Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- Valproate use by women and girls. On 28th November, the Medicines and Healthcare products Regulatory Agency (MHRA) added information on the valproate registry to guidance on the risks of taking the drug during pregnancy. Click to view source
- Safety Public Assessment Reports. On 28th November, the public assessment report ‘Valproate: review of safety data and expert advice on management of risks.’ Click to view source
European Commission releases information on the 7th Biosimilar Multi-stakeholder Event
The European Commission released information on the 7th Biosimilar Multi-stakeholder Event taking place on the 13th of December 2023 from 9am-4:30pm. The following topics will be discussed:
- How to address the challenges and lack of biosimilar competition in certain areas of the biologic pipeline.
- Disparities in biosimilar uptake and access (across EU Member States, within countries and regions, between the in- and outpatient sector etc.);
- Consequences of product formulation and administration for patients, healthcare professionals and systems (both in terms of opportunities and challenges).
Industry Updates
MHRA issues latest Drug Safety Update
On 23rd November, the MHRA issued the November Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines.
bit.bio and KCL IoPPN to collaborate for neurodevelopmental disorders
On 24th November, Kings College London (KCL) Institute of Psychiatry, Psychology and Neuroscience (IoPPN) announced its collaboration with bit.bio, a company coding human cells for novel cures, to build multi-cell models of the human brain using bit.bio’s ioCells™️. Across three years, the IoPPN’s Professor Deepak Srivastava and Dr Anthony Vernon will combine bit.bio’s three ioWild Type Cells: ioGlutamatergic Neurons, focusing on excitatory neurons of the brain cortex, ioGABAergic Neurons and ioMicroglia, to develop bi- and tri-cell models.
Specific batches of carbomer-containing lubricating eye gels recalled as a precaution due to possible microbial contamination
On 24th November, the MHRA issued precautionary safety advice regarding possible contamination of certain eye gels and told patients and users of the affected products to stop using them immediately. These types of products are known as carbomer-containing eye gels and are generally used to relieve the symptoms of dry eye.
FDA approves first therapy for rare type of non-cancerous tumours
On 27th November, the US Food and Drug Administration (FDA) approved Ogsiveo tablets for adult patients with progressing desmoid tumours who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumours and received FDA Fast Track and Breakthrough Therapy designations for the indication noted above, as well as Orphan-Drug designation for the treatment of desmoid tumour (aggressive fibromatosis).
FDA withdraws as a member of GHWP
On 27th November, the FDA announced its withdrawal as a member of the Global Harmonisation Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). In 2024, the FDA, as chair of IMDRF, will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally.
FDA protects patients from harmful drugs through the Drug Supply Chain Security Act
On 27th November, published the FDA Voices: “FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act,” by Jaqueline Corrigan-Curay, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Jill Furman, Office of Compliance, CDER. Since 2013, the FDA has been implementing the Drug Supply Chain Security Act (DSCSA) which gives it more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful. By fully implementing DSCSA, together with industry and other stakeholders, the agency will create a more secure pharmaceutical supply chain that will ensure the continued distribution of safe prescription drugs for the benefit of public health.
FDA investigating serious risk of T cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (car) T cell immunotherapies
On 28th November, the FDA issued a safety communication regarding reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. The reports were received from clinical trials and/or post-marketing adverse event data sources and although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA is investigating the identified risk of T-cell malignancy with serious outcomes including hospitalisation and death.
MHRA instructs health organisations to prepare for new measures to reduce the known harms of valproate
On 28th November, the MHRA announced that healthcare organisations are being instructed to put a plan in place to implement the first phase of new regulatory measures to reduce the known harms of valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.
Milner Therapeutics Institute partners with AstraZeneca and the Medical Research Council to establish genomics laboratory
On 28th November, Milner Therapeutics Institute announced a new partnership with AstraZeneca and the Medical Research Council (MRC) that will establish a new state-of-the-art functional genomics laboratory. Set to become part of the MRC’s Human Functional Genomics Initiative, the new establishment will support the Life Sciences Vision to support research and innovation in functional genomics and will contribute to the UK’s genomic healthcare system.
SMART researchers develop rapid contamination-detection method for safer T-Cell therapy
On 28th November, it was announced that researchers from the Singapore-MIT Alliance for Research and Technology’s (SMART) Critical Analytics for Manufacturing Personalised-Medicine (CAMP) Interdisciplinary Research Group, in collaboration with the Singapore Centre for Environmental Life Sciences Engineering (SCELSE) and Massachusetts Institute of Technology (MIT) have developed a novel method capable of identifying contaminants in T-cell cultures within 24 hours.
Thousands of illicit medicines seized in Manchester
On 29th November, the MHRA announced its Criminal Enforcement Unit (CEU) had seized hundreds of thousands of doses of suspected illegally traded medicines, including powerful prescription-only medicines, following coordinated raids at two residential and two business premises across North Manchester.
Issue Number: WN00140
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