To clarify the extent of patent protection and the right to benefit from the orphan incentive package, the European Commission (DG24 committee) recently defined "similarity" between orphan products as the same substance, or a substance that differs from the original substance in molecular structure, source material, or manufacturing process, or an organism (living or nonliving) that is comparable with the original substance or organism in terms of biologic action and properties (including efficacy and safety) and ability to act through the same mechanism.
This number was a clear improvement over that of the previous 14 years, during which 34 medicinal orphan products obtained authorization.
13, 2014 /PRNewswire/ -- The National Organization for Rare Disorders (NORD) today announced the agenda for the Rare Diseases and Orphan Product
Breakthrough Summit, to be held October 21-22, 2014 at the Hilton Mark Center in Alexandria, VA.
Orphan drug designation is granted by the FDA Office of Orphan Products
Development (OOPD) to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.
Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products
, BioAlliance (Paris:BIO) conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.
He has played a critical leadership role in the launch of other orphan products having spearheaded market access and pricing strategies for companies such as Genzyme and TKT.
Scioderm is a privately held, clinical-stage pharmaceutical company focused on developing innovative therapies for treating diseases with high unmet need, including orphan products.
rd] Annual DIA-NORD Conference on Rare Diseases & Orphan Products
in Bethesda, MD.
His extensive knowledge of the biopharmaceutical industry, understanding of the orphan products
space, and successful commercial experience will be highly valuable as we prepare for the potential launches of Gattex and Natpara.
18, 2013 /PRNewswire-USNewswire/ -- One of the hottest trends in the pharmaceutical and biotechnology industries in recent years has been the development of orphan products
or treatments for people with rare diseases.
While over 35 Canadian companies have had orphan products
approved in the US, in Canada, the Common Drug Review has issued 'do not list' recommendations (to the provinces) for over 75% of rare disease therapeutics approved by Health Canada.