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Joint Advisory Committee Says Exalgo Should Have Phased-In Entry To Market

This article was originally published in The Pink Sheet Daily

Executive Summary

A joint advisory committee said Neuromed's extended-release hydromorphone, Exalgo, should get a phased roll-out, as was used with Purdue's now-withdrawn Palladone.

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Regulatory News In Brief

Antigenics pulls European application for Oncophage: Antigenics has withdrawn its EMEA Marketing Authorization Application for its cancer vaccine Oncophage (vitespen) for early-stage, localized renal cell carcinoma, the firm announced Nov. 20. The decision follows a negative opinion from EMEA's Committee for Medicinal Products for Human Use, which has been formally ratified after the Oct. 21 meeting. Antigenics CEO Garo Armen has been candid about the difficulties in getting cancer immunotherapies approved given current regulatory standards, and the firm indicated that it may re-file the application later. The CHMP felt that the company's main study "did not show that Oncophage was effective at prolonging the length patients lived without the cancer coming back," the committee said in a Nov. 19 release, adding that the company also did not provide enough information on the drug's contents, the manufacturing process, how it was supposed to fight renal cell carcinoma and what the appropriate dose should be

Reopening Of Public Comment Period For Opioid Class REMS Confirms Long Road Ahead

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