Deals Update (01/2008)
A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.
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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.
Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.
Lumicell’s Cancer Imaging Drug Faces Clinical Meaningfulness, Anaphylaxis Risk Questions At FDA Panel
US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.