Tower Mains Weekly Newsletter

Regulatory Updates

International Council on Harmonisation (ICH) M10 Guideline Issued

On 27th July, final ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis has been published. This guideline provides recommendations for the validation of bioanalytical methods and their application in the analysis of study samples. Additional supporting guidance, ICH guideline M10 on bioanalytical method validation and study sample analysis – Frequently Asked Questions, has also been issued.

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US Food and Drug Administration (FDA) Guidance Updates

The following US FDA final guidance documents have been issued:

  • Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings Guidance for Industry issued on 27th of July – Click to view source
  • General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry issued on 27th of July – Click to view source
  • Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry issued on 29th of July – Click to view source
  • Policy Regarding N-acetyl-L-cysteine: Guidance for Industry issued on 1st of August- Click to view source

Additionally, the following draft guidance documents have been issued:

  • Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff issued on 28th of July- Click to view source
  • Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Draft Guidance for Industry on 2nd of August- Click to view source

Medicines and Healthcare products Regulatory Agency (MHRA) News

The following updates have been made on the MHRA’s website:

  • Updated list of accredited Phase I units on 26th of July – Click to view source
  • Updated lists of medical devices given exceptional use authorisations andmedical devices that are no longer covered by an exceptional use authorisation during the COVID-19 pandemic on 27th of July – Click to view source
  • Updated list of suspended manufacturing and wholesale distribution authorisations on 28th of July – Click to view source
  • Updated list of expired orphan registrations on 1st of August – Click to view source

Big Data Steering Group Publication of 2022-2025 Workplan

On 28th of July, the Big Data Steering Group set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published its workplan that sets actions to be undertaken between 2022–2025. It will lead to further enhancement of the efficient integration of data analysis into the evaluation of medicinal products by regulators, the workplan deliverables include but are not limited to the following:

  • Data quality
  • Data discoverability
  • EU network skills

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EMA Payable Fees Update

On 1st of August, the EMA has revised their implementing rules to the Fee Regulation, as a result, the following documents have been issued:

  • Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures – Click to view source
  • Explanatory note on general fees payable to the European Medicines Agency- Click to view source

Industry Updates

Ipsen and Marengo Therapeutics Partner to Advance Precision Immuno-oncology Candidates

On 1st of August 2022, Ipsen and Marengo Therapeutics announced establishment of a collaboration to advance two of Marengo’s preclinical Selective T Cell Activation Repertoire (STAR) platform-generated candidates into the clinic. As basis of their partnership, they will be using Marengo’s novel mechanism of T cell activation, STAR platform a multi-specific fusion protein library, and Ipsen’s clinical development and commercialisation oncology capabilities.

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Tevogen Bio Reveals Attaining Positive Safety Data Upon Enrolment Completion in T cell Therapy Trial of Elderly or High-Risk COVID-19 Patients

On 1st of August 2022, Tevogen Bio, a late-stage clinical biotechnology, announced completing enrolment in the Proof-of-Concept clinical trial of TVGN-489, for elderly or high-risk ambulatory COVID-19 patients. Patients were infected with the Delta variant at an early stage of the trial with successive patients having Omicron and its lineage subvariants. For all patients and at any dose level, no dose-limiting toxicities or significant treatment-related adverse events were observed.

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US FDA Halts Testing of Beam Therapeutics’ Genetic Base Editing Cancer Therapy

On 1st of August 2022, Beam Therapeutic, a biotechnology company developing precision genetic medicines through base editing, announced that they have been informed via communication from the US FDA that they are required to halt testing of their preclinical cancer medicine (BEAM-201). The regulator will provide the company with an official clinical hold letter within 30 days. The company plans to provide additional updates pending discussion with the US FDA.

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Issue Number: WN00072

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