Ascletis Pharma Receives the US FDA IND Clearance to Initiate P-II Trial of ASC30 for Type 2 Diabetes

Shots: FDA has granted IND clearance to initiate its P-II trial of ASC30 (40, 60 & 80mg) vs PBO in ~100 pts with type 2 diabetes mellitus, with enrolment expected to begin in Q1’26 Trial will assess mean change in HbA1c up to 13wks. as 1EP & 2EPs will incl. mean change in fasting blood…

ByRidhi RastogiJanuary 5, 2026

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Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management

Shots: FDA has approved Wegovy (25mg, QD, PO) for weight loss, chronic weight management & major adverse CV events risk reduction in adults with obesity/overweight; US availability expected in early Jan 2026. Regulatory filing is made to the EMA & other authorities in H2’25 Approval was based on the P-IIIb (OASIS 4) trial assessing oral…

ByRidhi RastogiDecember 24, 2025

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Novo Nordisk Reports the US FDA’s NDA Submission of CagriSema for Weight Management

Shots: The U.S. FDA has accepted the NDA for Novo's CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg) to support long-term weight loss & maintenance in adults with obesity or overweight & ≥1 related comorbidity, alongside lifestyle intervention NDA was supported by the P-III (REDEFINE 1) trial assessing CagriSema (QW) vs semaglutide 2.4mg alone, cagrilintide 2.4mg alone,…

ByRidhi RastogiDecember 19, 2025

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Eli Lilly Reports Topline P-III (ATTAIN-MAINTAIN) Trial Results of Orforglipron for Weight Loss Maintenance

Shots: Lilly's P-III trial assessed orforglipron vs PBO in maintaining weight loss in 376 adults with obesity/overweight & weight-related comorbidities who previously completed the initial treatment with Wegovy/Zepbound in the SURMOUNT-5 trial; NDA was submitted to FDA & received a US FDA’s CNPV Trial met its 1EP in SURMOUNT-5 pts at a weight plateau, showing superior…

ByRidhi RastogiDecember 19, 2025

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Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

Shots: Trial assessed Lilly’s retatrutide (9 & 12mg) + lifestyle intervention in adults with obesity or overweight & knee osteoarthritis, & without diabetes, meeting its co-1EPs with 26.4% (9mg) & 28.7% (12mg) vs 2.1% weight loss & reduced WOMAC pain by 4.5 & 4.4 vs 2.4 points It also reduced known CV risk markers &…

ByRidhi RastogiDecember 12, 2025

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Pfizer Collaborates with YaoPharma in a ~$2.1B Licensing Deal for YP05002

Shots: Pfizer has entered into an exclusive global collaboration & license agreement with YaoPharma for YP05002, a GLP-1 receptor agonist for chronic weight management As per the deal, YaoPharma will complete the ongoing P-I trial of YP05002 & grant Pfizer exclusive global rights for further development, manufacturing & commercialization, receiving $150M upfront & ~$1.935B in…

ByRidhi RastogiDecember 10, 2025

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Ascletis Advances ASC37 as an Oral Triple Agonist for Metabolic Disease

Shots: Ascletis Pharma has selected ASC37 tablets (PO), a GLP-1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate ASC37, utilizing Ascletis’ POTENT tech, showed an average of 4.2% absolute oral bioavailability, higher than semaglutide, tirzepatide, & retatrutide in oral SNAC formulations, & ~57-fold greater AUC vs retatrutide (PO) in NHP studies, with an observed t½ of…

ByRidhi RastogiDecember 1, 2025

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Gan & Lee Pharmaceuticals Initiates P-III (GRADUAL-3) Trial of Bofanglutide for Weight Management

Shots: Gan & Lee Pharmaceuticals has initiated a P-III (GRADUAL-3) study of bofanglutide (GZR18) in adults with obesity or overweight The trial will assess the safety & efficacy of bofanglutide (SC, Q4W) in obese or overweight pts for 24wks., while evaluating the change and the percentage change from baseline in body weight at 24wk. as…

ByRidhi RastogiNovember 28, 2025

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Innovent Biologics Reports P-III (GLORY-2) Trial Data on Mazdutide for Obesity

Shots: The P-III (GLORY-2) trial assessed mazdutide (9mg) plus lifestyle intervention vs PBO in 462 Chinese adults with obesity (BMI ≥30kg/m²), incl. 16% with T2D, with an NDA submission to the NMPA planned in the near term Trial met its 1EP, showing continuous weight loss with no plateau through Wk. 60, with pts achieving a…

ByRidhi RastogiNovember 20, 2025

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Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty

Shots: Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG) EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure times The company has planned to launch EndoZip in select EU centers &…

ByRidhi RastogiNovember 7, 2025

Ascletis Pharma Receives the US FDA IND Clearance to Initiate P-II Trial of ASC30 for Type 2 Diabetes

Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management

Novo Nordisk Reports the US FDA’s NDA Submission of CagriSema for Weight Management

Eli Lilly Reports Topline P-III (ATTAIN-MAINTAIN) Trial Results of Orforglipron for Weight Loss Maintenance

Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

Pfizer Collaborates with YaoPharma in a ~$2.1B Licensing Deal for YP05002

Ascletis Advances ASC37 as an Oral Triple Agonist for Metabolic Disease

Gan & Lee Pharmaceuticals Initiates P-III (GRADUAL-3) Trial of Bofanglutide for Weight Management

Innovent Biologics Reports P-III (GLORY-2) Trial Data on Mazdutide for Obesity

Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty

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