Tower Mains Weekly Newsletter
Company Updates
We are delighted to announce that we have moved our office to Newington Business Centre, 5, Dalkeith Road Mews, Edinburgh, EH16 5GA. We couldn’t be more excited about the possibilities our new office will bring and look forward to settling into our new home and workspace and continuing to deliver excellence in what we do!
Regulatory Updates
MHRA reinforces anaphylaxis emergency guidance as hospital admissions rise
On 2nd August, the MHRA reinforced the recently published guidance on how to recognise and respond to the signs of anaphylaxis, including the use of adrenaline auto-injectors which are prescribed to people at risk of anaphylaxis. The steps taken immediately in response to anaphylaxis can be the difference between life and death. This comes as the most recent NHS figures show 25,721 admissions in 2022-23, more than double the 12,361 admissions in 2002-03 (a 108% increase).
Further MHRA updates
- Renewing Marketing Authorisations for medicines. On 28th July, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on renewal applications to reflect changes to the submission requirements for products within the MR/DCP. Click to view source
- Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework. On 28th July, guidance was published to provide information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework. Click to view source
FDA guidance updates
- Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder. On 27th July, the US Food and Drug Administration (FDA) published draft guidance describing recommendations for the design of pivotal clinical studies for devices intended to treat Opioid Use Disorder (OUD) and used to support marketing submissions. These apply to the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD. Click to view source
- Assessing User Fees Under the Biosimilar User Fee Amendments of 2022. On 27th July, final guidance was published describing the types of user fees authorised by BsUFA III, how FDA determines which products are subject to a fee, and FDA’s policies regarding exceptions and waivers. This guidance also describes the process for submitting payments to FDA and the consequences for failing to pay BsUFA fees, and the process for requesting reconsideration if FDA denies a request for a waiver or return of user fees. Click to view source
Industry Updates
FDA Mutual Recognition Agreement with Swissmedic enters into force
On 27th July, the FDA’s Mutual Recognition Agreement with Switzerland entered into force, allowing the FDA and Swiss medical product regulatory authority, Swissmedic, to begin relying on each other’s factual findings from a good manufacturing practice (GMP) inspection of a pharmaceutical manufacturing facility. In addition to covering GMP inspections of facilities making human drugs, the MRA with Swissmedic also includes veterinary drugs.
FDA approves second over-the-counter naloxone nasal spray product
On 28th July, approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), non-prescription use for the emergency treatment of known or suspected opioid overdose. This is the second non-prescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription.
Abionyx Pharma manufactures a new batch of ApoA-I CER-001
On 28th July, Abionyx Pharma, a new-generation biotech company, announced the successful completion of a second batch for the Good Manufacturing Practice (GMP) industrial biomanufacturing of its apoA-I CER-001 candidate using a novel and robust industrial process. CER-001 is a negatively charged lipoprotein particle which contains human recombinant apoA-I, the natural HDL protein, and two natural phospholipids. It mimics all the structural and functional biological properties of natural, nascent HDL and has been shown to perform all steps of the Reverse Lipid Transport pathway (RLT), the only natural pathway responsible for lipid elimination. The second batch represents a critical step on the therapy’s pathway to regulatory approval.
Governments hold further discussions on proposed amendments to International Health Regulations (2005)
On 31st July, the World Health Organisation (WHO) published details from the detailed examination of a significant number of the over 300 proposed amendments to the WHO International Health Regulations 2005 (IHR). Throughout the 5-day meeting from 24-28th July, the Working Group on Amendments to the IHR (WGIHR) stressed the importance of thoroughly considering the proposed amendments on their merits of filling critical gaps in the implementation of the IHR, while being mindful of the importance of the principles of equity, sovereignty, and solidarity.
Bimervax COVID-19 vaccine authorised in UK
On 1st August, the MHRA announced the authorisation of Bimervax, the COVID-19 vaccine developed by HIPRA Human Health. The vaccine combines a part of the SARS-CoV-2 virus spike protein with an ‘adjuvant’ – an additional ingredient designed to trigger a stronger immune response – and can be given as a booster injection in the upper arm, to those aged 16 years and over.
MHRA: Extended recognition of CE marking does not apply to medical devices or IVDs
On 1st August, the MHRA confirmed that the extended recognition of CE marking does not apply to medical devices or IVDs. The government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE-marked medical devices on the Great Britain market.
Update issued on the ongoing actions to resolve shortages of prescription stimulant medications
On 1st August, the FDA and the Drug Enforcement Administration provided an update on the ongoing actions being taken to resolve the shortages of prescription stimulant medications. Actions include calling on manufacturers to increase production to meet their allotted quota amount ad asking professional groups and healthcare providers to accelerate efforts to support appropriate diagnosis and treatment of ADHD, such as further development of additional clinical guidelines for ADHD in adults.
EMA publishes July issue of SME Office Newsletter
The European Medicines Agency (EMA) issued the July issue of its SME Office Newsletter, which includes information for SMEs on the EU regulatory environment for medicines. Topics include scientific guidelines for human medicines, clinical data publication, the Accelerating Clinical Trials in the EU (ACT) and the Scientific Advice pilot for high-risk medical devices.
Invizius receives MHRA approval to commence first-in-human clinical study of H-Guard® Priming Solution
On 1st August, Invizius, a biotechnology company developing second-generation therapies for a range of complement-driven autoimmune and inflammatory disorders, announced it has received MHRA approval to commence its first-in-human clinical study of lead product, H-Guard. The study will investigate the safety and tolerability of H-Guard as a potential solution to address serious complement-driven inflammatory complications of haemodialysis (HD) and will be conducted at the Manchester University Hospitals NHS Foundation Trust (MFT).
Issue Number: WN00123
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