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Amgen
NEWS

Amgen Reports Data from the P-III (FORTITUDE-101) Study Evaluating Bemarituzumab in FGFR2b+ 1L Gastric Cancer

Amgen’s P-III (FORTITUDE-101) study (n=547) met its 1EP at interim analysis, showing statistically significant OS improvement with bemarituzumab + CT (mFOLFOX6) vs PBO + CT in FGFR2b+ unresectable locally advanced/metastatic G/GEJ cancer (FGFR2b ≥10% IHC 2+/3+) P-III (FORTITUDE-101) study 2EPs include PFS and ORR; the safety profile of bemarituzumab + CT was consistent with prior…
July 1, 2025

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VIEWPOINTS

Unlocking Approval: Christophe Piketty from Galderma in an Illuminating Conversation with PharmaShots 

Shots:   Backed by positive results from the P-III ARCADIA study, Galderma’s Nemluvio recently received approval from the US FDA for patients with moderate to severe atopic dermatitis  Nemluvio (nemolizumab) has previously been approved for the treatment of prurigo nodularis  Christophe Piketty, VP, Head of Innovation, Therapeutic Dermatology, Global Clinical Sciences, Galderma, highlighted insights from the…
June 30, 2025

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NEWS

Sobi Reports the US FDA Approval of Gamifant for Macrophage Activation Syndrome in Still’s Disease

Shots: The US FDA has approved Gamifant (emapalumab-lzsg) for treating hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease, including systemic Juvenile Idiopathic Arthritis (sJIA), in pts of all ages who are unresponsive, intolerant to glucocorticoids, or have recurrent MAS Approval was based on pooled data from two pivotal trials, P-III (EMERALD) and P-II (NI-0501-06),…
June 30, 2025

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NEWS

Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)

Neurocrine reported new post-hoc patient data from the P-III KINECT-HD study (n=128; 18-75yrs.) showing significant reductions in cognitive and motor-related burden with INGREZZA (valbenazine) vs. PBO in HD chorea At maintenance (10-12wks.), INGREZZA showed greater mean score reductions across 18 cognition items and 32 of 33 motor items vs PBO. The study used the UHDRS…
June 30, 2025

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Pfizer New
NEWS

Pfizer Reports the P-III (BASIS) Study Data Evaluating HYMPAVZI to Treat Hemophilia A or B with Inhibitors

Shots: Pfizer reported positive topline results from the P‑III (BASIS) study evaluating HYMPAVZI (marstacimab) in hemophilia A or B pts (N=48) with inhibitors, meeting the 1EP and demonstrating a 93% reduction in annualized bleeding rate (ABR) vs. on‑demand treatment (1.39 vs. 19.78; p < 0.0001)  over 12mos. HYMPAVZI, a once‑weekly SC therapy that targets TFPI,…
June 27, 2025

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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Shots: The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CT Approval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR…
June 26, 2025

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Bio-Thera New
NEWS

Bio-Thera Solutions Reports First Patient Dosing in P-III Study Evaluating BAT8006 for Pt Resistant Ovarian Cancer

Shots: Bio‑Thera reported the dosing of the first patient in a P‑III study assessing the efficacy of BAT8006 vs. the investigator’s choice of single-agent CT in individuals with Pt resistant high‑grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer Early clinical Data (N=133; irrespective of FRα expression or treatment history) presented at ASCO’25, from…
June 26, 2025

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NEWS

GSK Reports the EMA’s MAA Acceptance of Linerixibat for Cholestatic Pruritus

Shots: The EMA has accepted the MAA of Linerixibat to treat cholestatic pruritus in pts with primary biliary cholangitis (PBC) MAA was supported by the P-III (GLISTEN) study (n=238), which showed that Linerixibat significantly and sustainably improved cholestatic pruritus and itch-related sleep interference, meeting all 1EPs & 2EPs. The safety profile aligned with previous studies.…
June 26, 2025

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