Tower Mains Weekly Newsletter
Company Updates
Tower Mains’ Shona Ross to attend and speak at the 7th Global QA Conference
We are delighted that our Head of Quality Assurance Shona Ross will be attending and speaking at the 7th Global QA Conference in National Harbour. Shona will be discussing how to make sure your system remains fit for purpose while engaging with quality improvement. To find out more about the conference taking place from 12th-17th March 2023, click here.
Regulatory Updates
MHRA provides update on the European Parliament’s extension of the Medical Device Regulations transitional period
The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations (EU MDR) and to extend the validity of certain device certificates. The Medicines and Healthcare products Regulatory Agency (MHRA) is working to consider carefully what the implications of these revisions are for the acceptance of CE-marked medical devices on the UK market. At present, a device with a valid CE mark can be placed on the UK market until 30th June 2023, which includes certificates valid under the latest EU’s revised transitional arrangements. As announced in October 2022, there are plans to extend acceptance of the CE marking in the UK.
First enzyme replacement therapy for alpha-mannosidosis approved in the US
On 16th February, the US Food and Drug Administration (FDA) announced it has approved Lamzede, the first enzyme replacement therapy approved in the US for the treatment of the non-central nervous system manifestations of alpha-mannosidosis, a rare genetic condition characterised by the lack of the alpha-mannosidase enzyme in the body. Lamzede acts the same way as the alpha-mannosidase enzyme in the human body thus restoring normal cellular activity in patients.
EMA issues highlights from its Committee for Veterinary Medicinal Products
On 17th February, the European Medicines Agency (EMA) issued meeting highlights from its Committee for Veterinary Medicinal Products (CVMP) which was held on the 14th-16th February 2023. Highlights include opinions on veterinary medicinal products, the adoption of five scientific advice reports, and the adopted two revised VICH pharmacovigilance guidelines: GL35 on IT systems and GL42 on IT systems.
FDA authorises device to assess the physiological response to painful stimuli in anaesthetised patients
On 17th February, the FDA authorised Medasense Biometrics’ PMD-200 with the Nociception Level (NOL) Index monitoring system to help healthcare specialists assess the physiological response to painful stimuli in anaesthetised patients receiving opioid medications as part of their treatment. The PMD-200 is indicated to be used adjunctively to help health care specialists tailor the administration of opioid-based analgesics in anaesthetised patients.
Pfizer and Valneva issue update on clinical trial evaluating Lyme disease vaccine candidate VLA15
On 17th February, Pfizer Inc. and Valneva SE announced that Pfizer, the study sponsor, has decided to discontinue a significant percentage of participants in the US who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) Phase 3 clinical study, which is investigating the efficacy, safety, and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.
First gene therapy for Haemophilia B receives green light from European Commission
On 20th February, CSL, a global biotechnology company, announced that the European Commission has granted conditional marketing authorisation (CMA) for HEMGENIX®, the first one-time gene therapy for the treatment of severe and moderately severe haemophilia B in adults without a history of Factor IX inhibitors. In the ongoing clinical trial, HEMGENIX® reduced the rate of annual bleeds with a single infusion by delivering a functional gene that acts as a blueprint for coagulation Factor IX.
FDA accepts Valneva’s chikungunya vaccine license application for priority review
On 20th February, Valneva SE announced that the FDA has completed a filing review of its Biologics License Application for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and has determined that the application is sufficiently complete to permit a substantive review.
Second bivalent COVID-19 booster vaccine from Moderna authorised by MHRA
On 21st February, it was announced that a new version of the Moderna ‘bivalent’ Covid-19 vaccine (Spikevax) that targets both the original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variant has been authorised by the MHRA. This adapted COVID-19 vaccine targets both the original coronavirus (SARS-CoV-2) and the Omicron BA.4 and BA.5 sub-variants.
Issue Number: WN00100
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