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A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid and Revlimid. Read More
As part of a broad effort to increase competition and lower drug prices, the FDA spelled out what it expects from sponsors of abbreviated new generic drug applications who are seeking early meetings to smooth the approval review process. Read More
Four Democratic senators are calling for an investigation into a Native American tribe’s acquisition of four patents from Allergan, saying the deal is a “blatantly anti-competitive” scheme to avoid review of Allergan’s patents and to maintain its high prices. Read More
The FDA published a new manual of policies and procedures for reviewing staff, detailing how the agency will communicate ANDA deficiencies with applicants — meeting one of its first commitments for the next generation of GDUFA. Read More
The agency must adjust the incremental cost from fiscal 2016 by the average amount costs rose in the three years before the current fiscal year. Read More