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Sandoz starts two late-stage biosimilar trials
HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.
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Provectus receives FDA guidance for late-stage trial of melanoma drug
KNOXVILLE, Tenn. — The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.
Provectus is planning to start a phase-3 trial of the investigational drug PV-10 for melanoma that has spread to other parts of the body, and said the FDA told the company that a meeting with the agency in addition to the one they had in October would not be required.