Even given huge optimism to date for immunotherapy checkpoint inhibitors, the rapid approval of Bristol’s PD-1 inhibitor nivolumab in squamous type lung cancer is a welcome surprise and bodes well for the class in the future.
FDA’s swift approval of the anti-PD-1 Opdivo (nivolumab) for a new use in second-line lung cancer means a competitive market advantage for Bristol-Myers Squibb Co., at least in the short term, for the most valuable indication targeted by cancer immunotherapy.
Opdivo is a member of the programmed-death family of immune checkpoint inhibitors, which release the brakes on mechanisms that would otherwise stop the typical responses of cancer-killing cells in the...
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.
A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.
In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.
US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
