pharmaphorum

JUNE 18, 2021

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD). The next steps?

Production 98

Production Regulation Manufacturing Packaging 98

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Clinical Trials 59

Clinical Trials Clinical Trials Insulin Radiology 59

XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. The company reported an investment of $2.7

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

Delveinsight

DECEMBER 29, 2020

Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. . It is a complication associated with diabetic patients who take insulin and certain anti-diabetic tablets.

Trials 52

Trials Drugs Hormones Radiology 52

Delveinsight

DECEMBER 10, 2020

The body’s immune system falsely attacks insulin-making beta cells in the pancreas in Type 1 diabetes. The Lancet paper offers background on how the U.K. trial came to give some subjects a half-dose primer and offers potential explanations for the effect but omits the key question of whether the regimen has 90% efficacy or not.

Gene Therapy 52

Gene Therapy Gene Vaccination Vaccine 52

Worldwide Clinical Trials

JANUARY 24, 2025

Existing Comorbidities: Many patients with MASH/MASLD have comorbid conditions such as insulin resistance, dyslipidemia, central obesity, and hypertension. GLP-1 agonists, or SGLT2 inhibitors), placebo-controlled studies are often less attractive for patient recruitment and retention in developed markets.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Radiology 130