate across the ... from 2.3 million in 2005 to 1.5 in 2013, with ... cause for such drastic changes in the infection rates has ...
(Date:8/18/2014)... According to the new ... (Municipal Wastewater Treatment and Industrial Wastewater Treatment), By ... By Configuration (Internal/Submerged and External/Sidestream), and By Region-Trends ... market for membrane bioreactor systems is projected to ... CAGR of 15.28% between 2014 and 2019. ...
Breaking Biology Technology:SQI Diagnostics Announces Investor Conference Call with Dr. Allan Pronovost 2SQI Diagnostics Announces Investor Conference Call with Dr. Allan Pronovost 3Sterne Kessler Files 11 IPR Petitions On Behalf Of GeneDx, Inc., Subsidiary Of BioReference Laboratories, Inc. 2Sterne Kessler Files 11 IPR Petitions On Behalf Of GeneDx, Inc., Subsidiary Of BioReference Laboratories, Inc. 3Global HIV Infection Drug Market Overview 2Global HIV Infection Drug Market Overview 3Global HIV Infection Drug Market Overview 4Membrane Bioreactor Systems Market Worth $2,927 Million by 2019 2Membrane Bioreactor Systems Market Worth $2,927 Million by 2019 3
... 8 Millstone Medical Outsourcing,announced today that the ... MA,to accommodate growing business with new and existing ... The new facility, located at,580 Commerce Drive, includes ... for advanced inspection services, ultrasonic cleaning,and sterile and ...
... PT. RICHMOND, Calif., Oct. 8 Transcept Pharmaceuticals,Inc., ... P. Soloway, Senior Vice President and Chief Financial ... Second Annual Hidden,Gems Conference in New York City ... Time., An audio webcast of the presentation ...
... J. Kern and Peter Ver ... Lee Among the Highlights, ... for optimizing patient outcomes is the topic,of multiple sessions at this ... 12-17 in,Washington, D.C., Radi Medical Systems, the first company to ...
Cached Biology Technology:Millstone Medical Outsourcing Acquires New Facility to Accommodate Growing Business, Provide Additional Clean Room Capacity 2Transcept Pharmaceuticals, Inc. to Present at the Natixis Bleichroeder Second Annual Hidden Gems Conference 2Radi Medical Systems Announces Schedule for TCT 2008 2
(Date:8/20/2014)... Research UK scientists have discovered that acral melanomas the ... Marley,s death are genetically distinct from other more common ... external) published in the journal Pigment Cell & Melanoma ... of the hands, soles of the feet, nail-beds and other ... of melanoma, it,s not caused by UV damage from the ...
(Date:8/20/2014)... past few years, Virginia Tech,s Wu Feng has built ... from the "Computing in the Cloud" program, and synergistically ... million award from the Air Force on "big computing" ... and the National Institutes of Health on "big data" ... the "parallel computing" aspects from each grant, he was ...
(Date:8/20/2014)... colony of honeybees grows to about 4,000 members, it ... the building of a special type of comb used ... experts from the Department of Neurobiology and Behaviour at ... the reproductive cycle of honeybee colonies. The results are ... of Nature . , Reproduction isn,t always a ...
Breaking Biology News(10 mins):Scientists learn more about rare skin cancer that killed Bob Marley 2The internet was delivered to the masses; parallel computing is not far behind 2The internet was delivered to the masses; parallel computing is not far behind 3The internet was delivered to the masses; parallel computing is not far behind 4Worker bees 'know' when to invest in their reproductive future 2
... 2011 - Tropical maize proves to be a valuable ... Belt maize. Most tropical maize varieties respond to the ... regions by flowering late. This delayed flowering response results ... hindering their incorporation into maize hybrids adapted to the ...
... Medical Center announced today that it is the first medical ... a cutting-edge biometric technology – to identify patients. Utilizing near ... through the veins in a person,s palm, the digital palm ... with the medical center,s electronic health record system. ...
... titanium dental implants could be improved. By studying the surface ... also at nano level, researchers at the University of Gothenburg; ... the healing time for patients. , "Increasing the active surface ... allows us to affect the body,s own biomechanics and speed ...
Cached Biology News:Unique gene combinations control tropical maize response to day lengths 2Patient Identification "In The Palm Of Your Hand" 2Patient Identification "In The Palm Of Your Hand" 3Healing times for dental implants could be cut 2
... MultiScribe Reverse Transcriptase is a recombinant ... transcriptase. MultiScribe Reverse Transcriptase is similar ... in its recommended usage. MuLV reverse ... polymerase that uses single-stranded RNA as ...
... determination of digitonin and digoxin. Physical form: Lyophilized ... and 0.06% NaCl Preparation Note: Sodium iodide ... Res. Commun., 19, 755 (1965). Unit Definition: ... phosphorus from ATP per min at pH 7.4 ...
... protease from human rhinovirus (HRV 3C) is ... line of restriction grade proteases. The recombinant ... protein, which recognizes the same cleavage site ... 22 KDa size of the protease, optimal ...
... IEC Centra CL3 series is designed ... research and clinical applications at a ... package includes quick connect rotors and ... yet intuitive interface allows you to ...
Biology Products: