Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Company Updates
Tower Mains is delighted to be exhibiting at the Scotsman Life Sciences Conference 2024 at the University of Strathclyde this Thursday, 28th November. Are you also attending? Come visit our stand for a chat!
Regulatory Updates
European Commission issues call for committees and board members for the EMA Committee for Advanced Therapies
On 21st November, the European Commission announced it has re-opened the selection procedure to appoint the Representatives of Patients’ Associations and Clinicians in the Committee for Advanced Therapies of the European Medicines Agency (EMA), originally launched on the 12th of August 2024.
FDA’s CDRH announces communications pilot to enhance medical device recall program
On 21st November, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced the launch of a pilot program to improve the medical device recall process. The initiative aims to accelerate communication about corrective actions taken by companies that may involve high-risk recalls, even if the FDA has not yet officially classified them as such. The goal is to enhance transparency and reduce the time between when the FDA first becomes aware of a potential issue and when it informs the public about possible high-risk device removals or corrections. This effort also emphasises the importance of incorporating patient feedback into regulatory decisions. The FDA is committed to ensuring clear communication about the benefits and risks of medical devices, supporting an informed public and a robust healthcare system.
MHRA guidance updates
- Digital mental health technology. On 22nd November, guidance on how the Medicines and Healthcare products Regulatory Agency (MHRA) published the latest newsletter on Regulating and evaluating digital mental health technologies. Click to view source
FDA guidance updates
- Transitional enforcement policy for ethylene oxide sterilisation facility changes for class III devices. On 26th November, the FDA published final guidance to communicate its policy regarding sterilisation site changes for ethylene oxide (EtO) sterilised PMA and HDE devices in situations where those devices are affected by the potential, actual, or temporary operation reductions at sterilisation facilities that may affect the availability of those sterile medical devices.
- Assessment of ovarian toxicity in premenopausal adults during drug development for oncologic products. On 26th November, draft guidance was published with recommendations to sponsors regarding the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enrol premenopausal adults with ovaries.
- Recommended follow-up testing for an Ames-positive drug (Active Ingredient) or metabolite to support first-in-human clinical trials with healthy subjects. On 27th November, draft guidance was published with recommendations on follow-up testing for Ames-positive active ingredients in circumstances when a sponsor decides to continue development.
ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force Request for Information (RFI)
On 25th November, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released information on its Request for Information (RFI) to determine interest and potential approaches to support the ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force’s initial assessment for a secure, standardised technology platform. For further information about this effort please refer to the ICH PQKM home page.
Industry Updates
Cytomos secures £5m to scale up cell analysis technology
On 19th November, Cytomos, an Edinburgh-based biotechnology company, announced it has raised £5 million to scale up production of its unique cell analysis technology. The new investment will allow the company to drive sales of its first commercial product, Celledonia™, built on its cell-analysis technology platform AuraCyt, which is already generating significant market traction. Celledonia™ is a benchtop cell analyser which aims to significantly enhance single-cell analysis, potentially transforming biological drug discovery, development processes, and biologics manufacturing, meeting a major unmet need for the biopharma industry.
Samsung Biologics signs manufacturing deal with EU pharmaceutical company
On 20th November, Samsung Biologics a global contract development and manufacturing organisation (CDMO), announced a series of manufacturing deals with a Europe-based pharmaceutical company. The disclosed deals, worth over USD 668 million combined, will run through December 2031.
BridgeBio secures FDA approval for heart disorder drug
On 22nd November, BridgeBio Pharma, a biopharmaceutical company focused on genetic diseases, announced that the FDA has approved Attruby™ (acoramidis), an orally administered near-complete (≥90%) stabiliser of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalisation. The approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalisation, and improved quality of life.
Johnson & Johnson seeks FDA approval for subcutaneous induction regimen of TREMFYA®
On 22nd November, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking approval of a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). The filing is supported by data from the Phase 3 ASTRO study of TREMFYA® SC induction therapy in adults with UC and builds upon the recent US approval of TREMFYA® in this indication.
Sanofi reveals $595 million vaccine facility in Singapore to prepare for potential pandemics
On 27th November, Sanofi unveiled its state-of-the-art manufacturing facility, Modulus, in Singapore, marking a significant milestone in its commitment to delivering innovative healthcare solutions globally. This next-generation facility, located in Tuas Biomedical Park, is highly digitalised and low-carbon, representing a new era in sustainable biopharmaceutical manufacturing. Modulus leverages an ‘industry-first’ modular concept that enables flexible manufacturing capabilities to produce next-generation vaccines and biological medicines. The inauguration was witnessed by Mr Ong Ye Kung, Singapore’s Minister for Health.
Issue Number: WN00190
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