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

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

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:
(Date:11/24/2015)... ... November 24, 2015 , ... The United States Golf Association ... 2016 USGA Green Section Award. Presented annually since 1961, the USGA Green Section Award ... work with turfgrass. , Clarke, of Iselin, N.J., is an extension specialist ...
(Date:11/24/2015)... , Nov. 24, 2015 /CNW/ - iCo Therapeutics ... today reported financial results for the quarter ended ... expressed in Canadian dollars and presented under International ... United States ," said Andrew Rae ... advancements regarding iCo-008 are not only value enriching ...
(Date:11/24/2015)... , Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. ... IIROC on behalf of the Toronto Stock Exchange, confirms ... there are no corporate developments that would cause the ... --> --> About Aeterna Zentaris ... . --> Aeterna Zentaris is a specialty ...
(Date:11/24/2015)... ... 24, 2015 , ... This fall, global software solutions leader SAP and AdVenture ... develop and pitch their BIG ideas to improve health and wellness in their schools. ... to win the title of SAP's Teen Innovator, an all-expenses paid trip to Super ...
Breaking Biology Technology:
(Date:10/29/2015)... , Oct. 29, 2015  Connected health pioneer, ... the explosion of technology-enabled health and wellness, and the ... book, The Internet of Healthy Things ... or smartphones even existed, Dr. Kvedar, vice president, Connected ... health care delivery, moving care from the hospital or ...
(Date:10/27/2015)... SAN JOSE, Calif. , Oct. 27, 2015 /PRNewswire/ ... human interface solutions, today announced that Google has adopted ... family of touch controller solutions to power its newest ... Nexus 6P by Huawei. --> ... ecosystem partners like Google to provide strategic collaboration in ...
(Date:10/23/2015)... GOLETA, California , October 23, 2015 ... and SensoMotoric Instruments (SMI) announce a mobile plug and ... captured during interactive real-world tasks SensoMotoric Instruments ... of their established wearable solutions for eye tracking and ... behavior captured with SMI Eye Tracking Glasses 2w ...
Breaking Biology News(10 mins):