Deals Shaping the Medical Industry (1/07)
The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Windhover's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.
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Shire's cash-strapped partner Xenetic, whose technology enabled the long-acting Factor VIII, said on May 22 that SHP656 could not achieve once-weekly dosing in a Phase I/II clinical trial. The market for such a product may be limited anyway given current competition and payer preferences.
EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.
It takes a lot of negotiation with regulators, advisory boards, and alignment between commercial and portfolio management teams to define and agree a clinical trial protocol. Why on earth would companies change it once a study is underway?