Tower Mains Weekly Newsletter

Company Updates

Scotsman Life Sciences Conference 2022

Tower Mains is delighted to be exhibiting at the Scotsman Life Sciences Conference 2022 this Thursday 24th November in Glasgow. If you’re there, pop along to our stand for a chat… our Head of QA Shona Ross, and Head of Operations Lianne Roeling will be waiting to say hi!

Regulatory Updates

MHRA updates guidance

  • On 17th November, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of medicines that cannot be exported from the UK or hoarded because they are needed for UK patients. Click to view source
  • On 18th November, the MHRA updated its guidance on the European Commission (EC) Decision Reliance Procedure to reflect the extension of 12 months granted in September 2022. Click to view source
  • On 21st November, clinical investigation numbers for 2021 were added to the guidance on notifying the MHRA about a clinical investigation for a medical device. Click to view source

Compounding certain beta-lactam products in shortage under section 503A of the Federal Food Drug and Cosmetic Act

On 18th November, the US Food and Drug Administration (FDA) published final guidance describing the agency’s regulatory and enforcement priorities regarding the preparation of beta-lactam oral antibiotic suspension products that appear on the FDA’s drug shortage list.

Click to view source

Industry Updates

MHRA Inspectorate Blog: Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed cannabis-based products for medicinal use

On 16th November, the MHRA Inspectorate published a blog providing information on what authorisations are required to manufacture cannabis-based medicinal products or active pharmaceutical ingredients.

Click to view source

FDA warns companies for illegally selling dietary supplements with claims to treat cardiovascular disease

On 17th November, the FDA issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, relieve, or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke, or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letter.

Click to view source

FDA approves first drug that can delay the onset of Type 1 Diabetes

On 17th November, the FDA approved Tzield injection to delay the onset of stage 3 type 1 diabetes in adults and paediatric patients 8 years and older who currently have stage 2 type 1 diabetes. Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes and is administered by intravenous infusion once daily for 14 consecutive days. It received Priority Review and Breakthrough Therapy designations for this indication.

Click to view source

ICMRA issues report on best practices to fight antimicrobial resistance

On 21st November, the International Coalition of Medicines Regulatory Authorities (ICMRA) highlighted successful regulatory and non-regulatory interventions used in different countries to address the growing public health problem of antimicrobial resistance (AMR) in a new report. Tackling AMR is one of ICMRA’s strategic priorities and the authority recognises that it is a complex, multifaceted problem and calls for better coordination across all sectors, including public health, animal health and the environment, through a ‘One Health’ approach.

Click to view source

EMA establishes Quality Innovation Expert Group to support medicine innovation

On 21st November, the European Medicines Agency (EMA) announced it has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the EU. These include, but are not limited to, new technologies, digitalisation, novel materials, and novel devices, in line with the priorities highlighted in EMA’s Regulatory Science Strategy for 2025. The group will also be a forum for exchange and interaction within the EU regulatory network, as well as between EU regulators and stakeholders such as academia and industry.

Click to view source

FDA approves first gene therapy to treat Hemophilia B

On 22nd November, the FDA approved Hemgenix, an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, or have a current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes. Hemgenix is a one-time gene therapy product given as a single dose by IV infusion and consists of a viral vector carrying a gene for clotting Factor IX. This gene is expressed in the liver to produce Factor IX protein, to increase blood levels of Factor IX, and thereby limit bleeding episodes. This application received Priority Review, Orphan, and Breakthrough Therapy designations.

Click to view source

ICH releases details from its November Assembly Meeting

On 22nd November, the International Council for Harmonisation (ICH) released details on its Assembly Meeting which took place on the 15th and 16th of November 2022 in the Republic of Korea. The meeting provided an important opportunity to advance the work of ICH’s thirty-three Working Groups and key activities including training and brought together a total of 20 Members and 36 Observers.

Click to view source

Issue Number: WN00088

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