Lipocine announced in an 8-K filed November 10 that the first participant has been dosed in its BLOOM Phase 3 study of LPCN 1154 in postpartum depression. First dosing is a programme milestone, not data: it starts the clock on the registrational trial of the company’s oral neurosteroid candidate, and the filing contains no efficacy or safety results. Progress from here is measured by enrollment pace and, eventually, a readout date the company has yet to give.
The Biotechnology Innovation Organization published its BioAdvance action plan on November 10, setting out seven priorities for Congress and the administration, including more flexible requirements for first-in-human trials, centralised trial-start processes, stronger National Institutes of Health funding, and a new White House Office of Biotechnology to coordinate a national strategy. The plan is a competitiveness document aimed at China: BIO notes that China now starts more than a quarter of the world’s clinical trials, that more than 100 licensing deals have been struck between Western companies and Chinese drugmakers, and that Beijing’s five-year plan targets at least a quarter of the world’s first-in-class drugs by 2030. BIO’s position is that the United States should build capacity rather than restrict deal flow, and it has criticised proposals to add biotech to the COINS Act investment-screening regime on that basis.
Medicaid expansion is a live possibility again in three of the ten states that have not adopted it, STAT reported on November 10. The Democratic governors-elect in Texas, Georgia and Wisconsin all campaigned on expansion, although Republicans still hold majorities in part of the state legislatures in Texas and Georgia, which complicates the path. Expansion under the Affordable Care Act covers adults earning up to 138 percent of the federal poverty line, with the federal government paying 90 percent of the cost for the newly eligible. STAT put the population that could gain coverage at more than a million people across the states in play. No expansion bill has passed anywhere yet; this is a change in political possibility, not in anyone’s coverage.