Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

Shots: The P-III (ACHIEVE-1) trial assessed orforglipron vs PBO in T2D adults (n=559) having inadequate glycemic control with diet & exercise alone; subjects started at 1mg QD, with dose escalation at every Q4W till assigned doses of 3, 12mg (via 1, 3 & 6mg), or 36mg (via 1, 3, 6, 12, & 24mg) Trial met…

ByPrince GiriApril 18, 2025

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BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Shots: BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer 37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data Trial showed 25/37…

ByRidhi RastogiApril 17, 2025

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Oak Hill Bio Enters an Exclusive Licensing Agreement with Roche for Rugonersen

Shots: Oak Hill Bio has entered into an exclusive license agreement with Roche to obtain global rights of rugonersen (RO7248824) for the treatment of angelman syndrome Oak Hill to initiate a pivotal P-III trial of rugonersen for angelman syndrome in early 2026, pending regulatory review of the final trial protocol TANGELO study led by Roche,…

ByRidhi RastogiApril 16, 2025

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Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Shots: Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26 Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…

ByRidhi RastogiApril 16, 2025

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Roche’s Columvi (Glofitamab) Regimen Receives the EC’s Approval to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: The EC has granted full approval to Columvi + GemOx for ASCT-ineligible r/r DLBCL pts based on P-III (STARGLO) trial assessing the regimen vs MabThera/Rituxan + GemOx in previously treated DLBCL pts At 11.3mos. mFU (primary analysis), trial showed improved OS, a 41% reduction in death risk, with a 63% improvement in PFS. At…

ByRidhi RastogiApril 14, 2025

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Amgen Reports P-III (DeLLphi-304) Trial Findings of Imdelltra for SCLC

Shots: Amgen has reported P-III (DeLLphi-304) trial data evaluating Imdelltra (tarlatamab-dlle) vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the US, Canada, Australia, Singapore, Korea; & amrubicin in Japan) in SCLC pts who progressed on or after single line of Pt-based CT In the interim analysis, trial met its 1EP, with superior OS; full…

ByRidhi RastogiApril 14, 2025

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The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)

Shots: The US FDA has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adults Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg, Q4W) vs lenvatinib/sorafenib in 668 pts with advanced HCC who had not received prior systemic therapy.…

ByRidhi RastogiApril 14, 2025

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Health Canada Approves AstraZeneca’s Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: Health Canada has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi (for ~24mos.) vs PBO Study showed reduced risk…

ByRidhi RastogiApril 11, 2025

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Oculis Completes Patient Enrollment in P-III (DIAMOND-1 & DIAMOND-2) Trials of OCS-01 for Diabetic Macular Edema

Shots: Oculis has completed pts enrollment in both P-III (DIAMOND-1 & DIAMOND-2) trials of OCS-01 in diabetic macular edema pts; trials to support NDA submission The trials will evaluate the efficacy & safety of OCS-01 in over 800 pts with DME across 119 sites in the US & other countries for 52wks.; topline data is…

ByRidhi RastogiApril 10, 2025

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Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

Shots: J&J has reported additional findings from P-III (Vivacity-MG3) trial & ongoing OLE assessing nipocalimab + SoC (30mg/kg, IV loading dose followed by 15mg/kg, Q2W) vs PBO in anti-AChR+, anti-MuSK+ & anti-LRP4+ adults (n=153) with gMG Trial showed a -4.9 QMG score improvement over 22 & 24wks. & pts were 4x more likely to sustain…

ByRidhi RastogiApril 10, 2025

Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Oak Hill Bio Enters an Exclusive Licensing Agreement with Roche for Rugonersen

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Roche’s Columvi (Glofitamab) Regimen Receives the EC’s Approval to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Amgen Reports P-III (DeLLphi-304) Trial Findings of Imdelltra for SCLC

The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)

Health Canada Approves AstraZeneca’s Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Oculis Completes Patient Enrollment in P-III (DIAMOND-1 & DIAMOND-2) Trials of OCS-01 for Diabetic Macular Edema

Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

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