The European Commission has granted a marketing authorization for UCB and Amgen’s bone-building MAb, romosozumab, and first launches are expected in the first half of 2020; patient groups suggest that the prevention and treatment of fragility fractures has not attracted the attention it deserves.

Turku, Finland-based Forendo Pharma has entered into a license and collaboration deal with Novartis involving the identification of novel drugs to treat chronic liver diseases.

A PFS benefit and favorable tolerability profile associated with AstraZeneca’s BTK inhibitor acalabrutinib used first-line in CLL, when given alone or combined with obinutuzumab, may serve it well against entrenched competitors and BTK inhibitors in clinical development.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Canada’s Aurinia Pharmaceuticals expects to file a US NDA in the first half of next year on the use of its next-generation calcineurin inhibitor, voclosporin, in lupus nephritis, a condition with no approved therapies.

The first part of Aldeyra’s Phase III RENEW study of the aldehyde trap candidate, reproxalap, shows positive effects on one of two co-primary endpoints and indicates an induction-maintenance dosing regimen should be used in part 2 of the study, expected to start in the first half of next year.