A European Union court ruled that the European Medicines Agency can offer access to clinical trial data in a blow to three drugmakers who argued this would hurt their business.…
The FDA flagged a problem with contaminated vial stoppers in a warning letter to Celltrion over deficiencies at its Incheon, South Korea facility, which manufactures Inflectra (infliximab-dyyb), the Ramicade biosimilar.…
The FDA hit Nexgen Pharma with a Form 483 after an inspection of its Irvine, California facility revealed procedural and documentation issues. Source: Drug Industry Daily
CDER denied a fourth petition from United Therapeutics calling on the center to impose additional conditions before approving ANDAs for combination products that reference its pulmonary arterial hypertension drug Tyvaso…
Three insurers sued Pfizer to stay off the hook for a $400 million settlement reached by the drugmaker over off-label marketing, claiming the relevant policies had expired. Source: Drug Industry…
CDER and CBER issued a joint data standards strategy on Monday, detailing how the centers will develop and use data standards to review pre- and post-market safety and efficiency data…
Leaders of the House Energy and Commerce Committee sent a letter to FDA Commissioner Scott Gottlieb Friday asking him to investigate contradictory data on available supplies of heparin, and explain…
Philippine health officials investigating the anti-dengue vaccine Dengvaxia announced Friday that the drug may be linked to the deaths of three children. Source: Drug Industry Daily
New York’s attorney general is suing Insys for deceptive marketing of the spray form of one of its fentanyl products, a move the state says is part of a multi-pronged…
The FDA issued a black box warning for Ocaliva (obeticholic acid), a liver disease medication that was incorrectly dosed as daily instead of weekly for patients with primary biliary cholangitis…