Pink Sheet Podcast: US FDA Suffers From Shutdown Threat, Alnylam’s CR Letter, ARPA-H Wants FDA Incentives
Pink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown, take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro, and incentives that the FDA could offer for ARPA-H projects that reach the application stage.
You may also be interested in...
Infographic: One of the more prominent arguments against the Medicare drug price negotiation program is that by limiting the number of years that products can be marketed before price caps are imposed, the scheme discourages development of additional indications.
Legislation to delink PBM payments from drug prices advances in House Energy and Commerce health subcommittee, putting a key pharma priority closer to the finish line. Whether patients will see any benefit remains a worry.
While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.