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

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Shots: The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned Application was backed by P-III…

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

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Shots: The EC has approved Breyanzi for r/r follicular lymphoma adults treated with ≥2 previous lines of systemic therapy in 30 EEA states Approval was based on global P-II (TRANSCEND FL) study, assessing Breyanzi’s safety & efficacy to treat r/r indolent B-cell NHL incl. FL In pts treated in 3L+ setting, study met…

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

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Shots: The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025 Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by…

ByRidhi RastogiMarch 13, 2025

NEWS

Geron Receives the EC’s Approval for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

Shots: The EC has approved Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy in 30 EEA states; commercialization to begin in select EU states by 2026 pending country-by-country reimbursement Approval was based on P-III (IMerge) study of Rytelo vs PBO…

ByRidhi RastogiMarch 12, 2025

NEWS

China’s NMPA Approves Kelun-Biotech’s Sacituzumab Tirumotecan (sac-TMT) for EGFR-mutant NSCLC

Shots: China’s NMPA has approved label expansion of sacituzumab tirumotecan (SKB264/MK-2870) to locally advanced or metastatic (LA/M) EGFRm NSCLC following disease progression on EGFR-TKI therapy or Pt-based Ct Approval was based on OptiTROP-Lung03 trial assessing sac-TMT alone (5mg/kg, IV, Q2W) vs docetaxel in mentioned pts, where it demonstrated improved ORR, PFS & OS sac-TMT is…

ByRidhi RastogiMarch 11, 2025

NEWS

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Shots: The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025) Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…

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

Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

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

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

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

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Geron Receives the EC’s Approval for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

China’s NMPA Approves Kelun-Biotech’s Sacituzumab Tirumotecan (sac-TMT) for EGFR-mutant NSCLC

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

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

Contact US

FOLLOW US