Tower Mains Weekly Newsletter

Regulatory Updates

EMA and HMA confirm biosimilar medicines can be interchanged

On 19th September, the EMA and the Heads of Medicines Agencies (HMA) issued a joint statement confirming that biosimilar medicines approved in the EU are interchangeable with their reference medicine or with an equivalent biosimilar. While the interchangeable use of biosimilars is already practiced in many Member States, this joint position harmonises the EU approach and brings more clarity for healthcare professionals, thus helping more patients gain access to biological medicines across the EU.

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MHRA guidance updates

  • Northern Ireland MHRA Authorised Route (NIMAR): On 20th September, the Medicines and Healthcare products Regulatory Agency (MHRA) added a section on ‘Advertising and promotions.’ Click to view source
  • Notifying the agency about a clinical investigation for a medical device: On 20th September, the MHRA added a section ‘Quarterly Summary Reports.’ Click to view source

Industry Updates

FDA and NIH launch public-private partnership for rare neurodegenerative diseases

On 14th September, the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. The FDA and NIH have selected the Critical Path Institute (C-Path) as the convener of this partnership, bringing together experts in rare neurodegenerative diseases, including, but not limited to, patient communities, advocacy organizations, and private entities.

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WHO responds to The Lancet COVID-19 Commission

On 15th September, the World Health Organisation (WHO) welcomed the recommendations of The Lancet COVID-19 Commission’s report on “Lessons for the future from the COVID-19 pandemic,” which align with our commitment to stronger global, regional, and national pandemic preparedness, prevention, readiness, and response. The Commission strongly endorses WHO’s vital role in global health, arguing that “WHO should be strengthened” and that reforms “should include a substantial increase of its core budget.”

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FDA authorises marketing of Phagenyx System

On 16th September, the FDA authorised the marketing of Phagenyx System, which delivers electrical stimulation to the oropharynx, part of the throat at the back of the mouth behind the oral cavity. It is used as an aid in the treatment of stroke patients who experience dysphagia (difficulty in swallowing) caused by stroke.

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New medicine to protect babies and infants from RSV infection

On 16th September, the European Medicines Agency (EMA) announced it has recommended a marketing authorisation in the EU for Beyfortus for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in new-born babies and infants during their first RSV season. Beyfortus was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to promising new medicines that address unmet medical needs.

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bluebird bio’s SKYSONA gene therapy granted accelerated approval in the US

On 16th September, the FDA granted accelerated approval to bluebird bio’s SKYSONA, the first cell-based gene therapy indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). Childhood CALD is a life-threatening genetic condition caused by mutations in the ABCD1 gene, which lead to a build-up of chemicals that cause inflammation and damage to the brain. Left untreated, symptoms typically progress to neurologic disability and death in the second decade of life. This application was granted a rare pediatric disease priority review voucher (PRV), in addition to receiving orphan drug and Breakthrough Therapy designations by the FDA.

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FDA issues warning to users of the Medtronic MiniMed 600 Series Insulin Pump System

On 20th September, the FDA issued a warning to medical device users about a potential cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System. There is a possible issue associated with the communication protocol for the pump system that could allow unauthorised access to the pump system, which if occurs, the pump’s communication protocol could be compromised, which may cause the pump to deliver too much or too little insulin.

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Issue Number: WN00079

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