Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA moves to speed up biosimilar approvals to cut drug costs
- The U.S. Food and Drug Administration announced draft guidance to reduce testing requirements for biosimilars, aiming to halve development time and lower costs by up to $100 million per drug.
- According to CNN, the policy seeks to boost competition and make complex biologic treatments more affordable without compromising safety or effectiveness.
Mexico’s faster regulatory pathway draws global medical device makers
- Mexico’s new Commission for the Protection Against Sanitary Risk provides a pathway that could shorten medical device approvals to 30 days by recognizing U.S., UK and European Union authorizations, and removing redundant documentation.
- MDDI Online reports that this reform cuts regulatory workloads by up to 80% and positions Mexico as Latin America’s leading hub for rapid medtech innovation.
Organizations partner to build pharma AI supercomputer
- Two organizations have collaborated to create a renewable energy–powered supercomputer that will drive a new “AI factory” for molecule discovery and faster drug development.
- The system, featuring over 1,000 GPUs, will support AI agents, digital twins and data sharing to advance research across the life sciences industry, reports Fierce Biotech.
UK braces for rising medicine bills amid US pricing talks
- The UK government expects some new innovative drugs to see inevitable price increases as talks with the U.S. over pharmaceuticals intensify, according to Reuters.
- Industry sources say the current voluntary pricing extension and scrutiny of the value-for-money framework indicate mounting pressure on the life sciences industry to adapt to global pricing shifts.
Another biotech IPO success
- A biotech company raised $258.9 million in its initial public offering and private placement, debuting with an 8% stock increase, despite the U.S government shutdown, making this the first U.S. IPO to use the “shutdown fix,” reports Bloomberg.
- The biotech firm is advancing mid-stage trials for treatments targeting schizophrenia and Alzheimer’s disease psychosis, with results expected in late 2026 and 2027.
For more insights in life sciences, check out RSM’s industry outlook.
