Last month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion of the marketing authorization application for Kynamro (mipomersen), developed by Isis Pharmaceuticals Inc. and Genzyme Corp., a unit of Sanofi SA, for the treatment of homozygous familial hypercholesterolemia (HoFH). Genzyme is appealing the decision, which should be completed in the second quarter of 2013. Read More
The "new normal" is not only causing big pharma firms to adapt their business strategies to current realities (see the cover story in this issue), but it also has cascaded down to impact companies which are just starting out on their journey of drug development. The "new normal" might not seem that much different from previous periods of fiscal constraints the biotech sector has experienced during its history. Read More
