Tower Mains Weekly Newsletter

Industry Updates

EMA approves adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2

On 12th September, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. In its decision to recommend the authorisation of Comirnaty Original/Omicron BA.4-5, the CHMP considered all the available data on Comirnaty and its adapted vaccines, including the recently authorised adapted vaccine Comirnaty Original/Omicron BA.1 as well as investigational vaccines against other variants of concern.

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FDA issues safety alert for squamous cell carcinoma and various lymphomas in scar tissue around breast implants

On 8th September, the US Food and Drug Administration (FDA) issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants. After an initial extensive review, the agency believes that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare. However, in this case, and when safety risks with medical devices are identified, it wanted to provide clear and understandable information to the public as quickly as possible.

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FDA and EMA accept regulatory submission for Pfizer’s Ritlecitinib for individuals with Alopecia Areata

On 9th September, Pfizer Inc. announced that the FDA accepted the New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata and is expected to decide in the second quarter of 2023. The EMA has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the same patient population with a decision anticipated in the fourth quarter of 2023. Ritlecitinib is an investigational oral once-daily treatment that is the first in a new class of oral highly selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine kinases and Janus kinase 3 (JAK3).

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FDA reissues Novavax COVID-19 vaccine authorisation letter

On 12th September, the FDA reissued the August 19th, 2022, letter of authorisation for Novavax COVID-19 Vaccine, Adjuvanted with revised conditions of authorisation related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax, Inc. to include myocarditis and pericarditis. The Fact Sheet for Healthcare Providers Administering Vaccine has also been updated to reflect this revision.

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Unauthorised medicinal products used in clinical trials: labelling rules

Annex VI of 536/2014 (Clinical Trial Regulation) had changes adopted to alleviate the restrictions caused by the need to have the expiry date on the inner label. The aim is to prevent additional safety and quality risks associated with the relabelling procedure and the need for more frequent re-supply, which may lead to delays in clinical trials.

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WHO launches guide to safely unlock benefits of the life sciences

On 13th September, the World Health Organisation (WHO) issued the Global guidance framework for the responsible use of the life sciences. This is the first global, technical, and normative framework for informing the development of national frameworks and approaches for mitigating bio risks and governing dual-use research. It aims to safely unlock the great promise for new and improved ways to improve global health offered by life sciences and related technologies.

Click to view source and Molecular Devices collaborate to automate cardiac organoids

On 12th September, AG, a biotech company developing cardiac organoids (Cardioids) for drug discovery, announced it had entered into a co-development agreement with Molecular Devices, LLC., a leading provider of high-performance life science solutions. The collaboration will provide automated solutions to better model disease physiology, discover novel drug targets, and test cardiac toxicity using 3D cell cultures that more accurately represent human biology as compared to traditional animal models. The commercialized offering will enable researchers to reliably scale the production of Cardioids and advance cardiac drug discovery.

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FDA publishes draft guidance on risk-based computer software assurance activities

On 13th September, the FDA issued draft guidance, Computer Software Assurance for Production and Quality System Software, to provide recommendations on risk-based computer software assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system. The draft guidance is intended to describe “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality systems, identify where additional rigor may be appropriate, and describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfil regulatory requirements.

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Issue Number: WN00078

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