Tower Mains Weekly Newsletter
Company Updates
Tower Mains Training
On 20-21st March, Founding Director Andrew Waddell debuted one of our new training courses for 2023 ‘Research Audit and Inspection’. Delegates in attendance included an experienced auditor, auditor in training, delegates who had experience in being audited and those with no exposure to audit at all. The course was a success with all involved. The presentations flowed into workshops that opened the opportunity for all levels of experience to share ideas, understanding and reach valuable conclusions as a team.
If you are interested in participating in Research Audit and Inspection training or would like to check out our other course options for Q2, keep an eye on our website for the upcoming drop!
Alternatively, you can reach out to Erin Bell (erin.bell@towermains.com) Click to view source
Regulatory Updates
The MHRA is set to revamp its regulations for clinical trial approvals in the most significant reform in two decades.
On 21st March, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that they will be announcing a series of new measures that aim to update, improve, and support the UK legislation that underpins the regulation of clinical trials. These are set out to ensure patient safety, create a proportionate and flexible regulatory environment, strengthen the UK as a destination for international trials, and provide a framework that is streamlined, agile and responsive to innovation. This overhaul of regulations will make it easier and faster to gain approval and to run clinical trials in the UK, helping to make it one of the best countries in the world to conduct clinical research for patients and researchers. Click to view source
Industry Updates
FDA news updates
- FDA approve expanded indication of Inspire II Upper Airway Stimulator
On 20th March, the US Food and Drug Administration (FDA) approved for an implantable nerve stimulator that detects patients breathing patterns and maintains an open airway with mild stimulation of the nerves of the tongue to be used by certain paediatric patients with Down Syndrome and severe obstructive sleep apnoea. This device was initially approved in 2014 and is now approved for use by patients between 13 and 18 years of age with the above diagnoses. Click to view source
- Production of human food from cultured animal cells
On 21st March, the FDA completed its second pre-market consultation for a human food made from cultured animal cells. The ability to take a small number of cells from living animals and grow them in a controlled environment to create food is an emerging area of food science. Developments in cell culture technology are allowing food developers to use cells acquired from livestock, poultry, seafood, and others in the production of food. Click to view source
New medicine from Norwegian university extends terminally ill cancer patients lives.
On 22nd March, the American Association for the Advancement of Science (AAAS) reported that a new drug that has been in development by researchers from the Norwegian University of Science and Technology is targeting only cancer cells and stopping their growth. It has been tested on 20 terminally ill cancer patients and is now in phase 2 of development. Click to view source
Marinus Pharmaceuticals receives FDA Orphan Drug Designation for Ganaxolone
On 22nd March, Marinus Pharmaceuticals announced that the FDA have granted orphan drug designation to their drug Ganaxolone for the treatment of Lennox-Gastaut syndrome (LGS). This is the seventh orphan drug designation for the drug, which reinforces its potential as an innovative treatment option for rare epilepsies and seizure disorders, including LGS. Click to view source
Issue Number: WN00104
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