Tower Mains Weekly Newsletter

Industry Updates

EMA issues meeting highlights from February PRAC meeting

On 11th February, the European Medicines Agency (EMA) issued meeting highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) held on the 7th-11th of February 2022. Highlights include the recommendation of suspending hydroxyethyl-starch solutions for infusion from the market and the safety review of Janus kinase inhibitors for inflammatory disorders.

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FDA authorises new monoclonal antibody for the treatment of COVID-19

On 11th February, the US Food and Drug Administration (FDA) issued an emergency use authorisation (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the Omicron variant. Bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age and older) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalisation or death, and for whom alternative COVID-19 treatment options approved or authorised by the FDA are not accessible or clinically appropriate.

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European Commission issues summary report on the public consultation on general pharmaceutical legislation

On 11th February, the European Commission published a summary report and replies to the public consultation on the revision of the general pharmaceutical legislation. This consultation aimed to collect views of stakeholders and the public to support the evaluation of the existing general pharmaceutical legislation on medicines for human use, and the impact assessment of its revision to ensure a future-proof and crisis-resistant medicines regulatory system.

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MHRA Inspectorate: New year, new standards for investigational medicines

On 10th February, the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate published a blog on the new GMP requirements that became effective as of the 31st of January 2022.

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European Commission publishes updated guidance on managing clinical trials during the pandemic

On 11th February, the European Commission published updated guidance on the management of clinical trials during the COVID-19 pandemic.

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MHRA updates guidance on how tests and testing kits for coronavirus (COVID-19) work

On 11th February, the MHRA updated guidance on the types of tests and testing kits for COVID-19, and the specifications for manufacturers. Information was added for COVID-19 test device manufacturers intending to register their device with the MHRA.

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European Commission publishes updated guidances concerning investigational medicinal products in clinical trials

On 14th February, the European Commission published updated guidance on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials and on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials.

FDA publishes 2021 highlights from the Office of Generic Drugs

On 14th February, the FDA published the FDA Voices, “Innovation and Scientific Collaboration Moved the Generic Drug Program Forward In 2021,” authored by Sally Choe, Director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. The document highlights a successful and productive year for generic drugs at the agency, captures key achievements for the program, and links to the new Office of Generic Drugs 2021 Annual Report.

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MHRA publishes February Drug Safety Update

On 15th February, the MHRA published the February issue of its Drug Safety Update newsletter from the agency and its independent advisor the Commission on Human Medicines.

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MHRA publishes guidance on reporting to the UK COVID-19 Antivirals Pregnancy Registry

On 15th February, the MHRA published guidance on reporting to the UK COVID-19 Antivirals Pregnancy Registry. As the safety of COVID-19 antivirals in pregnancy has not been established, it is important to report any pregnancies which occur during the use of an antiviral, including paternal use, to the UK COVID-19 Antivirals Pregnancy Registry. This advice applies to molnupiravir, the combination of PF-07321332 (nirmatrelvir) plus ritonavir, and remdesivir.

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FDA requests public comments on the use of antimicrobials in companion animals

On 15th February, the FDA released a request for public comments about antimicrobial use (AMU) in companion animals (e.g., cats, dogs, horses) and the potential impact of this use on antimicrobial resistance in both animals and people. The FDA’s Center for Veterinary Medicine (CVM) intends to use the information collected to help develop strategies to further promote antimicrobial stewardship in companion animals.

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Human medicines: EMA issues 2021 highlights

On 15th February, the EMA published an overview of its key recommendations of 2021 regarding human medicines. The overview includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.

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Veterinary medicines: EMA issues 2021 highlights

On 15th February, the EMA published an overview of its key recommendations of 2021 regarding the authorisation and safety monitoring of veterinary medicines.

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Issue Number: WN00048

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