Worldwide: Food, Drugs, Healthcare, Life Sciences

For developers, seed companies, and their advisers, this development provides long-awaited certainty on regulatory pathways for gene edited crops.

The clinical success of PARP inhibitors has validated DNA damage response (DDR) as a major therapeutic target in oncology, but resistance to first-generation therapies is driving innovation toward new strategies.

The European Parliament has approved new regulations for gene-edited crops, establishing a two-tier framework that distinguishes between plants equivalent to conventional breeding and those requiring full GMO oversight. The legislation preserves patent protection while introducing transparency measures and public databases to track NGT-derived varieties across the European Union.

Half of women working in law say the demands of their job are unsustainable for their long-term health, according to new research which canvassed the views of more than 500 female legal professionals.

Recent investigations reveal the systemic pressures facing UK maternity care, raising critical questions about safety standards, accountability and the legal framework supporting families when care falls short. What does the evidence tell us about the current state of maternity services, and how can legal processes drive meaningful improvement?

Medical Protection has released a paper calling for law reform to address the liability gap when doctors' decisions are influenced by AI recommender systems.

Following widespread litigation over Halozyme's SPC families for Herceptin Hylecta and MabThera, Europe's highest court received a critical referral addressing whether recombinant human hyaluronidase can be considered an "active ingredient" despite its classification as an excipient in marketing authorisation documents. Advocate General Emiliou has now published a significant legal opinion proposing that substances expressly designated as excipients cannot be regarded as active ingredients for SPC purposes.

The UK pharmaceutical sector faces significant challenges from counterfeit medicines that threaten patient safety and undermine legitimate supply chains. This analysis examines the current landscape of pharmaceutical counterfeiting...

The UK's medicines regulator is proposing fundamental changes to how gene therapy products are defined, shifting from origin-based classifications to mechanism-driven frameworks. This consultation raises critical questions about where regulatory boundaries will be drawn for synthetic biology, genome editing platforms, and engineered cell therapies as biotechnology advances beyond traditional biological manufacturing.