Tower Mains Weekly Newsletter

Industry Updates

MHRA Spikevax vaccine update

On 10th June, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its Spikevax COVID-19 vaccine information to allow for heterologous boosting and to shorten the dose interval between the primary course and booster dose from at least 6 months to at least 3 months.

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EMA publishes 2021 annual report

On 10th June, the European Medicines Agency (EMA) published its 2021 annual report, providing an overview of the agency’s activities and highlighting its most significant achievements. It features main outcomes regarding the evaluation and monitoring of human and veterinary medicines and the European medicines regulatory network’s response to COVID-19 and contains an interactive timeline of important milestones in 2021, allowing readers to explore each topic in more depth.

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EMA’s PRAC recommends the withdrawal of EU marketing authorisations for amfepramone medicines.

On 10th June, the EMA’s safety committee (PRAC) announced it had recommended the withdrawal of EU marketing authorisations for amfepramone obesity medicines. The recommendation follows a review that found that measures to restrict the use of these medicines for safety reasons have not been effective. It found that the medicines were being used for longer than the recommended maximum period of 3 months, thereby potentially increasing the risk of serious side effects, such as pulmonary arterial hypertension and dependency. The committee, therefore, concluded that the benefits of amfepramone medicines do not outweigh their risks and recommended that the medicines be removed from the market in the EU.

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Data strategy for veterinary medicines in the EU

On 10th June, the EMA and the Heads of Medicines Agencies (HMA) announced that have implemented a Veterinary Big Data strategy to 2027 outlining their vision for adopting data-driven, digital innovations in the veterinary medicines’ domain in the EU. Building on key objectives of the recently implemented Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), the strategy aims to converge traditional regulatory practice with innovative digital solutions. It impacts different business areas, such as pharmacovigilance, the fight against antimicrobial resistance (AMR), environmental risk assessment, regulatory submission, innovation of veterinary medicinal products development, and demonstration of efficiency.

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Study reveals molecule in the nervous system may hold key to treating chronic pain

A study by University of Calgary researchers has revealed a potential new way to treat chronic pain using anti-cancer drugs rather than opioid-based pain medication. In the study, the team used drugs for treating lung cancer and a type of brain cancer, testing them on mice to see if they could control pain. They specifically tested for pain resulting from nerve injury and inflammation and found the cancer drugs worked very well. The next step is to secure funding for clinical trials on people suffering from these chronic conditions and explore other types of chronic pain such as abdominal pain and post-surgery pain.

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FDA approves drug to treat alopecia

On 13th June, the US Food and Drug Administration (FDA) approved Olumiant oral tablets to treat adult patients with severe alopecia areata, an autoimmune disorder in which the body attacks its hair follicles, causing hair to fall out, often in clumps. Olumiant is a Janus kinase (JAK) inhibitor that blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. The drug received priority review and breakthrough therapy designations for this indication.

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FDA: Q9(R1) Quality Risk Management

On 14th June, the FDA published draft guidance offering a systematic approach to quality risk management for better, more informed, and timely decisions. It serves as a resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It provides guidance on the principles and tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle.

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MHRA Compliance Monitor (CM) Overview and Application Process

On 15th June, the MHRA updated the eligibility criteria in its Compliance Monitor (CM) guidance.

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Issue Number: WN00065

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