Tower Mains Weekly Newsletter

Industry Updates

MHRA updates guidance on how it involves patients and the public in regulatory decision-making

​​On 8th October 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how the agency engages and involves patients and the public in their regulatory decision-making. The section ‘Other examples of patients’ involvement in our regulatory processes’ was edited.

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FDA approves innovative treatment for pediatric patients with congenital athymia

​​On 8th October 2021, the US Food and Drug Administration (FDA) announced that it had approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic improved survival of children with congenital athymia and it reduced the frequency and severity of infections over time. Rethymic is the first thymus tissue product approved in the US.

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FDA announces several actions related to surgical stapler and staple regulation and safety

On 8th October 2021, the FDA announced several actions related to surgical stapler and staple regulation and safety including final guidance that describes labelling recommendations for manufacturers of surgical staplers and staples for internal use to help promote the safe and effective use of these devices by providing recommendations for developing labelling to communicate information about specific risks, limitations, and directions for use of the device. It also issued a final order reclassifying surgical staplers for internal use from Class I (general controls) to Class II (special controls) and requiring them to undergo premarket review. As a result, surgical staplers for internal use will be subject to more rigorous regulatory requirements, including requiring pre-market notification and special controls to help mitigate known risks of the device.

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EMA starts evaluating application for marketing authorisation for Ronapreve for the treatment of COVID-19

On 11th October 2021, the European Medicines Agency announced it had started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve. Ronapreve, co-developed by Regeneron Pharmaceuticals Inc. and Roche Registration GmbH, is intended for the treatment of COVID-19 in adults and adolescents from 12 years of age who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19, and for the prevention of COVID-19 in adults and adolescents aged 12 years and older. EMA will assess the benefits and risks of Ronapreve under a reduced timeline and could issue an opinion within two months.

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ICMRA issues statement on pre-requisites for regulatory flexibility in pharmaceutical manufacturing change management

The International Coalition of Medicines Regulatory Authorities (ICMRA) issued a statement on the pre-requisites for regulatory flexibility in pharmaceutical manufacturing change management. As regulatory authorities work to extend regulatory reliance and collaborative assessment and refine their tools and approaches to expedite the availability of safe and effective medicines and vaccines worldwide, ICMRA calls on pharmaceutical companies and manufacturers to continually demonstrate their commitment to quality, including striving for better product and process knowledge, ensuring good manufacturing practice (GMP), and implementing an effective pharmaceutical quality system. These collectively enable regulatory authorities to grant suitable flexibilities that can facilitate regulatory decision-making for increased manufacturing capacity for COVID-19 therapeutics and vaccines post approval.

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AstraZeneca’s AZD7442 shows reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial​​

On 11th October 2021, AstraZeneca announced positive results from the TACKLE Phase III COVID-19 treatment trial showing AstraZeneca’s AZD7442, a long-acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19.

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EMA ends review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG

On 12th October 2021, the EMA announced it had ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company withdrew from the process. Since February 2021, EMA’s human medicines committee (CHMP) had been reviewing data on CVnCoV as part of a rolling review, whereby the company submits data as they become available to speed up the evaluation of an eventual marketing authorisation application.

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FDA withdraws temporary guidances for alcohol-based hand sanitisers

​​On 12th October 2021, the FDA announced that it intends to withdraw – effective of 31st December 2021 – temporary guidances outlining policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitiser and alcohol for use in hand sanitisers during the COVID-19 pandemic. Hand sanitisers manufactured before or on the 31st of December 2021 and produced under the temporary guidances must no longer be sold to wholesalers or retailers by March 31, 2022.

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MHRA issues list of marketing authorisations granted in September 2021

​​On 13th October 2021, the MHRA issued its list of marketing authorisations granted in September 2021.

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Issue Number: WN00032

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