Protocols

FDA OKs Xeomin in fourth indication; Nextbiotix raises $8M for microbiome tech

→ The FDA has green-lighted Merz North America’s supplemental Biologics License Application (sBLA) for Xeomin for the treatment of excessive drooling (chronic sialorrhea) in adult patients. Drooling is a common symptom among patients who suffer from neurological disorders including Parkinson’s disease, ALS, cerebral palsy and stroke. Merz says Xeomin is the first and only neurotoxin with this approved indication in the US. This is the fourth neurological indication for Xeomin, which was first approved by the FDA in 2010.

→ Vaulting out of incubator stage, Lyon, France-based Nextbiotix has raised a $8 million (€7 million) Series A to join the race to treat inflammatory bowel disease by rebalancing the microbiome. The company’s work centers around Faecalibacterium prausnitzii, a species of bacteria that’s one of the gut’s most abundant. Auriga Partners led the round, which also featured Sofimac Innovation, Cap Innov’Est, INRA, and Biocodex.

→ Tel Aviv’s Cellect Biotechnology is partnering with a public research university in Dresden, Germany to see if their combined stem cell tech is well-suited. If the two technologies perform well together, they might be used to develop collaborative products in regenerative medicine, the companies said in a statement. Cellect is contributing ApoGraft, its apoptosis-driven approach to separating stem cells from mature cells. The university, TU Dresden, is contributing the denovoMATRIX technology, a biomimetic coating for use in cell culture and a cell culture plate for testing extracellular matrix factors. The denovoMATRIX team will conduct a line of experiments in Cellect’s R&D facility in Israel.


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