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Novo-Nordisk
NEWS

Novo Nordisk’s Alhemo Receives the US FDA’s Approval for Hemophilia A or B (HA/HB) Without Inhibitors

Shots: The US FDA has approved label expansion of Alhemo (concizumab-mtci) to prevent or reduce the frequency of bleeding episodes in pts (≥12yrs.) with HA/HB without inhibitors Approval was based on P-III (Explorer8) trial assessing Alhemo (n=42, 1mg/kg followed by 0.2mg/kg QD) vs no prophylaxis (n=21) in 156 males with HA/HB, where median duration of…
August 1, 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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Pfizer
NEWS

Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B 

Shots:  US FDA granted approval to Pfizer’s Beqvez, based on BENEGENE-2 (P-III) study (n=45) to treat of Haemophilia B adult patient using factor IX (FIX) prophylaxis therapy, with life-threatening hemorrhage, spontaneous bleeding episodes, no FDA-approved test detected neutralizing antibodies to AAVRh74var capsid; met 1EP of non-inferiority in the ABR of total bleeds  Based on durability…
April 26, 2024

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PharmaShots Interview Frank Leebeek & Greta Mulder of Erasmus MC, Lutz Bonacker of CSL Behring Share Insight on Etranacogene Dezaparvovec for the Treatment of Hemophilia B
VIEWPOINTS

PharmaShots Interview: Frank Leebeek & Greta Mulder of Erasmus MC, Lutz Bonacker of CSL Behring Share Insight on Etranacogene Dezaparvovec for the Treatment of Hemophilia B

In an interview with PharmaShots, Frank Leebeek, MD, Ph.D., Hematology Department Head & Greta Mulders, Nurse Practitioner, Study Coordinator at the Erasmus Medical Center in Rotterdam, Lutz Bonacker, Senior Vice President, General Manager, Commercial Operations Europe at CSL Behring shared their views on the data of Etranacogene Dezaparvovec in P-III (HOPE-B) trial for the treatment of Hemophilia B, presented at EAHAD 2022…
April 4, 2022

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