Tower Mains Weekly Newsletter

Regulatory Updates

MHRA guidance updates

  • On 9th December, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on how to get a parallel import licence in the UK, including pharmacovigilance requirements and submitting an application. Click to view source
  • On 13th December, the list of medicines that cannot be exported from the UK or hoarded because they are needed for UK patients was updated. Click to view source

FDA issues final guidance describing actions for homeopathic drug products

On 7th December, the US Food and Drug Administration (FDA) issued final guidance describing the agency’s approach to prioritising enforcement and regulatory actions for homeopathic products marketed in the US without the required FDA approval. The FDA has developed a risk-based approach under which the Agency intends to prioritse specific categories of homeopathic drug products that potentially pose a higher risk to public health.

Click to view source

Industry Updates

FDA approves extension of indication for Endomagnetics Ltd. Magtrace and Sentimag Magnetic Localization System for breast cancer staging procedures

On 7th December, the FDA approved an expansion of the indications for use for the Endomagnetics Ltd. Magtrace and Sentimag Magnetic Localization System to use in patients with breast cancer undergoing mastectomy or lumpectomy. The system uses an injection of a tracing agent, Magtrace, to assist in sentinel lymph node biopsies, which are used to determine whether the cancer has spread beyond the initial tumor.

Click to view source

FDA authorises bivalent COVID-19 vaccines for children down to 6 months of age

On 8th December, the FDA amended the emergency use authorisations (EUAs) of the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children from six months of age.

Click to view source

ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2

On 8th December, the European Medicines Agency (EMA) announced its Emergency Task Force (ETF) has warned that monoclonal antibodies currently authorised for COVID-19 are unlikely to be effective against emerging strains of SARS-CoV-2. These monoclonal antibodies are designed to neutralise the virus by binding to the spike protein on its surface, however, emerging strains have mutations in this protein which can reduce the ability of the antibodies to bind to them. Although it is not yet known to what extent the reduced neutralising activity translates into reduced benefits for patients, healthcare professionals must consider alternative treatments, especially if subvariants such as BQ.1 and BQ.1.1 become widespread.

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FDA approves first oral treatment for cats with diabetes mellitus

On 8th December, the FDA announced the approval of the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Bexacat is also the first sodium-glucose cotransporter 2 (SGLT2) inhibitor new animal drug approved by the FDA in any animal species. An SGLT2 inhibitor is not insulin and is not for use in cats with the type of diabetes mellitus that requires insulin treatment. The labelling for Bexacat includes a boxed warning regarding the critical need for appropriate patient selection and the potential for certain severe adverse reactions.

Click to view source

EMA issues highlights from the latest CHMP meeting

On 9th December, the EMA issued meeting highlights from the latest CHMP meeting held on the 6th-8th December 2022. Highlights include opinions on veterinary medicinal products, union referrals, and related procedures, and the adoption of a draft concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products (EMA/CVMP/637041/2022) for a three-month period of public consultation.

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MHRA publishes reminder of the potential risks of valproate

On 12th December, the MHRA published an article to remind healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements and to provide information about the potential risks of valproate in other patients following a review of the latest safety data. Following advice from the Commission on Human Medicines (CHM), new safety measures for valproate-containing medicines will be implemented in the coming months. Patients currently taking valproate must be advised not to stop taking it unless a specialist advises them to do so, and any patient who thinks they are pregnant while on valproate should be advised to talk to a specialist urgently.

Click to view source

European Commission proposes EMA fee update

On 13th December, the European Commission announced a proposal to update and simplify the legislation on fees charged by the EMA. The main objective is to ensure that these fees reflect better the underlying costs of the work done and coordinated by EMA.

Click to view source

Issue Number: WN00091

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