Tower Mains Weekly Newsletter
Company Updates
Tower Mains’ Head of QA, Shona, is at the SQA’s 7th Global QA Conference
Our Head of Quality Assurance, Shona Ross, has been having a great time at the Society of Quality Assurance’s 7th Global QA Conference in Washington DC this week. She told us: “It’s been great to catch up with colleagues and friends (old and new) while learning and engaging through panel and round table sessions as well as talks from regulators and professionals sharing their experience and knowledge to give us all a better understanding of the theatre we’re working in.”
Here’s a few photos from her time so far…
Regulatory Updates
EMA published guidance on computerised systems and electronic data in clinical trials
On 7th March, the European Medicines Agency (EMA) published guidance on computerised systems and electronic data in clinical trials. The guidance describes some generally applicable principles and definitions of key concepts, and covers requirements and expectations for computerised systems, including validation, user management, security, and electronic data for the data life cycle. This will come into effect six months after the date of publication.
FDA guidance updates
- COVID-19-related guidance documents: On 13th March, the US Food and Drug Administration (FDA) published a notice addressing its COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the cessation of the PHE, and which of those guidance documents the agency is amending to temporarily continue in effect. Click to view source
- The use of published literature in support of new animal drug approvals: On 15th March, the FDA released final guidance for animal drug sponsors on specific areas of the approval process where the available scientific literature may be useful to support the approval of a new animal drug application (NADA), an abbreviated new animal drug application (ANADA), or a conditionally approved new animal drug application (CNADA), as well as procedures to ensure the validity of conclusions drawn by animal drug sponsors from the scientific literature to support an approval. Click to view source
- Developing local anesthetic drug products with prolonged duration of effect: On 15th March, the FDA announced the availability of a draft guidance for industry entitled “Development of Local Anesthetic Drug Products with Prolonged Duration of Effect.” This guidance reflects current recommendations regarding drug development and trial design issues relevant to the study of local anesthetic drug products with prolonged duration of effect for which submission of a new drug application (NDA) is planned. The recommendations in the guidance are intended to assist developers in generating the data necessary to support different indications and labelling claims for these drugs. Click to view source
MHRA guidance updates
- Good laboratory practice (GLP) for safety tests on chemicals: On 8th March, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on good laboratory practice (GLP) for safety tests on chemicals with a list of current members of the UK GLP compliance programme. Click to view source
- MHRA phase I accreditation scheme: On 8th March, a list of accredited units was added to MHRA guidance on joining its phase I accreditation scheme. Click to view source
Industry Updates
FDA publishes update on reports of Squamous Cell Carcinoma in the tissue around breast implants
On 9th March, the FDA provided an update on reports of squamous cell carcinoma (SCC) in the scar tissue that forms around breast implants following its safety communication informing the public of reports of cancers, including SCC and various lymphomas in September 2022.
LEO Pharma and ICON announce partnership to boost clinical trial execution within medical dermatology
On 10th March, LEO Pharma, a global leader in medical dermatology, and ICON announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution that is patient-centric and cost-effective. The aim of the partnership is to improve the lives of dermatology patients with access to innovative clinical trials and the launch of new medicines.
FDA seeks $7.2 billion to enhance advancing medical product availability
On 9th March, the FDA announced it is requesting $7.2 billion as part of the president’s fiscal year (FY) 2024 budget to allow the agency to continue to leverage new and emerging technologies, recruit and support a highly skilled workforce and adapt oversight to new production and business models. This work will have an immediate impact on food, tobacco and medical product safety and will prepare the agency to address rapid innovation across the food and medical products fields.
Three jailed for involvement in illegal sale and supply of prescription medicines valued at £3.7m
On 13th March, three members of an organised criminal gang were sentenced after pleading guilty to offences relating to the illegal sale of more than three million doses of prescription-only and unlicensed medicines, including controlled drugs, valued at £3.7m. This followed a three-year investigation by the Criminal Enforcement Unit of the Medicines and Healthcare products Regulatory Agency (MHRA).
MHRA reclassifies Cialis Together tablets
On 14th March, the MHRA announced it has reclassified Cialis Together tablets to a Pharmacy medicine. This means that in future, it will be available to purchase from pharmacies, if marketed, and could be available to buy without a prescription.
FDA authorises bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children
On 14th March, the FDA amended the emergency use authorisation (EUA) of the bivalent Pfizer-BioNTech COVID-19 vaccine to provide for a single booster dose of the vaccine in children from six months to four years of age at least two months after completion of primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID-19 vaccine.
Pholcodine-containing medicines withdrawn from UK market as precautionary measure
On 14th March, the MHRA announced that pholcodine-containing cough and cold medicines have been withdrawn from the UK market as a precaution following a review which found that their benefits do not outweigh the increased risk of the rare event of anaphylaxis to neuromuscular blocking agents (NMBAs) used in general anaesthesia. Dr Alison Cave, MHRA Chief Safety Officer said: “Following a thorough scientific safety review of all the available evidence on pholcodine, together with advice from the independent Commission on Human Medicines, it has been recommended, as a precautionary measure, that these products should no longer be used.”
Owlstone Medical collaborates with Bicycle Therapeutics for the development of antigen-targeted probes for early cancer detection
On 15th March, Owlstone Medical, a company focused on precision medicine and early disease detection, announced it has entered into a Research Agreement with Bicycle Therapeutics, a biotechnology company pioneering a new and differentiated class of therapeutics based on its bicyclic peptide technology. Under the Agreement, the companies will investigate the potential of combining technologies and methods to develop antigen-targeted diagnostic probes that use bicyclic peptides as their targeting mechanism linked with Owlstone’s Exogenous Volatile Organic Compound (EVOC®) probes.
Issue Number: WN00103
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