WASHINGTON – An annual development fee may be necessary to get the biosimilar pathway up and running, but it should be considered a stopgap measure that will end once the route is established, industry representatives told the FDA. Read More
A new public offering of 8 million stock units and 8 million Series B warrants could raise up to $20 million for StemCells Inc., of Newark, Calif. The company just completed enrollment in a Phase I/II trial of its HuCNS-SC neural stem cells in chronic spinal cord injury. Read More
LONDON – NeuroSearch A/S is spinning out two start-ups to take forward programs that were parked in September when the company announced it was restructuring and would be focusing all resources on its Phase III Huntington's disease product, Huntexil. Read More
Investors in hepatitis C virus (HCV) firms went into panic mode Friday after Pharmasset Inc. dropped guanine nucleotide analogue PSI-938 from its Phase IIb QUANTUM trial after routine monitoring unveiled laboratory abnormalities associated with liver function in patients receiving the drug. Read More
• Fate Therapeutics Inc., of San Diego, was granted U.S. Patent No. 8,044,201, titled "Stem Cell Cultures," which claims Thiazovivin, a small-molecule Rho-associated kinase inhibitor, as well as compositions and cell culture media comprising Thiazovivin. Read More
• Galectin Therapeutics Inc., of Newton, Mass., presented a poster at the European Association for the Study of the Liver Special Conference on Liver Transplantation in Lisbon, Portugal, showing that its galectin inhibitor candidate GR-MD-02 reversed fibrosis in mouse models of steatohepatitis and prevented collagen deposits in mice treated before fibrotic cells formed. Read More
• Advaxis Inc., of Princeton, N.J., said preliminary data from a Phase II trial of ADXS-HPV, with or without cisplatin, in Indian women with recurrent/refractory cervical cancer, showed no serious adverse events. The primary endpoint is overall survival and, though early in the trial, clinical responses have been seen alone or in combination with chemotherapy and have included one complete reponse and three partial responses. Read More
