La Jolla Riquent SPA
This article was originally published in Pharmaceutical Approvals Monthly
La Jolla initiates a Phase IV trial of its pending lupus agent Riquent (abetimus) to support full approval, the firm announces Aug. 2. The randomized, double-blind, placebo-controlled study was agreed to under the special protocol assessment process and will meet FDA's accelerated approval requirement for a confirmatory postmarketing study. La Jolla said the trial design has "several enhancements" compared to prior Riquent studies, "including twice as many patients receiving Riquent compared with placebo, increased patient enrollment of approximately 500 to 600 patients, more control of immunosuppressive drugs at baseline, higher doses of Riquent in some treatment groups, and 12-month treatment duration for each patient." The primary endpoint is time to renal flare. The study will continue for "several years." Riquent's PDUFA date is Oct. 16 (1Pharmaceutical Approvals Monthly Jan 1, 2004, p. 15)...
You may also be interested in...
Aventis was the most prominent participant in the year-end NDA filing rush, submitting four applications: two new molecular entities, a vaccine and a new formulation.
Cosmetics Europe Talks Microplastic: ECHA Frustrations, ‘Value Judgments’ And International Trade Uncertainty
The European Chemicals Agency's microplastic restriction proposal received committee backing in 2020 without changes sought by the cosmetics industry, which faces €15bn in projected costs and scarce alternatives at present. It may come down to EU Member States to decide whether the ECHA restriction proposal is proportionate in balancing environmental goals and socio-economic impacts.
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.