Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Company Updates
RQA 2024 International QA Conference
We had the pleasure of attending the RQA 2024 International QA Conference in Brighton last week! The conference had high energy, great networking and a broad range of interesting topics for delegates of all levels. Looking forward to next year!
Regulatory Updates
MHRA publishes webinar on implementing the new UK Clinical Trials regulations
On 13th November, the MHRA published a webinar on implementing the new UK Clinical Trials regulations, which took place on Tuesday, 15th October 2024. The webinar, led by James Pound, Interim Executive Director of Innovation and Compliance at the MHRA, covers legislative updates, the strategy for developing guidance, and the clinical trials roadmap.
Further MHRA guidance updates
- Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion. On 12th November, the Medicines and Healthcare products Regulatory Agency (MHRA) added a new Scientific opinion application form to guidance on applying for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion. Click to view source
- Good laboratory practice (GLP) for safety tests on chemicals. On 14th November, the ‘Current Members of the UK GLP compliance programme’ document was updated in guidance on GLP for safety tests on chemicals. Click to view source
European Commission to host multi-stakeholder event on biosimilar medicines
On 11th November, the European Commission announced an upcoming multi-stakeholder event on biosimilar medicines scheduled for 5th December 2024. The event aims to bring together regulators, healthcare professionals, and industry experts to discuss recent advancements in biosimilar development and highlight the potential of biosimilars in enhancing affordability and access to medicines.
The following sessions will take place:
- Ensuring biosimilar development and competition in Europe: where are we now?
- Promoting biosimilar uptake: current developments
- AUGMENT: an EU4Health biosimilar capacity-building project
FDA guidance updates
Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. On 12th November, the US Food and Drug Administration (FDA) published draft guidance which, when finalised, will provide recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support clinical development and marketing of these products.
ICH Assembly meeting in Montreal advances global pharmaceutical standards and collaboration
On 13th November, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued meeting highlights from its Assembly meeting in Montréal, Canada, on 5th-6th November 2024, alongside meetings of 11 Working Groups and one Discussion Group. During this meeting, key discussions were held regarding guideline developments, monitoring harmonisation progress, MedDRA updates and training initiatives.
MHRA launches consultation on pre-market regulations for medical devices
On 14th November, the MHRA launched a consultation on proposed changes to the regulatory requirements that medical devices must meet before being placed on the UK market. The consultation will focus on four key policy areas, which have evolved since the MHRA’s initial 2021 consultation aimed at strengthening medical device legislation. These areas include: UKCA marking, international reliance, in vitro diagnostic (IVD) devices, and assimilated EU law. These topics are part of broader regulatory reforms informed by the Independent Medicines and Medical Devices Safety (IMMDS) review, designed to help accelerate the development of transformative technologies while ensuring patient safety. The consultation will close on 5th January 2025.
Industry Updates
Scottish Medicines Consortium announces decisions on new medicines for NHS Scotland
On 11th November, the Scottish Medicines Consortium (SMC) announced its decisions on seven medicines for NHS Scotland. SMC Chair Dr Scott Muir highlighted the benefits of some new treatments for patients, such as those with lymphoma or atopic dermatitis, but noted the committee could not accept pembrolizumab for lung cancer due to insufficient evidence.
VIVOLTA and Neurochase collaborate to manufacture brain therapy micro-catheters
On 13th November, VIVOLTA, the medical electrospinning solutions provider, announced a long-term partnership with Neurochase, the central nervous system (CNS) delivery platform specialist, to manufacture electrospun micro-catheters to deliver advanced therapies to the brain. The partnership will enable Neurochase to develop a scalable system for delivering therapies directly to the brain using Convection Enhanced Delivery (CED). This technique allows drugs to bypass the blood-brain barrier and reach deep brain structures through micro-catheters, and by generating a pressure gradient at the catheter tip, the drug is evenly distributed, maximising its therapeutic effect.
Microbiotica announces the commencement of Phase 1b Trial for ulcerative colitis treatment
On 13th November, Microbiotica, a clinical-stage biopharma company, announced that the first patient has been dosed in its Phase 1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis (UC) patients. The COMPOSER-1 study will investigate the safety, tolerability, and initial signals of the efficacy of MB310 in a randomised, placebo-controlled, double-blind, clinical trial. The degree to which the bacteria within MB310 successfully engraft into patients’ intestinal microbial community will be measured. This international trial is due to recruit up to 30 adult patients at clinical centres in the UK, Austria, Bulgaria, Poland and Spain.
Blenrep shows survival benefit in DREAMM-7 Trial for multiple myeloma
On 14th November, GSK plc announced positive results from the DREAMM-7 head-to-head Phase III clinical trial evaluating Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma. The trial met its key secondary endpoint, showing that this combination significantly improved overall survival (OS) compared to the standard of care combination of daratumumab plus BorDex. Hesham Abdullah, Senior Vice President of Oncology R&D at GSK, emphasised that these results highlight the potential for Blenrep to extend the lives of patients with this challenging form of cancer, marking a significant advancement in treatment.
Issue Number: WN00188
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