Deals Update
Executive Summary
A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.
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Rethinking Alzheimer's: Mapping Out an Approval Process
Drug companies involved in Alzheimer's disease research are a little fed up with FDA. Some, like Wyeth, believe the agency should put Alzheimer's research higher up on its priority list and allow the use of surrogate endpoints for clinical trials. But FDA says that no validated surrogate exists for Alzheimer's, and until it has hard data from products in development, it is loath to recommend one. A recent reorganization of the agency's neurology group may provide an opening to press home those arguments.
Bluebird’s Zynteglo Approval Kicks Off Commercial Operations
Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.
AbbVie Halts Another Trial With I-Mab Antibody, Slashes Deal Size
AbbVie is to terminate the clinical development of lemzoparlimab for myelodysplastic syndrome and acute myeloid leukemia and will also reduce the size of its 2020 deal with originator I-Mab by $445m, in the latest blow to the Chinese firm.