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Janssen’s Apalutamide First To Gain Approval Under International Work Sharing Program

 
• By Ian Schofield

The ACSS Consortium’s work-sharing pilot for new drugs has yielded its first twin approval, for Janssen’s prostate cancer treatment, apalutamide.

Approved
The first new drug has been approved under the ACSS work-sharing pilot

Janssen’s prostate cancer treatment, apalutamide, has become the first drug to receive approval under a pilot work-sharing program for new chemical entities (NCEs) launched earlier this year by the ACSS Consortium, which brings together the regulatory agencies of Australia, Canada, Singapore and Switzerland.

The product has been authorized for marketing in two of the participating countries, Australia and Canada, where it will be...

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