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 time and on budget because of PharmaDirections' long term relationships with CRO and CMOs, and the extensive scientific expertise.

For more information please visit http://www.PharmaDirections.com.

About Hyperion Therapeutics

Hyperion Therapeutics, Inc. is a commercial stage biopharmaceutical company committed to developing and delivering life-changing treatments for orphan diseases and hepatology. For more information, please visit http://www.hyperiontx.com.

Read the full story at http://www.prweb.com/releases/2013/2/prweb10442980.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

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:6/27/2016)... 27, 2016  Liquid Biotech USA ... of a Sponsored Research Agreement with The University ... (CTCs) from cancer patients.  The funding will be ... correlate with clinical outcomes in cancer patients undergoing ... then be employed to support the design of ...
(Date:6/24/2016)... ... , ... While the majority of commercial spectrophotometers and fluorometers use the z-dimension ... are higher end machines that use the more unconventional z-dimension of 20mm. Z-dimension ... bottom of the cuvette holder. , FireflySci has developed several Agilent flow cell ...
(Date:6/23/2016)... Mass. , June 23, 2016   ... development of novel compounds designed to target cancer ... napabucasin, has been granted Orphan Drug Designation from ... the treatment of gastric cancer, including gastroesophageal junction ... stemness inhibitor designed to inhibit cancer stemness pathways ...
(Date:6/23/2016)... ... June 23, 2016 , ... Charm Sciences, Inc. is ... has received AOAC Research Institute approval 061601. , “This is another AOAC-RI approval ... Bob Salter, Vice President of Regulatory and Industrial Affairs. “The Peel Plate methods ...
Breaking Biology Technology:
(Date:6/2/2016)... June 2, 2016 The Department of ... awarded the 44 million US Dollar project, for the ... Plates including Personalization, Enrolment, and IT Infrastructure , ... the production and implementation of Identity Management Solutions. Numerous renowned ... Decatur was selected for the most ...
(Date:5/20/2016)... May 20, 2016  VoiceIt is excited to ... VoicePass. By working together, VoiceIt and ... VoiceIt and VoicePass take slightly different approaches to ... both security and usability. ... this new partnership. "This marketing and ...
(Date:4/28/2016)... and BANGALORE, India , April ... EdgeVerve Systems, a product subsidiary of Infosys (NYSE: ... today announced a global partnership that will provide ... to use mobile banking and payment services.      ... a key innovation area for financial services, but it also ...
Breaking Biology News(10 mins):