Ed Silverman has covered the pharmaceutical industry for more than three decades, focusing on pricing, affordability and access, regulation, marketing, and the legal battles surrounding major drug companies. Silverman’s reporting on prescription drug pricing led to him being named a Pulitzer Prize finalist in explanatory journalism.
European regulators are increasing pressure on clinical trial sponsors to report study results on time, rolling out new monitoring, reminders and guidance as patient advocates welcome the progress but question whether stronger oversight and enforcement will follow.
Recent changes at the U.S. Patent and Trademark Office are making it harder to challenge pharmaceutical patents, raising concerns that slower generic and biosimilar competition could undermine efforts to lower drug costs while strengthening protections for brand-name innovators.
