Quality management problems at its contract manufacturer, Ben Venue Laboratories Inc., have forced Clavis Pharma ASA to slow recruitment in a Phase III trial of elacytarabine in late-stage acute myeloid leukemia (AML) and will result in a delay of one quarter in the reporting of its results.
The threatened public health crisis engendered by the Poly Implant Proth se (PIP; La Seyne-sur-Mer, France) breast implant scandal has altered the context in which the reform of the Europe Union's (EU's) regulatory framework for medical devices is taking place.
BioInvent International AB could earn up to €11 million (US$14 million) in up-front and milestone payments, as well as royalties on eventual product sales, from a cancer antibody discovery collaboration with Les Laboratoires Servier SA.
Apogenix AG took in €7.5 million (US$9.6 million) in new investments, plus a further €2.3 million in government funding, to continue clinical development of its lead molecule, APG101, and to fund associated biomarker research.
BioInvent International AB could earn up to €11 million (US$14 million) in up-front and milestone payments, as well as royalties on eventual product sales, from a cancer antibody discovery collaboration with Les Laboratoires Servier SA.
Apogenix AG took in €7.5 million (US$9.6 million) in new investment, plus a further €2.3 million in government funding, to continue clinical development of its lead molecule, APG101, and to fund associated biomarker research.
Zealand Pharma A/S closed out 2011 with a €3 million (US$3.9 million) milestone from partner Helsinn Healthcare SA and could pocket several more such payments in the coming year if other partnered programs make progress.
Thrombogenics NV is entering the most crucial year of its existence, with decisions from both the U.S. and European regulators due over the coming months on its filing for ocraplasmin as a treatment for symptomatic vitreomacular adhesion (VMA) including macular hole.
