Tower Mains Weekly Newsletter
Company Updates
We Are Hiring: Principal Associate, Clinical QA
We are looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted to the right person for hours and travel. For more information, click here.
Regulatory Updates
MHRA guidance updates
- Regulation of devices in Northern Ireland. On 25th March, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health Institution Exemption. Click to view source
- Clinical trials for medicines: Managing your authorisation and reporting safety issues. On 26th March, the MHRA updated the guidance on changing your protocol, updating your authorisation, reporting safety issues, submitting safety updates, and completing the end-of-trial study report. Click to view source
- Clinical trials for medicines: Applyng for authorisation in the UK. On 28th March, added a link to the case study: ‘Agile, responsive regulation helps early breast cancer patients to benefit from a study to potentially improve survival outcomes’ to the section ‘Common issues identified during clinical trial applications’. Click to view source
FDA guidance updates
- Real-world evidence: Considerations regarding non-interventional studies for drug and biological products. On 21st March, the US Food & Drug Administration (FDA) published draft guidance with recommendations to sponsors who are considering submitting a non-interventional study, also referred to as an observational study, to the agency to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug. Click to view source
- Handling and retention of bioavailability and bioequivalence testing samples. On 27th March, draft guidance was made available to provide recommendations for study sponsors and/or drug manufacturers, contract research organisations (CROs), site management organisations (SMOs), clinical investigators, and independent third parties regarding the procedure for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies, as required by 21 CFR 320.38 and 320.63. Click to view source
EMA: Adjusted fees to come into effect from April 2024
On 27th March, the European Medicines Agency (EMA) published a reminder to applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1st of April 2024.
Industry Updates
FDA approves non-steroidal treatment for Duchenne Muscular Dystrophy
On 21st March, the FDA approved Duvyzat oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle and is the first non-steroidal drug approved to treat patients with all genetic variants of DMD.
New antibiotic to fight infections caused by multi drug-resistant bacteria recommended in EU
On 22nd March, the EMA recommended granting a marketing authorisation in the EU for Emblaveo (aztreonam-avibactam), indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria where treatment options are limited.
FDA approves treatment for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
On 22nd March, the FDA approved mirvetuximab soravtansine-gynx for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
AbbVie to acquire Landos Biopharma, strengthening its portfolio in inflammatory and autoimmune diseases
On 25th March, AbbVie Inc. and Landos Biopharma, Inc. announced an agreement under which AbbVie will acquire Landos, a clinical-stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases. Landos’ lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist with a bimodal mechanism of action (MOA), which is anti-inflammatory and facilitates epithelial repair.
FDA issues warning over certain topical pain relief products
On 26th March, the FDA issued a warning to consumers not to use certain over-the-counter analgesic products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency also issued warning letters to six companies for marketing these products in violation of federal law.
PhaSER Biomedical partners with Sanders Tri-Institutional Therapeutic Discovery Institute
On 26th March, Scottish-based PhaSER Biomedical announced a long-term partnership with the Sanders Tri-Institutional Therapeutic Discovery Institute (TDI) to advance the institute’s pre-clinical drug discovery research. As part of the ten-year agreement, PhaSER will provide 8HUM mouse models for TDI to use to accelerate the discovery and development of new treatments for disease, reduce attrition when drugs reach the clinic and reduce animal use and development costs.
University of Liverpool to lead £125m research facility supported by UKRI investment
On 27th March, the University of Liverpool announced it will lead a new £125 million national research facility to drive forward scientific discoveries and technological advances in areas such as sustainable energy, advanced materials, quantum technologies, and personalised medicine. Supported by the UK Research and Innovation (UKRI) Infrastructure Fund, the facility known as RUEDI (Relativistic Ultrafast Electron Diffraction and Imaging) will be the world’s most powerful microscope for imaging dynamics and position the UK as a global leader in ultrafast electron microscopy.
Strand Therapeutics develops new class of mRNA molecules for cancer
On 27th March, the Massachusetts Institute of Technology (MIT) announced its spinout Strand Therapeutics has developed a new class of mRNA molecules that can sense where they are in the body, for more targeted and powerful treatments. Set to begin its first clinical trial in April 2024, Strand will be testing a proprietary, self-replicating mRNA molecule’s ability to express immune signals directly from solid tumours, including melanoma and triple-negative breast cancer, to elicit the immune system to attack and eradicate the tumour cells directly. The company is also actively developing mRNA therapies that could be used to treat blood cancers and plans to partner with pharmaceutical companies, as well as investors, to continue developing drugs across a broad range of diseases.
Issue Number: WN00155
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