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Home Industry News Merck Sharpe and Dohme’s ridaforolimus accepted for review

Merck Sharpe and Dohme’s ridaforolimus accepted for review

19th August 2011

Merck Sharpe and Dohme's investigational oral mTOR inhibitor therapy ridaforolimus has been accepted for review by the European Medicines Agency (EMA).

The healthcare regulator has completed the administrative validation process for the regulatory application of the compound, which is intended for use in combating metastatic soft-tissue or bone sarcomas.

Ridaforolimus is being developed in partnership between Merck Sharpe and Dohme and Ariad Pharmaceuticals, and has also been recently submitted for approval by the US Food and Drug Administration.

The EMA's Committee for Medicinal Products for Human Use will now commence a formal scientific review process to decide whether or not to recommend the drug for approval.

Marty Duvall, senior vice-president and general manager for the oncology franchise at Merck Global Human Health, said: "This acceptance of the EMA filing for review is an important milestone as we seek to bring forward a potential treatment option for patients with metastatic bone and soft tissue sarcomas."

Earlier this month, the company allied with Serum Institute of India on the development and commercialisation of a new pneumococcal conjugate vaccine for use in underprivileged nations.ADNFCR-8000103-ID-800704901-ADNFCR

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