Updates

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.

We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.

We have advised manufacturers, distributors and authorised representatives on all aspects of the IVDR, including assisting a diagnostics manufacturer with the classification and conformity assessment of its in vitro diagnostic medical devices under the new IVDR framework.

Axon acted on behalf of an investor in connection with their investment in a clinical-stage biotech company developing first-in-class therapeutics and diagnostics for fibrosis. We conducted legal due diligence on the target company and reviewed the transaction documentation on behalf of the investors.

Axon assisted a Dutch IVD company in securing a EUR 24M equity financing round, advising on the transaction structure, investment documentation and related matters.

We have advised pharmacies on the regulatory aspects of pharmaceutical compounding.

Axon advised a stock-listed biopharmaceutical company on antibody licensing and technology transfer agreements with two major US-based pharmaceutical companies. The deals involved the grant of commercial rights to the licensor's proprietary antibody platform technology.