Tower Mains Weekly Newsletter
EMA to hold second Veterinary Big Data Stakeholder Forum
Following the success of the 2021 stakeholder forum, the European Medicines Agency (EMA) has announced the second Veterinary Big Data Stakeholder Forum, scheduled for Wednesday, 23rd November 2022. Driven by the principles embraced by the European Medicines Regulatory Network in the European Veterinary Big Data strategy for 2021-2027, the forum will explore data-driven advanced digital solutions to support key veterinary regulatory activities in areas such as veterinary medicines information dissemination, pharmacovigilance, and antimicrobial resistance. The forum will be broadcast live on the EMA web page and a video recording of the event will be made available after the event.
MHRA publishes July’s Drug Safety Update newsletter
On 21st July, the Medicines and Healthcare products Regulatory Agency (MHRA) issued the July edition of its Drug Safety Update newsletter from the agency and its independent advisor the Commission on Human Medicines.
MHRA guidance: GLP (Good Laboratory Practice) for safety tests on chemicals
On 21st July, the MHRA added UK Good Laboratory Practice Monitoring Authority (GLPMA) guidance on the content of QA Statement 2022 and UK GLPMA Study Reporting Guidance 2022 to its guidance on GLP for safety tests on chemicals.
FDA authorises extended expiration dates for Paxlovid
On 22nd July, the US Food and Drug Administration (FDA) authorised extended expiration dates for Paxlovid to reflect the 12-month product shelf-life, when stored according to the storage conditions detailed in the authorised Fact Sheet for Health Care Providers and the Letter of Authorisation for Emergency Use Authorisation (EUA).
Global regulators to integrate real-world evidence into regulatory decision-making
On 22nd July, the International Coalition of Medicines Regulatory Authorities (ICMRA) published a statement pledging to foster global efforts and further enable the integration of real-world evidence into regulatory decision-making. They identify four focus areas for regulatory cooperation: harmonisation of terminologies for real-world data and real-world evidence; regulatory convergence on real-world data and real-world evidence guidance and best practice; readiness to address public health challenges and emerging health threats; and transparency. The statement was developed following an ICMRA workshop held on real-world evidence co-organised by the EMA, FDA, and Health Canada, held in Amsterdam in June 2022.
EMA recommends restricting the use of cancer medicine Rubraca
On 22nd July, the EMA’s human medicines committee (CHMP) announced it had recommended that Rubraca should no longer be used as a third-line treatment for cancers of the ovary, fallopian tubes, or peritoneum with a BRCA mutation in patients whose cancer has come back after at least two platinum-based chemotherapies and who cannot have further platinum-based therapy. The recommendation follows the review of final data from the ARIEL4 study,1 which compared Rubraca with chemotherapy in patients whose cancer had come back after at least two earlier treatments and who were still eligible for further chemotherapy. This recommendation does not affect the use of Rubraca as a maintenance treatment following chemotherapy.
New medicine for multiple myeloma patients with limited treatment options
On 22nd July, the EMA announced the recommendation of a conditional marketing authorisation in the EU for Tecvayli, a monoclonal antibody for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. Tecvayli was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs.
EMA’s Paediatric Committee elects Brian Aylward as its new Chair
EMA’s Paediatric Committee (PDCO) has elected Brian Aylward from Ireland as its new chair for a three-year mandate. Dr Aylward has been actively involved in various PDCO activities since 2010 when he was appointed as alternate for Ireland before becoming a committee member in 2013. He has been chair of the Formulations Working Group of the PDCO since 2014.
First biologic recommended for EU approval in patients with severe asthma
On 25th July, AstraZeneca announced its Tezspire has been recommended for marketing authorisation in the EU as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Tezspire is the first and only biologic for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine.1-4 Tezspire consistently and significantly reduced asthma exacerbations across Phase II and III clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status, and fractional exhaled nitric oxide.
FDA shares updates on Cyclospora prevention and research efforts
On 25th July, the FDA released updates detailing the agency’s Cyclospora prevention and research efforts. Cyclospora cayetanensis is a parasite that causes the foodborne intestinal illness cyclosporiasis. People can become infected with cyclosporiasis by ingesting food or water that’s contaminated with C. cayetanensis. The most common symptoms of cyclosporiasis are diarrhoea, weight loss, nausea, and fatigue.
EMA initiates series of actions to respond to monkeypox outbreak
On 27th July, the EMA announced it has introduced a series of actions to respond to the ongoing monkeypox public health emergency, which has been escalated by the World Health Organisation (WHO) to a Public Health Emergency of International Concern (PHEIC) on Saturday 23rd of July. This is the first new PHEIC to be declared since the regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices has become applicable.
Issue Number: WN00071
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