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

NEWS

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

NEWS

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

NEWS

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer

Shots: The EC has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts who have received endocrine therapy & ≥1L of CT in the advanced setting Approval was based on global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT (eribulin,…

ByDipanshu DixitApril 10, 2025

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Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Shots: Remegen has reported P-III trial data assessing Telitacicept (RC18; 240mg; n=57) vs PBO (n=57) in 114 chinese gMG pts, with baseline MG-ADL score ≥6 & QMG score ≥8; trial incl. 24wk. double-blind phase followed by an open-label phase. BLA is under the NMPA’s review, with decision expected in Q2’25 Trial showed 98.1% vs 12% pts achieved…

ByRidhi RastogiApril 9, 2025

NEWS

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

Shots: The EC has approved label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT Approval was backed by P-III (PALOMA-3) trial, evaluating non-inferiority of…

ByRidhi RastogiApril 9, 2025

NEWS

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has approved Opdivo + Yervoy for 1L treatment of MSI-H/dMMR unresectable mCRC pts (≥12yrs.) based on P-III (CheckMate-8HW) study assessing Opdivo + Yervoy vs Opdivo alone or CT in 839 pts (Approved before PDUFA: Jun 23, 2025) Regimen vs Opdivo monotx. showed 38% PFS (mPFS: not reached (NR) vs 39.3mos) in…

ByRidhi RastogiApril 9, 2025

NEWS

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots: The EC has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) in 30 EEA states Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in first study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO + 52wk. CS taper regimen…

ByRidhi RastogiApril 8, 2025

NEWS

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Shots: The P-III (TRANSCEND) trial (N=120) assessed setmelanotide (n=81: 33 adults & 48 pediatric) vs PBO (n= 39) for acquired hypothalamic obesity in 49 adults & 71 pediatric pts; additional arm of 12 Japanese pts is ongoing, with topline data expected by Q1’26. FDA & EMA filings to be completed by Q3’25 Trial met its…

ByRidhi RastogiApril 8, 2025

NEWS

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention

Shots: The US FDA has accepted sBLA of Ajovy to prevent episodic migraine in children & adolescents (6-17yrs.; ≥45Kg) Submission was based on P-III (SPACE) trial assessing Ajovy (SC) vs PBO for 12wks. to treat episodic migraine in 237 pediatric pts, which showed improvements in reducing monthly migraine & headache days Ajovy (CGRP antagonist) is…

ByRidhi RastogiApril 8, 2025

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

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer

Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention

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