Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- Paclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease. On 5th February, the Medicines and Healthcare products Regulatory Agency (MHRA) published updated guidance on PCD used in the treatment of peripheral arterial disease. Following a review, the agency updated its previous advice on PCD to remove restrictions on indication, dose, and repeated exposure. Click to view source
- Guidance on registering a homeopathic medicine. On 6th February, the MHRA updated guidance on how to register homeopathic medicinal products through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme. Click to view source
FDA guidance updates
- Conducting remote regulatory assessments. On 2nd February, the US Food & Drug Administration (FDA) published draft guidance describing the agency’s current thinking regarding its use of remote regulatory assessments (RRAs) to increase the industry’s understanding of RRAs and facilitate the FDA’s process for conducting RRAs. The guidance also provides answers to frequently asked questions regarding what RRAs are, when and why the FDA may use them, and how the FDA may conduct them. Click to view source
- Reporting amount of listed drugs and biological products under section 510(j)(3) of the FD&C Act. On 5th February, final guidance was published to assist registrants of drug establishments in submitting reports to the FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Click to view source
- Notifying the FDA of a discontinuance or interruption in manufacturing of finished products or active pharmaceutical ingredients under section 506C of the FD&C Act. On 6th February, draft guidance was published to assist applicants and manufacturers in providing the FDA with timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the agency in its efforts to prevent or mitigate shortages. The guidance also explains how the FDA communicates information about products in shortage to the public. Click to view source
Guidance on GMP and GDP: Questions and Answers
The European Medicines Agency (EMA) has published answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group. It provides an additional interpretation of the European Union (EU) GMP guidelines and GDP guidelines published by the European Commission. Click to view source
Clarification of HRA policy on registration of CTIMPs taking place in the UK and EU
The Health Research Authority (HRA) has issued an update clarifying its policy regarding the registration of Clinical Trials of Investigational Medicinal Products (CTIMPs) with the EU Clinical Trials Information System (CTIS). Click to view source
Industry Updates
Study reveals AI can predict patients’ survival in glioblastoma
On 31st January, the King’s College London (KCL) announced that its researchers have developed an artificial intelligence (AI)-based model that can predict adult brain cancer patients’ rates of survival after receiving radiotherapy treatment. It would allow clinicians to be better informed for planning the next stage of treatment and refer patients to potentially life-saving treatment quicker.
New heart treatment to help grow replacement heart valves
On 31st January, it was announced that replacement heart valves that grow inside the body are a step closer to reality following a study led by researchers at Harefield Hospital and Imperial College London’s (ICL) National Heart and Lung Institute.
Updated WHO Benchmarks for Strengthening Health Emergency Capacities published
On 2nd February, the updated World Health Organisation (WHO) Benchmarks for Strengthening Health Emergency Capacities was published to support the implementation of the International Health Regulations (IHR) and the health emergency prevention, preparedness, response, and resilience capacities.
Warning issued over certain Cardinal Health Monoject Luer-Lock and enteral syringes
On 2nd February, the FDA issued a safety communication to warn consumers, healthcare providers, and healthcare facilities not to use certain Cardinal Health Monoject luer-lock and enteral syringes. Dimensional changes made to the syringes, when used with syringe pumps, patient-controlled analgesia (PCA) pumps, or enteral syringe pumps, may result in recognition, compatibility, and pump performance issues, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding.
Novo Holdings to merge with Catalent
On 5th February, Catalent, a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings announced that they have entered into a merger agreement under which Novo Holdings will acquire Catalent. The merger will provide Catalent with a strong foundation to continue developing, manufacturing, and supplying top products.
ALTURiX acquires rights to three new products
On 6th February, ALTURiX announced the acquisition of the exclusive rights to three new products in the areas of gastrointestinal and respiratory for commercialisation in the UK. The new agreements align with the British pharmaceutical company’s aim to supply important products reliably and affordably to prescribers, patients, families, and the NHS.
Brainomix’s AI-enabled stroke software endorsed by NICE
On 6th February, the National Institute of Health and Care Excellence (NICE) issued guidance endorsing the use of Brainomix 360 (formerly known as e-Stroke) to help clinical decision-making in stroke. The NICE guidance elevates the AI-powered tool, which is now entering the US market, into an evidence-generation framework, allowing stroke units across the UK to utilise the technology while further evidence is collected.
BridgeBio and Kyowa Kirin announce partnership for an exclusive license on Skeletal Dysplasias drug
On 7th February, BridgeBio Pharma and Kyowa Kirin announced a partnership wherein BridgeBio’s affiliate, QED Therapeutics, grants Kyowa Kirin an exclusive license to develop and commercialise infigratinib for achondroplasia, hypochondroplasia, and other skeletal dysplasias in Japan. Infigratinib is an oral small molecule designed to inhibit FGFR3 and thus target FGFR3-driven skeletal dysplasias at their source.
Issue Number: WN00148
Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to info@tower mains.com with the subject “Weekly Newsletter Please.”