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

Regulatory Updates

FDA guidance updates

  • Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. On 28th June, the US Food & Drug Administration (FDA) published draft guidance intended to facilitate and streamline the development of stand-alone devices, and combination products with device constituent parts, intended to deliver drugs and biological products, by improving the consistency of drug delivery performance information included in applications and submissions. Click to view source
  • M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines. On 2nd July, draft guidance was published to provide recommendations and high-level best practices for the conduct of Pharmacoepidemiological studies. It is intended to streamline the development and regulatory assessment of post-marketing Pharmacoepidemiological safety studies that include Real-World Data.  Click to view source

MHRA guidance updates

  • Notify MHRA about a clinical investigation for a medical device. On 2nd July, the Medicines and Healthcare products Regulatory Agency (MHRA) updated information to clarify the fees and payment process and added guidance on early terminations and temporary halts in GB and NI and clarification that Annex XVI applications cannot be accepted in GB. Click to view source

EMA announces recent additions to management team

On 4th July, the European Medicines Agency (EMA) announced new appointments in the Legal Department and the Regulatory Science and Innovation Task Force. This includes Emmanuel Cormier as the Head of the Regulatory Science and Innovation Task Force and Marco Cavaleri as Head of the Public Health Threats Department (ad interim).

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Industry Updates

ICL granted over £150k to explore link between breast cancer and breastfeeding

On 25th June, it was revealed that researchers at Imperial College London (ICL) have been awarded funding to investigate how breastfeeding lowers the risk of breast cancer. The £150,715 award will enable Dr James Flanagan and PhD student Sophia D’Alessandro in the Department of Surgery and Cancer to study whether the length of time a woman breastfeeds affects her breast cancer risk. Previous research has already shown that breastfeeding is linked to a lower risk of developing breast cancer and data analysis has shown that the risk of developing the disease decreases by 4% for every 12 months of breastfeeding.

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University of Liverpool launches biotech spin-out company

On 27th June, the University of Liverpool announced the launch of a new biotech spin-out company, Galytx, to develop novel therapeutic drugs to treat cancer and fibrotic diseases. Its focus is on developing small molecular therapeutic drugs against a highly clinically molecular target, galectin-3, a carbohydrate-binding protein that has a close association with the pathogenesis, progression and morbidity of multiple fatal diseases, including cancer, fibrosis and inflammation.

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First-in-class medicine to treat pulmonary arterial hypertension recommended in EU

On 28th June, the EMA announced the recommendation for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity.

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EMA recommends first nasal adrenaline spray for emergency treatment against allergic reactions

On 28th June, the EMA’s human medicines committee (CHMP) recommended granting a marketing authorisation in the EU for Eurneffy (epinephrine), the first medicine to be taken through the nose for the emergency treatment of allergic reactions (anaphylaxis). Treatment with epinephrine (also known as adrenaline) decreases the anaphylactic reaction; it binds to adrenergic receptors and lessens the widening of blood vessels and blood vessel permeability induced by histamine during anaphylaxis.

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FDA expands Total Product Life Cycle Advisory Program to accelerate medical device development

On 1st July, the FDA’s Center for Devices and Radiological Health (CDRH) announced the continued expansion of the Total Product Life Cycle (TPLC) Advisory Program (TAP), which was launched in 2023 as a commitment under the Medical Device User Fee Amendments (MDUFA) V reauthorisation to help spur faster development of high-quality, safe, effective, and innovative medical devices that are critical to meeting public health needs. TAP encourages early, frequent, and strategic communications between developers of Breakthrough Devices, CDRH, and others, such as patient advocates, and physician professional societies, to make the path for innovative devices of public health importance to market and patient access faster, more predictable, and more transparent.

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Man who illegally imported unlicensed medicines sentenced in UK

On 1st July, a man who had unlicensed medicines from India, the Middle East and the Far East sent to his parents’ address, has been sentenced at Southwark Crown Court to a term of imprisonment. The sentencing follows an investigation by the MHRA’s Criminal Enforcement Unit (CEU) into the illegal supply of unlicensed medicines. The man’s activities came to the attention of the CEU following the interception of a series of parcels by UK Border Force officers during routine checks at airports and throughout the postal system.

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Herantis Pharma granted €3.6m to assess treatment for Parkinson’s disease

On 1st July, Herantis Pharma, a clinical-stage biotechnology company developing disease-modifying therapies for Parkinson’s disease, revealed it has been awarded €3.6m in funding from Parkinson’s UK’s Virtual Biotech programme and the Michael J. Fox Foundation to finance its Phase 1b clinical trial of HER-096 in Parkinson’s disease and its on-going biomarker project.

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FDA approves treatment for adults with Alzheimer’s disease

On 2nd July, the FDA approved the Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. Treatment is intended to be initiated in patients with mild cognitive impairment or mild dementia stage of disease and is administered as an intravenous infusion every four weeks.

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Sanofi and Regeneron’s Dupixent approved as the first biologic to treat COPD

On 3rd July, Sanofi and Regeneron Pharmaceutical announced the EU approval of Dupixent, the first biologic and first targeted therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils. Dupixent has been approved as an add-on maintenance treatment with current therapies, which include inhaled corticosteroids, which reduce inflammation, and bronchodilators, which relax muscles in the lungs and widen the airways. The European Commission approved the treatment following a recommendation by the EMA at the end of May.

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Issue Number: WN00169

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