Tower Mains Weekly Newsletter
Company Updates
New Course: Conducting Laboratory Investigations
When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our new ‘Conducting Laboratory Investigations’ course is designed to equip you with the skills and knowledge to conduct a successful investigation. Our next open course date is the 22nd of November 2023 or if you are interested in this training for your organisation at a time of your choosing, please get in touch at training@towermains.com. For further information, click here.
2023 RQA Conference
We are at the 2023 Research Quality Association (RQA) Conference in Belfast this week, where our Head of Quality Assurance, Shona Ross will also be speaking. If you’re attending, visit us at booth 10, Andrew, Shona, Rhona, and Lianne will be there to say hi!
Regulatory Updates
MHRA guidance updates
Drug Safety Update. On 31st October, the Medicines and Healthcare products Regulatory Agency (MHRA) issued the October issue of the Drug Safety Update newsletter from the agency and its independent advisor, the Commission on Human Medicines. Click to view source
FDA guidance updates
Enforcement policy for certain supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions. On 2nd November, the US Food and Drug Administration (FDA) published final guidance providing clarification on its policies and regulatory review expectations for certain limited modifications affecting the safety and effectiveness of a device required to have an approved PMA or the safety and probable benefit of a device required to have an approved HDE after the COVID-19 public health emergency. Click to view source
Industry Updates
NICE recommends new Parkinson’s treatment
On 26th October, the National Institute for Health and Care Excellence (NICE) announced it has recommended AbbVie’s foslevodopa–foscarbidopa (also called Produodopa) as an option for treating advanced Parkinson’s. The treatment is delivered by an infusion pump and works by releasing the drugs foslevodopa and foscarbidopa into the body where foslevodopa is turned into the chemical dopamine, which is used to transmit messages between the parts of the brain and nerves that control movement.
MHRA to launch the AI-Airlock, a new regulator-monitored virtual area for developers
On 30th October, the MHRA announced it is taking forward the AI-Airlock – its new ‘regulatory sandbox’ – that will provide a regulator-monitored virtual area for developers to generate robust evidence for their advanced technologies. This will support innovators to work within the current regulatory system, identify where their products need to build more evidence needed for a safety and efficacy assessment and help resolve these issues.
MHRA announces new rules for acne drug isotretinoin
On 31st October, the MHRA introduced regulatory changes to strengthen the safe use of isotretinoin, the acne medicine commonly known by the brand names Roaccutane and Reticutan. These include additional safeguards when prescribing isotretinoin to patients under 18 years old, along with closer monitoring of a patient’s mental health and sexual well-being during treatment. T
MedSafetyWeek to take place from 6th-12th November 2023
On 31st October, the MHRA published information on the eighth annual #MedSafetyWeek social media campaign. Running from the 6th-12th November 2023, the campaign will focus on the importance of reporting suspected adverse reactions to medicines and suspected problems with medical devices. The agency is encouraging healthcare professionals to support the campaign and talk to their patients and colleagues about side effects and how to report safety concerns to the Yellow Card scheme.
Operation Pangea: Two million illegally traded medicines and devices seized in the UK so far this year
On 31st October, an update was published on the MHRA’s Operation Pangea, an initiative cracking down on medicines crime. Working with law enforcement partners, the MHRA’s Criminal Enforcement Unit (CEU) seized over two million doses of medicines this year valued at nearly £5 million. Among the products seized in the UK were several prescription-only medicines including anti-depressants, pain medication and human growth hormones.
FDA approves interchangeable biosimilar for multiple inflammatory diseases
On 31st October, the US FDA approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. The approval exemplifies the agency’s commitment to supporting a competitive marketplace for biological products
EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
On 31st October, the European Medicines Agency (EMA) announced that its human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus. The vaccine, known as Nuvaxovid XBB.1.5, is to be used for preventing COVID-19 in adults and children from 12 years of age, and in line with previous recommendations and the European Centre for Disease Prevention and Control (ECDC), those who require vaccination should have a single dose, regardless of their COVID-19 vaccination history.
MHRA authorises treatment for severe alopecia areata in individuals 12 years and older
On 1st November, it was announced that the MHRA has authorised a new medicine called Litfulo (ritlecitinib), an enzyme inhibitor treatment for severe alopecia areata in patients 12 years and older. The active ingredient in the treatment, ritlecitinib, is an enzyme inhibitor that works by reducing the activity of enzymes in the body called JAK3 and TEC kinases, which are involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata.
ViroCell poised to relieve strain on clinical research caused by the viral vector shortage
On 1st November, ViroCell Biologics, a specialist contract development and manufacturing organisation for cell and gene therapy (CGT) clinical trials, announced it is now able to manufacture and globally export viral vectors from Great Ormond Street Hospital’s (GOSH) state-of-the-art manufacturing facility. This follows the grant of a Manufacturer’s Authorisation License (MIA) to GOSH to manufacture viral vectors by the MHRA.
AI twice as accurate as a biopsy when grading aggressiveness of sarcomas
On 2nd November, the Institute of Cancer Research (ICR) announced that a study conducted in partnership with The Royal Marsden NHS Foundation Trust has revealed that artificial intelligence (AI) could be twice as accurate at grading the aggressiveness of some sarcomas as a biopsy. Results suggest that a new AI algorithm could help tailor the treatment of some sarcoma patients more accurately and effectively than a biopsy and the technology could help with the diagnosis of subtypes of the rare disease.
Issue Number: WN00136
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