Navigation Links
PharmaDirections Succeeds Through its Client’s Successes: Cortendo Receives Positive Orphan Drug Opinion from EMA for NormoCort for Cushing’s Disease
Date:6/26/2012

Radnor, PA (PRWEB) June 26, 2012

Cortendo AB [ticker: CORT on the Norwegian NOTC-A], a biopharmaceutical Corporation focused on the development of new therapies in the field of Metabolic Diseases, obtained a positive opinion by the European Medicines Agency's Committee for Orphan Medicinal Products, on its application for orphan drug designation for NormoCort (COR-003) for the treatment of hypercortisolism (Cushing’s Syndrome). The positive opinion of the COMP for NormoCort has now been forwarded to the EU commission for final approval and publication in the EU community register. With orphan drug designation granted in the US by the FDA in March and now with this positive opinion from the EU’s COMP, Cortendo is well positioned to move NormoCort into pivotal global clinical trials in Cushing’s Syndrome.

Cortendo is a biopharmaceutical company that relies in part on quality consultants and CRO’s to support the research and development of its pipeline. For the past year, Cortendo has contracted with PharmaDirections for a number of key services ranging from CMC to US and European Regulatory support. PharmaDirections’ regulatory services have ranged from the successful preparation and support to orphan drug designation applications in both the US and Europe to support with both IND and CTA preparation. “Cortendo has appreciated the high quality of support particularly in the areas of regulatory, CMC, and project management services offered by PharmaDirections”, said Dr. Ted Koziol, COO of Cortendo.

“Our Cortendo relationship is a great example of a virtual company using outsourced resources to their maximum advantage” said Dr. Richard Soltero, President of PharmaDirections.

About Cortendo:

Cortendo is a pioneer in the field of cortisol inhibition. The development of the lead drug candidate NormoCort (COR-003), the 2S,4R-enantiomer of ketoconazole, has been directed to Cushing’s Syndrome. The company’s strategy is to focus its resources to opportunities where the path to commercialization or partnership is clear and relatively near-term. Strategically, Cortendo’s business model is to commercialize relevant opportunities in the United States while partnering its assets ex-US. Backed by a highly experienced leadership team Cortendo has plans to continue to implement its pipeline expansion efforts in osteoarthritis and diabetes, as well as other near term revenue opportunities.

About PharmaDirections:

PharmaDirections, Inc. provides pharmaceutical consulting and project management services with a focus on preclinical development, formulation development and CMC, and regulatory affairs. The company was founded in 2003 and is based in Cary, North Carolina.

Read the full story at http://www.prweb.com/releases/2012/6/prweb9539917.htm.


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

Related biology technology :

1. Microfabrication breakthrough could set piezoelectric material applications in motion
2. Elsevier Supports International Crisis Aid Through Pillars of Hope Campaign
3. Transparent material breakthrough
4. Blocked holes can enhance rather than stop light going through
5. U of Toronto experiment named top breakthrough of 2011 by Physics World
6. Epitomics, Inc. and University of California, Davis, Complete Star Program for High-Throughput Measurement of Antibody-Antigen Interactions
7. Almost perfect: A breakthrough in superlens development
8. Water sees right through graphene
9. Nanosurgery and the fight against cancer: Major breakthrough at Polytechnique Montral
10. Low-cost optical components through nanoimprinting lithography
11. Research breakthrough takes supercomputing out of the lab
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... ... October 10, 2017 , ... San Diego-based team building ... corporate rebranding initiative announced today. The bold new look is part of a ... company moves into a significant growth period. , It will also expand its service ...
(Date:10/10/2017)... Oct. 10, 2017 SomaGenics announced the receipt ... to develop RealSeq®-SC (Single Cell), expected to be the ... RNAs (including microRNAs) from single cells using NGS methods. ... need to accelerate development of approaches to analyze the ... "New techniques for measuring levels of mRNAs in ...
(Date:10/9/2017)... ... ... At its national board meeting in North Carolina, ARCS® Foundation President ... and Astronomy, has been selected for membership in ARCS Alumni Hall of Fame ... Prize in Fundamental physics for the discovery of the accelerating expansion of the universe, ...
(Date:10/7/2017)... 2017  The 2017 Nobel Prize in Chemistry ... Dubochet, Joachim Frank and Richard ... microscopy (cryo-EM) have helped to broaden the ... community. The winners worked with systems manufactured by ... highly resolved, three-dimensional images of protein structures that ...
Breaking Biology Technology:
(Date:6/14/2017)... PARIS , June 15, 2017  IBM (NYSE: IBM ... the international tech event dedicated to developing collaboration between startups ... on June 15-17. During the event, nine startups will ... deliver value in various industries. ... in the international market, with a 30 percent increase in ...
(Date:5/6/2017)... , May 5, 2017 RAM ... announced a new breakthrough in biometric authentication based ... quantum mechanical properties to perform biometric authentication. These new ... semiconductor material created by Ram Group and its ... entertainment, transportation, supply chains and security. Ram Group ...
(Date:4/17/2017)... , April 17, 2017 NXT-ID, Inc. ... company, announces the filing of its 2016 Annual Report on Form ... Exchange Commission. ... Form 10-K is available in the Investor Relations section of the ... on the SEC,s website at http://www.sec.gov . 2016 ...
Breaking Biology News(10 mins):