Tower Mains Weekly Newsletter
Company Updates
FDA, Health Canada, and MHRA GCP and Pharmacovigilance Symposium 2024
Missed out on the February 2024 FDA, Health Canada, and MHRA GCP and Pharmacovigilance Symposium? Don’t worry, we’ve got you covered… from Data Integrity and Computer System Validation to technological innovations and patient-centric approaches, our Senior Associate, Nicole Ainsworth, has summarised the key themes and takeaways from each day!
To have a read, click here.
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
- Apply for a licence to market a medicine in the UK. On 15th March, the Medicines and Healthcare products Regulatory Agency (MHRA) added a YouTube tutorial for the Established Medicines licensing process. Click to view source
- Medicines: reclassify your product. On 18th March, the MHRA updated the guidance on reclassification. Click to view source
- Advanced therapy medicinal products: regulation and licensing in Great Britain. On 19th March, guidance on how to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in the UK was updated Click to view source
- Medicines that you cannot export from the UK or hoard. On 20th March, vitamin B substances with ascorbic acid was added to medicines that cannot be exported from the UK or hoarded because they are needed for UK patients. Click to view source
FDA guidance updates
- Evaluation of thermal effects of medical devices that produce tissue heating and/or cooling. On 15th March, the US Food & Drug Administration (FDA) published draft guidance to provide recommendations on testing to assess the thermal effects of medical devices. This guidance applies to devices that produce tissue temperature changes (i.e., heating and/or cooling) as an intended or unintended consequence of device uses. Click to view source
- Requests for feedback and meetings for Medical Device Submissions. On 15th March, draft guidance was made available to provide an overview of the mechanisms available to submitters through which they can request interactions with the FDA related to medical device submissions. Click to view source
- Pharmacokinetics in patients with impaired renal function. On 15th March, final guidance was published to assist sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. Click to view source
- Manufacture of batches in support of original NADAs, ANADAs, and CNADAs. On 18th March, the FDA issued draft guidance to provide recommendations for the primary batches of drug products manufactured to support the approval or conditional approval of new animal drug products. Click to view source
- Controlled correspondence related to generic drug development. On 18th March, the FDA issued final guidance to provide information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to the FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence. Click to view source
- Real-world evidence: Considerations regarding non-interventional studies for drug and biological products. On 20th March, draft was published to provide recommendations to sponsors who are considering submitting a non-interventional study, also referred to as an observational study, to the FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of the safety of a drug. Click to view source
Industry Updates
SMC publishes an updated Collaborative Advice Document for COVID-19 medicines
On 13th March, the Scottish Medical Consortium (SMC) published an updated Collaborative Advice Document for COVID-19 medicines, which includes new advice for nirmatrelvir plus ritonavir following a partial review. The recommendations are aligned with the updated NICE final guidance for TA878.
First treatment for patients with liver scarring approved in US
On 14th March, the FDA approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring, to be used along with diet and exercise.
CAR T-Cell Therapy for adults with leukaemia or lymphoma gets green light from FDA
On 14th March, Bristol Myers Squibb announced that the FDA has granted accelerated approval of Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
myTomorrows Partners with the ALS Association to Support ALS Patients in Accessing Clinical Trials
On 14th March, myTomorrows, a global health technology, announced a new partnership with the Amyotrophic Lateral Sclerosis (ALS) Association. Through the partnership, the ALS Association will tap into myTomorrows’ vast database of ongoing clinical trials and leverage its patient navigation service to ensure that treating physicians and those living with ALS are equipped with up-to-date information about appropriate pre-approval treatment options and ultimately guided towards relevant clinical trials.
Company director convicted of falsifying medicine quality data
On 15th March, a company director and his pharmaceutical manufacturing company were sentenced in court after pleading guilty to two charges of falsifying data that supported the shelf life of a medicine, adversely affecting its quality to obtain a licence to sell the medicine in the UK.
FDA discusses focus on the development and use of AI
On 15th March, the FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) jointly published a new paper, ‘Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together’. It outlines specific focus areas regarding the development and use of AI across the medical product lifecycle and helps further align and streamline the agency’s work in AI.
Highlights from latest CVMP meeting
On 18th March, the European Medicines Agency (EMA) published meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) held on the 12th-13th March 2024. Topics include opinions on veterinary medicinal products and international harmonisation.
Swedish researchers develop new AI computer model to detect lymphatic cancer
On 18th March, the Chalmers University of Technology in Sweden announced its researchers had developed a new computer model using AI, which can successfully detect signs of lymph node cancer in 90 per cent of cases of lymphatic cancer. The model was developed with researchers from Memorial Sloan Kettering Cancer Center, Chalmers University of Technology, Medical University in Vienna, Icahn School of Medicine at Mount Sinai, and NYU Langone Health.
First therapy for children with early-onset Metachromatic Leukodystrophy approved in US
On 18th March, Orchard Therapeutics, a company focused on accelerating the delivery of new gene therapies to patients, announced the FDA has approved Lenmeldy™, formerly known as OTL-200, for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ)—collectively referred to as early-onset—metachromatic leukodystrophy (MLD).
FDA launches new portal for reporting potential drug shortage issues directly into CDER’s NextGen system
On 18th March, the FDA launched a new public portal for patients, consumers, and healthcare professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account.
Multi-stakeholder platform established to enhance the clinical trials environment in the EU
On 20th March, the EMA announced the Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the EU. The launch of the MSP fosters collaboration and promotes open dialogue around the challenges and opportunities represented by advances in clinical trials regulation, methodologies, and technology for the benefit of EU citizens. It follows a public consultation and a workshop organised in 2023.
European Commission and Belgian Presidency increase support to the African Medicines Agency
On 20th March, the European Commission, Belgian Presidency of the Council of the European Union, African Union Development Agency-NEPAD (AUDA-NEPAD) and EMA came together to strengthen their support of the African Medicines Agency (AMA). The European Commission announced a contribution of €10 million and Belgium a contribution of €4 million to AUDA-NEPAD, for the African Medicines Regulatory Harmonisation (AMRH) initiative to continue advancing the establishment of AMA.
Issue Number: WN00154
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