The Decision on Timing in the BPCI Act

2019-01-09T13:51:14+00:00By |

This week, the path to market for biosimilar developers cleared up just a bit. The Supreme Court made a final decision in the three-year lawsuit between Amgen and Sandoz that sets a precedent regarding the interpretation of some widely-contested language in the BPCI Act. The language in question referred to the ‘patent [...]

Emerging Challenges in Global Clinical Studies

2017-06-22T10:50:21+00:00By |

Clinical research is going global. This growth translates to sponsors no longer running separate studies in each and every country they are seeking marketing approval; instead they are opting for large, global studies that have percentages of the required subjects in each venue they desire for marketing approval. A major benefit of [...]

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