Teva is on track to respond to FDA’s complete response letter for deutetrabenazine by the end of September, with a potential for approval and launch in early 2017.
Teva Pharmaceutical Industries Ltd. intends to respond to FDA’s complete response letter for deutetrabenazine for the treatment of chorea associated with Huntington disease by the end of September, which could position the drug for approval and launch in March 2017, President Global R&D Michael Hayden said during the company’s second quarter conference call Aug. 4.
Teva is working to quickly resolve the outstanding issues because deutetrabenazine (also known as SD-809) is expected to be an...
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A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
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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