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 that the treatment may be associated with a higher risk...
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.
Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.
The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.
The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
