The initial moonshot aimed to increase cancer research while the reboot seeks to boost screenings to reduce death rate. New cancer cabinet mirrors previous task force. Biopharmaceutical companies are to participate in summit to highlight new commitments.
In reigniting the Cancer Moonshot initiative, President Biden called on the biopharmaceutical industry to develop new treatments, make drugs more affordable, and share knowledge. But while the program launched in 2016 had specific goals to increase research, the reboot is primarily targeting cancer screening.
At a 2 February briefing in the White House East Room, Biden said the goal was to “supercharge the Cancer...
A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.
Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.
The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
