Takeda’s acquisition of Shire–perhaps better characterized as a merger–is already transforming the pharma landscape. As is often the case, however, the first year of marriage can be rocky. Challenges abound, including manufacturing glitches and an array of review and development issues. The merged company is poised to become a market leader in rare diseases and plasma derivatives. It is expected to have roughly $30 billion in revenues and will join the ranks of the top 10 drugmakers. Still, nagging questions remain: Will the U.S. FDA approve lanadelumab?