Drug Development Pharma - January 9, 2014
FDA and European Medicines Agency launch generic drug application inspections initiative
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies. Studies […]
Drug Development Pharma - January 7, 2014
International pharmaceutical breakthrough backed by public funding
A multi-billion kroner agreement on a new pain-relief medication has been signed between the Norwegian innovation company, Inven2, and the pharmaceuticals giant, Merck. Public funding has played an important role in the Norwegian researchers’ success. The agreement confirms the vast potential of Norwegian health research. There are many outstanding researchers carrying out innovative basic and […]
Drug Development Pharma - December 18, 2013
BerGenBio presents promising data for CML treatment
Norwegian oncology biopharmaceutical company BerGenBio has presented results from preclinical studies on the agent BGB324 which suggest that the cancer therapy may be effective as new treatment for patients with drug resistant Chronic Myeloid Leukemia (CML). The data was presented at the Annual Meeting of the American Society of Hematology (ASH), which took place on December 7-10, […]
Drug Development Pharma - December 13, 2013
Bayer granted marketing authorization in Norway for prostate cancer treatment
Bayer HealthCare announced recently that the company has received the marketing approval for Xofigo by the Norwegian Medicines Agency. Xofigo (radium Ra 223 dichloride) has been developed by Algeta. In September 2009, the two companies signed an agreement for the further development and commercialization of radium-223. Xofigo is produced in Norway at the Institute for Energy Technology (IFE) at […]
Drug Development Pharma - December 3, 2013
CMC Contrast granted orphan drug designation
The US Food and Drug Administration, FDA, has granted orphan drug designation for the company’s liver specific contrast agent CMC-001. The Orphan Drug Designation has been granted for CMC-001 for use as a targeted contrast agent for diagnostic MRI for detection and localization of focal liver lesions in patients where gadolinium-based contrast agents are contraindicated […]
Drug Development Pharma - November 25, 2013
US approval of Simeprevir
Medivir has received US approval of its Simeprevir for the treatmeant of hepatitis C. On Friday 22 Medivir and Janssen’s drug candidate Simeprevir was approved for the US market by the Food and Drug Administration (FDA). The product will be approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with […]
