Navigation Links
Sequella Lead Drug Compound SQ109 Receives Orphan Drug Status From the US FDA and Orphan Medicinal Product Designation From the European Medicines Agency for the Treatment of Tuberculosis
Date:10/22/2007

n from the FDA user fee, and FDA assistance in clinical trial design. Importantly, the Orphan Drug Act facilitates a close working relationship between regulatory agencies and companies aimed at accelerating the drug development and approval processes for treatment of rare diseases. For further information, please visit: http://www.fda.gov/orphan/oda.htm.

The European Medicines Agency is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products. The Agency provides the Member States and the institutions of the EU the best-possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use referred to it in accordance with the provisions of EU legislation relating to medicinal products.

In 2001, the EMEA established the Committee for Orphan Medicinal Products (COMP), and charged it with reviewing designation applications from persons or companies who intend to develop medicines for rare diseases (so-called 'orphan drugs'). Orphan Medicinal drug products are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union at the time of the submission of the designation application. Orphan Medical Product Designation of SQ109 for the treatment of tuberculosis entitles Sequella to incentives such as protocol assistance (scientific advice during the product-development phase), 10-year marketing exclusivity, certain fee reductions or exemptions, and national incentives detailed in an inventory made available by the European Union, including the ability to apply for EU grants. For more information, visit:

