MannKind Reports Initiation of P-II (INHALE-1st) Trial of Afrezza in Pediatric Patients with Newly-Diagnosed Type 1 Diabetes

Shots: MannKind has enrolled the first patient in the P-II (INHALE-1st) trial assessing initiation of Afrezza(insulin human) Inhalation Powder in pediatric pts shortly after their type 1 diabetes diagnosis Trial will evaluate Afrezza over 13wks., followed by an optional extension phase for pts continuing to use Afrezza with basal insulin up to 26wks., assessing the proportion…

ByRidhi RastogiFebruary 9, 2026

NEWS

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Shots: The EC has approved Sanofi's Teizeild (Tzield outside the EU) 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 Approval was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32)…

ByRidhi RastogiJanuary 12, 2026

NEWS

Sanofi Reports the US FDA Priority Review of Tzield to Delay Progression of Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has accepted sBLA & granted priority review to Tzield (teplizumab-mzwv) to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D (PDUFA: Apr 29, 2026) sBLA was supported by an interim 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of…

ByRidhi RastogiJanuary 5, 2026

NEWS

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

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…

ByRidhi RastogiNovember 17, 2025

NEWS

EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology

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…

ByRidhi RastogiOctober 17, 2025

NEWS

MannKind Reports the US FDA’s sBLA Acceptance of Afrezza (Inhaled Insulin) for Children and Adolescents with Diabetes

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.)…

ByRidhi RastogiOctober 14, 2025

NEWS

Sanofi’s Tzield Receives the NMPA’s Approval to Delay Progression of Type 1 Diabetes

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…

ByRidhi RastogiSeptember 10, 2025

NEWS

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

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…

ByRidhi RastogiJuly 22, 2025

VIEWPOINTS

Dr. Philip M. Toleikis, President & CEO at Sernova Shares Insights on the Partnership with Evotec to Develop a ‘Functional Cure’ for Diabetes

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…

BySenior EditorFebruary 7, 2023

MannKind Reports Initiation of P-II (INHALE-1st) Trial of Afrezza in Pediatric Patients with Newly-Diagnosed Type 1 Diabetes

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Sanofi Reports the US FDA Priority Review of Tzield to Delay Progression of Type 1 Diabetes in Children (≥1years)

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology

MannKind Reports the US FDA’s sBLA Acceptance of Afrezza (Inhaled Insulin) for Children and Adolescents with Diabetes

Sanofi’s Tzield Receives the NMPA’s Approval to Delay Progression of Type 1 Diabetes

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Dr. Philip M. Toleikis, President & CEO at Sernova Shares Insights on the Partnership with Evotec to Develop a ‘Functional Cure’ for Diabetes

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