Latest from Anabel Costa-Ferreira
Matthew Wood, director and chief scientific officer at Oxford-Harrington Rare Disease Center, discusses the state of rare disease R&D, the evolving landscape of genomics and genetic therapies, and the challenges around the biopharma industry’s narrow focus on only 5-10% of rare diseases.
Regulators in the US and Canada are working together to streamline approval timelines for generic drugs through a voluntary information sharing program.
Deputy chief Jonathan Benger moves up to become NICE’s fourth-ever CEO. While the face may be familiar, the challenges are anything but as the HTA body has launched a new joint scientific advice process with the MHRA and will implement new cost-effectiveness thresholds driven by a US trade deal.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The UK medicines regulator, the MHRA, and England’s health technology appraisal (HTA) body, NICE, spoke to the Pink Sheet about the new pathway that aligns the HTA and regulatory processes to cut the time it takes to bring medicines to market.
The UK’s medicines regulator reports promising outcomes from a pilot scheme testing streamlined processes for reviewing low-risk substantial modifications to ongoing clinical trials.
