Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- MHRA phase I accreditation scheme. On 10th July, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of accredited phase I units in the guidance on joining the scheme. Click to view source
- Borderline products: how to tell if your product is a medical device and which risk class applies. On 11th July, the MHRA added an additional section ‘Annex A – MHRA borderline determinations’ to the guidance on how to tell if a product is a medical device and which risk class applies. This has been added to assist manufacturers to arrive at the appropriate classification for their products. Click to view source
FDA guidance updates
- Inborn errors of metabolism that use dietary management: considerations for optimising and standardising diet in clinical trials for drug product development. On 9th July, the US Food and Drug Administration (FDA) published draft guidance describing current recommendations for optimising and standardising dietary management in clinical trials for the development of drug products intended to treat inborn errors of metabolism (IEM) when dietary management is a key component of a patient’s metabolic control. Optimising and standardising dietary management in these patients before they enter clinical trials and during clinical trials is essential to providing an accurate evaluation of the efficacy of new drug products. Click to view source
Industry Updates
Phasing out of extraordinary COVID-19 regulatory flexibilities
On 6th July, the European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) announced they are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This follows the end of the COVID-19 public health emergency declared by the World Health Organisation (WHO) in May 2023.
Novel Alzheimer’s treatment converted to traditional approval in the US
On 6th July, the FDA converted Leqembi, indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. It works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease.
Novavax’s Nuvaxovid™ receives full marketing authorisation in the EU for the prevention of COVID-19
On 6th July, Novavax, Inc., a global company specialising in advancing protein-based vaccines, has been granted full Marketing Authorisation (MA) by the European Commission for Nuvaxovid™. This decision follows positive opinion for a full MA from the Committee for Medicinal Products for Human Use of the EMA. The vaccine is now fully authorised for use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older for the prevention of COVID-19. Nuvaxovid was originally granted a conditional MA in the EU for these indications.
EMA issues latest PRAC meeting highlights
On 7th July, the EMA issued meeting highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) held on the 3rd-6th July 2023. This covered all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.
MHRA authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults
On 7th July, GSK plc announced that the MHRA has authorised Arexvy for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been authorised for use in UK by the MHRA.
CBT device for type 2 diabetes receives marketing authorisation in US
On 8th July, FDA authorised the marketing of Better Therapeutics’ BT-001, a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to patients 18 years or older with type 2 diabetes. BT-001 provides CBT to help users who are under the care of a healthcare provider better adhere to behaviors that aid in the management of diabetes.
WHO launches platform featuring digital resources on ending TB
On 10th July, the World Health Organisation (WHO) announced its Global Tuberculosis Programme has created an online platform to help users find practical advice to implement digital technologies to support TB care worldwide. The platform includes easy access to guidelines and job aids developed by WHO and technical partners, as well as links to key literature and country examples.
Issue Number: WN00120
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