Each week we highlight five things affecting the life sciences industry. Here’s the latest.
UK and U.S. regulators move toward alignment in the medtech sector
- The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) reaffirmed its commitment to work with the U.S. Food and Drug Administration to better align medical device regulations, including exploring mutual recognition mechanisms and reducing duplicative reviews for manufacturers to speed patient access.
- According to Medtech Dive, as part of its post-Brexit regulatory approach, the MHRA is expanding their international reliance route, potentially recognizing U.S., European Union and other peer approvals to provide clearer, more predictable pathways to market while maintaining UK safety and effectiveness standards.
Late‑March surge signals renewed biopharma M&A momentum
- Over a 12-day stretch in March, biopharma companies announced seven deals worth more than $1 billion each, totaling approximately $29 billion, reinforcing expectations that 2026 could be a strong year for industry mergers and acquisitions.
- The spree included multiple $5+ billion‑transactions by large pharma players, with analysts and dealmakers pointing to improved capital availability, a reopening of initial public offering markets and looming patent expirations as key drivers, reports Fierce Pharma.
Canadian government backs diabetes cell therapy
- Aspect Biosystems received $79 million from the Canadian government’s Strategic Response Fund to advance its stem cell–derived diabetes therapy, which aims to enable patients to produce their own insulin, while strengthening the company’s clinical development capabilities.
- According to Endpoints News, funding supports Canadian-based growth and development. The investment is part of a $280 million multiyear project and reflects the government’s goal of keeping major diabetes innovations and biomanufacturing capabilities in Canada as Aspect prepares for future clinical studies.
Record European biopharma fund raise
- Paris-based Jeito Capital closed $1.2 billion for its second fund, Jeito II, calling it the largest raise ever by an independent, biopharma-focused European fund and exceeding its original target, according to Fierce Biotech.
- With nearly double the capital of its first fund, Jeito plans to invest in 15–20 European clinical stage biopharma companies, increasing average investments to up to €150 million per company to help advance assets through late-stage development and commercialization.
FDA’s budget targets advertising, biosimilars and approval pathways
- According to FirstWord Pharma, the FDA has released its fiscal 2027 budget request which asks Congress to provide it with more authority to address misleading drug advertising.
- Additionally, the FDA aims to have a policy change to make it easier to review and approve biosimilars and a faster “expedited investigational new drug” pathway for early-stage drugs.
For more insights in life sciences, check out RSM’s industry outlook.
