Regulation & Policy

The US Food and Drug Administration has issued its first-ever draft guidance on the development of stimulant drugs to treat attention deficit hyperactivity disorder (ADHD), a condition whose symptoms include inattention and high levels of activity. While many of the recommendations are already in practice, the document gives clarification on the agency’s expectations for clinical trial design.

The European Commission has published proposed rules for electronic commerce that, among other things, would guarantee the validity of e-contracts and e-signatures and introduce measures to combat spam. The proposal has been introduced within the context of ongoing negotiations among World Trade Organization members about making e-commerce more transparent and reliable.
“Despite a fast increase in digital trade, there are currently no multilateral rules in this area,”
the Commission said in a statement issued on 3 May.

The European Medicines Agency has given a positive opinion to an implant for the treatment opioid addiction which is intended to treat the disorder by giving users a steady but low supply of an opioid drug. Called Sixmo, the implant consists of four small rods that are placed in a patient’s arm by a physician using a local anaesthetic.

The first non-drug treatment for attention deficit hyperactivity disorder (ADHD) – a device that stimulates the trigeminal nerve – has been approved by the US Food and Drug Administration.

Called the Monarch external trigeminal nerve stimulation (eTNS) system, it is intended to be used in the home under the supervision of a caregiver. The prescription-only device is indicated for patients from seven to 12 years of age who have been diagnosed with ADHD but are not taking a drug treatment.

The European Parliament has given its backing to Horizon Europe, a multi-year research programme for the sciences with a proposed budget of €100 billion. The programme is scheduled to run from 2021 to 2027, succeeding Horizon 2020.

On the heels of a regulatory approval, Nanobiotix SA has raised €29.5 million in a private share placement to continue the clinical development of its radioenhancer products for the treatment of cancer. The placement was oversubscribed during an accelerated bookbuilding process. Both existing and new investors from the US and Europe supported the offering.

An early stage chimeric antigen receptor (CAR) T cell therapy that targets an antigen expressed on myeloma cells has been singled out for a fast-track review by the European Medicines Agency. The cell-based gene therapy, JNJ-4528, is being co-developed by Nanjing Legend Biotech Co of China and Janssen Research & Development LLC.

A new gene therapy has been given a favourable scientific review in Europe paving the way for its use in patients with beta-thalassaemia as early as the second quarter. The treatment, Zynteglo, uses a lentiviral vector to deliver functional copies of a beta-globin gene into a patient’s haematopoietic stem cells in order to correct for a shortage of beta-globin. It was given a positive opinion by the European Medicines Agency on 29 March.

A type of inflammatory arthritis that affects the spine but cannot be detected by x-ray now has an approved treatment. The US Food and Drug Administration has authorised Cimzia (certolizumab pegol) for the treatment of non-radiographic axial spondyloarthritis, a disease that starts in patients under the age of 45 years and can get progressively worse. The fact that the disorder cannot be identified by x-ray sets it apart from other inflammatory conditions in the same disease group.

The US Food and Drug Administration has approved a new drug for the treatment of patients with multiple sclerosis (MS) whose disease gradually worsens over time leading to a disruption of brain function through inflammation and tissue loss. The drug, Mayzent (siponimod), is a small molecule indicated for active secondary progressive MS.