Navigation Links
Hyperion Wins NDA Approval for UCD Drug Developed With Support from PharmaDirections
Date:2/27/2013

Cary, NC (PRWEB) February 27, 2013

PharmaDirections congratulates Hyperion Therapeutics on achieving a NDA approval for their RAVICTI™ (glycerol phenylbutyrate) Liquid for Treatment of Urea Cycle Disorders. PharmaDirections is proud to have been involved as a pharmaceutical development partner and to have helped in the development of Hyperion's first product to complete full clinical development.

Hyperion has achieved a major milestone for adult and pediatric patients =2 years of age with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of UCD. In clinical studies, RAVICTI kept ammonia at safe levels throughout the day and night and over the long-term (1 year).

PharmaDirections participated in this important program by providing CMC and PK support over the past four years. They were responsible for overseeing the development of the API manufacturing process. They used their process chemistry expertise to review the synthetic scheme and to propose improvements for API synthesis development and optimization that led to improvements in the manufacturing process. Their scientific experts led efforts in formulation development, bioanalytical method development and pharmacokinetic analyses. Their regulatory affairs experts helped in the NDA preparation process by authoring and completing specific areas of the CMC section. PharmaDirections was proud to be a part of this team.

About PharmaDirections

PharmaDirections is a pharmaceutical consulting and project management company with special expertise in preclinical development, Chemistry and Manufacturing Controls, and regulatory affairs. They design and direct outsourced R&D programs for biotech and pharmaceutical firms. They allow virtual biotech firms to achieve their development milestones on
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related biology technology :

