• Novartis never has tried to explain why the FDA has rejected its biosimilar of Amgen’s Neulasta. And it’s being equally reticent about its decision to yank its application in Europe. The “application for a marketing authorization for Zioxtenzo (pegfilgrastim) has been withdrawn,” the EMA noted today. “Zioxtenzo was developed as a biosimilar medicine to treat neutropenia in cancer patients.” Novartis loves to highlight its R&D progress, but setbacks are dealt with silently. The EMA, though, did explain that the biosimilar appeared to be unapprovable. “One concern was that study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta. The other concern was the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine’s manufacturing site. An inspection of the site will therefore be needed before the medicine can be approved.”
• The GTJA Investment Group has led a $39 million round for Mabworks Biotech, a Chinese company that’s been working on a cocktail for Ebola. Harvest Capital Management, Mefund Capital and E-Town Biomedical Park also participated in the round for the Beijing based antibody developer.
• Pfizer says that its Phase II study of a new C diff vaccine, passed muster in a Phase II trial, setting up a late-stage study set to launch in the first half of this year. “We are very encouraged by these interim immunogenicity and safety results demonstrating robust increases in vaccine-elicited neutralizing antibodies to both toxins, that we believe could provide protection against C. difficile disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer.
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