Tower Mains Weekly Newsletter
Company Updates
Happy New Year from the Tower Mains team
Happy New Year from the Tower Mains team. Thank you to all our clients and collaborators for your continued support, and here’s to a fantastic year ahead!
Regulatory Updates
MHRA guidance updates
- Exporting active substances. On 8th January, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the ‘Register of Written Confirmations for UK active substance manufacturers.’ Click to view source
- Borderline products: how to tell if your product is a medicine. On 8th January, the file ‘Final determinations by the MHRA on borderline products’ to December 2023 was updated in guidance on how the MHRA makes decisions on what is a medicinal product (borderline products). Click to view source
FDA guidance updates
- Submission and review of sterility information in premarket notification (510(k)) submissions for devices labelled as sterile. On 8th January, the US Food & Drug Administration (FDA) published final guidance updating and clarifying the information regarding sterilisation processes that we recommend sponsors include in 510(k)s for devices labelled as sterile. It also provides details about the pyrogenicity information that the agency recommends sponsors include in a 510(k) submission. Click to view source
Good Clinical Practice & Pharmacovigilance Compliance Symposium
The FDA has published information on the joint Good Clinical Practice & Pharmacovigilance Compliance Symposium organised by the FDA, MHRA and Health Canada. Taking place from the 13th-15th of February 2024, the workshop will focus on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post-pandemic world. Topics covered will include key updates to ICH E6(R3), the use of technology in clinical trials and clinical and bioanalytical challenges in bioequivalence studies.
FDA launches new function for searching Pharmaceutical Quality documents
The FDA has launched a new search function on the FDA’s Office of Pharmaceutical Quality webpage to improve access to drug quality resources and web content. The new search webpage scans existing FDA guidance documents, manuals of policies and procedures (MAPPs), and compliance programs to provide users with relevant and up-to-date resources and information.
Regulatory Roadmap points the way ahead for new measures to support safe access to medical technology
On 9th January, the MHRA announced a path for developing new and robust regulations for medical devices in the UK. The new regulations will put patient safety first and help to ensure that patients continue to have access without delay to the devices they need, whilst boosting the UK’s position as a leading environment for medical technology innovators.
Industry Updates
FDA authorises Florida’s drug importation programme
On 5th January, the FDA announced it has authorised Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating the importation of certain prescription drugs from Canada.
Advancing Health Through Innovation: New Drug Therapy Approvals
On 5th January, the FDA published a report on new drug approvals in 2023. This features novel approvals along with notable approvals of drugs for new and expanded uses, new formulations, and new dosage forms. The report also highlights drugs for patients with few or no treatment options, including those with rare diseases.
Evotec and Owkin enter partnership to accelerate therapeutics pipeline in oncology and I&I
On 5th January, Evotec SE and Owkin, a techbio company, announced an AI-powered multi-target collaboration in oncology, immunology and inflammation. The collaboration brings together highly complementary platforms and expertise to accurately select targets and discover and develop new therapeutics. Pairing Owkin’s cutting-edge target discovery engine with Evotec’s end-to-end shared R&D platforms and disease biology expertise will accelerate Owkin’s programmes from the discovery phase to the clinic.
Deepcell announces collaboration with NVIDIA to advance AI in single-cell research
On 8th January, Deepcell, a pioneer in artificial intelligence AI-powered single cell analysis to fuel deep biological discoveries, announced a research collaboration with NVIDIA to accelerate the development and adoption of advanced computer vision solutions in life sciences. Deepcell will incorporate NVIDIA AI into its single-cell analysis technology, working collaboratively with NVIDIA to co-develop new uses for generative AI and multimodal applications in cell biology.
Global £30m study into liver cirrhosis announced
On 8th January, the University of Edinburgh announced a new £30 million study involving Boehringer Ingelheim, a research-driven global biopharmaceutical company, and Newcastle University to advance the development of new treatments for liver cirrhosis. The Accelerating Discovery: Actionable NASH Cirrhosis Endpoints (ADVANCE) study is the most extensive study into liver cirrhosis ever conducted worldwide and will harness Edinburgh University’s single-cell RNA sequencing technology.
WHO decision improves children’s access to safer polio vaccine
On 9th January, the type 2 oral polio vaccine (nOPV2), developed by a team including scientists from the MHRA, was prequalified by the World Health Organisation (WHO). This comes three years after it received its Emergency Use Listing (EUL) and the delivery of 950 million doses worldwide. Prequalification is a mark of quality assurance the WHO grants and will make it easier for more countries to access and use nOPV2. Now it is granted, WHO member countries can obtain and use nOPV2 without the need to meet the strict readiness and monitoring requirements previously required under EUL.
EMA publishes an updated version of the Big Data Workplan
On 9th January, the European Medicines Agency (EMA) published an updated version of the Big Data Workplan. This document outlines key deliverables and is structured in line with the key recommendations of the Big Data Task Force. The scope of activities under these recommendations covers mainly human medicines, however veterinary aspects are included when relevant.
Issue Number: WN00144
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.”