Two decades in the making, a mutual recognition agreement between the FDA and EMA is now fully implemented. Slovakia was the last EU member state to get the FDA's seal of approval for its conduct of drug manufacturing inspections.
A False Claims Act suit was unsealed alleging that Johnson & Johnson fraudulently obtained a patent to block generic competition for prostate cancer drug Zytiga (abiraterone acetate), a drug that costs roughly $9,000 per month and generates about $2.4 billion in annual revenue for New Brunswick, N.J.-based J&J, according to law firm Herrera Purdy LLP.
The Institute for Clinical and Economic Review (ICER) unveiled its preliminary list of potential assessment topics for next year. The list is based on the projected timing and likelihood of FDA approval, and whether an evidence review would suggest specific actions for payers, physicians, patients and policymakers to improve clinical practice.
The World Health Organization (WHO) Tuesday updated its list of essential medicines, with a focus on cancer and other global health challenges. WHO added 28 drugs for adults and 23 for children to the medicines list and specified new uses for 26 drugs already on the list.
The U.S. Court of Appeals for the Federal Circuit Friday unsealed its decision in the patent lawsuit between Enzo Life Sciences Inc. and a group of defendant-appellees led by Roche Molecular Systems Inc., affirming a lower court's decision to grant summary judgment against Enzo for lack of enablement of the disputed patent claims.
In an ongoing crackdown on repackers, the FDA recently issued warning letters to three repackers of active pharmaceutical ingredients (API) for significant violations of current good manufacturing practice requirements.
