North America

Former Sen. Richard Burr suggested to the Pink Sheet that Trump’s HHS leadership picks will have less ability to enact their agendas than people expect.

A new congressional report on the public health response to the COVID-19 pandemic underscores that the FDA and its top managers may be in the hot seat.

Strategies championed by the Oncology Center of Excellence, including early planning and use of a single randomized study to support accelerated approval and later verify clinical benefit, are reflected in a new draft guidance broadly applicable to drugs and biologics.

Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccines under the Trump Administration, the DOGE commission’s search for spending cuts and its impact on the FDA, as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program’s costs.

A new methods guide from Canada’s health technology assessment agency should help drug sponsors generate and report appropriate clinical evidence.

The UK’s drug regulator, the MHRA, is exploring new opportunities to work closer with its counterparts from Australia, Canada, Singapore and Switzerland under the ACCESS Consortium group, with a focus on pre-submission scientific advice.

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

The rolling reimbursement reviews that Canada’s Drug Agency introduced as a pilot scheme to speed up patient access to COVID-19 products can now be used for any drug application. The move to open up the mechanism follows prompts by industry.