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The European Medicines Agency updated two guidelines on clinical trials for cardiovascular treatments in acute coronary syndrome and chronic heart failure, first adopted in 2000. Both guidelines are scheduled to take effect March 1, 2018. Read More
Pfizer is suing Johnson & Johnson over its contracts and rebate policies with insurers and hospitals, saying they are designed to block sales of a biosimilar for J&J’s blockbuster Remicade therapy. Read More
The European Medicines Agency updated its advice on navigating its centralized pre-authorization procedures to include a section on combination packs of medications. Read More
New guidance from the UK’s National Institute of Health and Care Excellence links the cost-effectiveness of different bisphosphonate medications for osteoporosis with a patient’s 10-year risk of bone fractures. Read More
The European Medicines Agency published an internal guide on the use of multinational assessment teams for pre-authorization reviews and post-authorization extensions for new medicines. Read More
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More