Astellas Pharma Inc. (TSE:4503), a Japan-based pharmaceutical company, announced on Tuesday that it has signed an agreement with Roche Diabetes Care Japan Co., Ltd., a global company involved in integrated Personalised Diabetes Management (iPDM).
The agreement has been signed for the development and commercialisation of Roche Diabetes Care's Accu-Chek Guide Me blood glucose monitoring system with advanced accuracy as a combined medical product with BlueStar, an FDA-approved digital health solution for diabetes patients, developed by Welldoc, Inc. BlueStar has been jointly developed by Astellas and Welldoc in Japan. Astellas is aiming to receive regulatory approval and reimbursement as a combined medical product.
The combined medical product solution is intended to help subjects with handling their diabetes by capturing, storing, and transmitting blood glucose data which is received from Roche Diabetes Care's Accu-Chek Guide Me system, and track medication, diet, activity and exercise in Welldoc's BlueStar(app). It is also intended to support subject's diabetes self-management with a unique algorithm designed utilising AI and personalised digital coaching messages.
Astellas is to manage the clinical trials of the combined medical product, which are scheduled to commence during 2023.
Caliway Biopharmaceuticals commences CBL-0204 Phase 2b study patient recruitment
Adiso Therapeutics completes Phase 1b multiple ascending dose clinical trial assessing ADS051
Pfizer receives FDA approval for RSV vaccine in older adults
Establishment Labs Receives CE Mark Approval for Minimally Invasive Surgical Tools
Lexicon Pharma's drug for heart failure gains US FDA approval
EU regulator looking to revoke Novartis' sickle cell drug marketing authorisation
Ipsen Pharma receives negative CHMP opinion for palovarotene as potential FOP treatment
CHMP recommends extending use of Veklury for COVID-19 in severe renal impairment
Endo Ventures announces bivalirudin injection US distribution agreement with MAIA Pharmaceuticals
AgonOx and Providence Cancer Institute announce PH-762 collaborative clinical trial initiation