The European Medicines Agency (EMA) has accepted for review Sanofi’s regulatory submission for sotagliflozin. If approved, the oral treatment would be used as an addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes mellitus.
The company, which was founded in 2015, also announced that it has raised $3.4 million in seed funding, from DCM, Khosla Ventures, and Founders Fund.
This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.
Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
Having an accurate record of food and alcohol intake is important for managing a number of diseases including diabetes, various cardiovascular conditions, and alcoholism. Currently, not much practical technology is available to do this aside from smartphone apps, and apps tend to be tedious and require constant vigilance of making sure to input all the data.
Artificial intelligence company twoXAR—a specialist in separating signals from noise in data-rich drug discovery projects—has raised $10 million in a first-round financing led by SoftBank Ventures.
AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorisation Variation forForxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).
A major medical association today suggested that doctors who treat people with Type 2 diabetes can set less aggressive blood sugar targets. But medical groups that specialize in diabetes sharply disagree.
Senseonics Holdings Inc has announced that people with diabetes using the Eversense® brand Continuous Glucose Monitoring Systems, in EMEA markets now have the option to invite others to remotely view their real-time glucose readings and alerts from anywhere.
The FDA has ordered the recall of a mHealth app that helps people with diabetes determine how much insulin they should inject. The issue points to the continuing challenge of verifying the accuracy of digital health devices and drug dosage apps.
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.