Protocols

Califf cautions against lowering FDA standards; Editas outlines $1B milestone package

→ Ex-FDA Commissioner Robert Califf is back at Duke. And he has some advice for the Trump administration as it follows through on plans to reorganize the agency and cut review times. “Shortening and expediting is a great idea, but it needs to be done without lowering the standards,” Califf told Duke’s The Chronicle. In the student newspaper, Califf pointed out that more than 90 percent of drugs entering clinical trials currently do not make it to the market. If regulations are loosened to approve those, he said “a lot of people are going to get hurt or end up taking ineffective drugs.”

→ When Editas did a collaboration pact with Allergan a few days ago, the company only announced the $90 million upfront payment Allergan made to ally itself with the CRISPR/Cas9 leader. No milestone package was detailed. But a company spokesman tells the Boston Business Journal the goal money amount to a potential $1 billion plus.

→ Israel’s BioLineRx $BLRX has acquired Agalimmune, a private UK-based biotech focused on an anti-cancer immunotherapy platform, for $6 million in cash and stock. Agalimmune’s lead compound is AGI-134, a synthetic alpha-Gal immunotherapy in development for solid tumors.



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