Biotech Business - June 26, 2017
Athera receives orphan drug designation
Athera Biotechnologies announces that the the U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to the fully human antibody PC-mAb, for the treatment of patients with end stage renal disease, who are preparing for or undergo hemodialysis, to prevent vascular access failure. “We are pleased that the FDA have granted orphan drug […]
Biotech Business - May 30, 2017
Co-cluster project at OCC stimulates IT-Biotech collaborations
Oslo Cancer Cluster (OCC) is currently involved in a big European collaboration through the cluster-to-cluster project PERMIDES. The project aims to utilize novel IT-solutions to accelerate drug development in biotech companies. “I know of companies who still manage their clinical trial studies using Excel. This is not a good idea. An Excel sheet may only hold […]
Clinical Trials - May 22, 2017
BerGenBio starts Phase I/II trial
BerGenBio announces that the first patients have been dosed and continue on therapy in a Phase I/II randomised trial evaluating the addition of BerGenBio’s selective, potent and orally bio-available AXL inhibitor BGB324 to standard of care treatments in patients with advanced, non-resectable or metastatic melanoma. The trial, which is sponsored by Haukeland University Hospital (Bergen, […]
Drug development - March 27, 2017
Idogen’s technology granted European patent
Idogen announces that the European Patent Office will formally grant a patent application, covering the company’s tolerogenic vaccine technology. The EPO approval strengthens the company’s patent portfolio for the vaccine technology. A patent in the same patent family has already been granted in Japan and a Notice of Allowance has been received from the USA. […]
Biotech Business - December 14, 2016
FDA accepts AstraZeneca’s biologics license application
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017. […]
Drug development - December 7, 2016
Swedish drug development on the rise
Earlier today, SwedenBIO presented its annual report on the Swedish drug discovery and development pipeline, showing for example that the number of clinical stage drug development projects has increased from 63 to 144 in 5 years. The report provides facts and figures about the current Swedish drug development pipeline for drugs intended for use in […]
