Three drugmakers are accused of paying kickbacks to nurses to promote their products to doctors in two newly unsealed lawsuits. Source: Drug Industry Daily

Parts of the FDA’s recently updated draft guidance on the content and formatting of REMS documents are overly prescriptive, stakeholders said in public comments to the agency. Source: Drug Industry…

The FDA warned sterile drug manufacturer PharmScript for adulterated products and insanitary conditions at its Somerset, New Jersey facility. Source: Drug Industry Daily

The Federal Circuit upheld the Patent Trial and Appeal Board’s invalidation of Daiichi Sankyo’s patents for the anti-clotting drug Effient (prasugrel). Source: Drug Industry Daily

PhRMA announced it is partnering with the Addiction Policy Forum as part of a “multi-year, multi-million dollar” initiative to address opioid addiction. Source: Drug Industry Daily

Lawmakers once again waded into the reasons for rising drug prices, as a House panel invited a diverse group of industry representatives to weigh in on the main causes and…

The FDA issued a warning to a Korean drugmaker for significant current good manufacturing practice violations and the lack of an adequate quality control unit. Source: Drug Industry Daily

France’s Agency for the Safety of Health Products has established a unit dedicated to overseeing early phase clinical trials. Source: Drug Industry Daily

A newly unsealed whistleblower lawsuit claims Regeneron fired a manager for raising concerns about the drugmaker’s manufacturing process. Source: Drug Industry Daily

The FDA issued draft guidance on when CDER may refuse to file new drug applications and biologics license applications, outlining errors or omissions that can lead them to classify the…