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Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to Wednesday guidance that sets specific timelines for every step of the dispute resolution process. Read More
The European Medicines Agency has released its recommendations for the 2015/2016 seasonal influenza vaccine composition, setting the clock for when manufacturers have to submit their strain variation applications to June 15. Read More
Sanofi Pasteur’s new combined Quadracel DTaP plus polio vaccine is about to hit the U.S. market for children four to six years old, following FDA approval Wednesday. Read More
Regeneron has won yet another indication for its Eylea injection, this time for patients with diabetic macular edema who develop retinopathy. Read More
The National Institute for Health and Care Excellence yesterday recommended that the National Health Service cover drugs for acute coronary syndrome and type 2 diabetes, but turned down one for multiple myeloma. Read More