Protocols

Stanford team preps first human CRISPR study for sickle cell disease cure; Shkreli fingers his former attorneys

Matthew Porteus

Matthew Porteus

Stanford scientists say they have been able to use CRISPR gene editing tech to correct a faulty gene that triggers sickle cell disease. And now the team wants to take their work into the first human studies for the disease. ”What we’ve finally shown is that we can do it. It’s not just on the chalkboard,” senior author Matthew Porteus tells Reuters.

Mylan and Biocon have submitted the latest biosimilar for an FDA review. This application is for a knockoff of Herceptin for HER-2 positive breast and gastric cancers. Biocon already won an approval in India, marking the first approved biosimilar of Herceptin. Meanwhile, the analysts at Research and Markets recently counted four in late-stage development that appeared to be headed to the market in coming years.

Martin Shkreli says it’s clear he’s innocent of the charges filed against him. Why, he was only following the advice of his former attorneys, says the former biotech exec, facing trial on federal fraud charges related to his defunct hedge fund and Retrophin, which he founded. And now he wants access to hundreds of thousands of pages of records held by Katten Muchin Rosenman LLP, according to a report from Bloomberg.

Cambridge, MA-based Surface Oncology says it’s wrapped up preclinical work on its CD47 antibody — SRF231 — and expects to begin clinical work in 2017.


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RAPS Regulatory Convergence 2017