The FDA warned Lijiang Yinghua Biochemical and Pharmaceutical for serious data management failures and quality unit errors. Source: Drug Industry Daily

Citing a Merck in-house attorney’s dishonesty under oath, the Federal Circuit upheld a 2016 ruling that dismissed a $200 million verdict against Gilead, affirming that Merck unethically obtained the rights…

The International Brotherhood of Teamsters — shareholders in McKesson — expressed skepticism about the outcome of a probe that cleared the drug company’s leadership of contributing to the opioid epidemic.…

Drug manufacturer Degasa did not adequately test its products or include all necessary data in laboratory records, according to a warning letter from the FDA. Source: Drug Industry Daily

In comments to the European Medicines Agency, leading drugmakers requested more clarification, simpler language and various other revisions for the International Conference on Harmonisation’s draft addendum to its E9 guidelines.…

Sponsors conducting clinical trials using imaging-based primary endpoints should consider the choice of modality — such as echocardiography or single-photon emission computed tomography — as well as centralized image interpretation…

The UK government aims to stay up-to-date with EU changes for clinical trial procedures amid uncertainties over next March’s implementation of Brexit. Source: Drug Industry Daily

The FDA’s Arthritis and Drug Safety Committee and the Risk Management Advisory Committee voted 15 to 5, with a single abstention, that Pfizer’s PRECISION trial, which compared Celebrex (celecoxib) to…

The FDA issued final guidance on electronic submissions of drug master files, giving sponsors of Type III DMFs for packaging materials an extra year before submission requirements kick in. Source:…

In a landmark decision for patent law, and to the disappointment of some drug makers, the U.S. Supreme Court upheld the legality of inter partes reviews, preserving a method that…