ISO norm guarantees highest biospecimen quality for pivotal studies
Hamburg-based Indivumed GmbH today has achieved ISO-9001:2008 certification. The company, which offers biobank products, clinical data and research services for the development of personalized cancer therapies, is now the world’s first ISO-certified provider of human biospecimens.
Micromet, Inc. (NASDAQ: MITI) a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, announced today that it has achieved a milestone under its collaboration agreement with Bayer Schering Pharma AG. The milestone was triggered by Micromet’s achievement of pre-clinical proof of concept for a BiTE antibody for the treatment of solid tumors. For more information, please read the complete press release
SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced that the FDA’s Office of Orphan Products Development has granted Orphan Drug Designation (ODD) for SuppreMol’s lead product SM101, a recombinant human soluble Fcγ receptor IIb, for the treatment of Idiopathic Thrombocytopenic Purpura (ITP).
European Market Expansion of 365 Energy Gains Further Momentum
365 Energy has announced the installation of the first Coulomb ChargePoint® Networked Charging Stations in Dublin, Ireland. The charging stations were provided to Ireland’s Electric Supply Board (ESB) and recently went live in the Dublin city centre. The installation of these charging stations is only the beginning of Ireland’s nationwide e-mobility infrastructure initiative. The ESB is planning to install charging stations in homes, on-street and along motor-ways throughout Ireland so that electric cars can be powered at a wide range of accessible venues.
SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced the initiation of a Phase Ib/IIa clinical trial with its lead product SM101 in Idiopathic Thrombocytopenic Purpura (ITP) in Europe. For further details on the trial and the compound, please see the complete press release.
In a Phase Ia trial in 48 healthy volunteers started in April 2009, no SM101-associated adverse reactions have been observed. Detailed results of this study will be published soon.
MediGene AG has signed a license and supply agreement with Meditrina Pharmaceuticals for the supply and commercialization of Veregen® in Greece and Cyprus. Meditrina will promote and distribute Veregen® for the treatment of genital warts in both territories. Upon the achievement of specific milestones, MediGene will be entitled to successive payments totaling up to 900 thousand euros, and will receive the first milestone payment upon the initiation of the approval procedure in Greece. In addition, MediGene will supply Meditrina with finished product and will receive double-digit royalties on net sales. MediGene believes that Greece is the sixth largest potential European market for Veregen® sales volume.
