The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access.
Consolidation in diagnostics continues apace, with Diasorin SpA set to take over Luminex Corp. in an all-cash deal that values the multiplex diagnostics and molecular testing specialist at $1.8 billion. At $37 per share, the price is a 23% premium to the Luminex (NASDAQ:LMNX) share price on Feb. 23, which is when rumors of the acquisition began to circulate, and 12% above the close last Friday, April 8.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Hemanext, Lumiradx.
LONDON – The U.K. is moving on to the next phase of testing mixed dosing schedules for COVID-19 vaccines, launching a study in which it will assess the effect of using Moderna Inc. or Novavax Inc.’s products as the second dose in a heterologous prime boost trial.
PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience. The objective of the government’s modern manufacturing strategy is to build scale and capture income in high-value areas of manufacturing where Australia either has established competitive strength or emerging priorities.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Avenue, Axcella Health, Celularity, Janssen, Kibow, Lintonpharm, Neuraptive, Novartis, RDIF, Vtv.
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