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A suggested link between Novartis’ heart failure drug LCZ696 and progression of Alzheimer’s disease could sour hopes of a pipeline replacement for the company’s failed Reasanz heart drug. Read More
The European Medicines Agency has issued guidance to help drugmakers improve their responses to scientific objections lodged by EMA review committees. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them, setting up a test case for the EU’s new trial transparency policy. Read More
Hospira is looking to add another biosimilar candidate to its growing pipeline by partnering with Pfenex to develop and market a biosimilar of Genentech’s retinal disease therapy Lucentis. Read More
Trials of drugs targeting complicated intra-abdominal infections should use only drugs that are standard of care as active comparators, the FDA says, and studies should minimize the use of outside antibiotics in trial subjects as much as possible to produce clear, definitive trial results. Read More
An FDA advisory committee will meet next month to consider Celltrion’s biosimilar version of Janssen’s Remicade, putting the agency on track to meet a goal of reviewing five biosimilar applications a year. Read More