President Trump has indicated the US may be interested in rejoining the Trans-Pacific Partnership free trade talks, but there would be multiple obstacles, not least whether strict US conditions could be met, including in the pharma IPR area. PhRMA meanwhile voices concerns over recent Japanese reforms.
There are increasing indications that the US is looking at rejoining the regional Trans-Pacific Partnership (TPP) free trade negotiations, but only on President Donald Trump’s demanding terms, creating much uncertainty in the process about some of the pact's long-debated provisions relating to intellectual property rights (IPRs) for drugs and biologics.
In a process stretching back to the start of expanded negotiations in 2008, a finalized TPP agreement was reached under...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
