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In response to congressional pressures, the HHS inspector general will investigate how recent increases in generic drug prices have impacted the Medicaid rebate program and whether those increases exceeded the inflation rate in 2005 through 2014. Read More
In response to overwhelming requests from industry, the FDA is extending to June 8 the comment period on its draft rule overhauling the ANDA and 505(b)(2) approval processes. Read More
Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment.
The requirement, spelled out in draft guidance Tuesday, would apply to drugs with estrogenic, androgenic or thyroid activity. Read More
The European Medicines Agency is seeking feedback on the chemical structure and properties it considers in evaluating new active substance status. Read More
GPhA Wednesday threw its weight behind Sandoz in closely watched litigation between Amgen and the French drugmaker, saying the U.S. district court in northern California was correct in denying Amgen’s request for a preliminary injunction to keep Sandoz’ biosimilar of Neupogen off the market. Read More
In response to overwhelming requests from industry, the FDA is extending to June 8 the comment period on its draft rule overhauling the ANDA and 505(b)(2) approval processes. Read More
The FDA is taking the unusual step of pressing Genervon Biopharmaceuticals to release all data from a Phase IIa trial of its amyotrophic lateral sclerosis drug, including an analysis of changes in patients’ lung function. Read More
Bristol-Myers Squibb has cut short the comparative arm of a trial of its immunotherapy drug Opdivo after interim results showed a clear benefit over chemotherapy. Read More