United Kingdom: Food, Drugs, Healthcare, Life Sciences

The MHRA’s proposed rare disease therapies regulatory framework (“the Proposed Framework”) represents an ambitious attempt to redesign medicines regulation around the realities of rare disease development.

The MHRA has launched a consultation on proposed updates to the definition of gene therapy medicinal products (“GTMPs”) under the UK Human Medicines Regulations 2012 (“HMRs”).

This podcast focuses on the pharmaceutical industry and, in particular, M&A activity in the sector and the recent surge in licensing deals involving Chinese biotechs.

Artificial intelligence is transforming how pharmaceutical companies identify new therapeutic uses for existing drugs, but this acceleration creates complex intellectual property challenges. As computational methods rapidly generate repurposing candidates, innovators must navigate the tension between filing early to secure priority and waiting for sufficient validation data, while ensuring their second medical use patents provide meaningful commercial protection in an increasingly competitive landscape.

Launching a product while a patent dispute remains unresolved has never been risk‑free, but many companies have taken the view that the commercial upside justified it.

The MHRA’s proposed rare disease therapies regulatory framework (“the Proposed Framework”) represents an ambitious attempt to redesign medicines regulation around the realities of rare disease development.

Launching a product while a patent dispute remains unresolved has never been risk‑free, but many companies have taken the view that the commercial upside justified it.

The MHRA’s proposed rare disease therapies regulatory framework (“the Proposed Framework”) represents an ambitious attempt to redesign medicines regulation around the realities of rare disease development.

Personal injury claims increasingly involve significant mental health consequences, from anxiety and PTSD to depression and emotional distress. Understanding the complex relationship between physical trauma and psychological harm is essential for victims seeking proper support and compensation, particularly when psychiatric injuries occur alongside or independently of physical injuries.