AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

Shots: AstraZeneca to present Tagrisso’s data from P-III (LAURA & FLAURA2) & P-II (SAVANNAH & ORCHARD) trials at ELCC 2025 for EGFRm NSCLC pts who failed or received 1L therapy; data to support global filings In LAURA, Tagrisso showed favorable OS trend (mOS: 58.8 vs 54.1mos.; maturity: 31%) despite 78% of PBO pts receiving it…

ByRidhi RastogiMarch 25, 2025

NEWS

Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Shots: The US FDA has accepted NDA & granted priority review to tolebrutinib for nrSPMS & slowing disability progression independent of relapse (PDUFA: Sep 28, 2025); MAA is under EMA review Submission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data…

ByRidhi RastogiMarch 25, 2025

NEWS

Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease

Shots: China’s NMPA has approved Sycume for the treatment of thyroid eye disease (TED) Approval was based on P-III (RESTORE-1) trial in TED pts, which met its 1EP in 2024, with 85.8% pts achieving ≥2mm proptosis reduction at 24wks., along with improved inflammation & QoL; data was presented at WOC, CSE, and CCOS Sycume (teprotumumab…

ByRidhi RastogiMarch 18, 2025

NEWS

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

Shots: The 2 P-III (STOP-HS1 & STOP-HS2) trials assessed povorcitinib (45 or 75mg, QD, PO) vs PBO in mod. to sev. HS pts (≥18yrs.; n=600 each) for 12wks., followed by 42wk. extension & 30-day follow-up STOP-HS1 met its 1EP, with povorcitinib (45 mg/75 mg) showing higher HiSCR50 rates at Wk. 12 (40.2%/40.6% vs 29.7%), while…

ByRidhi RastogiMarch 18, 2025

NEWS

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3)

Shots: NANOBIOTIX & Janssen have amended their 2023 collaboration to develop & commercialize JNJ-1900 (NBTXR3), adjusting the deal value from $2.7B to $2.6B As per the revision, NANOBIOTIX will receive ~$1.77B in milestones related to cisplatin-ineligible HNSCC & inoperable stage 3 NSCLC, with ~$165M in milestones for China, South Korea, Singapore, & Thailand. J&J will cover…

ByRidhi RastogiMarch 18, 2025

NEWS

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions 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…

ByRidhi RastogiMarch 17, 2025

NEWS

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

Shots: Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25 Pts received an initial loading dose…

ByRidhi RastogiMarch 17, 2025

NEWS

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

Shots: AbbVie has reported final analysis data from P-III (MIRASOL) trial assessing Elahere vs CT in FRα+ PROC pts (n= 453) who had previously received 1-3L of therapy At 30.5mos. mFU, trial showed 37% improved PFS (mPFS: 5.59 vs 3.98mos.) & superior ORR (41.9% vs 15.9%), while mOS was 16.85 vs 13.34mos., with 32% reduced…

ByRidhi RastogiMarch 17, 2025

NEWS

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Shots: Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024 Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…

ByRidhi RastogiMarch 17, 2025

NEWS

Arvinas & Pfizer Reports Topline Data from P-III (VERITAC-2) Trial of Vepdegestrant for Breast Cancer

Shots: Arvinas & Pfizer have reported topline data from ongoing P-III (VERITAC-2) trial of vepdegestrant in ER+/HER2- advanced or metastatic breast cancer pts who had progression with CDK 4/6 inhibitors & endocrine therapy Pts received either vepdegestrant (PO, QD) for 28 days or fulvestrant (intramuscular) on Day 1 & 15 of first 28-day cycle,…

ByRidhi RastogiMarch 12, 2025

AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3)

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Arvinas & Pfizer Reports Topline Data from P-III (VERITAC-2) Trial of Vepdegestrant for Breast Cancer

Contact US

FOLLOW US