Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- Early access to medicines scheme (EAMS): scientific opinions: On 4th April, the Medicines and Healthcare products Regulatory Agency (MHRA) moved ‘Lutetium (177Lu) vipivotide tetraxetan in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)’ to expired EAMS SO in the information on granted EAMS scientific opinions. This change was made due to the granting of marketing authorisation. Click to view source
- How to draft a direct healthcare professional communication: On 4th April, the MHRA updated guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs). Click to view source
FDA guidance updates
- FDA issues draft guidance on Human User Safety in new and abbreviated new animal drug applications. On 4th April, the US Food and Drug Administration (FDA) issued draft guidance clarifying the current approaches and recommendations for Human User Safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs before approval. Click to view source
- Patient-focused drug development: Incorporating clinical outcome assessments into endpoints for regulatory decision-making. On 5th April, the FDA issued draft guidance on incorporating clinical outcome assessments into endpoints for regulatory decision-making. This guidance is the fourth in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. Click to view source
- Notifying FDA of discontinuance or interruption in manufacturing of finished products or active pharmaceutical ingredients. On 5th April, the FDA announced the availability of draft guidance intended to aid applicants and manufacturers in providing timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the agency prevent or mitigate shortages. The guidance also explains how FDA communicates information about products in shortage to the public. Click to view source
ECA publishes new guidance on GMP-compliant equipment design
On 5th April, the leading European organisation regarding pharmaceutical Quality Assurance and GMP compliance, the ECA Foundation, published new guidance on good manufacturing practice (GMP) compliant equipment design. The purpose of the guidance is to illustrate the applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made.
EMA GCP IWG issues points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters, or other major disruption
On 5th April, the European Medicines Agency’s GCP Inspectors Working Group published a document on ‘points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other major disruptions’. The document aims to help sponsors address the resulting challenges and mitigate risks to the rights, safety, dignity, and well-being of trial participants and the scientific value of the clinical trials.
Industry Updates
New fees for MHRA services introduced from 1st April 2023
On 1st April, the MHRA introduced new fees for a range of services, to ensure the agency covers its costs and achieves financial stability in the years ahead. Key changes coming into effect include:
- A 10% uplift across statutory fees. This reflects increases in costs since the last substantial MHRA fees review in 2016
- A further uplift for 58 fees for services that are significantly under-recovering costs, to achieve full cost recovery
- The introduction of 18 new fees for services that require cost recovery
ABPI’s Patient Advisory Council announce new leaders
On 3rd April, the Association of the British Pharmaceutical Industry (ABPI) announced that five new patient organisation leaders have been appointed to its Patient Advisory Council, which provides advice and insight on the patient perspective to the ABPI Board and leadership team.
New features introduced to strengthen Priority Medicines scheme (PRIME)
On 4th April, the European Medicines Agency (EMA) announced the introduction of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of unmet medical needs. Implementing the new features follows a review of the first five years of experience with the scheme, which highlighted some opportunities for further strengthening the scheme.
Adcendo announces funding to boost antibody-drug conjugates development
On 4th April, Adcendo ApS, a biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of cancers with a high unmet medical need, announced the successful completion of a Series A extension financing. The company intends to use the financing to initiate a broad clinical development program for uPARAP ADC in Sarcoma and is also planning to advance the development of its 2nd ADC pipeline asset with Development Candidate Nomination (DCN) planned in H1 2024.
Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development
On 4th April, the FDA published a Spotlight on CDER Science examining pharmacodynamic (PD) biomarkers in biosimilar product development. The spotlight summarises research that the FDA and outside investigators have been conducting in this area.
FDA approved three first-time generic animal drugs
Last week, the FDA approved three first-time generic animal drugs, bringing additional options to the table for veterinarians, pet owners and animal producers. These include:
- The first generic Maropitant Citrate tablets for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.
- Tauramox, the first generic moxidectin injectable solution indicated for beef and nonlactating dairy cattle for the treatment and control of internal and external parasites in cattle.
- Modulis for Cats, the first generic cyclosporine oral solution for cats. Modulis for Cats is indicated for the control of certain skin conditions resulting from a disease called feline allergic dermatitis.
Issue Number: WN00106
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