News & Comment

The US Food and Drug Administration (FDA) must clarify how it intends to enforce device regulation on direct-to-consumer (DTC) services that offer to interpret genome variation.

In an environment of crisis and cuts, innovative patent management strategies may offer a way for countries to improve return on R&D investment.

A growing market for therapeutic drugs to treat pets is fostering a startup boom. Gunjan Sinha reports.

Regulatory fallout from a scandal surrounding the fabrication of data used to support a molecular test in a Duke University cancer trial is exacting an unjustifiable toll not only on health economics but also on patient lives.

Fundraising is an integral part of almost every young biotech's business strategy, yet many entrepreneurs do not have a systematic approach for identifying and prioritizing potential investors—many of whom work outside of traditional venture capital.

The most comprehensive survey of clinical success rates across the drug industry to date shows productivity may be even lower than previous estimates.

Biologics sales grew at an incredible rate during the past 18 months, especially when compared with pharmaceuticals. But with pressure on pricing and biosimilars looming, how long will it be until biologics' last hurrah?

Compared with other US public-sector research institutions, the US National Institutes of Health has contributed inventions that have had a disproportionately greater impact on the overall number of products produced, drugs granted orphan status and drugs granted priority review.