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FDA requests more data for Baxter, Halozyme biotech treatment
DEERFIELD, Ill. — The Food and Drug Administration is requesting additional data from two drug makers for a treatment for immune system disorders.
Baxter and Halozyme said the FDA wanted more data to review their application for HyQ, a combination of immune globulin and recombinant human hyaluronidase.
The companies said they would work to develop studies to provide additional data to address the agency's concerns.
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Merck, Endocyte sign deal to develop cancer drug
WHITEHOUSE STATION, N.J. — Two drug makers have signed a deal to develop an experimental drug for treating two types of cancer.
Merck and Endocyte announced that they would develop and commercialize the latter's drug EC145 (vintafolide), currently in a phase-3 trial, as a treatment for platinum-resistant ovarian cancer and a phase-2 trial for non-small cell lung cancer. Both studies are also using Endocyte's experimental diagnostic agent, EC20 (etarfolatide).