Tower Mains Weekly Newsletter

Company Updates

RQA RE: UNITED International Conference

We are delighted to be attending the Research Quality Association (RQA) RE: UNITED International Conference, 9th-11th November 2022. If you’re there, make sure to visit booth #16 for a chat and to help us celebrate our 21st birthday with one of your favourite Scottish delicacies (Tunnock’s Tea Cakes or Caramel Wafers!) … don’t forget to bring your cup of tea!

Tower Mains welcomes Robert King

Tower Mains is delighted to welcome Robert King to the team! Robert joins us as Principal Associate and comes with a wealth of experience and over 15 years in the pharmaceutical industry (both human and veterinary). His experience includes conducting a range of audits including internal audits and vendor audits for API, OSD, and Sterile medicinal products against GDP and GMP requirements. Other experience includes the delivery of GMDP training preparation and hosting of client audits and regulatory inspections; as well as support/review of internal Pharmaceutical Quality Systems. Welcome, Robert!

Regulatory Updates

MHRA guidance updates

  • On 7th November, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidelines on the licensing of biosimilar products. The ‘Interchangeability’ section was updated with “Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP.” Click to view source
  • On 8th November, the MHRA updated its guidance on clinical trials for medicines. Information on the grace period for users of the eSUSAR website to continue collecting historical reports has been removed as it has come to an end. Click to view source

FDA final guidance on studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

On 4th November, the US Food and Drug Administration (FDA) published final guidance on Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial. The guidance provides recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial for a single disease. Sponsors have expressed interest in gathering preliminary evidence of safety and activity using multiple versions of a cellular or gene therapy product in a single clinical trial. Although multiple versions of a product can be studied together in a single clinical trial, each version of the product is distinct and is generally submitted to FDA in a separate investigational new drug application (IND). The objective of these early-phase clinical studies is to guide which version(s) of the product to pursue further development in later-phase studies.

Click to view source

Industry Updates

Third meeting of the IHR Emergency Committee regarding the monkeypox outbreak

On 1st November, the World Health Organisation (WHO) published details on the third meeting of the International Health Regulations (2005) (IHR) Emergency Committee concerning the multi-country outbreak of monkeypox which was held on Thursday, 20th October 2022. The Emergency Committee acknowledged that progress has been made in the global response to the outbreak of monkeypox since the last meeting, including the emerging information on the effectiveness of behavioural interventions and vaccines, and highlighted the primary reasons for ongoing concern.

Click to view source

Pfizer’s elranatamab granted FDA Breakthrough Therapy Designation for multiple myeloma

On 3rd November, Pfizer Inc. announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the FDA for the treatment of people with relapsed or refractory multiple myeloma (RRMM). Elranatamab is a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb). The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a medicine that is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies.

Click to view source

FDA releases updates on bebtelovimab

On 4th November, the FDA updated information on bebtelovimab to include the expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2; this shows that bebtelovimab is not expected to neutralise Omicron subvariants BQ.1 and BQ.1.1. Several treatments are authorised or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1, including Paxlovid, veklury, and lagevrio

Click to view source

MHRA Inspectorate: Return to International GMP Inspections

On 8th November, the MHRA Inspectorate published a blog post on returning to international GMP Inspections. Following a successful pilot, the MHRA is now resuming its programme of international onsite inspections. The agency will be adopting a risk-based approach, prioritising inspections with the greatest impact on UK public health and patient safety, and it will do this in conjunction with its product licence assessors and using existing risk-based inspection (RBI) tools. Whilst it is implementing this return to international inspections, the MHRA urges sites not to contact them to arrange a routine inspection or to enquire about when they can expect their inspection; the agency will make contact when they can arrange each inspection. To read more, click here.

MHRA regulatory approval of COVID-19 vaccine Nuvaxovid

On 9th November, the Information for healthcare professionals and the public about the COVID-19 vaccine Nuvaxovid following its approval for use as an adult booster for those aged 18 and above.

Click to view source

Issue Number: WN00086

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