After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice. But recent decisions call into question ...

The U.S. District Court for the Southern District of Georgia, applying Georgia law, has held that a prior knowledge exclusion bars coverage as a matter of law because the insured should have known ...

FDA and industry weigh broader use of prior knowledge in biotechnology testing and production. Efforts to streamline the development of new medicines, particularly breakthrough therapies, are focusing ...

The United States District Court for the District of North Dakota has held that an insurer had no duty to defend a claim under a lawyers professional liability policy where the insured had prior ...