Final 2018 Weekly Update

We added 20 more drugs to the database and 17 more citations. The Pharmaceutical Pipeline Tracker now features comprehensive, unbiased, actionable information on 643 investigational drugs including URL links directly to 874 citations.

The FDA accepted the NDA for Acer Therapeutics’ celiprolol (Edsivo) on 12/26/2018 and set a PDUFA for 6/25/2019.

300mg of anifrolumab from Medarex and MedImmune, AstraZeneca in a Phase IIb trial, the primary endpoint of the SLE Responder Index (SRI-4) response with reduction in corticosteroid dose at 24 weeks was 34.3% compared to 17.6% with placebo in adult patients with moderate-to-severe systemic lupus erythematosus. The 1000 mg anifrolumab dose was no different than placebo. At 52 weeks, the SRI-4 was 51.5% with anifrolumab 300 mg, 38.5% with 1000 mg and 25.5% with placebo. A post-hoc analysis suggested an improvement in rash and arthritis symptoms at 52-weeks. 

In a 153 patient, Phase II trial, treatment with Genentech and Array BioPharma’s ipatasertib added to mFOLFOX6 did not improve progression-free survival compared to mFOLFOX6 alone in all patients or in patients who were phosphatase and tensin homolog (PTEN)-low with locally advanced or metastatic gastric/gastroesophageal junction cancer.

In an 86 patient Indian study, a continuous infusion of Mallinckrodt and Biovie's terlipressin, 4.7% of portal hypertension patients with acute variceal bleeding experienced treatment failure compared to 20.7% with placebo.