The US biotech expects to finally get its PARP inhibitor for ovarian cancer onto the European market in the next few months to compete with rivals AstraZeneca and Tesaro after the CHMP "communicated a positive trend vote" ahead of an opinion being issued next month.
It is looking likely that a third PARP inhibitor will soon be available in Europe to patients with ovarian cancer with Clovis Oncology Inc.'s announcement that it expects a recommendation for approval for Rubraca (rucaparib) from the EU's regulators at the end of next month.
The company says that following a meeting with the European Medicines Agency's Scientific Advisory Group Oncology last week and an...
As it races AstraZeneca’s baxdrostat to market, Mineralys plans to file an NDA later this year, backed by strong efficacy and safety data across four trials.
After the failure of its lead asset in a Phase II trial earlier this year, Korea's Bridge Biotherapeutics has accepted an acquisition offer from bitcoin group Parataxis.
Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.
