We are delighted to announce that we will be offering an Introduction to ICH GCP (R2) Training Course on the 28th of April 2021. This virtual course (held on TEAMS) is a suitable introduction or refresher for those involved in any aspect of clinical trials with human participants.
EMA publishes PRAC meeting highlights
On 9th April 2021, the European Medicines Agency published the highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) on the 6-9th April 2021. Highlights include a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated with Vaxzevria (previously COVID-19 Vaccine AstraZeneca) and a review of a safety signal to assess reports of thromboembolic events in people who received COVID-19 Vaccine Janssen.
FDA authorises marketing of first device that uses AI to help detect potential signs of colon cancer
On 9th April 2021, the U.S. Food and Drug Administration (FDA) authorised the marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumours) in the colon in real-time during a colonoscopy.
MHRA updates guidance on equipment being used to help prevent COVID-19
On 9th April 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on the different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment). A section has been added to reflect guidance on transparent face masks.
European Committee releases the Pharmaceutical Committee meeting summary record
On 12th April 2021, the European Committee (EC) released the summary record for the Pharmaceutical Committee meeting held on the 17th-22nd February 2021. This includes the work plan on the revision of the general pharmaceutical acts, post-Brexit framework, and the revision of the orphan and paediatrics medicines legislation.
CDC and FDA recommend pause in the use of the Johnson & Johnson COVID-19 vaccine
On 13th April 2021, the U.S. Centres for Disease Control and Prevention (CDC) and the FDA recommended a temporary halt to the use of Johnson & Johnson’s COVID-19 vaccine while they investigate at least 6 US cases of potentially dangerous blood clots in people who received the vaccine over blood clot concerns. All six cases occurred among women between the ages of 18 and 48, and symptoms 6 to 13 days after vaccination.
Exscientia to start first AI-designed immuno-oncology drug trial
Oxford-based Exscientia, an artificial intelligence (AI) driven pharma company, is preparing to initiate Phase I trials with the world’s first AI-designed molecule for immuno-oncology. A joint venture between Exscientia and Evotec has led to the co-invention and development of an A2a receptor antagonist for adult patients with advanced solid tumours, applying Exscientia’s next-generation AI-powered drug discovery platform, Centaur Chemist. The drug is the first AI-designed molecule for immuno-oncology to enter human clinical trials with high selectivity for the target receptor having been discovered in just eight months.
Issue Number: WN0006
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