Protocols

Scott Gottlieb takes a turn in the spotlight for FDA candidates; Triumphant Achaogen lines up stock sale

Scott Gottlieb

Scott Gottlieb

Reuters has stumbled on to the news that Scott Gottlieb is under consideration by the Trump team for new chief of the FDA. Most of the rest of the biopharma world, though, was well aware that the Republican stalwart would factor in as a top candidate for this position, which he has been prepping for throughout the Obama administration’s 8-year term. The recent brouhaha over reports that Peter Thiel associate Jim O’Neill – who has expressed some radical ideas on approving new drugs on safety data alone – may well have helped Gottlieb’s position as the more acceptable figure for the post.

Just hours after Achaogen $AKAO sparked a huge rally for its stock with positive data, the biotech followed up with an offering of 5.7 million shares. Achaogen says it plans to prep for the commercialization of plazomicin, now that the key study has come through.

Spain’s Almirall has signed up to collaborate with Stockholm-based Nuevolution A/S on a RORγt inverse agonist program for treatment of inflammatory skin diseases and disorders as well as for treatment of psoriatic arthritis. Nuevolution gets about $12 million upfront as well as $190 million more in milestones.

Shares of BioDelivery Sciences International $BDSI in Raleigh, NC, slid 10% this morning after the company said that its Clonidine Topical Gel had failed to outperform a placebo on pain. BDSI says its discontinuing the program.

AcelRx Pharmaceuticals $ACRX has submitted an NDA for ARX-04 (sufentanil sublingual tablet, 30 mcg) for moderate-to-severe acute pain in a medically supervised setting.


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