Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to […]readmore
Tags : Achillion
1. Johnson & Johnson Initiates Voluntarily Recall of a Single Lot of its Baby Powder in the US Published: Oct 18, 2019 | Tags: JnJ, Initiates, Voluntarily, Recall, Baby Powder, US […]readmore
Shots: Alexion acquires Achillion with initial all-cash transaction for ~$930M at $6.30/share, including Achillion’s cash on hand of ~$230M, CVRs as clinical & regulatory milestones if achieved within specified periods […]readmore
Regulatory
Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal
Shots: The FDA’s BT designation is based on safety & efficacy data of ongoing P-II study assessing Danicopan in combination with C5 mAb for patients with paroxysmal nocturnal hemoglobinuria (PNH) […]readmore