Key Regulatory and Compliance Considerations for Early-Stage Life Sciences Companies and Their Investors

Early-stage life sciences companies and the investors that back them are laser-focused on evidenced-based development and approval hurdles. However, even at early stages, failure to adequately prioritize more nuanced regulatory and compliance issues can have a significant impact on exit value and create potential liability for investors and acquirers. Geoffrey Levin, Torrey Cope, Marie Manley, Donielle McCutcheon, Andrew Shoyer, Michele Tagliaferri, and Julea Lipiz highlight eight key areas for focus.

New EU Subsidies Rules Likely to Catch Global Life Sciences Companies

Given their extensive involvement in public procurement contracting, life sciences companies are likely to be heavily impacted by the EU’s Foreign Subsidies Regulation (the “FSR”), which has the potential to hold up tender awards over competition concerns. Michele Tagliaferri and Alessandra Moroni explain.

Seven Things Life Sciences Buyers and Sellers Should Know About CVRs

The life sciences industry has recently seen a proliferation of Contingent Value Rights (CVRs), the public M&A equivalent of the earnout used in private deals.  Sally Wagner Partin, Sharon Flanagan, and Hannah Brown explain what you need to know about them.

Why Venture Capital Investors Are Focused on Femtech

Andrew Harper in San Francisco and Francesca Blythe in London look at some of the drivers that are fueling interest in digital health products aimed at women.

The term ‘Femtech’ was coined by the founder of a fertility app company in response to her experience that male investors often struggle with the specifics of discussing products focused on women’s reproductive health. However, Femtech covers a wider range of products than the purely fertility-focused, including all health software and tech-enabled products that cater to female biological needs and to the wider wellness market for all those who identify as women.

(more…)