Tower Mains Weekly Newsletter
Company Updates
We Are Hiring: Principal Associate, Clinical QA
Tower Mains is 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.
Visit us at the Diagnostics North East Conference 2024
Delighted to announce that we will be exhibiting at the Diagnostics North East Conference in Newcastle on Friday, 19th April. Looking forward to seeing new and familiar faces, and hearing from industry experts. For more information on the event, click here.
Regulatory Updates
MHRA Inspectorate: DSUR submissions and fees update
On 4th April, the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate published a blog on the changes to Development Safety Update Report (DSUR) submissions and fees commencing the 1st of June 2024. It contains information on how to prepare, late submissions and failure to provide evidence of payment. Payment of annual safety reports (ASRs) such as the DSUR will only be accepted via the agency’s online portal MHRA Pay.
MHRA guidance updates
- Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework. On 5th April, section 12 (Parallel Import Packs) was updated to reflect guidance on UK Parallel Import Licences following the agreement of the Windsor Framework. Click to view source
- Innovative Licensing and Access Pathway. On 5th April, information on the Innovative Licensing and Access Pathway (ILAP) application process was updated. Click to view source
- The Target Development Profile Toolkit. On 5th April, information on the toolkit for Innovation Passport holders following the ILAP was updated. Click to view source
- International Recognition Procedure. On 8th April, the supplementary information on the International Recognition Procedure was updated. Click to view source
- Clinical trials for medicines. On 10th April, the Combined IMP Device guidance attachment was updated in guidance on how to apply for a clinical trial. Click to view source
EMA systems disruption expected from 11th to 17th April
On 8th April, the European Medicines Agency (EMA) announced that due to planned system maintenance, several EMA applications will be fully or partially inaccessible from 11th-17th April. During this time, EMA will load nationally and centrally authorised product data to its Product Management Service (PMS) database and has recommended that external users plan their access.
Industry Updates
Unitaid funds over £6m to advance revolutionary long-acting therapeutic technologies
On 3rd April, the University of Liverpool announced that Unitaid has awarded more than £6M of new funding to its LONGEVITY project, a project aiming to improve the long-acting therapeutics available to treat or prevent tuberculosis, malaria, and hepatitis C. It is part of the University of Liverpool’s Centre of Excellence for Long-acting Therapeutics (CELT), a cross-faculty research initiative combining world-leading expertise in pharmacology and materials chemistry and collaborating with international partners to disseminate research findings in long-acting medicine and change the global landscape of drug administration.
Precautionary recall of some sodium chloride solutions for irrigation, eyewash, and inhalation
On 5th April, the MHRA announced that batches of irrigation, inhalation and eyewash solutions manufactured by Legency Remedies Pvt Ltd are being recalled as a precaution, due to potential contamination with the bacteria Ralstonia pickettii. The MHRA has published a Devices Safety Information notice to notify those within healthcare settings, including hospitals and care homes, of the recall.
ENHERTU® approved as first tumour agnostic HER2 directed therapy in US
On 5th April, it was announced that the FDA has approved Daiichi Sankyo and AstraZeneca’s ENHERTU® for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR), and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
MMI granted FDA approval for Symani Surgical System
On 8th April, MMI (Medical Microinstruments, Inc.), a robotics company committed to increasing treatment options and improving clinical outcomes for patients with complex conditions, announced that its Symani Surgical System is now commercially available in the US. The FDA granted De Novo Classification to the system for soft tissue manipulation to perform microsurgery, a highly specialised technique that involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair. It is designed to encourage surgeons to perform complex surgeries on delicate anatomy while allowing hospitals to expand their surgical offerings.
Bio-Rad and Allegheny Health Network partner to advance monitoring of solid tumour cancers
On 8th April, Bio-Rad Laboratories, a company specialising in life science research and clinical diagnostics products, announced a partnership with Allegheny Health Network (AHN) to generate clinical evidence across a range of cancer types to support the implementation of Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology for tumour-informed molecular residual disease (MRD) monitoring of patients with solid tumour cancer following curative-intent treatment. Collectively, through this project, Bio-Rad and AHN aim to generate clinical evidence to support the use of Bio-Rad’s Droplet Digital PCR Systems, including the QX600™ ddPCR System, in routine MRD monitoring of patients with a range of solid tumour types.
Federal Court enters consent decree following recall of certain sleep therapy machines
On 9th April, the FDA announced that the US District Court for the Western District of Pennsylvania has entered a consent decree of permanent injunction against Philips RS North America LLC (“Philips Respironics”), Respironics California LLC, and Philips Holding USA Inc., and Roy Jakobs, CEO of Royal Philips, along with several other individual defendants. The consent decree, with limited exceptions, restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the US until certain requirements are met.
Fosdenopterin approved to treat adult patients with MoCD Type A
On 9th April, the MHRA announced the approval of the medicine fosdenopterin to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A. The pharmaceutical form of this medicine is a 9.5 mg powder for solution for injection and the route of administration is intravenous.
WHO announces updates on co-administration of treatment for drug-resistant tuberculosis and hepatitis C
On 9th April, the World Health Organisation (WHO) issued a rapid communication on co-administration of treatment for drug-resistant tuberculosis and hepatitis C (HCV). It aims to inform national TB programmes, technical partners, and other stakeholders about the key implications for the co-administration of treatment for drug-resistant tuberculosis and hepatitis C, facilitating seamless integration and planning at the country level.
Issue Number: WN00157
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