Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…

ByRidhi RastogiMarch 28, 2025

NEWS

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The US FDA has approved Cabometyx for treatment-experienced, inoperable, LA/M, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts (≥12yrs.) Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts (2 arms: pNET: n=99; epNET: n=199) that showed improved PFS; data was presented at ESMO 2024 & published…

ByRidhi RastogiMarch 27, 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

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

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

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

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

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