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NEWS

Johnson & Johnson Seeks the EC’s Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

The EMA has received an application for label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone to treat adults with mHSPC & HRR gene alterations Submission was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered…
July 4, 2025

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NEWS

Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

Shots: The EC has granted conditional approval to Ziihera in 30 EEA states for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) BTC adults, who were previously treated with ≥1L of therapy Approval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+…
July 2, 2025

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Amgen
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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
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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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