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Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The FDA has also recently launched the Software Pre-Certification Pilot Program to provide an efficient regulatory framework for developers of SaMD products.
Oramed Pharmaceuticals, a company focused on the development of oral drugdelivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate.
Being hailed as the world’s shortest and thinnest needle for insulin injection, Droplet Micron has recently been introduced into the pen needle market by HTL (High Tech Lab)-STREFA, Inc. These are important feature innovations for those that depend on insulin injections. The new and innovative needle measures at just 34G x 3.5mm.
Drugdelivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. per share in the initial deal, which will give it a 64.6% stake in the company.
The injection experience is an often-overlooked aspect in insulin administration. For many daily insulin users, the experience is an important one, as it is directly related to quality of life and medication compliance. Related: Droplet Micron Insulin Needle Offers Innovation in Crowded Diabetes Supply Market.
Therefore, medical technology is rapidly evolving, enabling more advanced and patient-friendly methods of drugdelivery. In the pursuit of creating patient-centric healthcare solutions, the medical industry has witnessed a groundbreaking advancement in drugdelivery with the emergence of large volume wearable injectors.
In SURPASS-4 – the last of Lilly’s registration studies for the dual GLP-1/GIP agonist – tirzepatide met all its primary and secondary objectives, besting treatment with insulin glargine, a long-acting human insulin product that is a mainstay of diabetes treatment, in diabetics with increased cardiovascular risk. Arecor alliance.
Further, in order to improve the quality of life in these patients, companies have developed novel devices capable of delivering a variety of formulations of different drugs / therapies, in an efficient and relatively simple manner. Autoinjector As Emerging DrugDelivery Device.
Editas Medicine is pausing its ocular gene therapy program after demonstrating a favorable safety profile and seeking a potential partner to develop EDIT-101, the company announced Thursday.
The current Team Lead for Injection Devices in CDRH’s Division of DrugDelivery and General Hospital Devices and Human Factors noted that depending on the product, the pre-market path for a connected combination product might require an IND, IDE, or a determination that it is a medical device data system , which are not regulated as devices.
There is a rising demand for vaccines, insulin, and many modern medicines used to treat cancer and other chronic diseases. As biologics are mainly administered through the injectable route, the significant growth in the biologics market is expected to drive the injectable drugdelivery and prefilled syringe market in the coming years.
Oramed Pharma has conceded defeat in its attempt to bring an oral formulation of insulin to market for people with type 2 diabetes, after its ORMD-0801 candidate missed the mark in a phase 3 trial. The post Phase 3 trial dashes Oramed’s oral insulin hopes appeared first on.
However, several drugdelivery devices that enable patients to self-administer their respective medications are now available. Biologics have emerged as a direct consequence of the rapid development that has taken place in the field of life sciences, particularly in cell and molecular biology, over the past few decades.
It can be reasonably argued that the upfront research and development of vaccine technologies leveraging mRNA – which can be widely applied against a number of viruses – will be the solutions that end our current pandemic and will effectively position society to be ready for the next. What’s Next: How Should Pharma Companies Respond?
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