Protocols

Merck scores priority review Keytruda in squamous NSCLC; Synthetic Genomics spinout SGI-DNA gets new CEO

→ The FDA has accepted — and given priority review — to Merck’s supplemental biologics license application for its cancer immunotherapy Keytruda. The pharma giant is hoping the drug will be approved in a new indication: metastatic squamous non-small cell lung cancer. This is Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment. Merck $MRK has been pouring billions of dollars into its Keytruda pipeline, and the investment has paid off handsomely with a blockbuster franchise and a collection of more than 750 trials — an explosion of clinical research. For this latest indication, the FDA gave Merck a PDUFA of October 30, 2018.

→ SGI-DNA, a La Jolla spinout from J. Craig Venter’s company Synthetic Genomics, has named a new leader to the helm. Todd Nelson, the former CEO of San Francisco Bay Area’s DiscoverX Corporation, is joining SGI-DNA as CEO. Nelson has led several companies through phases of growth, including eBioscience, which was acquired by Affymetrix (now Thermo Fisher); and MP Biomedicals, which was acquired by Valeant Fine Chemicals. The news of Nelson’s appointment comes just weeks after SGI-DNA’s former president Nathan Wood announced he was leaving the company for a new gig at Swift Biosciences.


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