Shots:
The CHMP has recommended Teizeild to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions
Opinion was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32) for 14 days in 76…
Shots:
EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunology
As per the deal, both companies will jointly lead research activities, with Sanofi responsible for global development & commercialization efforts. In exchange, EVOQ will receive over $500M, incl. upfront, preclinical, development & sales milestones, with tiered…
Shots:
The US FDA has accepted sBLA of Afrezza (insulin human) Inhalation Powder for the treatment of children & adolescents with type 1 or type 2 diabetes (PDUFA: May 29, 2026)
sBLA was supported by P-III (INHALE-1), assessing Afrezza vs multiple daily injections (MDI), both in addition to basal insulin among type1/2 diabetic pts (4-17yrs.)…
Shots:
China’s NMPA has approved Tzield (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the EU & other regions
Approval was based on the P-II (TN-10) trial assessing Tzield (QD for 14 days) vs PBO, which…
Shots:
Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underway
Approval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…
Shots:
Dr. Philip shared his views on the collaboration of Sernova with Evotec for iPSC-Based Beta cell replacement therapy to develop and commercialize a ‘Functional Cure’ for diabetes.
He also gave an overview on the benefits of Evotec’s iPSC-based insulin-producing beta cells on the next generation of Sernova’s Cell Pouch System
The interview discusses about how Sernova…

