The U.S. Court of Appeals for the Federal Circuit in Washington ruled that patents relating to The Medicine Co.'s anticoagulant drug, Angiomax (bivalirudin), were not invalid under the so-called "on-sale" bar. The case, The Medicines Co. v. Hospira, focused primarily on the question of whether an inventor's use of a third-party manufacturing service can invalidate patentability.

An international project to develop a large, globally accessible bank of new cancer cell culture models for the research community was launched by the National Cancer Institute; Cancer Research UK in London; the Wellcome Trust Sanger Institute in Cambridge, U.K.; and the foundation Hubrecht Organoid Technology in Utrecht, the Netherlands. The Human Cancer Models Initiative is designed to bring together global expertise to make about 1,000 cancer cell models. Using new techniques, scientists will make models that will better resemble the tissue architecture and complexity of human tumors than the cell lines used now.

The FDA released a draft guidance to help generics sponsors update their labeling after the reference listed drug has been withdrawn from the market for reasons other than safety or effectiveness. The draft clarifies that, when the listed drug is no longer being marketed, some labeling changes may continue to be made for pending ANDAs and generics already on the market. It also lays out a process for making those changes. The comment period will be open for 60 days.

The FDA released a new draft guidance to help sponsors in the clinical development of drugs to treat bacterial vaginosis. It recommends superiority trials, defines enrollment criteria and characterizes the primary efficacy endpoint in light of recent scientific advances.