EU doctors are being told not to prescribe Rubraca as third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation.
The European Medicines Agency has recommended that Clovis Oncology’s PARP inhibitor Rubraca (rucaparib) should no longer be used as a third-line treatment for BRCA-mutated ovarian, fallopian tube or primary peritoneal cancer.
A study that was designed to confirm the benefit of Rubraca for this indication failed to do so, and showed...
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
