Protocols

J&J disputes report it’s dropping JLabs plans for UK; Takeda takes Zika vaccine into PhI

→ The Telegraph reported that J&J is planning to pull the plug on its plans to open a JLabs facility in the UK, citing the political and economic uncertainty around Brexit. But a company spokesperson tells me it’s all tosh: “This story is completely unfounded and we have actually asked for a retraction.”

→ Takeda has pushed its Zika virus vaccine candidate (TAK-426) into a Phase I clinical trial 15 months after the biopharma company received a contract to develop a Zika vaccine from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; and Biomedical Advanced Research and Development Authority (BARDA).

→ After demonstrating ZX008’s impressive effects on Dravet syndrome, Zogenix $ZGNX is moving on to the second study of the lead drug’s Phase III trial, this time targeting Lennox-Gastaut syndrome — another form of rare but severe epilepsy that affects both children and adults. The Emeryville, CA-based biotech announced the enrollment of the first child patient today. The global study, for which Zognix plans to treat 225 patients across three arms, will consist of a 18-week double-blind first part and 12-month open-label second part. Despite the number of existing therapeutic options, says US principal investigator Kelly Knupp, “(t)there is a significant need for new medicines that can substantially reduce seizure activity in LGS, and I am hopeful that this Phase III trial of ZX008 may offer hope to the children and adults living with this debilitating condition.”

PhaseBio has secured a total of $15.6 million to fund its expanded orphan disease pipeline, which features a lead drug, PB1046, that treats pulmonary arterial hypertension. The money comes through two channels: the biotech is taking out a $7.5 million loan from Silicon Valley Bank, to be withdrawn in three tranches; it is also drawing $8.1 million from the second tranche of a previous financing agreement. AstraZeneca, J&J Innovation and Hatteras Venture Partners are among the investors in that financing deal.


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