Opinions on Neurocrine Biosciences, Inc. ’s top-line Phase II data for schizophrenia candidate NBI-1117568 were anything but clear cut on 28 August, as the company expressed strong optimism about the
AI And FDA: A Risk-Based Approach And New Industry User Fees? The US Food and Drug Administration likely will need a risk-based approach to reviewing the artificial intelligence aspects of drug applic
The Pros And Cons Of Flying Solo With Ex-US Launches There is plenty of money to be made in the international markets for US biotechs, but deciding to go it alone or find a partner abroad remains a tr
The US Federal Trade Commission took on the biopharmaceutical industry last year with a series of unusual enforcement actions challenging proposed mergers and industry patent listings. Stakeholders ar