Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Company Updates
Merry Christmas and a Happy New Year from all of us!
As we wrap up our final newsletter of 2024, we want to take a moment to thank you for your continued support throughout the year. We wish you a joyful holiday season filled with peace and happiness.
Please note,, we will be closed from Christmas Eve and will be back on Friday 3rd January 2025.
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As of 2025, our weekly newsletter will be going monthly. This change will allow us to deliver more comprehensive coverage of industry news, regulatory updates, and key developments, with detailed insights into the latest updates, all delivered directly to your inbox once a month.
Regulatory Updates
MHRA guidance updates
- Medicines: register to manufacture, import or distribute active substances. On 18th December, the Medicines and Healthcare products Regulatory Agency (MHRA), added guidance on how to register as a manufacturer, importer or distributor of active substances. Click to view source
- In-house manufacture of medical devices in Great Britain. On 16th December, the MHRA added a note to say that that guidance is currently under review. Click to view source
- Medicines: reclassify your product. On 17th December, a webinar recording was added underneath the ‘additional information’ section. Click to view source
- Clinical investigations guidance. On 17th December, the section ‘Northern Ireland’ was updated to include attachments for ‘flow chart’ and ‘accompanying guidance’ and revised wording underneath serious adverse event (SAE) reporting. Click to view source
Announcement of the new Secretary General of the ICH Secretariat
On 13th December, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the appointment of Géraldine Lissalde Bonnet as Secretary General of the ICH Secretariat in Geneva, Switzerland. She is set to assume the role on March 12, 2025.
EMA and HMA overhaul guidance on CCI and personal data for human medicines
On December 18th, the EMA and HMA (Heads of Medicines Agencies) published a major revision of their guidance on identifying commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The update reaffirms the regulatory authorities’ commitment across the European Economic Area (EEA) to transparency, emphasising the importance of both responding to access-to-documents requests and proactively publishing data once a medicine is authorised.
Successful EU pilot sets the stage for ePI implementation
On December 17th, the European Medicines Agency (EMA) released a report on a pilot project aimed at creating and testing electronic product information (ePI) in real regulatory settings. The pilot concluded that the EU regulatory system is largely ready for the introduction of ePI and can progress toward its phased implementation. However, it also highlighted the need for further development, including enhanced functionalities and better integration with existing IT systems.
FDA guidance updates
- Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Non-alcoholic Steatohepatitis (NASH). On 11th December, the FDA published final guidance with detailed information and specifications for the content of the tabulated domains and analysis data sets submitted to the FDA as part of the sponsor’s application for drugs intended to treat noncirrhotic non-alcoholic steatohepatitis (NASH).
- Global Unique Device Identification Database (GUDID). On 17th December, final guidance was published with recommendations on the information necessary for labellers submitting data to the Global Unique Device Identification Database (GUDID). FDA has updated this document to reflect changes to the Global Medical Device Nomenclature (GMDN) field in GUDID.
Industry Updates
McKinsey to pay $650 million to settle investigation into OxyContin marketing with Purdue Pharma
On 13th December, McKinsey & Company, a global management consulting firm headquartered in New York, agreed to pay $650 million to settle both criminal and civil investigations related to its consulting work with Purdue Pharma L.P., the maker of opioids. The settlement addresses McKinsey’s role in advising Purdue on the sales and marketing strategies for its extended-release opioid, OxyContin, including a 2013 engagement where McKinsey recommended strategies to significantly boost OxyContin sales.
FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
On 13th December, the FDA approved Unloxcyt (cosibelimab-ipdl), an antibody targeting programmed death ligand-1 (PD-L1), for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are ineligible for curative surgery or radiation.
Beckley Psytech announces positive topline results from Phase 2a study of ELE-101 for MDD
On 16th December, Beckley Psytech Ltd, a clinical-stage biopharmaceutical company developing effective and accessible medicines for mental health conditions, announced positive topline results from its open-label Phase 2a study of ELE-101 in patients with Major Depressive Disorder (MDD). Initial findings show that ELE-101 can deliver rapid, robust and lasting antidepressant effects for up to 3 months following a single dose.
MindMed commences phase 3 study of MM120 for anxiety disorder
On 16th December, MindMed, a clinical-stage biopharmaceutical company focused on developing innovative treatments for brain health disorders, announced that the first patient has been dosed in its Phase 3 Voyage study of MM120 ODT, a pharmaceutically optimised form of lysergide D-tartrate (LSD) for the treatment of Generalized Anxiety Disorder (GAD). Voyage is the first of two Phase 3 trials assessing the efficacy and safety of MM120 ODT compared to a placebo, with around 200 participants expected to be enrolled in the US.
FDA issues warning to veterinarians over adverse events in dogs treated with Librela
On 16th December, the FDA’s Center for Veterinary Medicine issued a letter to veterinarians concerning its review of adverse events reported in dogs of various ages treated with Librela. The identified and analysed adverse events include ataxia, seizures, and other neurological symptoms such as paresis, recumbency, urinary incontinence, polyuria, and polydipsia. In some cases, these events led to death, including instances of euthanasia.
German cancer centre treats first patient in the world with Elekta Evo
On 17th December, Elekta announced that Diagnostisch Therapeutisches Zentrum Berlin (DTZ) has become the first facility globally to treat a patient using Elekta Evo, the company’s AI-powered adaptive CT-Linac. The first patient treated at DTZ is a 62-year-old man undergoing curative treatment for bladder cancer.
Issue Number: WN00193
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