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Regeneron Pharmaceuticals and CytomX Therapeutics have partnered to develop bispecific cancer drugs in a deal whose value could exceed $2 billion. Read More
The integrity of manufacturers’ data is a major focus of FDA inspections and the agency’s investigators will go to great lengths to uncover problems, three former FDA inspection officials told attendees at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. last week. Read More
The World Health Organization (WHO) is working on an international pandemic response accord that would, in part, require pharmaceutical companies to publicly disclose prices or deals for any of their products that might be used in future health emergencies. Read More
While accelerated approval (AA) is a valuable and appropriate path for many promising drugs, for others — particularly those that don’t finish or even start confirmatory trials after they win approval — it’s a thorn in the FDA’s side. Read More
Lupin has again run afoul of the FDA, drawing a Form 483 over deficiencies observed at its injectable drug manufacturing plant in Nagpur, Maharashtra, India, following a pre-approval inspection conducted from Oct. 17 to 29. Read More
More than 150 industry organizations and drugmakers have submitted a letter to Congressional leaders urging passage of the Pasteur Act, a languishing bill first introduced in 2020 to incentivize development of new treatments for combating drug-resistant pathogens. Read More