Industry News Update: 3/1

This week in Pharma, Akron Pharmaceuticals, which recently received 2 FDA manufacturing warnings, got hit with a form 483 for stability findings. The FDA and EMA also came together to agree on warnings of increased risk of cardiovascular events regarding Pfizers JACK inhibitor Xeljanz. In the world of patent litigation, BI was forced to share their Humira Biosimilar launch plans with AbbVie. This forces BI to quantify delay and damages resulting from patent litigation and could weaken their arguments in court. Furthermore, a jury ruled that the patents protecting Amgen drug Repatha from Sanofi/Regeneron rival are valid but the two pharmas plan to continue to press the case going foward. Roche is planning to expand further into gene therapy by acquiring Spark Therapeutics for 4.3 billion dollars. Spark has a controversial approved gene therapy in Luxterna and has candidates in the hemophilia space. There appears to be consensus that gene therapies in the hemophilia space show potential to be big earners. Furthermore, Spark’s experience with manufacturing potentially problematic gene therapies could prove beneficial. The Merck and AstraZeneca Lymparza collaboration topped placebo in pancreatic cancer potentially putting it at the top of the PARP drug class. The companies expect the revenue from this breakthrough will conserve the momentum of their oncology sales departments.