Tower Mains Weekly Newsletter

Regulatory Updates

MHRA updates guidance on its Software and AI as a Medical Device Change Programme

On 17th October, the Medicines and Healthcare products Regulatory Agency (MHRA) added a roadmap to the guidance on its programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).

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Industry Updates

Consultation on how MHRA communicates with healthcare professionals

On 13th October, the MHRA launched a consultation on its approach to engagement with healthcare professionals to ensure that they are receiving actionable information and guidance on the safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients. Healthcare professionals and their professional bodies have been urged to share their views and influence regarding safety communications and safety reporting systems. The consultation closes at 11:45am on 18th January 2023.

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First therapy to treat transplant patients with post-transplant lymphoproliferative disease

On 14th October, the European Medicines Agency (EMA) announced it has recommended a marketing authorisation in the EU for Ebvallo for the treatment of adult and paediatric patients who experience a serious complication following solid organ transplantation (SOT) or bone marrow transplantation (hematopoietic cell transplant – HCT) called EBV+ PTLD, one of the most important malignancies after transplantation. Ebvallo is indicated in patients after a transplant and who have received at least one prior therapy when the symptoms of the disease come back after treatment or when the treatment does not work.

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FDA announces the authorisation of medical device for patients receiving cancer treatment

On 14th October, the US Food and Drug Administration (FDA) announced it has authorised the marketing of the Cooral System, a device intended to cool the inside of the mouth during chemotherapy cancer treatment to reduce the likelihood and severity of oral mucositis (OM), which is swelling and irritation inside the mouth. The device is prescription only and intended for adult patients.

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New vaccine to protect people against dengue

On 14th October, the EMA’s human medicines committee (CHMP) adopted a positive opinion for Dengue Tetravalent Vaccine Takeda, used to prevent disease caused by dengue virus serotypes 1, 2, 3, and 4 in people from four years of age. The CHMP has reviewed the vaccine for the EU market, under the centralised procedure, and non-EU countries, under the ‘EU-Medicines for all’ programme – or EU-M4all. The EMA’s initiative to support parallel applications for the EU-M4all opinion, and the centralised procedure aims to make innovative or generic medicines and vaccines that address unmet medical needs or are of major public health interest available in Europe and globally faster while avoiding duplication of efforts from regulators.

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FDA awards 19 grants and two contracts related to rare diseases

On 17th October, the FDA announced it has awarded 19 new grants and two new contracts totalling more than $38 million in funding over the next four years to support clinical trials, natural history studies, and regulatory science tools related to rare diseases. These grants and contracts, which were funded by the FDA’s Orphan Products Grants Program, aim to advance the development of medical products to treat rare diseases. Several awards support the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (ACT for ALS) which recently established the FDA Rare Neurodegenerative Disease Grant Program to promote medical product development for rare neurodegenerative diseases such as ALS.

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London medicines wholesale business sentenced for illegally importing and distributing over £2.9m of medicines

On 19th October, the owner of a medicines wholesale business was sentenced at Southwark Crown Court to 20 weeks imprisonment, suspended for 12 months, and community service after pleading guilty on 20th June 2022 to importing and distributing medicines worth over £2.9m sale value without holding the correct licenses.

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European Commission to host Biosimilar Multistakeholder Event

On 19th October, the European Commission announced it will host a full-day hybrid “Biosimilar Multistakeholder Event” on Tuesday, 13th December 2022. Highlights will include the impact of biosimilar competition in Europe, the interchangeability of biosimilars, and the full potential of biosimilars.

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Issue Number: WN00083

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