Tower Mains Weekly Newsletter
Company Updates
Meet our Training Associate Erin Bell. After graduating with an honour’s degree in Microbiology, Erin began her scientific career as a lab technician in a veterinary serology laboratory before transitioning to a global CRO to work in human clinical trials. From here, she progressed her way into a team lead position where she led technical development and troubleshooting, as well as developing and conducting training, before making her way to Tower Mains as Training Associate. Here, Erin tells us what initially attracted her to her role, her career highlights, and what makes her tick outside of work.
Find further information on our range of courses on our website, or if you are interested in discussing your specific training requirements or if you wish to book a course for your group or organisation, please don’t hesitate to contact training@towermains.com.
Regulatory Updates
ICH E6(R3) Principles, Annex 1 and Annex 2
On 19th May, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a draft version of the E6(R2) Guideline “Good Clinical Practice” (GCP), which is under public consultation. The E6(R3) Expert Working Group (EWG) is currently working on the revision of the guideline with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare-related decision-making on drugs and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. When complete, E6(R3) will be composed of an overarching principles and objectives document, Annex 1 and Annex 2.
FDA publishes two Guidance Snapshots to highlight the agency’s commitment to improving the diversity of participants in clinical trials
On 22nd May, the FDA’s Center for Drug Evaluation and Research published two Guidance Snapshots to highlight the agency’s commitment to improving the diversity of participants in clinical trials, and to increase awareness of the 2020 guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, which presents recommendations sponsors can apply to diversify participation in clinical trials. One snapshot set is for industry, and the other set is for patient communities.
Industry Updates
Debiopharm launches pivotal glioblastoma therapy trial
On 17th May, Debiopharm, a Swiss-based biopharmaceutical company aiming to establish future standards of cancer care and infectious diseases, announced the launch of its open-label Phase 1/2 study evaluating Debio 0123, a brain-penetrant and highly selective WEE1 inhibitor, in combination with temozolomide (TMZ) in patients with recurrent or progressive glioblastoma and in combination with TMZ/RT (SOC) in newly diagnosed patients. The initial phase of the study aims to establish the recommended phase 2 doses of the treatment.
FDA approves first oral treatment for moderately to severely active Crohn’s disease
On 18th May, the FDA announced it has approved Rinvoq for adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumour necrosis factor blockers. The drug is the first approved oral product available to treat moderately to severely active Crohn’s disease.
MHRA Patient Safety Alert: Removal of Philips Health Systems V60 and V60 Plus ventilators from service
On 18th May, the MHRA issued updated advice that Philips Respironics V60 and V60 Plus non-invasive ventilators must be permanently removed from use. This advice follows an in-depth review of additional safety evidence and recent regulatory issues in consultation with a number of external stakeholders and the MHRA’s independent Interim Devices Working Group. It has been concluded that the benefits of these devices no longer outweigh the potential risks.
FDA clears new insulin pump and algorithm-based software to support automatic insulin delivery
On 19th May, the FDA announced it has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.
First topical gene therapy for patients with dystrophic epidermolysis bullosa approved in US
On 19th May, the FDA approved Vyjuvek, a herpes simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. Vyjuvek is a genetically modified herpes-simplex virus used to deliver normal copies of the COL7A1 gene to wounds. COL7 molecules arrange themselves into long, thin bundles that form anchoring fibrils that hold the epidermis (skin) and dermis together, which is essential for maintaining the integrity of the skin. The treatment is mixed into a non-active ingredient gel before topical application.
WHO launches global network to detect and prevent infectious disease threats
On 20th May, the World Health Organisation (WHO) announced it is launching a global network to help protect people from infectious disease threats through the power of pathogen genomics. The International Pathogen Surveillance Network (IPSN) will provide a platform to connect countries and regions, improving systems for collecting and analysing samples, using these data to drive public health decision-making, and sharing that information more broadly.
Eisai submits MMA for lecanemab as a treatment for early Alzheimer’s disease in UK
On 22nd May, Eisai Co., Ltd. and Biogen Inc. announced that Eisai has submitted a Marketing Authorisation Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive MHRA. Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
Meeting highlights from the latest EMA CVMP
On 22nd May, the European Medicines Agency (EMA) issued highlights from the Committee for Veterinary Medicinal Products (CVMP), held on the 15th and 16th May 2023.
Approval of new treatment for pneumonia caused by certain bacteria
On 23rd May, the FDA approved Xacduro, a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older.
Issue Number: WN00113
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