Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.

Regulatory Updates

FDA guidance updates

  • CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use. On 24th June, the US Food & Drug Administration (FDA) published draft guidance describing the Center for Veterinary Medicine’s (CVM) recommendations for the information to be included in Chemistry, Manufacturing, and Controls (CMC) submissions to New Animal Drug Applications (NADAs), Conditional New Animal Drug Applications (CNADAs), Investigational New Animal Drug (INAD) files, and Veterinary Master Files (VMFs) specific to recombinant protein-based intermediates, drug substances, and drug products. Click to view source
  • CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process. On 26th June, final guidance was published outlining the eligibility criteria a new animal drug should meet to obtain PZAD designation and describes the process sponsors may use to request such designation.  Click to view source
  • CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs. On 26th June, final guidance was published providing recommendations for evaluating the effectiveness of drugs indicated for the prevention of heartworm disease caused by Dirofilaria immitis in dogs. Click to view source
  • Diversity Action Plans to Improve Enrolment of Participants from Underrepresented Populations in Clinical Studies. On 26th June, the FDA issued draft guidance describing the form, content, and manner of diversity action plans, the applicable medical products, and clinical studies for which a diversity action plan is required, the timing and process for submitting diversity action plans, and the criteria and process by which the agency will evaluate sponsors’ requests for waivers from the requirement to submit a Diversity Action Plan. Click to view source

Industry Updates

MHRA warns of risk of adverse drug interactions with tramadol

On 20th June, the MHRA issued a warning that taking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalised Ratio (INR), and result in severe bruising and bleeding, which in some patients could be fatal. This follows a Coroner’s report that raised concerns that the interaction between warfarin and tramadol was not well known and emphasised the need to highlight this interaction to healthcare professionals.

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KCL’s mini liver model promises a more effective drug testing method

On 20th June, King’s College London (KCL) revealed its researchers have created a laboratory-grown mini liver model, promising a new and more effective drug testing method. By addressing the ethical and practical of animal models, including physiological differences, associated high costs and limited tissue availability, this innovative approach shows great potential as a more accurate and ethical alternative.

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New pregnancy prevention measures introduced for topiramate

On 20th June, the MHRA announced the introduction of new safety measures for topiramate following a major safety review triggered by a new study conducted in the EU. Following recommendations made by the Commission on Human Medicines (CHM), the agency is now advising healthcare professionals that topiramate should not be prescribed to treat epilepsy during pregnancy unless there is no suitable alternative treatment.

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WHO issues warning on falsified medicines used for diabetes treatment and weight loss

On 20th June, the World Health Organisation (WHO) issued a medical product alert on falsified medicines used for the treatment of type 2 diabetes and obesity in some countries. The alert addresses three falsified batches of semaglutide products, which have been detected in Brazil in October 2023, the UK and Northern Ireland in October 2023, and the US in December 2023. The WHO Global Surveillance and Monitoring System (GSMS) has been observing increased reports on falsified semaglutide products in all geographical regions since 2022. This is the first official notice issued by WHO after confirmation of some of the reports.

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Latest Drug Safety Update from the MHRA

On 20th June, the June issue of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines, was published.

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EFPIA publishes its annual Pharmaceutical Industry in Figures report

On 24th June, the European Federation of Pharmaceutical Industries and Associations (EFPIA) published its annual ‘Pharmaceutical Industry in Figures report’. This includes figures on key trends, research and development and biosimilars.

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UCL begins first UK trial of deep brain stimulation for children with rare epilepsy

On 24th June, the University College London (UCL) announced the commencement of the UK’s first-ever deep brain stimulation (DBS) trial for children with epilepsy. A collaboration between Great Ormond Street Hospital, UCL, King’s College London, the University of Oxford and Amber Therapeutics, the Children’s Adaptive Deep rain stimulation for Epilepsy Trial (CADET) pilot will investigate the safety of a cranially-mounted DBS device called the Picostim with software called DyNeuMo-1, manufactured by Bioinduction, in paediatric patients living with Lennox-Gastaut syndrome (LGS).

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IHI’s launches new funding round to include topics on CVD and arthritis

On 25th June, the Innovative Health Initiative (IHI) announced the launch of a new call for proposals, which includes topics on cardiovascular disease (CVD), osteoarthritis and arthritis, as part of a total budget worth €96.5m to tackle challenges in health research and innovation. The IHI aims to identify and create models, interventions and best practices to improve the management of CVD in EU cities, covering healthcare delivery, individual lifestyle changes and the living environment. It will include five pilot studies in cities to generate evidence for wider use of the models.

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EU takes action to tackle shortages of GLP-1 receptor agonists

On 26th June, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), issued recommendations to tackle shortages of the glucagon-like peptide-1 (GLP-1) receptor agonists Ozempic (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide) and Victoza (liraglutide). GLP-1 receptor agonists are authorised for the treatment of diabetes or weight management under certain conditions or both.

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Issue Number: WN00168

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