Tower Mains Weekly Newsletter

Industry Updates

FDA authorises pharmacists to prescribe Paxlovid with certain limitations

On 6th July, the US Food and Drug Administration (FDA) revised the Emergency Use Authorisation (EUA) for Paxlovid to authorise pharmacists to prescribe the medicine to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing.

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WHO and I-DAIR to partner for research in artificial intelligence and digital health

On 6th July, the World Health Organisation (WHO) announced its partnership with the International Digital Health and AI Research Collaborative (I-DAIR) to advance the use of digital technologies for personal and public health. Through this agreement, the agencies will work together to harness the digital advancement towards urgent health challenges, while emphasising greater participation from Low and Middle-Income Countries (LMIC) in the research and development and governance of the digital health and AI space, with particular focus on the inclusion of young researchers and entrepreneurs.

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MHRA guidance: Phase I accreditation scheme

On 7th July, the Medicines and Healthcare products Regulatory Agency (MHRA) added an updated list of accredited Phase I units to its Phase I accreditation scheme guidance. The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, in particular for those conducting first-in-human (FIH) trials.

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EMA adopts further measures to identify and address medicine shortages during public health emergencies

On 7 July 2022, the EMA’s Shortages Steering Group (MSSG) adopted the list of the main therapeutic groups of medicines used in emergency care, surgery, and intensive care. This list will form the basis from which EMA will draw up lists of critical medicines needed to deal with a crisis. While the list of main therapeutic groups is purely informative, the lists of critical medicines impose obligations on companies to regularly update EMA with relevant information, including data on potential or actual shortages and available stocks, forecasts of supply and demand through their Industry Single Point of Contact (i-SPOC).

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MHRA guidance: Project Orbis

On 7th July, the MHRA added REZUROCK to the list of Project Orbis approvals. The Project Orbis programme provides a framework for concurrent submission and review of oncology products among international partners and aims to deliver faster patient access to advanced cancer treatments with potential benefits over existing therapies.

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FDA approves Comirnaty COVID-19 vaccine for use in individuals aged 12 through to 15

On 8th July, the FDA approved the Comirnaty COVID-19 vaccine for active immunisation to prevent COVID-19 in individuals 12 through to 15 years of age.

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New measures recommended to minimise the risk of meningioma

On 8th July, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. In addition to restricting the use of the high-dose medicines, the PRAC has recommended that patients should be monitored for symptoms of meningioma, and if a patient is diagnosed with the (usually) non-cancerous tumour, treatment with these medicines must be permanently stopped. The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of the EMA’s final opinion.

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ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines

On 11th July, the European Centre for Disease Prevention and Control (ECDC) and the EMA announced the recommendation that second booster doses of mRNA COVID-19 vaccines be considered for people between 60 and 79 years old and people with medical conditions putting them at high risk of severe disease. Both agencies have called on public health authorities across the EU to plan for additional boosters during the autumn and winter seasons for people with the highest risk of severe disease, possibly combining COVID-19 vaccinations with those for influenza.

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Medical devices given exceptional use authorisations during the COVID-19 pandemic

On 12th July, the MHRA updated its list of manufacturers and their medical devices which have been granted an exemption by the agency. The list also includes manufacturers whose exemption expired or was cancelled.

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EMA launches pilot project on analysis of raw data from clinical trials

On 12th July, the EMA launched a pilot project to assess whether the analysis of raw data from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications and to explore the practical aspects of the submission and analysis of such data. The pilot project is open to applicants or MAHs that are about to submit marketing authorisation applications or post-authorisation applications. Upon the conclusion of the pilot, the EMA will organise a workshop with relevant stakeholders to discuss the learnings and will also publish a summary report.

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Issue Number: WN00069

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