Kedrion receives FDA authorisation to sell its Albumin on the US market
Kedrion announces that on 3rd June 2011 it has received from the Food and Drug Administration, the government agency responsible for supervising and authorising the marketing of pharmaceuticals in the United States, the authorisation to sell its albumin on the US market, with the brand name KEDBUMIN. Under such authorisation, Kedrion will produce albumin for
Kedrion received QSEAL certification from PPTA
Kedrion has been awarded Quality Standards of Excellence, Assurance, and Leadership (QSEAL) certification from the Plasma Protein Therapeutics Association (PPTA). The international QSEAL Program relies on independent, third-party evaluation and recognizes strict adherence to a set of voluntary standards, which underscore the industry’s quality and safety commitment to patients who rely on essential plasma protein
Kedrion Group: investments and acquisitions to expand its market share
Kedrion Group, the Italian leader in the development, manufacture and distribution of plasma derived medicinal products, continues its investment policy. Composed of nine companies based in the United States, Mexico, Switzerland, Germany, Austria and Hungary, the eighth largest group in the world, with offices in over 40 countries, Kedrion group has started a new reorganisation
Increased product range: studies on Fibrin Glue just started
Kedrion’s initiatives to strengthen and extend its market share are going on. With the start of its clinical trials on fibrin glue, the company started a plan that, if these trials prove successful, should enable it to market the new product in 2011. In order to extend its product range, the company started clinical trials
New method for the purification of Factor VIII VIII/FVW concentrate study published on
The study Progress in large-scale purification of Factor VIII/von Willebrand factor concentrates using ion-exchange chromatographyhas been published on “Vox Sanguinis” (2008) 95, 298–307, Entirely conducted by Kedrion’s researchers, the study presents the results of the development of a new purification method for a Factor VIII/von Willebrand Factor concentrate. A process scale-up is now being investigated
Agreement between Kedrion and ProMetic for the development of Hyperimmune products
Kedrion S.p.A. and ProMetic Life Sciences Inc. (TSX:PLI) announced that they have signed the definitive agreement for two hyperimmunes. The first product to be developed will target the Hepatitis B Hyperimmune. Kedrion has in-licensed ProMetic’s technologies for the manufacturing of hyperimmune products in Europe. Royalties, licensing and service fees for the sales of products in
New method for purifying plasma proteins used to treat Haemophilia A and von Willerbrand disease
Increased availability of Factor VIII and von Willebrand Factor (vWF) using a new chromatography method for purifying Factor VIII and vWF concentrates that can be transferred to an industrial scale: is the result achieved by researchers in Kedrion. This is a particularly effective technique which makes it possible to purify almost double the quantity of
Human plasminogen acknowledged as Orphan Drug
The European Commission, following the positive opinion of the European Medicines Agency (EMEA), has granted the designation of orphan drug to Human Plasminogen, made by Kedrion, in the form of eye drops used for the treatment of ligneous conjunctivitis. Ligneous conjunctivitis is a rare form of conjunctivitis which may lead to blindness and is characterized
Research project for developing a new plasma derivative for the treatment of Hepatitis C
For the first time in Europe, a project is currently underway in Naples to develop an anti-infective product for Hepatitis C, containing neutralising immunoglobulins directed against specific viral antigens. With the western market estimated at $400 million ($200 million in the United States alone and about $40 million in Italy), it should guarantee a better
Kedrion and ProMetic form strategic alliance to develop orphan drugs from plasma
Kedrion S.p.A. and ProMetic BioTherapeutics, Inc., a subsidiary of ProMetic Life Sciences Inc. (TSX: PLI) (“ProMetic”) have formed a strategic alliance to develop orphan drugs derived from human plasma utilizing ProMetic’s proprietary manufacturing process, the Plasma Protein Purification System (PPPS). The alliance between the two companies was created to select specific proteins which can be manufactured