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How TRB is proactively addressing the new European Medical Devices Regulation (MDR)
The new European Medical Devices Regulation (MDR) just came into effect, with immediate application for new medical devices, generating an interesting debate. Some players welcome this major change which will align national regulations, and believe it will help to remove from the market several medical devices with limited evidence and quality control.
Others highlight that the lack of enforcement of the directives in the past rather than the gaps in regulations originated a critical situation and therefore the need for a new MDR. Still others argue that some of the new, more restrictive regulations might be detrimental to innovation. For example, the classification of most medical software has shifted to class IIa or higher, thereby putting many start-ups and medical applications under pressure.
Irrespective of any personal opinion with regard to this regulation, the more demanding reviewing processes are meant to ensure safer and more effective solutions to the patient’s health conditions.
As a non-exhaustive list of the key changes impacting our products and dossiers we can quote:
- Risk classification of devices and scope of the Regulations
- Clinical investigations and performance studies
- Obligations and regulatory requirements of economic operators
- Traceability
- Identification
- Labelling and instructions for use
You will be able to find a more comprehensive overview on the changes in the Factsheet for healthcare professionals and health institutions, published by the European Commission.
As a Swiss pharmaceutical company, it is our duty to meet some of the highest quality standards in the world and stay one step ahead. That is why we have taken a proactive stance towards being MDR compliant. Our OSTENIL® Line, focused on rheumatology and tendinopathy, received MDR approval and new registrations for OSTENIL®, OSTENIL® Plus, OSTENIL® Mini and OSTENIL® Tendon from the 1st semester of 2022.
In a similar fashion, although we still have a few years until the deadline to switch our VISMED® ophthalmology line over to MDR, our regulatory departments are working extensively to make sure our products will be ready for conformity assessments as well as seamlessly available on the European market.
To learn more about our products, visit your local website.
TRB Chemedica announces a collaboration with InnoMedica to develop liposomal GM1
TRB Chemedica International S.A. and InnoMedica Holding AG enter in a long-term relationship regarding the production of GM1 (monosialotetrahexosylganglioside) and its development as a liposomal formulation under the trade name Talineuren®.
Geneva, January 7, 2019 – TRB Chemedica and InnoMedica signed recently a letter of intent, agreeing to collaborate for the production and development of GM1 as liposomal formulation. Gangliosides are sialic acid-containing glycosphingolipids that are naturally present in the plasma membrane of most vertebrate cells, particularly in the nervous system where they constitute up to 10% of the total lipid mass in the brain. They play important roles in many physiological processes including cell differentiation, apoptosis, neuronal protection and neutrotrophins release.1 TRB Chemedica has dedicated significant research resources over many years to better understand the neuroprotective effects of GM1 on neurons and astrocytes to evaluate its potential in the treatment of neurological disorders.
InnoMedica started its venture in 2013. The independent pharmaceutical company develops innovative medicines in the field of liposomal drug delivery systems using a patent-protected technology platform. Liposomal GM1 is currently being developed as Talineuren® for use in neurological diseases such as Parkinson’s disease, Huntington’s disease or amyotrophic lateral sclerosis. Thanks to its specific composition, Talineuren® is able to cross the blood-brain barrier and to deliver drugs directly into the brain. This has been confirmed in preclinicial studies performed by InnoMedica in Parkinson’s and Huntington’s disease models. Liposomal formulation can be administrated orally, which is expected to simplify the mode of administration of GM1 as opposed to intravenously or intramuscularly injections and to reduce side effects.
TRB Chemedica’s GM1 is produced in Vouvry, Switzerland, under GMP conditions via a proprietary production process entirely developed and scaled up on the Vouvry site. A ganglioside powder is initially obtained after different steps of cleaning, extraction and purification. It constitutes the principal raw material of the GM1 active ingredient. This raw material undergoes various industrial and biochemical treatments, including concentration and dialyses. After this processing, it then goes through an ion exchange resin based column in order to obtain a high purity GM1.
The collaboration between TRB Chemedica and InnoMedica is considered strategically important for successful clinical translation and large-scale manufacturing of liposomal GM1. InnoMedica already uses TRB Chemedica’s GM1 for the production of Talineuren® and TRB Chemedica agreed to adapt its production of GM1 based on Talineuren® clinical development steps.
References:
- Aureli M, Mauri L, Ciampa MG, Prinetti A, Toffano G, Secchieri C, et al. GM1 ganglioside: Past studies and future potential. Mol Neurobiol. 2016;53(3):1824-42.
Are more expensive products any more clinically effective?
Do the more expensive products work better? It’s an interesting talking point and one I often find myself discussing with many an intrigued user. Do the more expensive Hyaluronic Acid products work better? Why do people pay almost four times the price for some injections? What’s the justification? SURELY they must be more effective? Last longer? Safer?
Read the European Business magazine interviews of Alessandro di Napoli
Alesandro Di Napoli talks about treating the symptoms of modern life.
Presentation of DISSCO results at the WCO-IOF-ESCEO congress in Paris (past event)
Geneva, March 5, 2019 – We are proud to announce the presentation of the results from the DISSCO (an international, multicentre, double-blind, randomised study of the effect of DIacerein vs celecoxib on Symptoms and Structural Changes in symptomatic knee Osteoarthritis patients as assessed by magnetic resonance imaging) study at the upcoming World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) which will take place on April 4-7 in Palais des Congrès, Paris.
DISSCO is an international, randomized clinical trial which compared the efficacy of diacerein and celecoxib in patients suffering from painful knee osteoarthritis Kellgren-Lawrence grade II-III. Patients were randomized to receive either diacerein 50 mg q.d. during one month and then 50 mg b.i.d., or celecoxib 200 mg b.i.d. The primary objective of DISSCO was to demonstrate the non-inferiority of diacerein versus celecoxib on pain reduction measured with the Western Ontario and McMaster Universities Arthritis Index pain subscale after six months of treatment. The second part of the study, which will evaluate structural changes in patients after two years of therapy, is currently ongoing in Canada.
The poster “DISSCO study: an international, multicenter, double-blind, randomized study on the effect of Diacerein versus Celecoxib on symptoms in knee osteoarthritis patients” by Prof. Jean-Pierre Pelletier and colleagues will present the first results of this study and has been selected for an oral presentation on Saturday 6 at 14:07. The poster will also be presented at the congress the whole day on Friday 5 (poster P170).