Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Shots: The P-III (3475A-D77) trial assessed SC Keytruda (Q6W) + berahyaluronidase alfa + CT vs IV Keytruda (Q6W) + CT in 1L metastatic NSCLC adults (n=377), regardless of PD-L1 TPS expression; BLA under the US FDA’s review (PDUFA: Sep 23, 2025) & MAA under EMA’s review Trial showed that SC is noninferior to IV in AUC…

ByRidhi RastogiMarch 28, 2025

NEWS

Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD)

Shots: Axsome Therapeutics has reported P-III (FOCUS) trial data assessing solriamfetol (150 or 300mg, QD) vs PBO for 6wks. to treat of ADHD adults (n=516) in the US Trial met its 1EP, with 150mg showing greater AISRS score reductions vs PBO at Wk. 6 (17.7 vs 14.3 mean point decrease); improvements began at Wk. 1,…

ByRidhi RastogiMarch 26, 2025

NEWS

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

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

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (March 10, 2025 – March 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars & Animal Health. Check out our full report below:  Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025 Read More: Incyte Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at…

BySenior EditorMarch 13, 2025

NEWS

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Shots: Novo Nordisk has reported P-III (REDEFINE 2) trial data assessing CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg, QW, SC) vs PBO in 1,206 obese/overweight pts (~102Kg) and type 2 diabetes for 68wks., and followed flexible dosing protocol with 61.9% pts reaching highest dose after 68wks. Trial met its co-1EPs demonstrated 15.7% superior weight loss…

ByRidhi RastogiMarch 11, 2025

NEWS

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Shots: J&J has reported P-III trial data incl. ICONIC-LEAD (vs PBO) & ICONIC-ADVANCE 1&2 (vs Sotyktu) assessing icotrokinra (JNJ-2113, QD, PO) to treat mod. to sev. plaque Ps OICONIC-LEAD showed that pts achieved IGA 0/1 (65% vs 8%) & reached PASI 90 (50% vs 4%) at 16wks. By Wk. 24, 74% achieved IGA 0/1,…

ByRidhi RastogiMarch 10, 2025

NEWS

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Shots: Incyte has reported P-III (TRuE-PN: TRuE-PN1 & TRuE-PN2) clinical program data assessing Opzelura (BID) vs vehicle in ~180 PN pts (≥18yrs.) each for 12wks TRuE-PN1 showed ≥4-point WI-NRS4 improvement at 12wks. (1EP; 44.6% vs 20.6%), with itch relief by Day 7 (22.4% vs 8.0%). It also met its 2EPs, incl. higher IGA-CPG-S-TS score…

ByRidhi RastogiMarch 10, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (March 03, 2025 – March 07, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below: GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025 Read More: GSK Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study…

BySenior EditorMarch 7, 2025

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD)

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

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)

PharmaShots Weekly Snapshots (March 10, 2025 – March 13, 2025)

Novo Nordisk Reveals P-III (REDEFINE 2) Trial data of CagriSema for Weight Loss in Obese/Overweight and T2D Patients

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

PharmaShots Weekly Snapshots (March 03, 2025 – March 07, 2025)

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