Tower Mains Weekly Newsletter
Company Updates
New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our new ‘Conducting Laboratory Investigations’ course is designed to equip you with the skills and knowledge to conduct a successful investigation. Our next open course date is the 22nd of November 2023 or if you are interested in this training for your organisation at a time of your choosing, please get in touch at training@towermains.com. For further information, click here.
2023 RQA Conference. Delighted to share that we will be attending the 2023 Research Quality Association (RQA) Conference in Belfast, where our Head of Quality Assurance, Shona Ross will also be speaking. Details below:
- Day One, Wednesday 1st November
11am: Exploring the depths of quality – regulator updates and Q&A
Join Shona alongside Chrissy Cochran, FDA, an MHRA representative and other regulators in this update and delegate Q&A session. - Day Two, Thursday 2nd November
1.30pm: Communication of an auditor
While technical expertise and knowledge of the regulatory requirements are essential for auditors, effectively communicating with management and auditees to effect change and improvements is key. Join Shona and the GLP Committee in this interactive workshop to look at developing these skills.
If you’re attending, come visit us at booth 10! Andrew, Shona, Rhona and Lianne will be there to say hi!
Regulatory Updates
MHRA publishes performance metrics for clinical trials and established medicines assessment
On 13th October, the MHRA published ‘Clinical Trials Performance Metrics: October 2022 -September 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments‘ and ‘Performance Metrics January 2023 – September 2023: Assessment of New Marketing Authorisation Applications and Variations‘.
ICH Q9 (R1) Quality Risk Management Training Materials available
On 13th October, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the publications of Q9(R1) Quality Risk Management Training Materials on the ICH website.
FDA guidance updates
- Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements. On 17th October, the US Food and Drug Administration (FDA) published final guidance addressing certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Click to view source
- Developing drugs for the treatment of diabetic foot infections. On 17th October, draft guidance was published to assist sponsors in the clinical development of drugs for treating diabetic foot infections (DFIs) without concomitant bone and joint involvement. Click to view source
- Benefit-risk assessment for new drug and biological products. On 17th October, draft guidance was published to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and post-market regulatory decisions that the FDA makes about new drug applications (NDAs) submitted under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as biologics license applications (BLAs) submitted under section 351(a) of the Public Health Service Act (PHS Act). Click to view source
Industry Updates
New treatment option for pre-treated multiple myeloma patients recommended in EU
On 13th October, the European Medicines Agency’s Human Medicines Committee (CHMP) announced it has recommended a conditional marketing authorisation in the EU for Elrexfio (elranatamab) as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies and whose cancer has worsened since they received their last treatment. The CHMP based its recommendation for a conditional marketing authorisation on an open-label, single-arm, multicentre, phase 2 clinical trial.
FDA approves new treatment for resectable non-small cell lung cancer
On 16th October, the FDA approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable non-small cell lung cancer (NSCLC). This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Webinar on the proposed rule regarding LDTs announced by the FDA
On 16th October, the FDA announced a webinar regarding its proposed rule regarding Laboratory Developed Tests (LDTs). The purpose of this is to provide an overview of the rulemaking proposal to amend the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. It will also describe the proposed phaseout of the FDA’s general enforcement discretion approach to LDTs. This will take place on the 31st of October 2023 from 1pm to 2pm ET.
Parkinson’s UK grants £400,000 to research projects in Scotland
On 16th October, Parkinson’s UK announced it is funding two projects at the University of Edinburgh which are investigating potential causes of Parkinson’s. The first project to be funded by the charity will look at the role of the key protein, alpha-synuclein, in the disease using live imaging technology whilst the second will look into the role of the LRRC37A2 gene.
Researchers find PCSK9 inhibitors could treat life-threatening aneurysms
On 16th October, the University of Leicester announced its researchers have found that PCSK9 inhibitors, which are already used to treat people with high cholesterol, could be repurposed as a treatment for people with abdominal aortic aneurysms (AAA). Findings from the study could help guide the search for more treatments for AAA, which currently has no cure.
NICE recommends Roche’s Columvi for advanced lymphoma
On 17th October, the National Institute for Health and Care Excellence (NICE) recommended glofitamab as a new treatment option for adults with relapsed or refractory diffuse large B cell lymphoma after 2 or more systemic treatments. The recommendation for its use in the NHS coincides with the treatment receiving its licence from the MHRA.
Falsified Ozempic pens identified at two wholesalers in the UK
On 18th October, the MHRA confirmed that pre-filled pens falsely labelled as the diabetes medicine Ozempic have been identified at two UK wholesalers. All affected pens have been recalled and accounted for, and none of the pens have been supplied to UK patients. There is no evidence that any of the falsified pens have been dispensed to patients from legitimate pharmacies or healthcare professionals in the UK and there are no reports of harm to patients concerning these pens. The EMA have also been notified of these falsified pens and have alerted EU patients and healthcare professionals. EMA is assisting national authorities in their investigations.
Issue Number: WN00134
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