Tower Mains Weekly Newsletter
EMA publishes highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) meeting
On 9th July 2021, the European Medicines Agency (EMA) issued meeting highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) held on the 5th-8th July. Highlights include the possible link to very rare cases of myocarditis and pericarditis with mRNA COVID-19 vaccines, the decision to extend the mandate of chair Sabine Straus, and direct healthcare professional communications (DHPCs) containing important safety information for Comirnaty, Spikevax, and Janssen COVID-19 vaccines.
Quidel attains CE mark for combined COVID, flu, RSV diagnostic platform
On 12th July 2021, it was announced that Quidel has been awarded a CE mark for its Savanna molecular testing platform and the first assay panel for the platform, allowing it to be sold and used across the EU. The first assay cartridge cleared for use with the analyser is the Savanna Respiratory Viral Panel-4, which detects RNA sequences associated with the two most common strains of the flu—influenza A and B—as well as COVID-19 and respiratory syncytial virus. The test is designated to diagnose these infections in patients showing symptoms of a respiratory tract infection.
MHRA updates data on clinical trial authorisation assessment performance
On 13th July 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the data on the time taken to assess clinical trial applications and substantial amendments. The data sets out the number of applications assessed by the MHRA, split by phase and commercial and non-commercial sponsors, and any substantial amendments, split by phase.
FDA releases information for the Regulatory Education for Industry Annual Conference 2021
On 13th July 2021, the U.S. Food and Drug Administration (FDA) issued information on its Regulatory Education for Industry (REdI) Conference taking place on the 19th-23rd July 2021. Presented by FDA regulatory experts, the free conference is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements and will feature three medical product centre tracks: drugs, devices, and biologics.
MHRA issues EAMS scientific opinion to Merck Serono Limited for tepotinib in treatment of NSCLC
On 14th July 2021, the MHRA issued EAMS (Early Access to Medicines Scheme) scientific opinion to Merck Serono Limited for tepotinib in the treatment of advanced non-small cell lung cancer (NSCLC). The opinion includes a public assessment report (PAR), treatment protocols, and information for NHS Medical Directors.
ICH accepts the 2021 DIA Award for Outstanding Contribution to Health
On 14th July 2021, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced it has been awarded the 2021 DIA Award for Outstanding Contribution to Health. The award, bestowed to individuals, groups, or organisations for significant and innovative contribution to advancing global health, is a testament to the dedication of ICH representatives and experts who actively contribute to its mission of harmonisation for better health.
EMA and ECDC issue update on COVID-19
On 14th July 2021, the EMA and European Centre for Disease Prevention and Control (ECDC) issued an update on COVID-19. Topics include the current COVID-19 situation in the EU, the importance of completing the recommended vaccination courses, and working together for public health.
COVID-19 Vaccine Updates
EMA advises against use of Janssen COVID-19 vaccine in people with history of capillary leak syndrome
On 9th July 2021, the EMA announced that its safety committee (PRAC) has recommended that people who have previously had capillary leak syndrome must not be vaccinated with the Janssen COVID-19 vaccine. The Committee recommended that the product information should be updated to include a contraindication in people with a history of capillary leak syndrome, and that Healthcare professionals should be aware of the signs and symptoms and of its risk of recurrence in people who have previously been diagnosed with the condition. The PRAC will continue to monitor for cases of the condition and will take further actions if necessary.
FDA announces revisions to fact sheets for Janssen COVID-19 vaccine
On 13th July 2021, the FDA announced it has updated the vaccine recipient and vaccination provider fact sheets for the Janssen COVID-19 vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination. The revision includes a warning about GBS, and the fact sheet for recipients and caregivers now includes information about GBS.
Issue Number: WN00019