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Updates

Explore our latest insights, regulatory updates, and strategic reports for the life sciences sector.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have guided several clients through notified body interactions and discussions with competent authorities on product classification.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have supported an IVD manufacturer in the design and conduct of performance studies. We regularly advise clients on post-market performance follow-up (PMPF) obligations.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.

Diagnostics Regulatory Compliance and Enforcement Testimonial

Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.

Diagnostics Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

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

Diagnostics Regulatory Compliance and Enforcement Testimonial

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

Biotech Diagnostics Corporate, Governance and Boardroom Counselling Due Diligence Financing and M&A Testimonial

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.

Biotech Corporate, Governance and Boardroom Counselling Financing and M&A Testimonial

Axon assisted a Dutch cultivated materials company in securing a EUR 22M Series A financing round. We advised on the transaction structure, investment documentation and related matters.

Biotech Pharmaceuticals Commercial Contracts Intellectual Property and Licensing Testimonial

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.