The US Treasury has issued a long-awaited proposal that would restrict US investment in biotech in China and other countries of concern, but whether licensing deals are covered would depend on their structure.
Saudi Arabia’s NADR rewrites rules for rare disease drug research with 20-day designation reviews and flexible evidence requirements including data from AI models in a departure from conventional clinical package requirements for approval, says SFDA in this interview.
By upholding its rejection of Yartemlea, the European Medicines Agency has left EU patients without routine access to a therapy that Omeros says is progressing toward becoming the US standard of care for transplant-associated thrombotic microangiopathy.
US FDA India director says that quality should be the “normal state of operation”, rather than a condition created ahead of an inspection while India’s Drugs Controller General outlines the impact of risk-based inspections, especially in areas like large volume parenterals.
Setting “artificial constraints” on the number of pivotal trials required to support a drug’s approval could detract from the more important task of determining what evidence is needed to answer key scientific questions, EMA officials say.
The Pink Sheet Drug Review Profile finds that FDA staff put in a considerable amount of work assessing the first oral PCSK9 inhibitor before the completed NDA submission under the Commissioner’s National Priority Voucher program.
The Pink Sheet’s Drug Review Profile looks at key milestones in the development, review and approval of the LDL cholesterol-lowering drug enlicitide under the Commissioner’s National Priority Voucher program.
The agency leveraged subcutaneous semaglutide’s STEP and SELECT data to grant the first GLP-1 obesity pill its weight loss and cardiovascular claims, while flagging greater exposure variability, a thin safety database and uncertain benefit in type 2 diabetics.
Moderna's shift in regulatory strategy produced a massive data set to respond to vaccine safety critics, as illustrated in the Pink Sheet's Drug Review Profile timeline.
Saudi Arabia’s NADR rewrites rules for rare disease drug research with 20-day designation reviews and flexible evidence requirements including data from AI models in a departure from conventional clinical package requirements for approval, says SFDA in this interview.
In an interview with the Pink Sheet, de Claro said he plans to continue refining programs on review efficiency and innovation, regulatory science, and external engagement, and said the speedy review of Revolution Medicines’ Rasonque proved OCE’s programs deliver for patients.
Former FDA acting commissioner Janet Woodcock said in an interview that spinal cord injury is not rare, but is varied enough from patient to patient to need rare-disease-style regulatory flexibility, including individualized endpoints that can be tested in randomized trials.
The FDA seeks ideas for incentives to sustain stakeholder investment in the new Quantitative Medicine Innovation Network, which is intended to be a collaboration across regulators, industry, academia and others.
