Novo Nordisk receives positive 17-2 vote from FDA Advisory Committee that Victoza® provides substantial evidence of cardiovascular risk reduction in patients with type 2 diabetes

Spago Nanomedical and Charles River Laboratories announce agreement for preclinical studies of SpagoPix

Spago Nanomedical has selected Charles River Laboratories, a leading global CRO, to conduct regulatory preclinical toxicology and safety studies of SpagoPix before clinical trials.

FDA posts briefing materials prior to Advisory Committee meeting for Victoza® label update

Novo Nordisk today announced that the US Food and Drug Administration has published the briefing documents ahead of the Advisory Committee meeting to discuss the supplemental New Drug Application for approval of Victoza injection.

SpagoPix promising results in toxicological pilot studies

Collective data from recently completed toxicity studies show that the product candidate SN132D can be given safely at doses that widely exceeds the expected clinical dose.

SpagoPix product patent approved in Japan

Spago Nanomedical announce today that the Japanese patent authorities has decided to approve the company's patent application comprising the nanoparticles that are the foundation of the SpagoPix project.

Xultophy® 100/3.6 demonstrated similar A1C reductions with significantly lower rates of hypoglycemia and a decrease in weight vs basal-bolus therapy

Spago Nanomedical appoints product candidate in the SpagoPix-project

The final formulation of the tumor-selective contrast agent SpagoPix has been biologically verified and fulfills the company criteria regarding tolerability and toxicity in pilot studies. SpagoPix is now ready for further development in regulatory studies.

Spago Nanomedical and Charles River Laboratories announce agreement for preclinical studies of SpagoPix

Spago Nanomedical has selected Charles River Laboratories, a leading global CRO, to conduct regulatory preclinical toxicology and safety studies of SpagoPix before clinical trials.

FDA Approves New Novo Nordisk Treatment for Patients with Hemophilia

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.

Phase I Clinical Trial Completes Using Cell Line Expertise at Cobra Biologics

Cobra’s maxXpress platform used to enable rapid and high-yielding expression of protein ADC-1013 for Alligator Bioscience Immuno-Oncology study in advanced solid tumours.