Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Company Updates
We are thrilled to announce that Erin Bell has been promoted to Senior Associate.
Congratulations to Erin! We can’t wait to see all the amazing things you’ll achieve in your new role.
Regulatory Updates
MHRA guidance updates
- International Recognition Procedure. On 9th July, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the International Recognition Procedure and eCTD guidance. Click to view source
FDA guidance updates
- Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products. On 8th July, the US Food & Drug Administration (FDA) published draft guidance providing information to industry and FDA staff on the purpose and content of a use-related risk analysis (URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product development and to support a marketing application. Click to view source
- Addressing Misinformation About Medical Devices and Prescription Drugs: Q&A. On 8th July, the FDA announced the availability of a revised draft guidance, which then finalised, will describe the FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. Click to view source
- Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder. On 11th July, final guidance with recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder (hereafter “OUD device studies”) and used to support marketing submissions. Click to view source
CTCG issues recommendation paper on GLP
The Heads of Medicines Agencies’ (HMA) Clinical Trials Coordination Group (CTCG), alongside EMA and EC working groups, has released a new recommendation paper on Good Laboratory Practices (GLP) for clinical trial applications under EU Clinical Trials Regulation (Regulation (EU) No 536/2014). This document aims to enhance transparency regarding GLP requirements and clarify the level of information on GLP status that should be included in Clinical Trial Applications.
WHO updates laboratory biosecurity guidance
On 4th July, the World Health Organisation (WHO) announced updated guidance for national authorities and biomedical laboratories on managing biological risks. The updates emphasise strengthening cybersecurity and handling confidential information, reducing risks from new technologies like genetic modification and AI, and ensuring laboratory safety and security during emergencies.
Industry Updates
WHO launches MeDevIS platform to enhance access to medical technologies and devices
On 8th July, the WHO announced the introduction of MeDevIS (Medical Devices Information System), an online platform providing global open access to information on medical devices. The system is designed to aid governments, regulators, and users in selecting, procuring, and utilising medical devices for diagnostics, testing, and treatment of diseases and health conditions.
Evotec expands tech partnership with Sandoz for biosimilars
On 8th July, Evotec announced its biologics segment, Just – Evotec Biologics, Inc., has expanded its strategic partnership with Sandoz for further development and long-term commercial manufacturing of biosimilars. The partnership, ongoing since May 2023, aims to improve access to high-quality biosimilar medicines and includes significant commercial manufacturing capacity from Evotec’s new facility in Toulouse, France.
SMC publishes newly licensed medicines for use by NHS Scotland
On 8th July, the Scottish Medicines Consortium (SMC) published advice on eight newly licensed medicines for use by NHS Scotland. This includes Voretigene neparvovec (Luxturna®) for the treatment of adults and children with inherited retinal dystrophy and Empagliflozin (Jardiance®) for the treatment of adults with chronic kidney disease.
Francis Crick and ICL spinout raises £90m to begin clinical development of cancer treatments
On 8th July, the Francis Crick Institute and Imperial College London (ICL) announced their cancer therapy spinout, Myricx Bio, has secured £90m in series A financing. This funding will advance its novel treatments for a range of different tumour types, including breast, lung and colorectal cancer, into clinical development.
Ligand Pharma to acquire APEIRON Biologics AG
On 8th July, Ligand Pharmaceuticals announced it has entered into an agreement to acquire APEIRON Biologics AG, which holds royalty rights to QARZIBA® for the treatment of high-risk neuroblastoma, for $100 million. This acquisition is part of Ligand’s strategy to expand its portfolio in the biotechnology sector, particularly focusing on innovative therapies and advancing its pipeline.
Flagship Pioneering raises $3.6billion to transform human health and sustainability
On 10th July, Flagship Pioneering, a bio-platform innovation company, announced it has raised $3.6 billion to support ground-breaking innovations aimed at transforming human health and sustainability. This funding will drive the development of transformative technologies that address critical challenges across various sectors, including healthcare.
Issue Number: WN00170
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