Huya Bioscience International LLC, of San Diego, said it is expanding clinical trials with lead cancer drug HBI-8000, a class I-selective oral histone deacetylase inhibitor, starting with a phase I combination trial in support of a breast cancer program. Read More
Lannett Co. Inc., of Philadelphia, signed a definitive agreement to purchase Kremers Urban Pharmaceuticals Inc., of Princeton, N.J., the U.S. specialty generic pharmaceuticals subsidiary of UCB SA, of Brussels, for $1.23 billion up front and undisclosed contingency payments. Read More
Barely a week after the Patent Trials and Appeals Board (PTAB) rejected his petition challenging two patents for multiple sclerosis drug Ampyra (dalfampridine) through an inter partes review (IPR), hedge fund manager Kyle Bass reportedly filed a new petition against the drug's developer, Acorda Therapeutics Inc., of Ardsley, N.Y., requesting IPR on four patents protecting the drug, including two patents that had been part of the original petition. Read More
A draft overhaul of human subject protections for clinical studies has emerged, and among the proposed changes is a mandatory use of a single institutional review board (IRB) for federally funded cooperative research, with the exception of instances in which "more than a single IRB is required by law." Read More
One of the major current goals of cancer immunotherapy research is to learn to predict who will benefit from it, and why, with the aim of broadening its successes. Read More
The wait is over. The U.S. has it first biosimilar. And it's on the market. Sandoz Inc. launched Zarxio (filgrastim-sndz) Thursday, making it the first biosimilar available in the U.S. Read More
