Aseptic processing lapses signal deeper problems at Takeda’s Hikari plant.
Aseptic processing and related investigational lapses led the US Food and Drug Administration to issue a warning letter to Takeda Pharmaceutical Co. Ltd. in which the agency questioned whether the company was giving its quality organization the authority and resources required to do its job.
The 9 June warning letter addressed to Takeda CEO Christophe Weber stemmed from an 18-26 November 2019 inspection of...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
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.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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