1. A New Type of Dendritic Cell-Based Cancer Vaccine has Received Approval for Clinical Tests and at the Same Time Secures Substantial Financing
2. Watsons Generic Yaz(R) Receives FDA Approval
3. ThermoGenesis Announces Approval of AXP® by India Ministry of Health
4. FDA Advisory Committee Declines to Recommend Approval of Progesterone Vaginal Gel 8% for the Reduction of Risk of Preterm Birth in Women with Short Uterine Cervical Length
5. Nautilus Neurosciences, Inc. Announces a New Approval for CAMBIA® for the Acute Treatment of Migraine
6. Watsons Generic BONIVA® 150mg Receives FDA Approval
7. Arteriocyte Receives FDA Approval to Initiate Compartment Syndrome Trial for Amputation Prevention Focused on Wounded Warriors
8. Champions Oncology Inc. Receives Approval from U.S. Regulatory Authorities
9. FDA Issues Orphan Status Approval for PermaDerm®
10. West Wireless Health Institute Applauds House Passage of Bill to Streamline FDA Medical Device Approval Process, Expedite Mobile Medical App Guidance
11. Lupin Receives FDA Approval for Generic LYRICA(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/25/2014)... 24, 2014 ... has announced the addition of the  "The ... Other 2-D Nanomaterials "  report to their ... ,CNTs and graphene are the strongest, lightest ... with a performance-per-weight greater than any other ...
(Date:10/22/2014)... The Americas Inorganic Refrigerants Market report defines ... with analysis and forecast of revenue. , Browse ... Market report, to get an idea of the ... of the segmentation in the Americas inorganic refrigerants ... figures. , http://www.micromarketmonitor.com/market/americas-inorganic-refrigerants-4191654241.html , Inorganic ...
(Date:10/22/2014)... October 22, 2014 WriteResult, LLC ... – has been working with a team of researchers ... Haven Farms Community Farming Collaborative to provide electronic questionnaire ... The study, which started in May, aims to ... provides participants weekly exposure to and participation in urban ...
(Date:10/22/2014)... According to new market research report "Cloud ... Deployment & Support), by Service Model (SaaS, PaaS, ... (Hybrid & Community)) - Global Forecast to 2019", ... Professional Services Market into various sub-segments with an ... identifies the drivers and restraints for this market ...
Breaking Biology Technology:The Global Market for Carbon Nanotubes, Graphene and Other 2-D Nanomaterials 2The Global Market for Carbon Nanotubes, Graphene and Other 2-D Nanomaterials 3The Global Market for Carbon Nanotubes, Graphene and Other 2-D Nanomaterials 4The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 2The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 3myPROpad™ Topic of Panel Discussion at the Yale Food Systems Symposium 2myPROpad™ Topic of Panel Discussion at the Yale Food Systems Symposium 3Cloud Professional Services Market by Public, Private, Hybrid & Community Expected to Reach $34.41 Billion by 2019 - New Report by MarketsandMarkets 2Cloud Professional Services Market by Public, Private, Hybrid & Community Expected to Reach $34.41 Billion by 2019 - New Report by MarketsandMarkets 3Cloud Professional Services Market by Public, Private, Hybrid & Community Expected to Reach $34.41 Billion by 2019 - New Report by MarketsandMarkets 4Cloud Professional Services Market by Public, Private, Hybrid & Community Expected to Reach $34.41 Billion by 2019 - New Report by MarketsandMarkets 5
... 10, 2011 Boston Scientific Corporation (NYSE: ... a clinical education program and online resource center for ... spinal cord stimulation (SCS) technology, procedures and techniques.  The ... the International Spine Intervention Society (ISIS) occurring this week ...
... Verenium Corporation (Nasdaq: VRNM ), a leading industrial ... enzymes, today reported a summary of recent Company highlights and ... June 30, 2011. "I am very pleased with ... partnership negotiations in the first half of the year," said ...
... NEW YORK, Aug. 9, 2011 Reportlinker.com ... is available in its catalogue: ...     http://www.reportlinker.com/p0591346/ ... Biochips, DNA Chips, Genosensors, Microarrays and Labs-on-the-Chip ...
Cached Biology Technology:Boston Scientific Launches Neuromodulation Learning Institute To Enhance Clinical Education For Spinal Cord Stimulation 2Boston Scientific Launches Neuromodulation Learning Institute To Enhance Clinical Education For Spinal Cord Stimulation 3Boston Scientific Launches Neuromodulation Learning Institute To Enhance Clinical Education For Spinal Cord Stimulation 4Verenium Reports Financial Results for the Second Quarter and Six Months Ended June 30, 2011 2Verenium Reports Financial Results for the Second Quarter and Six Months Ended June 30, 2011 3Verenium Reports Financial Results for the Second Quarter and Six Months Ended June 30, 2011 4Verenium Reports Financial Results for the Second Quarter and Six Months Ended June 30, 2011 5Verenium Reports Financial Results for the Second Quarter and Six Months Ended June 30, 2011 6Verenium Reports Financial Results for the Second Quarter and Six Months Ended June 30, 2011 7Verenium Reports Financial Results for the Second Quarter and Six Months Ended June 30, 2011 8Verenium Reports Financial Results for the Second Quarter and Six Months Ended June 30, 2011 9Biochips: Genosensors, Microarrays, Labs-On-The-Chip 2
(Date:10/15/2014)... the pandemic risk from strains of influenza virus increases ... ourselves to become complacent that the most substantial threats ... , Influenza pandemics arise when a new virus strain ... immunity – spreads in the human population. There have ... the worst of which – the 1918 Spanish Flu ...
(Date:10/15/2014)... University Mainz (JGU) as a full member, ensuring ... a significant nationwide standing in the field of ... Gutenberg University Mainz as a full member of ... and international competition for the best minds and ... proud that Mainz University has been recognized as ...
(Date:10/15/2014)... increased resistance to bacterial pneumonia in female mice to ... , Females are naturally more resistant to respiratory infections ... shown that increased resistance to bacterial pneumonia in female ... 3 (NOS3). They also show that this enzyme is ... hormone estrogen. , The team, lead by Professor Lester ...
Breaking Biology News(10 mins):Scientists 'must not become complacent' when assessing pandemic threat from flu viruses 2Johannes Gutenberg University Mainz joins Germany's Gauss-Allianz as a full member 2Johannes Gutenberg University Mainz joins Germany's Gauss-Allianz as a full member 3
... when a mouse repeatedly experiences defeat by a dominant ... memory molecule in a brain circuit for social learning, ... National Institute of Mental Health (NIMH) have discovered. ... welcome strangers in spite of repeated social defeat. Their ...
... cure rate for the once almost universally fatal childhood ... in the near future, thanks to improvements in diagnosis ... investigators at St. Jude Children's Research Hospital. Almost 4,000 ... each year, about two-thirds of which are in children ...
... in repairing damaged DNA causes mice to develop the ... have discovered. , Scientists at OHSU, the University of ... that generating mice that lack the gene encoding the ... obesity and reach nearly twice the weight of their ...
Cached Biology News:Mice lacking social memory molecule take bullying in stride 2Mice lacking social memory molecule take bullying in stride 3St. Jude projects 90 percent cure rate for ALL 2St. Jude projects 90 percent cure rate for ALL 3St. Jude projects 90 percent cure rate for ALL 4St. Jude projects 90 percent cure rate for ALL 5Removing DNA repair gene causes metabolic syndrome 2Removing DNA repair gene causes metabolic syndrome 3
... The FDSS6000 System is an ... assays, assay development and high throughput ... and luminescence modalities., The Hamamatsu light ... highlight our companys decades-long experience in ...
...
... supplies, for 10 chips, provides the ... high-sensitivity RNA analysis (picogram levels) with ... electrophoresis system. Supplied are 1,250 microliters ... stain, 20 microliters RNA ladder, 900 ...
... 3-(3,5-Dibromo-4-hydroxy-benzoyl)-2-ethyl-benzofuran-6-sulfonicacid-(4-(thiazol-2-ylsulfamyl)-phenyl)-amide White solid. ... GAS. A cell-permeable sulfanamido-benzbromarone compound that ... non-competitive allosteric inhibitor of PTP1B (IC ... 8 μM for PTP1B 403 ...
Biology Products: