Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
MHRA launches consultation on the ICH E6 (R3) Guideline for Good Clinical Practice Annex-2
On 15th November, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice (GCP) Annex 2. Whilst feedback on the guidance can be provided via the ICH website, MHRA is consulting directly with UK stakeholders to compile and co-ordinate their comments to the Expert Working Group (EWG).
MHRA guidance updates
- How Marketing Authorisation Applications referred under Article 29 are handled. On 15th November, guidance on how the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29 was updated for clarity. Click to view source
- Windsor Framework explainer. On 20th November, the MHRA published an explainer for industry on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland. Click to view source
- Innovative Licensing and Access Pathway. On 20th November, added a notification: ‘As of 20 November 2024 17:00 (GMT), applications under the current ILAP scheme are no longer accepted’. Click to view source
Anthony Harnden appointed as new Chair of MHRA
On 19th November, Anthony Harnden was announced as the new Chair of the MHRA. A professor of primary care at the University of Oxford, Harnden brings 33 years of experience as a general practitioner and has previously served on key committees such as the JCVI. He succeeds Stephen Lightfoot and will play a key role in driving forward the strategic direction of MHRA to maintain the UK as a global centre of excellence in life sciences.
FDA guidance updates
- Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products. On 18th November, the US Food and Drug Administration (FDA) published draft guidance to provide answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. It is also intended to help facilitate the development of safe, effective, and high-quality CGT products.
- 510(k) Third Party Review Program and Third-Party Emergency Use Authorisation (EUA) Review. On 21st November, final guidance was published outlining the FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third-party review of Emergency Use Authorisation (EUA) requests by describing the FDA’s expectations for the review of 510(k) submissions and EUA requests by third-party review organisations.
ICH Q13 IWG Video Training Material Modules 1-12 available on the ICH website
On 19th November, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the publication of ICH Q13 IWG ” Continuous Manufacturing of Drug Substances and Drug Products” Modules 1-12 video training material.
Industry Updates
Osivax announces Phase 2a clinical booster trial of influenza vaccine
On 14th November, Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, announced that the first participant has been vaccinated in a Phase 2a clinical trial (NCT06582277) evaluating OVX836, its broad-spectrum influenza vaccine candidate as a booster in participants previously administered with OVX836. Based on the encouraging data gathered so far, Osivax launched this study to further assess the safety and immunogenicity of a booster dose of OVX836.
Teva and Immunai collaborate to improve clinical trials in Oncology and Immunology
On 14th November, Immunai, an AI-driven biotech company focused on mapping the human immune system, and Teva Pharmaceuticals announced a partnership aimed at optimising clinical trials in immunology and immuno-oncology. The multi-year collaboration will utilise Immunai’s proprietary immune cell atlas, AMICA, as well as its AI model, the Immunodynamics Engine (IDE), to improve clinical decision-making in Teva’s immunology trials.
Syndax’s Revuforj® approved In US as first menin inhibitor to treat leukaemia with KMT2A translocation
On 15th November, Syndax Pharmaceuticals announced FDA approved for Revuforj® (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukaemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and paediatric patients one year and older.
Ardena’s new state-of-the-art nanomedicine facility granted full GMP approval
On 18th November, Ardena, a specialist pharmaceutical Contract Development and Manufacturing Organisation (CDMO), announced it has received full Good Manufacturing Practice (GMP) approval for its expanded nanomedicine facility in Oss. Granted by the Dutch Healthcare Authority, the approval enables GMP manufacturing operations for nanomedicines, marking a major milestone in Ardena’s mission to support clients in bringing innovative therapies to clinic and to market. The authorisation follows a €20m investment in a 45,000 sq. ft facility that comprises GMP-compliant Grade C and Grade D cleanrooms specifically designed for nanomedicine manufacturing.
Sparsentan approved in UK to treat primary immunoglobulin A nephropathy
On 18th November, the MHRA announced the approval of sparsentan for treating primary immunoglobulin A nephropathy (IgAN), a kidney disease caused by IgA buildup. Sparsentan works by blocking receptors for endothelin and angiotensin, which helps reduce kidney inflammation and slow disease progression. The MHRA will continue monitoring its safety and effectiveness, urging patients to report any side effects through the Yellow Card scheme.
FDA approves first generic propofol injectable emulsion for dogs
On 18th November, the FDA approved PropofolVet Multidose, the first generic propofol injectable emulsion for dogs. It is approved for use as an injectable anaesthetic in dogs and contains the same active ingredient (propofol injectable emulsion) as the approved brand name drug product, PropoFlo 28.
WHO grants Emergency Use Listing for LC16m8 mpox vaccine
On 19th November, the World Health Organisation (WHO) announced it has granted Emergency Use Listing (EUL) for the LC16m8 mpox vaccine, which is the second approved for use during the current outbreak. The vaccine, developed by KM Biologics, is recommended for individuals over one year old and administered as a single dose via a bifurcated needle.
Issue Number: WN00189
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