Regulation & Policy

Regulators in both the US and Europe are preparing for the first submissions of a new class of cancer drugs that have been shown to vanquish cancer in some patients b

Kite Pharma Inc plans to make a US regulatory submission for its lead chimeric antigen receptor (CAR) T cell therapy for patients with non-Hodgkin lymphoma starting at the end of December. Following talks with the Food and Drug Administration, the US company announced in early November that it will make a rolling regulatory submission.

France-based Nicox SA said it anticipates a regulatory review of its glaucoma drug latanoprostene bunod to take place soon, and if the result is positive, the treatment could be on the US market by mid-2017.

The Food and Drug Administration has approved a new device for closing small holes in the heart called patent foramen ovales (PFO), which in some patients can be a cause of recurrent strokes. The non-surgical device can be inserted through a catheter in a vein in the leg.

A new medicine that is expected to protect against a rare liver disease known as primary biliary cholangitis, has been recommended for approval in the European Union following a Phase 3 study in which the treatment showed a clear benefit over placebo.

The European Medicines Agency has appealed against a court order preventing it from releasing documents relating to two marketed medicines, arguing that the disclosures are consistent with its policy on transparency.

The Food and Drug Administration has approved a new device for people with Type 1 diabetes – the first to automatically monitor blood glucose levels and release insulin at the appropriate dose. The so-called ‘artificial pancreas’ is intended to adjust insulin levels in the blood with little or no input from the user.

Rejecting the advice of its advisory committee, the Food and Drug Administration has approved the first drug for Duchenne muscular dystrophy, a rare disorder that causes a progressive deterioration in the muscles of people with a specific gene mutation.

The European Medicines Agency has recommended two new cancer drugs for marketing authorisation in the European Union, one of which is for the treatment of breast cancer and the other for soft tissue sarcoma.

The European Medicines Agency is recommending a tightening of its guideline on first-in-human clinical trials to provide better protections for volunteers and a new approach to evaluating protocols that cover a number of different study parts.