Tower Mains Weekly Newsletter

Company Updates

RQA RE: UNITED International Conference

We were delighted to attend and participate in the Research Quality Association (RQA) RE: UNITED International Conference last week. It was great to see so many new and familiar faces! To view our Quality ASAP poster, click here.

Regulatory Updates

Q5A(R2) viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

On 14th November, the US Food and Drug Administration (FDA) published draft guidance concerning the testing and evaluation of the viral safety of biotechnology products and outlining what data should be submitted in marketing applications and registration packages for those products.

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MHRA updates guidance

  • On 16th November, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on registering medical devices to place on the market by adding a link to information on ‘Borderline products: how to tell if your product is a medical device.’ Click to view source
  • On 16th November, the MHRA added a link to the recently published Horizon Scanning Case Study to its Innovation Accelerator guidance. Click to view source

Industry Updates

EMA recommends approval of VidPrevtyn Beta as COVID-19 booster vaccine

On 10th November, the European Medicines Agency (EMA) announced its Committee for Medicinal Products for Human Use (CHMP) has recommended authorising the VidPrevtyn Beta COVID-19 vaccine as a booster in adults previously vaccinated with an mRNA COVID-19 vaccine. The vaccine, developed by Sanofi Pasteur, contains a version of the spike protein found on the surface of the Beta variant of the SARS-CoV-2 virus and an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine. The CHMP concluded that the benefits of VidPrevtyn Beta outweigh its risks and thus recommended granting a standard marketing authorisation in the EU.

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EMA issues highlights from the latest CHMP meeting

On 11th November, the EMA issued meeting highlights from the latest CHMP meeting held on the 7th-10th November 2022. Highlights include recommendations on the extension of therapeutic indications for 11 medicines, COVID-19 updates, and the latest CHMP statistics.

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EMA issues highlights from the latest CVMP meeting

On 11th November, the EMA issued meeting highlights from the latest Committee for Veterinary Medicinal Products (CVMP) held on the 8th-10th November 2022. Highlights include opinions on veterinary medicinal products, limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6, and the adoption of the mandate, objectives and rules of procedure for the European Sales and Use of Veterinary Antimicrobials Working Group (ESUVA WG – name to be confirmed), a new working group proposed to replace the voluntary ESVAC network.

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Enhertu recommended for approval in the EU by CHMP for expanded use

On 14th November, AstraZeneca announced Enhertu has been recommended for approval in the EU as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

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FDA conditionally approves the first drug to manage acute onset of pancreatitis in dogs

On 15th November, the FDA conditionally approved Panoquell-CA1 for the management of clinical signs associated with the acute onset of pancreatitis in dogs. Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalised for treatment of the disease.

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Access Consortium releases statement on GMP Inspections reliance and recognition

On 15th November, the MHRA issued the Access Consortium’s statement on its commitment to reliance and recognition arrangement in Good Manufacturing Practice (GMP) Inspections. GMP Inspection reliance arrangements and formal mutual recognition arrangements are highly effective tools that can help regulatory authorities manage increasing complexity in the manufacturing and supply chain of medicines in a timely manner. Establishing such arrangements reduces duplication of GMP inspections and allows for more efficient use of each authority’s resources, allowing these to be channelled to areas where most needed.

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MHRA publishes case study on developing standards for Adeno-associated virus gene therapies

On 16th November, the MHRA published a Horizon Scanning Case Study on developing standards for Adeno-associated virus (AAV) gene therapies. Horizon scanning at the MHRA leads to external funding being secured, helping our scientists work in a new area of standardisation that will support developers and manufacturers of AAV gene therapies.

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Issue Number: WN00087

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