Regulation & Policy

A gene therapy for a rare, genetic eye disorder has been selected by the US Food and Drug Administration for its Regenerative Medicine Advanced Therapy Designation in recognition of the product’s potential to treat an unmet medical need.

The European Medicines Agency is restricting the use of two checkpoint inhibitor drugs as first-line treatments for urothelial cancer, or cancer of the bladder and urinary tract, because they may not work as well as chemotherapy in this group of patients.

The US Food and Drug Administration has approved the marketing of an artificial intelligence algorithm which is part of a diagnostic intended to help physicians detect wrist fractures.

The European Medicines Agency has issued a positive opinion for Aimovig (erenumab), an antibody treatment for migraine prevention, only weeks after it was given approval by the US Food and Drug Administration. Both agencies highlighted the novelty of the drug

The US Food and Drug Administration has approved the first stand-alone prosthetic iris, a surgically implanted device to treat adults and children whose irises are completely missing or damaged due to aniridia, a congenital condition, or other damage to the eye.

The US Food and Drug Administration has requested permanent injunctions against stem cell clinics in two regions of the country to prevent them from administering unapproved stem cell treatments to patients with cancer and other diseases. The move comes nearly 10 months after it issued warning letters to the clinics.

Subject to approval from US regulators, Bayer AG hopes to conclude its $66 billion takeover of Monsanto Co in the second quarter. The transaction would be the third merger of its kind in just under 12 months, illustrating the global consolidation of the agrochemical and seed businesses. This is being enabled by biotechnology, which makes it possible for crops to be engineered to resist insects, and digital technology which gives farmers new tools for managing their fields.

If everything goes according to plan, member states of the European Union will in future use a common methodology to decide whether a new medicine or medical device is clinically effective, relative to certain benchmarks, and therefore be considered for reimbursement. This is the scenario envisioned by the European Commission under a proposed Regulation on Health Technology Assessment, which was unveiled earlier this year.