Protocols

European watchdog wants to manage “risks” of early contacts between regulators, biopharma

→ At the FDA, the focus is on getting started as early as possible in talks with biopharma companies aimed at guiding development of new drugs. But those early, pre-submission involvements are attracting the scrutiny of a European watchdog who is suspicious of contacts between regulators and drug developers. In a letter to EMA chief Guido Rasi, EU ombudsman Emily O’Reilly notes: “(S)uch activities may pose some risks, such as that the eventual decisions by EMA on the authorisation of medicines may be influenced by what has been discussed during the meetings with medicine developers prior to receiving their marketing authorisation application. I note that EMA sees pre-submission meetings as a way to “enable medicine

Emma Walmsley

developers to establish contact with the Agency staff who will be involved with the application.” Even if EMA were to ensure that its subsequent assessments of applications for marketing authorisations are objective and complete, there is still a risk that pre-submission activities create, in the eyes of the public, at least some perception of bias. These risks must be managed.”

→ The UK’s Horizon Discovery has struck a deal to buy Dharmacon, GE’s gene editing tech company, for $85 million.

GSK is pondering the sale of some old antibiotics and new CEO Emma Walmsley continues to reorganize the pharma giant.


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