SOURCE Sequella, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Isolation and Characterization of Anti-Viral Nucleoside Compounds from the Chinese Herb Taraxacum Mongolicum
2. TSKgel ODS-100Z and TSKgel ODS-100V column series provides a universal solution for the analysis of samples containing acidic, basic, polar & non-polar compounds
3. UW compound counters Avian flu
4. Medical College receives $377K to study brain disease
5. Lucigen receives $750K grant to boost biofuel yields
6. Medical College receives $1.4M cancer grant
7. Wisconsin biotech firm receives $107K NIH grant
8. InvivoSciences receives NIH grant for heart technology
9. Medical College receives $11 million grant to study high blood pressure
10. Madison business receives $115,000 of new state biofuels funding
11. Superior receives funds for technical training
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... 19, 2014 BioTech News Coverage: ... and results of studies and trials.  Companies in focus ... (NYSE: LLY ), Gilead Sciences Inc. (NASDAQ: ... CELG ) and Arena Pharmaceuticals Inc. (NASDAQ: ARNA) ... prodrug therapeutics for the treatment of cancer, announced that ...
(Date:9/19/2014)... September 19, 2014 Cereal grain ... industries will gather October 5–8, 2014, for the ... Island Convention Center in Providence, Rhode Island. The ... work of food scientists, chemists, microbiologists, nutritionists, and ... food production management. To date, 1,000 attendees have ...
(Date:9/19/2014)... , September 19, 2014 , ... European Society for Paediatric Endocrinology (ESPE) Meeting  ... and medical research in the field of growth  , ... Darmstadt, Germany , today announced the ... for 2014. The awards were announced during a Satellite ...
(Date:9/18/2014)... 18, 2014 Bipartisan passage this week ... designed to stimulate development and commercialization of new technologies ... by leaders of SPIE, the international society for ... Manufacturing and Innovation (RAMI) Act, now moves to the ... said they are optimistic that it will win passage ...
Breaking Biology Technology:Biotech Companies Pushing Sector Higher With Recent Therapeutic Advancements & Patent Approvals - Company Wins Summary Judgment For Prodrug Patent 2Biotech Companies Pushing Sector Higher With Recent Therapeutic Advancements & Patent Approvals - Company Wins Summary Judgment For Prodrug Patent 3Biotech Companies Pushing Sector Higher With Recent Therapeutic Advancements & Patent Approvals - Company Wins Summary Judgment For Prodrug Patent 4Biotech Companies Pushing Sector Higher With Recent Therapeutic Advancements & Patent Approvals - Company Wins Summary Judgment For Prodrug Patent 5Biotech Companies Pushing Sector Higher With Recent Therapeutic Advancements & Patent Approvals - Company Wins Summary Judgment For Prodrug Patent 6Biotech Companies Pushing Sector Higher With Recent Therapeutic Advancements & Patent Approvals - Company Wins Summary Judgment For Prodrug Patent 7Latest Research on Cereal Grain Quality, Health Benefits and Food Production to be Presented During the AACC International Annual Meeting 2Latest Research on Cereal Grain Quality, Health Benefits and Food Production to be Presented During the AACC International Annual Meeting 3EMD Serono Awards Grant for Growth Innovation (GGI) for the First Time 2EMD Serono Awards Grant for Growth Innovation (GGI) for the First Time 3House passage of high-tech manufacturing bill is move toward stronger economy, say SPIE leaders 2House passage of high-tech manufacturing bill is move toward stronger economy, say SPIE leaders 3
... tracking the number and dimension of particles or droplets as they ... are specific and possibly unique, changes that are of critical importance ... provide you with the knowledge, information and best practices you need ... ...
... of a new system to study crystallization processes for ... name,Crystalline. , The Crystalline has ... to learn as much as possible about a drug ... "Avantium is proud to launch its next system ...
... Institute have discovered a new method for controlling ... potentially one step closer to realizing the mass ... sheet of carbon, was discovered in 2004 and ... silicon as the fundamental building blocks of nanoelectronics. ...
Cached Biology Technology:Maximize Data Analysis with METTLER TOLEDO FBRM 2Avantium Launches the Crystalline, a New Parallel System for Crystallization Research 2Light-speed nanotech: Controlling the nature of graphene 2
(Date:9/18/2014)... a world-leading provider of scientific, technical and medical ... Management Society (ARMS), recognized the academic research achievements ... Young Researcher of the Year Awards. , The ... Convention Centre and in conjunction with the ARMS ... Australia,s and New Zealand,s scientific community. Guest of ...
(Date:9/18/2014)... is probably the ultimate form of camouflage: you don,t ... this strategy is not as uncommon as you might ... County, USA, explains that the larval life stages of ... part of the anatomy that most creatures cannot make ... have to shield each individual eye unit with an ...
(Date:9/17/2014)... to reproductive technologies, the justice and well-being of ... to identify key issues, articulate their values and ... most defensible ways forward. But what are the ... The Hastings Center and the Presidential Commission for ... to publish a series of essays to highlight ...
Breaking Biology News(10 mins):Elsevier and Australasian Research Management Society award scientists at Scopus ceremony 2Transparent larvae hide opaque eyes behind reflections 2Why bioethics literacy matters 2Why bioethics literacy matters 3
... This release is available in German . ... blood cells and the functioning of the nervous system. Unable to ... via animal proteins. So far it has been known that on ... organelles, so-called lysosomes. From there, the vitamin enters the cell interior ...
... CITY, MOTwo opposing teams battle it out to regulate ... activators, keeps DNA open to enzymes that transcribe DNA ... twisting DNA into an inaccessible coil around histone proteins, ... by enzymes that elongate an RNA strand. Both ...
... scientists have, for the first, time created a type ... functional, bio-compatible nanoscale wires into engineered human tissues. ... in Nature Materials , a multi-institutional research team ... Professor of Chemistry at Harvard and Daniel Kohane, a ...
Cached Biology News:Vitamin B12 deficiency: Tracing the causes 2Controlling gene expression: How chromatin remodelers block a histone pass 2Controlling gene expression: How chromatin remodelers block a histone pass 3Merging the biological and the electronic 2Merging the biological and the electronic 3
... Kit is designed for concentration and ... samples. Proteomics sample analysis is often ... impurities such as buffers, salts and ... interfere with electrophoretic separations or enzymatic ...
... offers maleimide activated carrier proteins to ... Imject Maleimide Activated Carrier Proteins are ... preactivated with a heterobifunctional cross-linker (Sulfo-SMCC). ... sulfhydryl-reactive carrier protein. Thus allowing ...
... kit allows for rapid, convenient, and efficient ... bind/wash/elute process utilizes a spin column to ... for concentration of proteins which were electro-eluted ... strong ion exchangers, offering high binding capacity ...
... polystyrene with frosted labeling surfaces, volume ... counting. 100% integrity tested. Linkage: This ... number, created to easily match Cornings ... yet, please order under the old ...
Biology Products: