Ahead of schedule, FDA approves Stivarga (regorafenib), partnered with Onyx, for late-stage mCRC patients with few options left. Bayer prices drug at under $10,000 a month, on par with competing treatments.
Newly approved as an end-of-the-line treatment for metastatic colon cancer, Bayer AG/Onyx Pharmaceuticals Inc.’s oral multi-kinase inhibitor Stivarga (regorafenib) will ship on Sept. 28 at the price of $9,350 per monthly cycle.
The drug was approved Sept. 27 for mCRC previously been treated with fluoropyrimidine, oxaliplatin and irinotecan based chemotherapy, an anti-VEGF...
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.
Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.
