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France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More
The U.S. Supreme Court has paved the way for Pfizer’s Hospira to develop a generic version of a Merck unit’s skin infection therapy after denying an appeal to uphold several of its patents. Read More
As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More
China has released details of a pilot program that extends drug product licensing to domestic research and development institutions and their personnel. Read More
The patent dispute over Janssen’s Remicade continues to balloon, with the drugmaker suing GE Healthcare subsidiary HyClone Laboratories over the use of cell cultures to grow a biosimilar of the drug. Read More
A new study of oncology approvals shows a majority of the candidates approved under accelerated review with surrogate endpoints lacked validation. Read More