Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- Medical devices: UK-approved bodies. On 23rd January, the Medicines and Healthcare products Regulatory Agency (MHRA) added a new entry (International (UK) Ltd Medical Devices Scope) to the guidance on UK-approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Click to view source
FDA guidance updates
- Characterisation of metallic coatings and/or calcium phosphate coatings on orthopaedic devices. On 22nd January, the US Food & Drug Administration (FDA) published draft guidance providing recommendations on information to support premarket submissions for metallic coatings and/or calcium phosphate coatings on orthopaedic devices. These recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of submissions for orthopaedic devices which contain metallic and/or calcium phosphate coatings. 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. 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.
European Commission issues summary record of November Pharmaceutical Committee meeting
On 23rd January, the European Commission issued the summary record of the latest Pharmaceutical Committee meeting held on the 23rd of November 2023. The meeting was organised in a hybrid format and was attended by representatives from the Commission, 27 EU Member States, Norway, Iceland, the European Medicines Agency (EMA) and the Council of Europe (EDQM).
EMA revises SME user guide
On 23rd January, the EMA announced the release of a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector. The revised guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development.
Industry Updates
FDA and CMS issue joint statement supporting increased oversight of lab-developed tests
On 18th January, the FDA and the Centres for Medicare & Medicaid Services (CMS) issued a joint statement confirming support for the proposed rule to increase oversight of laboratory-developed tests (LDTs). The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs and believe that the same oversight approach to laboratories and non-laboratories that manufacture tests would better assure the safety and effectiveness of LDTs
9th ICMRA COVID-19 Real-World Evidence Observational Studies Working Group minutes
On 18th January, the International Coalition of Medicines Regulatory Authorities (ICMRA) published minutes from the 9th ICMRA meeting on COVID-19 Real-World Evidence and Observational studies, held in September 2023. Led by Kelly Robinson and Peter Arlett, the meeting aimed to first reflect on what has been done and achieved over the last three years of collaboration, and second, to discuss five options put forward for the future of the Working Group (WG).
MHRA launches new fees calculator
On 19th January, the MHRA announced the development of a fees calculator to help companies calculate the fees they will be charged when making an initial or a variation application for a medicinal product. Applications can be invalidated because the correct fee has not been paid and this new calculator will support companies in avoiding this problem.
BALVERSA® granted US approval for locally advanced or metastatic urothelial carcinoma
On 19th January, Johnson & Johnson announced the FDA has approved a supplemental New Drug Application (sNDA) for BALVERSA® for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
Serac to present data from study evaluating 99mTc-maraciclatide as new imaging marker for endometriosis
On 19th January, Serac Healthcare, a clinical radiopharmaceutical company, revealed that an abstract on the preliminary data from the first group of patients in the “Detecting Endometriosis expressed integrins using technetium-99m” imaging (DETECT) study, has been accepted for oral presentation at the Society for Reproductive Investigation (SRI) annual meeting in March 2024. The study is investigating whether it is possible to visualise endometriosis, including superficial peritoneal disease using 99mTc-maraciclatide and SPECT-CT imaging.
MHRA introduces new restrictions for fluoroquinolone antibiotics
On 22nd January, the MHRA announced fluoroquinolone antibiotics given systemically must only be administered when no other antibiotics are appropriate for use. This means that fluoroquinolones should only be prescribed when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient.
Latest Drug Safety Update newsletter published
On 22nd January, the MHRA published the January issue of the Drug Safety Update newsletter from the agency and its independent advisor, the Commission on Human Medicines
Researchers repurpose cancer compound to treat PKD
On 23rd January, the Massachusetts Institute of Technology (MIT) disclosed that its researchers, along with researchers at the Yale University School of Medicine, have repurposed a compound originally developed to treat cancer for polycystic kidney disease (PKD) treatment. The drug works by exploiting kidney cyst cells’ vulnerability to oxidative stress – a state of imbalance between damaging free radicals and beneficial antioxidants.
Newly launched Calluna Pharma raises €75m to develop novel therapies for immunological diseases
On 23rd January, Oxitope Pharma and Arxx Therapeutics pronounced their merger Calluna Pharma Inc. has raised €75m in a series A financing to develop novel therapies that harness the transformative potential of the body’s immune system. Calluna’s unique approach involves precision targeting of upstream innate immune amplifiers, enabling disruption of a comprehensive range of disease-associated downstream signalling pathways while maintaining a favourable safety profile.
Issue Number: WN00146
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