Tower Mains Weekly Newsletter

Industry Updates

EMA recommends authorisation of two monoclonal antibody medicines

​​​​On 11th November, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) had recommended authorising Ronapreve and Regkirona for the treatment of COVID-19. The CHMP will now send its recommendations for both medicines to the European Commission for rapid legally binding decisions. Both medicines are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for COVID-19 and join the list of COVID-19 products that have received a positive opinion since Veklury (remdesivir) was recommended for authorisation in June 2020.

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EMA recommends first-in-class medicine for the treatment of rare blood vessel inflammation

​​​​On 12th November, the EMA announced it had recommended granting a marketing authorisation in the European Union (EU) for Tavneos, a first-in-class medicine to treat adult patients suffering from two forms of a rare multisystem autoimmune condition – granulomatosis with polyangiitis and microscopic polyangiitis Tavneos is to be used in combination with rituximab or cyclophosphamide – two medications used to treat certain autoimmune diseases and types of cancer. The opinion adopted by the CHMP is an intermediary step on the medicine’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

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FDA approves treatment for rare blood disease

​​​​On 12th November, the US Food and Drug Administration (FDA) approved Besremi injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots. Besremi is the first FDA-approved medication for polycythemia vera that patients can take regardless of their treatment history, and the first interferon therapy specifically approved for the disease. The effectiveness and safety of Besremi were evaluated in a multicentre, single-arm trial that lasted 7.5 years. In this trial, fifty-one adults with polycythemia vera received Besremi for an average of about five years.

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MHRA updates guidance on GLP for safety tests on chemicals

​​​​On 15th November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated information on the current members of the UK Good laboratory practice (GLP) compliance monitoring programme.

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FDA updates test policies to help ensure accuracy and reliability of COVID-19 tests

​​​​On 15th November, the FDA announced it was taking important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centres, and emergency rooms without having to be sent to a central lab for testing.

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MHRA updates guidance on managing clinical trials during COVID-19

​​​​On 16th November, the MHRA updated its guidance on how investigators and sponsors should manage clinical trials during COVID-19. It updated information with regards to Urgent Safety Measures (USM). As of 16th November 2021, the notification of USMs to the MHRA should be performed following the standard procedure for USMs notifications as detailed here: Urgent Safety Measures.

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FDA authorises marketing of immersive virtual reality system for chronic pain reduction

​​​​On 16th November, the FDA announced it had authorised the marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioural therapy and other behavioural methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.

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MHRA publishes November’s Drug Safety Update newsletter

​​​​On 16th November, the MHRA issued the PDF edition of November’s Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines.

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MHRA issues roundup of COVID-19 updates for November 2021

​​​​On 16th November, the MHRA issued a roundup of the information relating to COVID-19 vaccines and medicines published since the October 2021 issue of Drug Safety Update, up to 12 November 2021.

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Two billion doses of AstraZeneca’s COVID-19 vaccine supplied across the world less than a year after first approval​​​​

On 16th November, AstraZeneca announced that two billion doses of its COVID-19 vaccine had been supplied to countries across the world less than 12 months after first approval. The milestone comes just over 18 months after AstraZeneca and Oxford University formed their partnership for the global development and distribution of a not-for-profit COVID-19 vaccine for the world and less than 12 months after its first emergency authorisation in the UK.

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MHRA updates information on Pfizer/BioNTech vaccine

​​​​On 16th November, the MHRA updated sections of the Summary of Product Characteristics and Patient Information Leaflet for COVID-19 Vaccine Pfizer/BioNTech (Conditional Marketing Authorisation documents) to include information about receiving a third dose. Also to include two new reagents, Sodium Hydroxide and Hydrochloric Acid, which are used in small quantities during the preparation of one of the solutions used in the manufacturing process. The official International non-proprietary name ‘tozinameran’ has also been added.

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EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine

​​​​On 16th November, the EMA announced it had started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid. The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety, and quality of the vaccine. If EMA concludes that the benefits of Nuvaxovid outweigh its risks in protecting against COVID‑19, it will recommend granting a conditional marketing authorisation.

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Issue Number: WN00037

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